<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03252756</url>
  </required_header>
  <id_info>
    <org_study_id>17-01001</org_study_id>
    <nct_id>NCT03252756</nct_id>
  </id_info>
  <brief_title>Effects of Cannabidiol in Alcohol Use Disorder</brief_title>
  <official_title>Effects of Cannabidiol in Alcohol Use Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tilray</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of the proposed project is to begin rigorous study of the clinically relevant&#xD;
      effects of non-psychoactive phytocannabinoid cannabidiol (CBD) in patients with severe&#xD;
      alcohol use disorder (AUD). This double-blind, randomized proof-of-concept study (n = 40) is&#xD;
      designed to assess feasibility and contrast effects of extended (8 weeks) treatment with CBD&#xD;
      to those of placebo in AUD patients. Participants with AUD will be randomized to receive&#xD;
      either placebo or 600mg CBD/day (PO) for 4 weeks, immediately followed by 1200mg CBD/day (PO)&#xD;
      for an additional 4 weeks (8 total weeks). These doses were chosen to reproduce serum CBD&#xD;
      levels reported to reduce alcohol-seeking behavior in animal studies. Measures will include&#xD;
      circulating levels of CBD, safety measures (THC serum levels, adverse events, cognitive and&#xD;
      motoric function), and physiological and psychological domains relevant to AUD (including&#xD;
      self-reported craving, depression, and anxiety, and responses to personalized scripts&#xD;
      designed to elicit stress- and cue-induced craving and anxiety). Assessments will be&#xD;
      conducted following 1 day, 1 week, and 4 weeks of treatment with each dose of CBD vs.&#xD;
      placebo, and 1 and 4 weeks after the cessation of treatment. Drinking outcomes across 8 weeks&#xD;
      of treatment and 4 weeks of follow-up will also be assessed as an exploratory outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is increasing recognition of the roles of the endocannabinoid system in neurobiological&#xD;
      processes and behavioral domains relevant to addiction. The non-psychoactive phytocannabinoid&#xD;
      cannabidiol (CBD) has attracted considerable attention due to its lack of abuse potential,&#xD;
      its excellent safety profile, its unique and complex pharmacology, and evidence that it&#xD;
      affects anxiety and stress response in animal models and humans. There is a growing body of&#xD;
      preclinical data demonstrating that CBD produces marked and persisting decreases in alcohol&#xD;
      self-administration and preference for alcohol, and alcohol-, cue- and stress-induced&#xD;
      reinstatement of alcohol-seeking behavior, yet there are few studies of the effects of CBD in&#xD;
      humans with addictive disorders, and none in alcohol dependent patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Actual">March 16, 2022</completion_date>
  <primary_completion_date type="Actual">March 16, 2022</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Double-blind, randomized proof-of-concept study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Trough CBD Plasma Levels</measure>
    <time_frame>Baseline</time_frame>
    <description>CBD &quot;trough&quot; plasma levels measured before dosing with CBD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trough CBD Plasma Levels</measure>
    <time_frame>Week 1</time_frame>
    <description>CBD &quot;trough&quot; plasma levels measured before dosing with CBD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trough CBD Plasma Levels</measure>
    <time_frame>Week 4</time_frame>
    <description>CBD &quot;trough&quot; plasma levels measured before dosing with CBD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trough CBD Plasma Levels</measure>
    <time_frame>Week 5</time_frame>
    <description>CBD &quot;trough&quot; plasma levels measured before dosing with CBD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trough CBD Plasma Levels</measure>
    <time_frame>Week 8</time_frame>
    <description>CBD &quot;trough&quot; plasma levels measured before dosing with CBD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trough CBD Plasma Levels</measure>
    <time_frame>Week 9</time_frame>
    <description>CBD &quot;trough&quot; plasma levels measured before dosing with CBD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak CBD Plasma Levels</measure>
    <time_frame>Baseline</time_frame>
    <description>CBD &quot;peak&quot; plasma levels measured 45 minutes after dosing with CBD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak CBD Plasma Levels</measure>
    <time_frame>Day 1</time_frame>
    <description>CBD &quot;peak&quot; plasma levels measured 45 minutes after dosing with CBD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak CBD Plasma Levels</measure>
    <time_frame>Week 1</time_frame>
    <description>CBD &quot;peak&quot; plasma levels measured 45 minutes after dosing with CBD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak CBD Plasma Levels</measure>
    <time_frame>Week 4</time_frame>
    <description>CBD &quot;peak&quot; plasma levels measured 45 minutes after dosing with CBD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak CBD Plasma Levels</measure>
    <time_frame>Week 4 + 1 Day</time_frame>
    <description>CBD &quot;peak&quot; plasma levels measured 45 minutes after dosing with CBD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak CBD Plasma Levels</measure>
    <time_frame>Week 5</time_frame>
    <description>CBD &quot;peak&quot; plasma levels measured 45 minutes after dosing with CBD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak CBD Plasma Levels</measure>
    <time_frame>Week 8</time_frame>
    <description>CBD &quot;peak&quot; plasma levels measured 45 minutes after dosing with CBD.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Heavy Drinking Days</measure>
    <time_frame>Baseline</time_frame>
    <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Heavy Drinking Days</measure>
    <time_frame>Week 1</time_frame>
    <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Heavy Drinking Days</measure>
    <time_frame>Week 2</time_frame>
    <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Heavy Drinking Days</measure>
    <time_frame>Week 3</time_frame>
    <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Heavy Drinking Days</measure>
    <time_frame>Week 4</time_frame>
    <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Heavy Drinking Days</measure>
    <time_frame>Week 5</time_frame>
    <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Heavy Drinking Days</measure>
    <time_frame>Week 6</time_frame>
    <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Heavy Drinking Days</measure>
    <time_frame>Week 7</time_frame>
    <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Heavy Drinking Days</measure>
