<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/NCT03248167</url>
  </required_header>
  <id_info>
    <org_study_id>17-00949</org_study_id>
    <nct_id>NCT03248167</nct_id>
  </id_info>
  <brief_title>Cannabidiol as a Treatment for AUD Comorbid With PTSD</brief_title>
  <official_title>Cannabidiol as a Treatment for Alcohol Use Disorder Comorbid With Posttraumatic Stress 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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project aims to determine whether cannabidiol (CBD), a compound derived from the&#xD;
      cannabis plant, is effective in treating alcohol use disorder (AUD) in individuals with&#xD;
      comorbid posttraumatic stress disorder (PTSD). Investigators will test the hypothesis that&#xD;
      oral cannabidiol (CBD) will reduce alcohol drinking in individuals with AUD comorbid with&#xD;
      PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or&#xD;
      severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or&#xD;
      placebo, for a period of 6 weeks, such that both participants and study staff are blind to&#xD;
      treatment condition. Participants (each treated for 6 weeks) will be continuously recruited&#xD;
      over a study period of 14 months until 48 have completed. Baseline and weekly data will be&#xD;
      collected on alcohol usage and PTSD symptoms, and investigators will assess whether CBD&#xD;
      treatment leads to a greater improvement in these measures relative to placebo, and whether&#xD;
      reduction in alcohol drinking is temporally linked to improvement in PTSD symptoms. Subjects&#xD;
      will also participate in a task designed to quantify the psychological and physiological&#xD;
      links between negative emotion produced by re-experiencing PTSD trauma, and alcohol craving.&#xD;
      The task will be administered following 4 weeks of treatment. Treatment-associated reduction&#xD;
      in alcohol craving elicited by trauma-associated negative emotion between CBD and placebo&#xD;
      groups will be compared. This study will be the first to test whether CBD is effective in&#xD;
      treating alcohol addiction and in treating PTSD in humans, and the first to examine the&#xD;
      interaction between these treatment effects. Results will serve as proof of concept and&#xD;
      provide guidance for a future larger clinical trial. Because CBD is a safe, readily available&#xD;
      drug, such a trial would have an immense potential to prevent death, medical illness, and&#xD;
      psychological suffering associated with AUD and PTSD. Further, because the brain circuits via&#xD;
      which CBD acts to produce hypothesized effects are relatively well-understood, results may&#xD;
      substantially advance understanding of the neurobiological basis of alcohol addiction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this project, investigators aim to test the hypothesis that CBD will reduce alcohol&#xD;
      drinking in individuals with AUD comorbid with PTSD. CBD is currently a medical research&#xD;
      focus because it shows promise for treating anxiety and other brain disorders, but does not&#xD;
      produce a 'high' like other parts of cannabis, has not been shown to be addictive, and is&#xD;
      safe, with few or no side effects. AUD, which is one of the most common and most debilitating&#xD;
      psychiatric conditions, is often associated with other comorbid psychiatric disorders - in&#xD;
      particular, PTSD: depending on the population studied, 30-60% of individuals with AUD also&#xD;
      have PTSD, with high comorbidity rates in military veterans. Evidence from animal models and&#xD;
      clinical studies suggests that the negative emotion caused by PTSD symptoms intensifies&#xD;
      craving for alcohol during alcohol withdrawal, perpetuating the addictive cycle; further,&#xD;
      evidence shows that the brain circuits underlying negative emotion and addiction are linked&#xD;
      in a forebrain area called the extended amygdala, which provides a neuropharmacological&#xD;
      target to simultaneously treat both negative emotion and alcohol addiction in individuals&#xD;
      with AUD and PTSD. CBD is known to inhibit brain activity in the extended amygdala, leading&#xD;
      to reduced anxiety in both animal models and humans. CBD also reduces addictive alcohol&#xD;
      seeking in animal models.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 16, 2019</start_date>
  <completion_date type="Actual">April 20, 2022</completion_date>
  <primary_completion_date type="Actual">April 20, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Drinks Per Day</measure>
    <time_frame>Baseline</time_frame>
    <description>Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Drinks Per Day</measure>
    <time_frame>Week 4</time_frame>
    <description>Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Drinks Per Day</measure>
    <time_frame>Week 6</time_frame>
    <description>Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PCL-5 Total Score</measure>
    <time_frame>Baseline</time_frame>
    <description>The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: &quot;Not at all,&quot; &quot;A little bit,&quot; Moderately,&quot; &quot;Quite a bit,&quot; and &quot;Extremely.&quot; A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PCL-5 Total Score</measure>
    <time_frame>Week 4</time_frame>
    <description>The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: &quot;Not at all,&quot; &quot;A little bit,&quot; Moderately,&quot; &quot;Quite a bit,&quot; and &quot;Extremely.&quot; A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PCL-5 Total Score</measure>
    <time_frame>Week 6</time_frame>
    <description>The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: &quot;Not at all,&quot; &quot;A little bit,&quot; Moderately,&quot; &quot;Quite a bit,&quot; and &quot;Extremely.&quot; A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Carbohydrate Deficient Transferrin (CDT)</measure>
    <time_frame>Baseline</time_frame>
    <description>CDT test performed on blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Carbohydrate Deficient Transferrin (CDT)</measure>
    <time_frame>Week 4</time_frame>
    <description>CDT test performed on blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Carbohydrate Deficient Transferrin (CDT)</measure>
