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Marijuana's Impact on Alcohol Motivation and Consumption

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ClinicalTrials.gov Identifier: NCT02983773
Recruitment Status : Recruiting
First Posted : December 6, 2016
Last Update Posted : January 16, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Jane Metrik, Brown University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alcohol Drinking Marijuana Drug: THC 7.2% Drug: THC 3.0% Drug: Placebo Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Marijuana's Impact on Alcohol Motivation and Consumption
Actual Study Start Date : January 23, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Experimental: High THC dose
1 marijuana cigarette (7.2% THC)
Drug: THC 7.2%
1 smoked marijuana cigarette with 7.2% THC

Experimental: Low THC dose
1 marijuana cigarette (3.0% THC)
Drug: THC 3.0%
1 smoked marijuana cigarette with 3.0% THC

Placebo Comparator: Placebo
Placebo marijuana cigarette
Drug: Placebo
1 smoked placebo marijuana cigarette




Primary Outcome Measures :
  1. 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 ]
    Alcohol Craving Questionnaire-Short Form-Revised (ACQ-SF-R)


Secondary Outcome Measures :
  1. 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 ]
    Alcohol demand curve is generated by estimating alcohol consumption (number of drinks) over the course of escalating prices.

  2. number of alcohol beverages consumed [ Time Frame: post-smoking during two-hour alcohol choice task during the experimental session ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 44 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 21 to 44
  • English-speaking
  • marijuana smoking in past month
  • report of current heavy episodic (binge) drinking
  • in good physical health and weighing < 250 lbs
  • zero breath alcohol at each visit

Exclusion Criteria:

  • history of seizures
  • smoking >20 tobacco cigarettes per day
  • positive pregnancy test
  • nursing
  • positive urine toxicology screen for drugs other than cannabis
  • interest to quit or receive treatment for marijuana or alcohol use
  • meeting criteria for a current affective disorder (depression, or mania, panic disorder, and having psychotic symptoms as assessed by the SCID)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02983773


Contacts
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Contact: Jane Metrik, PhD 4018636650 Jane_Metrik@brown.edu

Locations
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United States, Rhode Island
Brown University Recruiting
Providence, Rhode Island, United States, 02912
Contact: Cassandra Tardif, MPH    401-863-6688    projectmars@brown.edu   
Sponsors and Collaborators
Brown University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Jane Metrik, PhD Brown University

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Responsible Party: Jane Metrik, Associate Professor (research), Brown University
ClinicalTrials.gov Identifier: NCT02983773     History of Changes
Other Study ID Numbers: 1511001372
R01AA024091 ( U.S. NIH Grant/Contract )
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Marijuana Abuse
Alcohol Drinking
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Drinking Behavior