    <time_frame>Week 8</time_frame>
    <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Heavy Drinking Days</measure>
    <time_frame>Week 9</time_frame>
    <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Drinks Per Day</measure>
    <time_frame>Baseline</time_frame>
    <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Drinks Per Day</measure>
    <time_frame>Week 1</time_frame>
    <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Drinks Per Day</measure>
    <time_frame>Week 2</time_frame>
    <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Drinks Per Day</measure>
    <time_frame>Week 3</time_frame>
    <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Drinks Per Day</measure>
    <time_frame>Week 4</time_frame>
    <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Drinks Per Day</measure>
    <time_frame>Week 5</time_frame>
    <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Drinks Per Day</measure>
    <time_frame>Week 6</time_frame>
    <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Drinks Per Day</measure>
    <time_frame>Week 7</time_frame>
    <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Drinks Per Day</measure>
    <time_frame>Week 8</time_frame>
    <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Drinks Per Day</measure>
    <time_frame>Week 9</time_frame>
    <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Penn Alcohol Craving Scale (PACS) Score</measure>
    <time_frame>Baseline</time_frame>
    <description>5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Penn Alcohol Craving Scale (PACS) Score</measure>
    <time_frame>Week 1</time_frame>
    <description>5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Penn Alcohol Craving Scale (PACS) Score</measure>
    <time_frame>Week 4</time_frame>
    <description>5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Penn Alcohol Craving Scale (PACS) Score</measure>
    <time_frame>Week 5</time_frame>
    <description>5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Penn Alcohol Craving Scale (PACS) Score</measure>
    <time_frame>Week 8</time_frame>
    <description>5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Penn Alcohol Craving Scale (PACS) Score</measure>
    <time_frame>Week 9</time_frame>
    <description>5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Anxiety Inventory (BAI) Score</measure>
    <time_frame>Baseline</time_frame>
    <description>21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Anxiety Inventory (BAI) Score</measure>
    <time_frame>Week 1</time_frame>
    <description>21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Anxiety Inventory (BAI) Score</measure>
    <time_frame>Week 4</time_frame>
    <description>21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Anxiety Inventory (BAI) Score</measure>
    <time_frame>Week 5</time_frame>
    <description>21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Anxiety Inventory (BAI) Score</measure>
    <time_frame>Week 8</time_frame>
    <description>21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Anxiety Inventory (BAI) Score</measure>
    <time_frame>Week 9</time_frame>
    <description>21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory (BDI) Score</measure>
    <time_frame>Baseline</time_frame>
    <description>21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory (BDI) Score</measure>
    <time_frame>Week 1</time_frame>
    <description>21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory (BDI) Score</measure>
    <time_frame>Week 4</time_frame>
    <description>21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory (BDI) Score</measure>
    <time_frame>Week 5</time_frame>
    <description>21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory (BDI) Score</measure>
    <time_frame>Week 8</time_frame>
    <description>21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory (BDI) Score</measure>
    <time_frame>Week 9</time_frame>
    <description>21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Alcohol Use Disorder</condition>
  <arm_group>
    <arm_group_label>Placebo for 4 weeks, followed by phytocannabinoid cannabidiol (CBD) for 4 weeks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>600mg/day Saline taken by mouth (PO) for 4 weeks, immediately followed by 1200mg saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CBD for 8 weeks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>600mg CBD/day (PO) for 4 weeks, immediately followed by 1200mg CBD/day (PO) for an additional 4 weeks (8 total weeks).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Saline taken by mouth (PO)</description>
    <arm_group_label>Placebo for 4 weeks, followed by phytocannabinoid cannabidiol (CBD) for 4 weeks</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phytocannabinoid cannabidiol (CBD)</intervention_name>
    <description>CBD taken by mouth (PO)</description>
    <arm_group_label>CBD for 8 weeks</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females age 18-65&#xD;
&#xD;
          -  DSM-5 diagnosis of moderate or severe AUD&#xD;
&#xD;
          -  Able to provide voluntary informed consent&#xD;
&#xD;
          -  At least 8 heavy drinking days (4 or more drinks for a woman, 5 or more drinks for a&#xD;
             man) in the 30 days prior to screen&#xD;
&#xD;
          -  If of childbearing potential (male or female), are willing to use approved form of&#xD;
             contraception from screening for duration of the trial&#xD;
&#xD;
          -  Able to provide at least two locators&#xD;
&#xD;
          -  Endorse desire to cut down or stop drinking&#xD;
&#xD;
          -  Agrees to abstain from all other cannabinoid use for duration of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current alcohol withdrawal (CIWA-Ar score &gt;7)&#xD;
&#xD;
          -  Exclusionary medical conditions (e.g. current severe alcohol withdrawal requiring&#xD;
             medical hospitalization, significantly impaired liver function)&#xD;
&#xD;
          -  DSM-5 diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder&#xD;
&#xD;
          -  High risk of adverse emotional or behavioral reaction based on investigator's clinical&#xD;
             evaluation (e.g., evidence of serious personality disorder, antisocial behavior,&#xD;
             serious current stressors, lack of meaningful social support)&#xD;
&#xD;
          -  Current significant suicidality (assessed using the C-SSRS), any suicidal behavior in&#xD;
             the past 12 months, or any history of serious suicide attempts requiring&#xD;
             hospitalization, or current significant homicidality&#xD;
&#xD;
          -  History of severe Traumatic Brain Injury (LOC &gt; 24 hours)&#xD;
&#xD;
          -  DSM-5 diagnosis of current mild cannabis use disorder and/or moderate or severe&#xD;
             substance use disorder for a substance other than alcohol or nicotine&#xD;