    <time_frame>Week 6</time_frame>
    <description>CDT test performed on blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Heavy Drinking Days</measure>
    <time_frame>Baseline</time_frame>
    <description>Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Heavy Drinking Days</measure>
    <time_frame>Week 1</time_frame>
    <description>Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Heavy Drinking Days</measure>
    <time_frame>Week 2</time_frame>
    <description>Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Heavy Drinking Days</measure>
    <time_frame>Week 3</time_frame>
    <description>Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Heavy Drinking Days</measure>
    <time_frame>Week 4</time_frame>
    <description>Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Heavy Drinking Days</measure>
    <time_frame>Week 5</time_frame>
    <description>Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Heavy Drinking Days</measure>
    <time_frame>Week 6</time_frame>
    <description>Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Very Heavy Drinking Days</measure>
    <time_frame>Baseline</time_frame>
    <description>Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Very Heavy Drinking Days</measure>
    <time_frame>Week 1</time_frame>
    <description>Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Very Heavy Drinking Days</measure>
    <time_frame>Week 2</time_frame>
    <description>Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Very Heavy Drinking Days</measure>
    <time_frame>Week 3</time_frame>
    <description>Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Very Heavy Drinking Days</measure>
    <time_frame>Week 4</time_frame>
    <description>Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Very Heavy Drinking Days</measure>
    <time_frame>Week 5</time_frame>
    <description>Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Very Heavy Drinking Days</measure>
    <time_frame>Week 6</time_frame>
    <description>Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With No Heavy Drinking Days</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With No Heavy Drinking Days</measure>
    <time_frame>Week 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With No Heavy Drinking Days</measure>
    <time_frame>Week 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With No Heavy Drinking Days</measure>
    <time_frame>Week 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With No Heavy Drinking Days</measure>
    <time_frame>Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With No Heavy Drinking Days</measure>
    <time_frame>Week 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With No Heavy Drinking Days</measure>
    <time_frame>Week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants That Are 'Present and Clear'</measure>
    <time_frame>Baseline</time_frame>
    <description>Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants That Are 'Present and Clear'</measure>
    <time_frame>Week 1</time_frame>
    <description>Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants That Are 'Present and Clear'</measure>
    <time_frame>Week 2</time_frame>
    <description>Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants That Are 'Present and Clear'</measure>
    <time_frame>Week 3</time_frame>
    <description>Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants That Are 'Present and Clear'</measure>
    <time_frame>Week 4</time_frame>
    <description>Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants That Are 'Present and Clear'</measure>
    <time_frame>Week 5</time_frame>
    <description>Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants That Are 'Present and Clear'</measure>
    <time_frame>Week 6</time_frame>
    <description>Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Days Abstinent</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Days Abstinent</measure>
    <time_frame>Week 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Days Abstinent</measure>
    <time_frame>Week 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Days Abstinent</measure>
    <time_frame>Week 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Days Abstinent</measure>
    <time_frame>Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Days Abstinent</measure>
    <time_frame>Week 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Days Abstinent</measure>
    <time_frame>Week 6</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">95</enrollment>
  <condition>Alcohol Use Disorder</condition>
  <condition>Post Traumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Cannabidiol (CBD 600 mg daily)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 weeks, such that both participants and study staff are blind to treatment condition.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>6 weeks, such that both participants and study staff are blind to treatment condition.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cannabidiol</intervention_name>
    <description>600 mg daily</description>
    <arm_group_label>Cannabidiol (CBD 600 mg daily)</arm_group_label>
    <other_name>CBD</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be administered to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females age 18-70&#xD;
&#xD;
          2. DSM-5 diagnosis of moderate or severe AUD&#xD;
&#xD;
          3. DSM-5 diagnosis of PTSD with Clinician Administered PTSD Scale (CAPS-5) OR subPTSD&#xD;
             diagnosis (meeting criterion A, F, G, H and at least 6 symptoms across any criteria&#xD;
             B-E) with Clinician Administered PTSD Scale (CAPS-5)&#xD;
&#xD;
          4. Able to provide voluntary informed consent&#xD;
&#xD;
          5. At least 6 heavy drinking days (4 or more drinks per day for a woman, 5 or more drinks&#xD;
             per day for a man) in the 30 days prior to screen&#xD;
&#xD;
          6. 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;
          7. Able to provide at least two locators&#xD;
&#xD;
          8. Endorse desire to cut down or stop drinking&#xD;
&#xD;
          9. Agrees to abstain from all other cannabinoid use for the duration of the study&#xD;
&#xD;
         10. Confirms they are reliably domiciled&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current alcohol withdrawal (CIWA-Ar score &gt;7)&#xD;
&#xD;
