<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/NCT02983773</url>
  </required_header>
  <id_info>
    <org_study_id>1511001372</org_study_id>
    <secondary_id>R01AA024091</secondary_id>
    <nct_id>NCT02983773</nct_id>
  </id_info>
  <brief_title>Marijuana's Impact on Alcohol Motivation and Consumption</brief_title>
  <official_title>Marijuana's Impact on Alcohol Motivation and Consumption</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Brown University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This laboratory study will employ a repeated measures experimental design to examine the&#xD;
      effect of high (7.2% THC) and moderate (3% THC) dose of marijuana, relative to placebo, on&#xD;
      alcohol craving and on behavioral economic measure of alcohol demand after exposure to&#xD;
      alcohol cues, and on subsequent drinking in an alcohol choice task in which participants&#xD;
      choose either to drink or receive monetary reinforcement for drinks not consume. The study&#xD;
      will recruit 173 non-treatment seeking heavy episodic alcohol drinkers who smoke marijuana at&#xD;
      least twice weekly.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This laboratory study will employ a repeated measures experimental design to examine the&#xD;
      effect of high (7.2% THC) and moderate (3.0% THC) dose of marijuana, relative to placebo, on&#xD;
      alcohol craving and on behavioral economic measure of alcohol demand after exposure to&#xD;
      alcohol cues, and on subsequent drinking in an alcohol choice task in which participants&#xD;
      choose either to drink or receive monetary reinforcement for drinks not consumed. Moderators&#xD;
      of the marijuana's effects on alcohol-related dependent variables will be tested: DSM5&#xD;
      alcohol use disorder severity, affective vulnerability, trait impulsivity, and working memory&#xD;
      functioning. Several empirically-determined mechanisms that may explain why marijuana may&#xD;
      increase risk of alcohol relapse and help maintain heavy drinking will be tested as mediators&#xD;
      of marijuana's effects on alcohol. The study will recruit 173 non-treatment seeking heavy&#xD;
      episodic alcohol drinkers who smoke marijuana at least twice weekly to obtain the final&#xD;
      sample of 150 with complete data (15% of attrition). Participants will be tested at a&#xD;
      baseline session and during three experimental sessions. Investigators will collect blood&#xD;
      samples for analysis of cannabinoid plasma levels and to examine marijuana-induced changes in&#xD;
      hormones and other biomarkers potentially related to appetite, inflammation and stress.&#xD;
      Collection of these biomarkers would allow for a greater understanding about the mechanisms&#xD;
      whereby marijuana may acutely increase alcohol motivation and use. The findings will inform&#xD;
      researchers and clinicians about how marijuana acutely increases alcohol craving and&#xD;
      consumption. The strategy of this proposal is to use the most comprehensive controlled test&#xD;
      characterizing marijuana's putative effects on alcohol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2017</start_date>
  <completion_date type="Actual">July 21, 2021</completion_date>
  <primary_completion_date type="Actual">July 21, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in alcohol craving</measure>
    <time_frame>T1: pre-smoking (-45 minutes) and post smoking at 20 (T2), 55 (T3), and 70 (T4) minutes for a total of two hours during the experimental session</time_frame>
    <description>Alcohol Craving Questionnaire-Short Form-Revised (ACQ-SF-R)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in alcohol demand measured with Alcohol Purchase Task-State Version (APT-SV)</measure>
    <time_frame>T1: pre-smoking (-45 minutes) and post smoking at 55 (T2) and 70 (T3) minutes for a total of two hours during the experimental session</time_frame>
    <description>Alcohol demand curve is generated by estimating alcohol consumption (number of drinks) over the course of escalating prices.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of alcohol beverages consumed</measure>
    <time_frame>post-smoking during two-hour alcohol choice task during the experimental session</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">131</enrollment>
  <condition>Alcohol Drinking</condition>
  <condition>Marijuana</condition>
  <arm_group>
    <arm_group_label>High THC dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 marijuana cigarette (7.2% THC)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low THC dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 marijuana cigarette (3.0% THC)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo marijuana cigarette</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>THC 7.2%</intervention_name>
    <description>1 smoked marijuana cigarette with 7.2% THC</description>
    <arm_group_label>High THC dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>THC 3.0%</intervention_name>
    <description>1 smoked marijuana cigarette with 3.0% THC</description>
    <arm_group_label>Low THC dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>1 smoked placebo marijuana cigarette</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21 to 44&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  marijuana smoking in past month&#xD;
&#xD;
          -  report of current heavy episodic (binge) drinking&#xD;
&#xD;
          -  in good physical health and weighing &lt; 250 lbs&#xD;
&#xD;
          -  zero breath alcohol at each visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of seizures&#xD;
&#xD;
          -  smoking &gt;20 tobacco cigarettes per day&#xD;
&#xD;
          -  positive pregnancy test&#xD;
&#xD;
          -  nursing&#xD;
&#xD;