&#xD;
          -  Significant laboratory abnormalities, including significantly impaired liver function,&#xD;
             serious abnormalities of complete blood count or metabolic panel&#xD;
&#xD;
          -  Active legal problems likely to result in incarceration within 12 weeks of treatment&#xD;
             initiation&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Current use of exclusionary medications, including cannabinoids; treatments for&#xD;
             addictions including alcohol; moderate to strong inhibitors of CYP3A4 or CYP2C19;&#xD;
             medications metabolized primarily by CYP3A4, CYP3A5, or CYP3A7; and medications with a&#xD;
             narrow therapeutic index which are substrates of UGT1A9, UGT2B7, CYP2C8, CYP2C9,&#xD;
             CYP2C19, CYP1A2, or CYP2B6.&#xD;
&#xD;
          -  Allergy to any ingredient of the study compound.&#xD;
&#xD;
          -  Current treatment for AUD, with exception of AA/12-step treatment&#xD;
&#xD;
          -  No inpatient psychiatric treatment in the last 12 months, with the exception of detox&#xD;
             and extended Emergency Department stays&#xD;
&#xD;
          -  A positive urine drug screen for THC, cocaine and/or opioids at screen&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Bogenschutz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <results_first_submitted>March 16, 2023</results_first_submitted>
  <results_first_submitted_qc>April 10, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">May 3, 2023</results_first_posted>
  <last_update_submitted>April 10, 2023</last_update_submitted>
  <last_update_submitted_qc>April 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cannabidiol</keyword>
  <keyword>Alcohol Use Disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cannabidiol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Beginning 3 months and ending 5 years following article publication.</ipd_time_frame>
    <ipd_access_criteria>Researchers who provide a methodologically sound proposal with have access to the data. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 20, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT03252756/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>600mg Saline/Day for 4 Weeks, Then 1200mg Saline/Day for 4 Weeks</title>
          <description>600mg Saline/ day (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
        </group>
        <group group_id="P2">
          <title>600mg CBD/Day for 4 Weeks, Then 1200mg CBD/Day for 4 Weeks</title>
          <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>COVID-19 Pandemic</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Drug Expiration</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>600mg Saline/Day for 4 Weeks, Then 1200mg Saline/Day for 4 Weeks</title>
          <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
        </group>
        <group group_id="B2">
          <title>600mg CBD/Day for 4 Weeks, Then 1200mg CBD/Day for 4 Weeks</title>
          <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="18"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.1" spread="9.71"/>
                    <measurement group_id="B2" value="37.75" spread="12.89"/>
                    <measurement group_id="B3" value="41.83" spread="11.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Trough CBD Plasma Levels</title>
        <description>CBD &quot;trough&quot; plasma levels measured before dosing with CBD.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Trough CBD Plasma Levels</title>
          <description>CBD &quot;trough&quot; plasma levels measured before dosing with CBD.</description>
          <units>CBD (ng/mL)</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0.7" spread="2.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Trough CBD Plasma Levels</title>
        <description>CBD &quot;trough&quot; plasma levels measured before dosing with CBD.</description>
        <time_frame>Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Trough CBD Plasma Levels</title>
          <description>CBD &quot;trough&quot; plasma levels measured before dosing with CBD.</description>
          <units>CBD (ng/mL)</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="22.79" spread="16.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Trough CBD Plasma Levels</title>
        <description>CBD &quot;trough&quot; plasma levels measured before dosing with CBD.</description>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Trough CBD Plasma Levels</title>
          <description>CBD &quot;trough&quot; plasma levels measured before dosing with CBD.</description>
          <units>CBD (ng/mL)</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.94" spread="2.66"/>
                    <measurement group_id="O2" value="31.21" spread="20.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Trough CBD Plasma Levels</title>
        <description>CBD &quot;trough&quot; plasma levels measured before dosing with CBD.</description>
        <time_frame>Week 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Trough CBD Plasma Levels</title>
          <description>CBD &quot;trough&quot; plasma levels measured before dosing with CBD.</description>
          <units>CBD (ng/mL)</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="74.54" spread="44.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Trough CBD Plasma Levels</title>
        <description>CBD &quot;trough&quot; plasma levels measured before dosing with CBD.</description>
        <time_frame>Week 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Trough CBD Plasma Levels</title>
          <description>CBD &quot;trough&quot; plasma levels measured before dosing with CBD.</description>
          <units>CBD (ng/mL)</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="100.03" spread="45.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Trough CBD Plasma Levels</title>
        <description>CBD &quot;trough&quot; plasma levels measured before dosing with CBD.</description>
        <time_frame>Week 9</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Trough CBD Plasma Levels</title>
          <description>CBD &quot;trough&quot; plasma levels measured before dosing with CBD.</description>
          <units>CBD (ng/mL)</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="22.71" spread="19.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Peak CBD Plasma Levels</title>
        <description>CBD &quot;peak&quot; plasma levels measured 45 minutes after dosing with CBD.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Peak CBD Plasma Levels</title>
          <description>CBD &quot;peak&quot; plasma levels measured 45 minutes after dosing with CBD.</description>
          <units>CBD (ng/mL)</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="52.04" spread="68.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Peak CBD Plasma Levels</title>