          2. Exclusionary medical conditions (e.g. current severe alcohol withdrawal requiring&#xD;
             medical hospitalization, significantly impaired liver function)&#xD;
&#xD;
          3. DSM-5 diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder&#xD;
&#xD;
          4. High risk of adverse emotional or behavioral reaction, and/or an inability to&#xD;
             understand study procedures or the informed consent process, based on investigator's&#xD;
             clinical evaluation (e.g., evidence of serious personality disorder, antisocial&#xD;
             behavior, serious current stressors, lack of meaningful social support)&#xD;
&#xD;
          5. Exposure to trauma in the last 30 days, including police duty or military service&#xD;
&#xD;
          6. Current significant suicidality (assessed using the C-SSRS), any significant suicidal&#xD;
             behavior in the past 12 months, or any history of serious suicide attempts requiring&#xD;
             hospitalization, or current significant homicidality&#xD;
&#xD;
          7. History of Severe Traumatic Brain Injury (TBI; as indicated by Loss of Consciousness &gt;&#xD;
             24 hours)&#xD;
&#xD;
          8. 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;
          9. Significant laboratory abnormalities, including significantly impaired liver function,&#xD;
             serious abnormalities of complete blood count or metabolic panel&#xD;
&#xD;
         10. Active legal problems likely to result in incarceration within 12 weeks of treatment&#xD;
             initiation&#xD;
&#xD;
         11. Pregnancy or lactation&#xD;
&#xD;
         12. Current use of exclusionary medications, including but not limited to cannabinoids;&#xD;
             those acting on serotonergic pathways; treatments for addictions including alcohol;&#xD;
             moderate to strong inhibitors of CYP3A4 or CYP2C19; medications metabolized primarily&#xD;
             by CYP3A4, CYP3A5, or CYP3A7; and medications with a narrow therapeutic index which&#xD;
             are substrates of UGT1A9, UGT2B7, CYP2C8, CYP2C9, CYP2C19, CYP1A2, or CYP2B6.&#xD;
&#xD;
         13. Current treatment for AUD (with exceptions of: AA/12-step treatment and/or&#xD;
             psychosocial treatment initiated more than 3 months prior to the screening visit)&#xD;
&#xD;
         14. Psychotherapy for PTSD or other psychiatric condition, if initiated within 3 months of&#xD;
             screening&#xD;
&#xD;
         15. Inpatient psychiatric treatment in the last 12 months, with the exception of detox and&#xD;
             extended Emergency Department stays&#xD;
&#xD;
         16. A positive urine drug screen for opioids at screen, baseline, or any later visits. If&#xD;
             a participant has a positive drug screen for THC or cocaine at screen, baseline or a&#xD;
             later visit- their enrollment will be subject to the clinical judgement of the&#xD;
             Principal Investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles Marmar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York University Grossman School of Medicine</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>June 2023</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <results_first_submitted>April 21, 2023</results_first_submitted>
  <results_first_submitted_qc>June 6, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 28, 2023</results_first_posted>
  <last_update_submitted>June 6, 2023</last_update_submitted>
  <last_update_submitted_qc>June 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cannabidiol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Alcohol Drinking</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</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>Undecided</sharing_ipd>
  </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>January 5, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03248167/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 8, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03248167/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 95 patients were enrolled in the trial. 65 of those failed screening or were lost to follow-up prior to starting medication. Thus, only 30 participants started medication in the trial.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cannabidiol (CBD 600 mg Daily)</title>
          <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Institution Mandated COVID-19 Research Pause</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cannabidiol (CBD 600 mg Daily)</title>
          <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</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="17"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.59" lower_limit="22" upper_limit="61"/>
                    <measurement group_id="B2" value="37.69" lower_limit="21" upper_limit="54"/>
                    <measurement group_id="B3" value="38.2" lower_limit="21" upper_limit="61"/>
                  </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="12"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </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="8"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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="8"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <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="17"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Drinks Per Day</title>
        <description>Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be administered to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Drinks Per Day</title>
          <description>Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking.</description>
          <units>drinks/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4885" spread="2.6620"/>
                    <measurement group_id="O2" value="5.3623" spread="2.7075"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Drinks Per Day</title>
        <description>Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking.</description>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Drinks Per Day</title>
          <description>Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking.</description>
          <units>drinks/day</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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9256" spread="2.1786"/>