          -  positive urine toxicology screen for drugs other than cannabis&#xD;
&#xD;
          -  interest to quit or receive treatment for marijuana or alcohol use&#xD;
&#xD;
          -  meeting criteria for a current affective disorder (depression, or mania, panic&#xD;
             disorder, and having psychotic symptoms as assessed by the SCID)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jane Metrik, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brown University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brown University</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>September 22, 2021</last_update_submitted>
  <last_update_submitted_qc>September 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brown University</investigator_affiliation>
    <investigator_full_name>Jane Metrik</investigator_full_name>
    <investigator_title>Associate Professor (research)</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Marijuana Abuse</mesh_term>
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dronabinol</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <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>June 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT02983773/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02983773
org study id: 1511001372
secondary id: R01AA024091
nct id: NCT02983773
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This laboratory study will employ a repeated measures experimental design to examine the
      effect of high (7.2% THC) and moderate (3% THC) dose of marijuana, relative to placebo, on
      alcohol craving and on behavioral economic measure of alcohol demand after exposure to
      alcohol cues, and on subsequent drinking in an alcohol choice task in which participants
      choose either to drink or receive monetary reinforcement for drinks not consume. The study
      will recruit 173 non-treatment seeking heavy episodic alcohol drinkers who smoke marijuana at
      least twice weekly.
This laboratory study will employ a repeated measures experimental design to examine the
      effect of high (7.2% THC) and moderate (3.0% THC) dose of marijuana, relative to placebo, on
      alcohol craving and on behavioral economic measure of alcohol demand after exposure to
      alcohol cues, and on subsequent drinking in an alcohol choice task in which participants
      choose either to drink or receive monetary reinforcement for drinks not consumed. Moderators
      of the marijuana's effects on alcohol-related dependent variables will be tested: DSM5
      alcohol use disorder severity, affective vulnerability, trait impulsivity, and working memory
      functioning. Several empirically-determined mechanisms that may explain why marijuana may
      increase risk of alcohol relapse and help maintain heavy drinking will be tested as mediators
      of marijuana's effects on alcohol. The study will recruit 173 non-treatment seeking heavy
      episodic alcohol drinkers who smoke marijuana at least twice weekly to obtain the final
      sample of 150 with complete data (15% of attrition). Participants will be tested at a
      baseline session and during three experimental sessions. Investigators will collect blood
      samples for analysis of cannabinoid plasma levels and to examine marijuana-induced changes in
      hormones and other biomarkers potentially related to appetite, inflammation and stress.
      Collection of these biomarkers would allow for a greater understanding about the mechanisms
      whereby marijuana may acutely increase alcohol motivation and use. The findings will inform
      researchers and clinicians about how marijuana acutely increases alcohol craving and
      consumption. The strategy of this proposal is to use the most comprehensive controlled test
      characterizing marijuana's putative effects on alcohol.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Outcomes Assessor)
measure: change in alcohol craving
time frame: T1: pre-smoking (-45 minutes) and post smoking at 20 (T2), 55 (T3), and 70 (T4) minutes for a total of two hours during the experimental session
description: Alcohol Craving Questionnaire-Short Form-Revised (ACQ-SF-R)
measure: change in alcohol demand measured with Alcohol Purchase Task-State Version (APT-SV)
time frame: T1: pre-smoking (-45 minutes) and post smoking at 55 (T2) and 70 (T3) minutes for a total of two hours during the experimental session
description: Alcohol demand curve is generated by estimating alcohol consumption (number of drinks) over the course of escalating prices.
measure: number of alcohol beverages consumed
time frame: post-smoking during two-hour alcohol choice task during the experimental session
arm group label: High THC dose
arm group type: Experimental
description: 1 marijuana cigarette (7.2% THC)
arm group label: Low THC dose
arm group type: Experimental
description: 1 marijuana cigarette (3.0% THC)
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo marijuana cigarette
intervention type: Drug
intervention name: THC 7.2%
description: 1 smoked marijuana cigarette with 7.2% THC
arm group label: High THC dose
intervention type: Drug
intervention name: THC 3.0%
description: 1 smoked marijuana cigarette with 3.0% THC
arm group label: Low THC dose
intervention type: Drug
intervention name: Placebo
description: 1 smoked placebo marijuana cigarette
arm group label: Placebo
criteria: 
gender: All
minimum age: 21 Years
maximum age: 44 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jane Metrik, PhD
role: Principal Investigator
affiliation: Brown University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brown University
investigator full name: Jane Metrik
investigator title: Associate Professor (research)
mesh term: Marijuana Abuse
mesh term: Alcohol Drinking
mesh term: Dronabinol
provided document: 