        <description>CBD &quot;peak&quot; plasma levels measured 45 minutes after dosing with CBD.</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Peak CBD Plasma Levels</title>
          <description>CBD &quot;peak&quot; plasma levels measured 45 minutes after dosing with CBD.</description>
          <units>CBD (ng/mL)</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.67" spread="2.22"/>
                    <measurement group_id="O2" value="104.45" spread="99.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Peak CBD Plasma Levels</title>
        <description>CBD &quot;peak&quot; plasma levels measured 45 minutes after dosing with CBD.</description>
        <time_frame>Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Peak CBD Plasma Levels</title>
          <description>CBD &quot;peak&quot; plasma levels measured 45 minutes after dosing with CBD.</description>
          <units>CBD (ng/mL)</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="83.67" spread="67.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Peak CBD Plasma Levels</title>
        <description>CBD &quot;peak&quot; plasma levels measured 45 minutes after dosing with CBD.</description>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Peak CBD Plasma Levels</title>
          <description>CBD &quot;peak&quot; plasma levels measured 45 minutes after dosing with CBD.</description>
          <units>CBD (ng/mL)</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.94" spread="2.65"/>
                    <measurement group_id="O2" value="211.83" spread="197.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Peak CBD Plasma Levels</title>
        <description>CBD &quot;peak&quot; plasma levels measured 45 minutes after dosing with CBD.</description>
        <time_frame>Week 4 + 1 Day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day (PO) for 4 weeks, immediately followed by 1200mg CBD/day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Peak CBD Plasma Levels</title>
          <description>CBD &quot;peak&quot; plasma levels measured 45 minutes after dosing with CBD.</description>
          <units>CBD (ng/mL)</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.17" spread="198.52"/>
                    <measurement group_id="O2" value="102.74" spread="117.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Peak CBD Plasma Levels</title>
        <description>CBD &quot;peak&quot; plasma levels measured 45 minutes after dosing with CBD.</description>
        <time_frame>Week 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day (PO) for 4 weeks, immediately followed by 1200mg CBD/day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Peak CBD Plasma Levels</title>
          <description>CBD &quot;peak&quot; plasma levels measured 45 minutes after dosing with CBD.</description>
          <units>CBD (ng/mL)</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="178.91" spread="211.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Peak CBD Plasma Levels</title>
        <description>CBD &quot;peak&quot; plasma levels measured 45 minutes after dosing with CBD.</description>
        <time_frame>Week 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Peak CBD Plasma Levels</title>
          <description>CBD &quot;peak&quot; plasma levels measured 45 minutes after dosing with CBD.</description>
          <units>CBD (ng/mL)</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="275.012" spread="236.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Heavy Drinking Days</title>
        <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Heavy Drinking Days</title>
          <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.6" spread="30.10"/>
                    <measurement group_id="O2" value="46.67" spread="28.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Heavy Drinking Days</title>
        <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
        <time_frame>Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Heavy Drinking Days</title>
          <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
          <units>percentage of days</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.71" spread="34.73"/>
                    <measurement group_id="O2" value="32.97" spread="32.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Heavy Drinking Days</title>
        <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Heavy Drinking Days</title>
          <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
          <units>percentage of days</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.14" spread="37.45"/>
                    <measurement group_id="O2" value="17.86" spread="22.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Heavy Drinking Days</title>
        <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
        <time_frame>Week 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Heavy Drinking Days</title>
          <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
          <units>percentage of days</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.86" spread="37.53"/>
                    <measurement group_id="O2" value="16.88" spread="24.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Heavy Drinking Days</title>
        <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Heavy Drinking Days</title>
          <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
          <units>percentage of days</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.43" spread="35.28"/>
                    <measurement group_id="O2" value="21.43" spread="23.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Heavy Drinking Days</title>
        <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
        <time_frame>Week 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Heavy Drinking Days</title>
          <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
          <units>percentage of days</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.71" spread="24.70"/>
                    <measurement group_id="O2" value="20.63" spread="28.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Heavy Drinking Days</title>
        <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
        <time_frame>Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Heavy Drinking Days</title>
          <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
          <units>percentage of days</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.57" spread="31.62"/>
                    <measurement group_id="O2" value="20.63" spread="21.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Heavy Drinking Days</title>
        <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
        <time_frame>Week 7</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Heavy Drinking Days</title>
          <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