                    <measurement group_id="O2" value="2.15" spread="2.2792"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Drinks Per Day</title>
        <description>Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking.</description>
        <time_frame>Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Drinks Per Day</title>
          <description>Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking.</description>
          <units>drinks/day</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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4881" spread="2.1679"/>
                    <measurement group_id="O2" value="2.8175" spread="2.2682"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>PCL-5 Total Score</title>
        <description>The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: &quot;Not at all,&quot; &quot;A little bit,&quot; Moderately,&quot; &quot;Quite a bit,&quot; and &quot;Extremely.&quot; A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>PCL-5 Total Score</title>
          <description>The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: &quot;Not at all,&quot; &quot;A little bit,&quot; Moderately,&quot; &quot;Quite a bit,&quot; and &quot;Extremely.&quot; A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.0588" spread="13.8549"/>
                    <measurement group_id="O2" value="49.1538" spread="13.7739"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>PCL-5 Total Score</title>
        <description>The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: &quot;Not at all,&quot; &quot;A little bit,&quot; Moderately,&quot; &quot;Quite a bit,&quot; and &quot;Extremely.&quot; A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.</description>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>PCL-5 Total Score</title>
          <description>The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: &quot;Not at all,&quot; &quot;A little bit,&quot; Moderately,&quot; &quot;Quite a bit,&quot; and &quot;Extremely.&quot; A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.9231" spread="15.7116"/>
                    <measurement group_id="O2" value="29.9" spread="16.7559"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>PCL-5 Total Score</title>
        <description>The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: &quot;Not at all,&quot; &quot;A little bit,&quot; Moderately,&quot; &quot;Quite a bit,&quot; and &quot;Extremely.&quot; A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.</description>
        <time_frame>Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>PCL-5 Total Score</title>
          <description>The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: &quot;Not at all,&quot; &quot;A little bit,&quot; Moderately,&quot; &quot;Quite a bit,&quot; and &quot;Extremely.&quot; A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.</description>
          <units>score on a scale</units>
          <param>Mean</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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.6364" spread="18.4921"/>
                    <measurement group_id="O2" value="26.8889" spread="17.7331"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Carbohydrate Deficient Transferrin (CDT)</title>
        <description>CDT test performed on blood sample</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Carbohydrate Deficient Transferrin (CDT)</title>
          <description>CDT test performed on blood sample</description>
          <units>percentage of CDT</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1118" lower_limit="0.6" upper_limit="2.6"/>
                    <measurement group_id="O2" value="2.2833" lower_limit="0.5" upper_limit="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Carbohydrate Deficient Transferrin (CDT)</title>
        <description>CDT test performed on blood sample</description>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Carbohydrate Deficient Transferrin (CDT)</title>
          <description>CDT test performed on blood sample</description>
          <units>percentage of CDT</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0909" lower_limit="0.6" upper_limit="2.1"/>
                    <measurement group_id="O2" value="1.4222" lower_limit="0.6" upper_limit="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Carbohydrate Deficient Transferrin (CDT)</title>
        <description>CDT test performed on blood sample</description>
        <time_frame>Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Carbohydrate Deficient Transferrin (CDT)</title>
          <description>CDT test performed on blood sample</description>
          <units>percentage of CDT</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.14" lower_limit="0.7" upper_limit="1.9"/>
                    <measurement group_id="O2" value="1.6625" lower_limit="0.6" upper_limit="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Heavy Drinking Days</title>
        <description>Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Heavy Drinking Days</title>
          <description>Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.</description>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49" lower_limit="17" upper_limit="97"/>
                    <measurement group_id="O2" value="58" lower_limit="13" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Heavy Drinking Days</title>
        <description>Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.</description>
        <time_frame>Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Heavy Drinking Days</title>
          <description>Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.</description>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29" lower_limit="0" upper_limit="100"/>
                    <measurement group_id="O2" value="31" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Heavy Drinking Days</title>
        <description>Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Heavy Drinking Days</title>
          <description>Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.</description>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25" lower_limit="0" upper_limit="100"/>
                    <measurement group_id="O2" value="31" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Heavy Drinking Days</title>
        <description>Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.</description>