          <units>percentage of days</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.57" spread="31.62"/>
                    <measurement group_id="O2" value="23.81" spread="20.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Heavy Drinking Days</title>
        <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
        <time_frame>Week 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Heavy Drinking Days</title>
          <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
          <units>percentage of days</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.57" spread="22.39"/>
                    <measurement group_id="O2" value="12.70" spread="15.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Heavy Drinking Days</title>
        <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
        <time_frame>Week 9</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Heavy Drinking Days</title>
          <description>The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.</description>
          <units>percentage of days</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.29" spread="36.92"/>
                    <measurement group_id="O2" value="15.87" spread="15.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Drinks Per Day</title>
        <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Drinks Per Day</title>
          <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
          <units>Drinks per day</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.38" spread="2.40"/>
                    <measurement group_id="O2" value="4.61" spread="2.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Drinks Per Day</title>
        <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
        <time_frame>Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Drinks Per Day</title>
          <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
          <units>drinks per day</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.23" spread="2.55"/>
                    <measurement group_id="O2" value="2.91" spread="2.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Drinks Per Day</title>
        <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Drinks Per Day</title>
          <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
          <units>drinks per day</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.36" spread="5.30"/>
                    <measurement group_id="O2" value="2.37" spread="2.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Drinks Per Day</title>
        <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
        <time_frame>Week 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Drinks Per Day</title>
          <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
          <units>drinks per day</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.28" spread="3.17"/>
                    <measurement group_id="O2" value="1.83" spread="1.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Drinks Per Day</title>
        <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Drinks Per Day</title>
          <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
          <units>drinks per day</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.49" spread="3.36"/>
                    <measurement group_id="O2" value="2.13" spread="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Drinks Per Day</title>
        <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
        <time_frame>Week 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Drinks Per Day</title>
          <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
          <units>drinks per day</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.66" spread="1.92"/>
                    <measurement group_id="O2" value="2.39" spread="2.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Drinks Per Day</title>
        <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
        <time_frame>Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Drinks Per Day</title>
          <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
          <units>drinks per day</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.82" spread="2.39"/>
                    <measurement group_id="O2" value="2.38" spread="1.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Drinks Per Day</title>
        <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
        <time_frame>Week 7</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Drinks Per Day</title>
          <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
          <units>drinks per day</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.82" spread="2.39"/>
                    <measurement group_id="O2" value="2.57" spread="1.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Drinks Per Day</title>
        <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
        <time_frame>Week 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Drinks Per Day</title>
          <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
          <units>drinks per day</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.26" spread="2.73"/>
                    <measurement group_id="O2" value="1.99" spread="1.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Drinks Per Day</title>
        <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
        <time_frame>Week 9</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Drinks Per Day</title>
          <description>The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.</description>
          <units>drinks per day</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.17" spread="4.28"/>
                    <measurement group_id="O2" value="2.40" spread="2.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Penn Alcohol Craving Scale (PACS) Score</title>
        <description>5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Penn Alcohol Craving Scale (PACS) Score</title>
          <description>5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.20" spread="4.58"/>
                    <measurement group_id="O2" value="17.77" spread="5.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Penn Alcohol Craving Scale (PACS) Score</title>
        <description>5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.</description>
        <time_frame>Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Penn Alcohol Craving Scale (PACS) Score</title>
          <description>5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.45" spread="7.16"/>
                    <measurement group_id="O2" value="14.09" spread="7.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Penn Alcohol Craving Scale (PACS) Score</title>
        <description>5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.</description>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Penn Alcohol Craving Scale (PACS) Score</title>
          <description>5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.67" spread="6.98"/>
                    <measurement group_id="O2" value="10.33" spread="4.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Penn Alcohol Craving Scale (PACS) Score</title>
        <description>5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.</description>
        <time_frame>Week 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Penn Alcohol Craving Scale (PACS) Score</title>
          <description>5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.78" spread="6.51"/>
                    <measurement group_id="O2" value="11.78" spread="6.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Penn Alcohol Craving Scale (PACS) Score</title>
        <description>5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.</description>
        <time_frame>Week 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Penn Alcohol Craving Scale (PACS) Score</title>
          <description>5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.22" spread="5.87"/>
                    <measurement group_id="O2" value="11.56" spread="5.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Penn Alcohol Craving Scale (PACS) Score</title>
        <description>5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.</description>
        <time_frame>Week 9</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Penn Alcohol Craving Scale (PACS) Score</title>
          <description>5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.22" spread="5.40"/>
                    <measurement group_id="O2" value="11.33" spread="3.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Beck Anxiety Inventory (BAI) Score</title>
        <description>21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Beck Anxiety Inventory (BAI) Score</title>
          <description>21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.92" spread="5.12"/>
                    <measurement group_id="O2" value="8" spread="7.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Beck Anxiety Inventory (BAI) Score</title>
        <description>21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.</description>
        <time_frame>Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Beck Anxiety Inventory (BAI) Score</title>
          <description>21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6" spread="7.14"/>
                    <measurement group_id="O2" value="8" spread="8.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Beck Anxiety Inventory (BAI) Score</title>
        <description>21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.</description>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Beck Anxiety Inventory (BAI) Score</title>
          <description>21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.33" spread="4.39"/>
                    <measurement group_id="O2" value="11.33" spread="8.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Beck Anxiety Inventory (BAI) Score</title>
        <description>21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.</description>
        <time_frame>Week 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Beck Anxiety Inventory (BAI) Score</title>
          <description>21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="4.48"/>
                    <measurement group_id="O2" value="6.57" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Beck Anxiety Inventory (BAI) Score</title>
        <description>21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.</description>
        <time_frame>Week 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Beck Anxiety Inventory (BAI) Score</title>
          <description>21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" spread="6.24"/>
                    <measurement group_id="O2" value="6.67" spread="8.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Beck Anxiety Inventory (BAI) Score</title>
        <description>21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.</description>
        <time_frame>Week 9</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Beck Anxiety Inventory (BAI) Score</title>
          <description>21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.89" spread="2.80"/>
                    <measurement group_id="O2" value="6.125" spread="9.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Beck Depression Inventory (BDI) Score</title>
        <description>21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Beck Depression Inventory (BDI) Score</title>
          <description>21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.25" spread="7.19"/>
                    <measurement group_id="O2" value="9.92" spread="7.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Beck Depression Inventory (BDI) Score</title>
        <description>21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.</description>
        <time_frame>Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Beck Depression Inventory (BDI) Score</title>
          <description>21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2" spread="7.64"/>
                    <measurement group_id="O2" value="7.83" spread="6.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Beck Depression Inventory (BDI) Score</title>
        <description>21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.</description>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Beck Depression Inventory (BDI) Score</title>
          <description>21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" spread="7.67"/>
                    <measurement group_id="O2" value="9" spread="7.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Beck Depression Inventory (BDI) Score</title>
        <description>21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.</description>
        <time_frame>Week 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Beck Depression Inventory (BDI) Score</title>
          <description>21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" spread="8.94"/>
                    <measurement group_id="O2" value="7.67" spread="6.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Beck Depression Inventory (BDI) Score</title>
        <description>21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.</description>
        <time_frame>Week 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Beck Depression Inventory (BDI) Score</title>
          <description>21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.67" spread="6.10"/>
                    <measurement group_id="O2" value="7.67" spread="7.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Beck Depression Inventory (BDI) Score</title>
        <description>21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.</description>
        <time_frame>Week 9</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