        <time_frame>Week 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Heavy Drinking Days</title>
          <description>Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.</description>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21" lower_limit="0" upper_limit="100"/>
                    <measurement group_id="O2" value="21" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Heavy Drinking Days</title>
        <description>Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.</description>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Heavy Drinking Days</title>
          <description>Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.</description>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23" lower_limit="0" upper_limit="100"/>
                    <measurement group_id="O2" value="25" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Heavy Drinking Days</title>
        <description>Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.</description>
        <time_frame>Week 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Heavy Drinking Days</title>
          <description>Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.</description>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26" lower_limit="0" upper_limit="100"/>
                    <measurement group_id="O2" value="32" lower_limit="0" upper_limit="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Heavy Drinking Days</title>
        <description>Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.</description>
        <time_frame>Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Heavy Drinking Days</title>
          <description>Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.</description>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21" lower_limit="0" upper_limit="100"/>
                    <measurement group_id="O2" value="39" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Very Heavy Drinking Days</title>
        <description>Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Very Heavy Drinking Days</title>
          <description>Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.</description>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17" lower_limit="0" upper_limit="67"/>
                    <measurement group_id="O2" value="27" lower_limit="0" upper_limit="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Very Heavy Drinking Days</title>
        <description>Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.</description>
        <time_frame>Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Very Heavy Drinking Days</title>
          <description>Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.</description>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="0" upper_limit="25"/>
                    <measurement group_id="O2" value="4" lower_limit="0" upper_limit="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Very Heavy Drinking Days</title>
        <description>Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Very Heavy Drinking Days</title>
          <description>Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.</description>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="0" upper_limit="29"/>
                    <measurement group_id="O2" value="4" lower_limit="0" upper_limit="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Very Heavy Drinking Days</title>
        <description>Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.</description>
        <time_frame>Week 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Very Heavy Drinking Days</title>
          <description>Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.</description>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="0" upper_limit="43"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Very Heavy Drinking Days</title>
        <description>Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.</description>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Very Heavy Drinking Days</title>
          <description>Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.</description>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="14"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Very Heavy Drinking Days</title>
        <description>Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.</description>
        <time_frame>Week 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Very Heavy Drinking Days</title>
          <description>Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.</description>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <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" lower_limit="0" upper_limit="14"/>
                    <measurement group_id="O2" value="3" lower_limit="0" upper_limit="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Very Heavy Drinking Days</title>
        <description>Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.</description>
        <time_frame>Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Very Heavy Drinking Days</title>
          <description>Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.</description>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <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" lower_limit="0" upper_limit="14"/>
                    <measurement group_id="O2" value="5" lower_limit="0" upper_limit="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With No Heavy Drinking Days</title>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With No Heavy Drinking Days</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With No Heavy Drinking Days</title>
        <time_frame>Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With No Heavy Drinking Days</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <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"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With No Heavy Drinking Days</title>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With No Heavy Drinking Days</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With No Heavy Drinking Days</title>
        <time_frame>Week 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With No Heavy Drinking Days</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With No Heavy Drinking Days</title>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With No Heavy Drinking Days</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With No Heavy Drinking Days</title>