          </group>
          <group group_id="O2">
            <title>Phytocannabinoid Cannabidiol (CBD)</title>
            <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
          </group>
        </group_list>
        <measure>
          <title>Beck Depression Inventory (BDI) Score</title>
          <description>21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.90" spread="3.92"/>
                    <measurement group_id="O2" value="6.5" spread="6.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 Weeks</time_frame>
      <desc>Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).</description>
        </group>
        <group group_id="E2">
          <title>Phytocannabinoid Cannabidiol (CBD)</title>
          <description>600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks).</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization for Ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Irregular Heartbeat</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Pink Eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Increased Bowl Movement</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Gum Problems</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Stomach/Abdominal Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Queasiness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Heartburn / Acid Reflux</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Loose Stool</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Tiredness/Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Drowsiness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Elevated Heptic Enzymes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gum Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Flu</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Appetite Increase</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Increased Thirst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Body Ache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Light-Headedness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Drowsy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Taste Abnormality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicidal Ideation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cognitive Slowing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Euphoria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Perceptual Problems</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Feeling &quot;High&quot;</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Perceptual Enhancement</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vivid Dreaming</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Increased Alcohol Craving</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Concentration Difficulty</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Memory Problems</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vivid Dreams</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Runny Nose</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sore Throat</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Shortness of Breath</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Relaxed Breathing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hair Problems</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Rash / Skin Irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Michael Bogenschutz, PhD</name_or_title>
      <organization>NYU Langone Health</organization>
      <phone>646-501-4026</phone>
      <email>Michael.Bogenschutz@nyulangone.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03252756
org study id: 17-01001
nct id: NCT03252756
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The goal of the proposed project is to begin rigorous study of the clinically relevant
      effects of non-psychoactive phytocannabinoid cannabidiol (CBD) in patients with severe
      alcohol use disorder (AUD). This double-blind, randomized proof-of-concept study (n = 40) is
      designed to assess feasibility and contrast effects of extended (8 weeks) treatment with CBD
      to those of placebo in AUD patients. Participants with AUD will be randomized to receive
      either placebo or 600mg CBD/day (PO) for 4 weeks, immediately followed by 1200mg CBD/day (PO)
      for an additional 4 weeks (8 total weeks). These doses were chosen to reproduce serum CBD
      levels reported to reduce alcohol-seeking behavior in animal studies. Measures will include
      circulating levels of CBD, safety measures (THC serum levels, adverse events, cognitive and
      motoric function), and physiological and psychological domains relevant to AUD (including
      self-reported craving, depression, and anxiety, and responses to personalized scripts
      designed to elicit stress- and cue-induced craving and anxiety). Assessments will be
      conducted following 1 day, 1 week, and 4 weeks of treatment with each dose of CBD vs.
      placebo, and 1 and 4 weeks after the cessation of treatment. Drinking outcomes across 8 weeks
      of treatment and 4 weeks of follow-up will also be assessed as an exploratory outcome.
There is increasing recognition of the roles of the endocannabinoid system in neurobiological
      processes and behavioral domains relevant to addiction. The non-psychoactive phytocannabinoid
      cannabidiol (CBD) has attracted considerable attention due to its lack of abuse potential,
      its excellent safety profile, its unique and complex pharmacology, and evidence that it
      affects anxiety and stress response in animal models and humans. There is a growing body of
      preclinical data demonstrating that CBD produces marked and persisting decreases in alcohol
      self-administration and preference for alcohol, and alcohol-, cue- and stress-induced
      reinstatement of alcohol-seeking behavior, yet there are few studies of the effects of CBD in
      humans with addictive disorders, and none in alcohol dependent patients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double-blind, randomized proof-of-concept study
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Trough CBD Plasma Levels
time frame: Baseline
description: CBD "trough" plasma levels measured before dosing with CBD.
measure: Trough CBD Plasma Levels
time frame: Week 1
description: CBD "trough" plasma levels measured before dosing with CBD.
measure: Trough CBD Plasma Levels
time frame: Week 4
description: CBD "trough" plasma levels measured before dosing with CBD.
measure: Trough CBD Plasma Levels
time frame: Week 5
description: CBD "trough" plasma levels measured before dosing with CBD.
measure: Trough CBD Plasma Levels
time frame: Week 8
description: CBD "trough" plasma levels measured before dosing with CBD.
measure: Trough CBD Plasma Levels
time frame: Week 9
description: CBD "trough" plasma levels measured before dosing with CBD.