        <time_frame>Week 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With No Heavy Drinking Days</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <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"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With No Heavy Drinking Days</title>
        <time_frame>Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With No Heavy Drinking Days</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <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"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants That Are 'Present and Clear'</title>
        <description>Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Are 'Present and Clear'</title>
          <description>Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants That Are 'Present and Clear'</title>
        <description>Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.</description>
        <time_frame>Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Are 'Present and Clear'</title>
          <description>Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants That Are 'Present and Clear'</title>
        <description>Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Are 'Present and Clear'</title>
          <description>Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants That Are 'Present and Clear'</title>
        <description>Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.</description>
        <time_frame>Week 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Are 'Present and Clear'</title>
          <description>Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants That Are 'Present and Clear'</title>
        <description>Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.</description>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Are 'Present and Clear'</title>
          <description>Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants That Are 'Present and Clear'</title>
        <description>Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.</description>
        <time_frame>Week 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Are 'Present and Clear'</title>
          <description>Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants That Are 'Present and Clear'</title>
        <description>Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.</description>
        <time_frame>Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Are 'Present and Clear'</title>
          <description>Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Days Abstinent</title>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Days Abstinent</title>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30" lower_limit="0" upper_limit="77"/>
                    <measurement group_id="O2" value="34" lower_limit="0" upper_limit="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Days Abstinent</title>
        <time_frame>Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Days Abstinent</title>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55" lower_limit="0" upper_limit="100"/>
                    <measurement group_id="O2" value="57" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Days Abstinent</title>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Days Abstinent</title>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55" lower_limit="0" upper_limit="100"/>
                    <measurement group_id="O2" value="53" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Days Abstinent</title>
        <time_frame>Week 3</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Days Abstinent</title>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66" lower_limit="0" upper_limit="100"/>
                    <measurement group_id="O2" value="56" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Days Abstinent</title>
        <time_frame>Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Days Abstinent</title>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56" lower_limit="0" upper_limit="100"/>
                    <measurement group_id="O2" value="57" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Days Abstinent</title>
        <time_frame>Week 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Days Abstinent</title>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52" lower_limit="0" upper_limit="100"/>
                    <measurement group_id="O2" value="51" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Days Abstinent</title>
        <time_frame>Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cannabidiol (CBD 600 mg Daily)</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Days Abstinent</title>
          <units>percentage of days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48" lower_limit="0" upper_limit="100"/>
                    <measurement group_id="O2" value="46" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>9 weeks</time_frame>
      <desc>Collection approach was systematic, a study Nurse Practitioner of Physician collected the SAFTEE form Part A (with Parts B and C as needed) to collect AEs from a list of known drug effects. This assessment includes questions related to description of AE, timeline, severity, relatedness to study drug/participation, etc. This assessment was completed on a weekly basis from the baseline assessment to week 7 and then again at the week 9 followup. All AEs were reviewed with the PI.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cannabidiol (CBD 600 mg Daily)</title>
          <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Cannabidiol: 600 mg daily</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>6 weeks, such that both participants and study staff are blind to treatment condition.&#xD;
Placebos: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.</description>
        </group>
      </group_list>
      <serious_events>
        <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="17"/>
                <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="17"/>
                <counts group_id="E2" subjects_affected="0" 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="15" subjects_at_risk="17"/>
                <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>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Irregular heartbeat</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Thyroid Nodule</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <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>Blurry Vision</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <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>Acid Reflux</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Stomach discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Lightheadedness/Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cold/Flu Symptoms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Drowsiness</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Elevated liver enzymes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Increased Hunger</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nightmares</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Perceptual problems</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Weight gain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sweating</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <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>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Arm surgery</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Feeling Overwhelmed</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Lack of motivation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Suicidal ideation (wish to be dead)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <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>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Shortness of breath</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" 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>Charles Marmar, MD</name_or_title>
      <organization>NYU Langone Health</organization>
      <phone>646-754-4855</phone>
      <email>Charles.marmar@nyumc.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/NCT03248167
org study id: 17-00949
nct id: NCT03248167
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This project aims to determine whether cannabidiol (CBD), a compound derived from the
      cannabis plant, is effective in treating alcohol use disorder (AUD) in individuals with
      comorbid posttraumatic stress disorder (PTSD). Investigators will test the hypothesis that
      oral cannabidiol (CBD) will reduce alcohol drinking in individuals with AUD comorbid with
      PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or
      severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or
      placebo, for a period of 6 weeks, such that both participants and study staff are blind to
      treatment condition. Participants (each treated for 6 weeks) will be continuously recruited
      over a study period of 14 months until 48 have completed. Baseline and weekly data will be
      collected on alcohol usage and PTSD symptoms, and investigators will assess whether CBD
      treatment leads to a greater improvement in these measures relative to placebo, and whether
      reduction in alcohol drinking is temporally linked to improvement in PTSD symptoms. Subjects
      will also participate in a task designed to quantify the psychological and physiological
      links between negative emotion produced by re-experiencing PTSD trauma, and alcohol craving.
      The task will be administered following 4 weeks of treatment. Treatment-associated reduction
      in alcohol craving elicited by trauma-associated negative emotion between CBD and placebo
      groups will be compared. This study will be the first to test whether CBD is effective in
      treating alcohol addiction and in treating PTSD in humans, and the first to examine the
      interaction between these treatment effects. Results will serve as proof of concept and
      provide guidance for a future larger clinical trial. Because CBD is a safe, readily available
      drug, such a trial would have an immense potential to prevent death, medical illness, and
      psychological suffering associated with AUD and PTSD. Further, because the brain circuits via
      which CBD acts to produce hypothesized effects are relatively well-understood, results may
      substantially advance understanding of the neurobiological basis of alcohol addiction.
In this project, investigators aim to test the hypothesis that CBD will reduce alcohol
      drinking in individuals with AUD comorbid with PTSD. CBD is currently a medical research
      focus because it shows promise for treating anxiety and other brain disorders, but does not
      produce a 'high' like other parts of cannabis, has not been shown to be addictive, and is
      safe, with few or no side effects. AUD, which is one of the most common and most debilitating
      psychiatric conditions, is often associated with other comorbid psychiatric disorders - in
      particular, PTSD: depending on the population studied, 30-60% of individuals with AUD also
      have PTSD, with high comorbidity rates in military veterans. Evidence from animal models and
      clinical studies suggests that the negative emotion caused by PTSD symptoms intensifies
      craving for alcohol during alcohol withdrawal, perpetuating the addictive cycle; further,
      evidence shows that the brain circuits underlying negative emotion and addiction are linked
      in a forebrain area called the extended amygdala, which provides a neuropharmacological
      target to simultaneously treat both negative emotion and alcohol addiction in individuals
      with AUD and PTSD. CBD is known to inhibit brain activity in the extended amygdala, leading
      to reduced anxiety in both animal models and humans. CBD also reduces addictive alcohol
      seeking in animal models.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Drinks Per Day
time frame: Baseline
description: Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking.
measure: Number of Drinks Per Day
time frame: Week 4
description: Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking.
measure: Number of Drinks Per Day
time frame: Week 6
description: Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking.
measure: PCL-5 Total Score
time frame: Baseline
description: The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.
measure: PCL-5 Total Score
time frame: Week 4
description: The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.