measure: Peak CBD Plasma Levels
time frame: Baseline
description: CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
measure: Peak CBD Plasma Levels
time frame: Day 1
description: CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
measure: Peak CBD Plasma Levels
time frame: Week 1
description: CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
measure: Peak CBD Plasma Levels
time frame: Week 4
description: CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
measure: Peak CBD Plasma Levels
time frame: Week 4 + 1 Day
description: CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
measure: Peak CBD Plasma Levels
time frame: Week 5
description: CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
measure: Peak CBD Plasma Levels
time frame: Week 8
description: CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
measure: Percentage of Heavy Drinking Days
time frame: Baseline
description: The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
measure: Percent of Heavy Drinking Days
time frame: Week 1
description: The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
measure: Percent of Heavy Drinking Days
time frame: Week 2
description: The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
measure: Percent of Heavy Drinking Days
time frame: Week 3
description: The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
measure: Percent of Heavy Drinking Days
time frame: Week 4
description: The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
measure: Percent of Heavy Drinking Days
time frame: Week 5
description: The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
measure: Percent of Heavy Drinking Days
time frame: Week 6
description: The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
measure: Percent of Heavy Drinking Days
time frame: Week 7
description: The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
measure: Percent of Heavy Drinking Days
time frame: Week 8
description: The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
measure: Percent of Heavy Drinking Days
time frame: Week 9
description: The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
measure: Number of Drinks Per Day
time frame: Baseline
description: The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
measure: Number of Drinks Per Day
time frame: Week 1
description: The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
measure: Number of Drinks Per Day
time frame: Week 2
description: The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
measure: Number of Drinks Per Day
time frame: Week 3
description: The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
measure: Number of Drinks Per Day
time frame: Week 4
description: The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
measure: Number of Drinks Per Day
time frame: Week 5
description: The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
measure: Number of Drinks Per Day
time frame: Week 6
description: The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
measure: Number of Drinks Per Day
time frame: Week 7
description: The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
measure: Number of Drinks Per Day
time frame: Week 8
description: The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
measure: Number of Drinks Per Day
time frame: Week 9
description: The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
measure: Penn Alcohol Craving Scale (PACS) Score
time frame: Baseline
description: 5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
measure: Penn Alcohol Craving Scale (PACS) Score
time frame: Week 1
description: 5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
measure: Penn Alcohol Craving Scale (PACS) Score
time frame: Week 4
description: 5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
measure: Penn Alcohol Craving Scale (PACS) Score
time frame: Week 5
description: 5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
measure: Penn Alcohol Craving Scale (PACS) Score
time frame: Week 8
description: 5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
measure: Penn Alcohol Craving Scale (PACS) Score
time frame: Week 9
description: 5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
measure: Beck Anxiety Inventory (BAI) Score
time frame: Baseline
description: 21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
measure: Beck Anxiety Inventory (BAI) Score
time frame: Week 1
description: 21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
measure: Beck Anxiety Inventory (BAI) Score
time frame: Week 4
description: 21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
measure: Beck Anxiety Inventory (BAI) Score
time frame: Week 5
description: 21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
measure: Beck Anxiety Inventory (BAI) Score
time frame: Week 8
description: 21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
measure: Beck Anxiety Inventory (BAI) Score
time frame: Week 9
description: 21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
measure: Beck Depression Inventory (BDI) Score
time frame: Baseline
description: 21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
measure: Beck Depression Inventory (BDI) Score
time frame: Week 1
description: 21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
measure: Beck Depression Inventory (BDI) Score
time frame: Week 4
description: 21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
measure: Beck Depression Inventory (BDI) Score
time frame: Week 5
description: 21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
measure: Beck Depression Inventory (BDI) Score
time frame: Week 8
description: 21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
measure: Beck Depression Inventory (BDI) Score
time frame: Week 9
description: 21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
arm group label: Placebo for 4 weeks, followed by phytocannabinoid cannabidiol (CBD) for 4 weeks
arm group type: Experimental
description: 600mg/day Saline taken by mouth (PO) for 4 weeks, immediately followed by 1200mg saline/ day (PO) for an additional 4 weeks (8 total weeks).
arm group label: CBD for 8 weeks
arm group type: Experimental
description: 600mg CBD/day (PO) for 4 weeks, immediately followed by 1200mg CBD/day (PO) for an additional 4 weeks (8 total weeks).
intervention type: Other
intervention name: Placebo
description: Saline taken by mouth (PO)
arm group label: Placebo for 4 weeks, followed by phytocannabinoid cannabidiol (CBD) for 4 weeks
intervention type: Drug
intervention name: Phytocannabinoid cannabidiol (CBD)
description: CBD taken by mouth (PO)
arm group label: CBD for 8 weeks
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Michael Bogenschutz, PhD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alcoholism
mesh term: Alcohol Drinking
mesh term: Cannabidiol
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Beginning 3 months and ending 5 years following article publication.
ipd access criteria: Researchers who provide a methodologically sound proposal with have access to the data. To gain access, data requestors will need to sign a data access agreement.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 