measure: PCL-5 Total Score
time frame: Week 6
description: The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.
measure: Percent Carbohydrate Deficient Transferrin (CDT)
time frame: Baseline
description: CDT test performed on blood sample
measure: Percent Carbohydrate Deficient Transferrin (CDT)
time frame: Week 4
description: CDT test performed on blood sample
measure: Percent Carbohydrate Deficient Transferrin (CDT)
time frame: Week 6
description: CDT test performed on blood sample
measure: Percentage of Heavy Drinking Days
time frame: Baseline
description: Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.
measure: Percentage of Heavy Drinking Days
time frame: Week 1
description: Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.
measure: Percentage of Heavy Drinking Days
time frame: Week 2
description: Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.
measure: Percentage of Heavy Drinking Days
time frame: Week 3
description: Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.
measure: Percentage of Heavy Drinking Days
time frame: Week 4
description: Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.
measure: Percentage of Heavy Drinking Days
time frame: Week 5
description: Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.
measure: Percentage of Heavy Drinking Days
time frame: Week 6
description: Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.
measure: Percentage of Very Heavy Drinking Days
time frame: Baseline
description: Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.
measure: Percentage of Very Heavy Drinking Days
time frame: Week 1
description: Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.
measure: Percentage of Very Heavy Drinking Days
time frame: Week 2
description: Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.
measure: Percentage of Very Heavy Drinking Days
time frame: Week 3
description: Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.
measure: Percentage of Very Heavy Drinking Days
time frame: Week 4
description: Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.
measure: Percentage of Very Heavy Drinking Days
time frame: Week 5
description: Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.
measure: Percentage of Very Heavy Drinking Days
time frame: Week 6
description: Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.
measure: Number of Participants With No Heavy Drinking Days
time frame: Baseline
measure: Number of Participants With No Heavy Drinking Days
time frame: Week 1
measure: Number of Participants With No Heavy Drinking Days
time frame: Week 2
measure: Number of Participants With No Heavy Drinking Days
time frame: Week 3
measure: Number of Participants With No Heavy Drinking Days
time frame: Week 4
measure: Number of Participants With No Heavy Drinking Days
time frame: Week 5
measure: Number of Participants With No Heavy Drinking Days
time frame: Week 6
measure: Number of Participants That Are 'Present and Clear'
time frame: Baseline
description: Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.
measure: Number of Participants That Are 'Present and Clear'
time frame: Week 1
description: Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.
measure: Number of Participants That Are 'Present and Clear'
time frame: Week 2
description: Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.
measure: Number of Participants That Are 'Present and Clear'
time frame: Week 3
description: Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.
measure: Number of Participants That Are 'Present and Clear'
time frame: Week 4
description: Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.
measure: Number of Participants That Are 'Present and Clear'
time frame: Week 5
description: Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.
measure: Number of Participants That Are 'Present and Clear'
time frame: Week 6
description: Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.
measure: Percentage of Days Abstinent
time frame: Baseline
measure: Percentage of Days Abstinent
time frame: Week 1
measure: Percentage of Days Abstinent
time frame: Week 2
measure: Percentage of Days Abstinent
time frame: Week 3
measure: Percentage of Days Abstinent
time frame: Week 4
measure: Percentage of Days Abstinent
time frame: Week 5
measure: Percentage of Days Abstinent
time frame: Week 6
arm group label: Cannabidiol (CBD 600 mg daily)
arm group type: Experimental
description: 6 weeks, such that both participants and study staff are blind to treatment condition.
arm group label: Placebo
arm group type: Placebo Comparator
description: 6 weeks, such that both participants and study staff are blind to treatment condition.
intervention type: Drug
intervention name: Cannabidiol
description: 600 mg daily
arm group label: Cannabidiol (CBD 600 mg daily)
other name: CBD
intervention type: Drug
intervention name: Placebos
description: This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be administered to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Charles Marmar, MD
role: Principal Investigator
affiliation: New York University Grossman School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alcoholism
mesh term: Stress Disorders, Traumatic
mesh term: Alcohol Drinking
mesh term: Stress Disorders, Post-Traumatic
mesh term: Cannabidiol
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 