- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02983773
Marijuana's Impact on Alcohol Motivation and Consumption
March 31, 2026 updated by: Jane Metrik, Brown University
This laboratory study will employ a repeated measures experimental design to examine the effect of high (7.2%
THC) and moderate (3.1% 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This laboratory study will employ a repeated measures experimental design to examine the effect of high (7.2%
THC) and moderate (3.1% 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.
Study Type
Interventional
Enrollment (Actual)
157
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02912
- Brown University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 44 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Placebo marijuana cigarette
|
1 smoked placebo marijuana cigarette
|
|
Experimental: 7.2% THC
1 marijuana cigarette (7.2% THC)
|
1 smoked marijuana cigarette with 7.2% THC
|
|
Experimental: 3.1% THC
1 marijuana cigarette (3.1% THC)
|
1 smoked marijuana cigarette with 3.0% THC
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alcohol Craving
Time Frame: T0: pre-smoking (-45 minutes) and post smoking at 12 mins (T1), 47 mins (T2), and 58 mins (T3), 116 mins (T4), 178 mins (T5) during the experimental session
|
Alcohol Craving Questionnaire-Short Form-Revised (ACQ-SF-R) is a 12-item state measure of alcohol craving in the current moment (i.e., right now), scored on a 7-point Likert scale, from (1) strongly disagree to (7) strongly agree, with higher scores indicating greater craving.
Scores on this measure are averaged to yield a total craving score.
|
T0: pre-smoking (-45 minutes) and post smoking at 12 mins (T1), 47 mins (T2), and 58 mins (T3), 116 mins (T4), 178 mins (T5) during the experimental session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent of Total Available Alcohol Consumed
Time Frame: post-smoking during two-hour alcohol choice task during the experimental session
|
Participants completed two 60-minute blocks in the bar lab, during which they could drink up to eight mini-drinks of their personal choice with total amount of alcohol available designed to raise blood levels up to 0.10 g/dl or receive monetary reinforcement (in each block $12 tab in which each drink is worth $3) for drinks not consumed.
The primary dependent variable for this task is percent of total available alcohol consumed.
|
post-smoking during two-hour alcohol choice task during the experimental session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jane Metrik, PhD, Brown University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 23, 2017
Primary Completion (Actual)
July 21, 2021
Study Completion (Actual)
July 21, 2021
Study Registration Dates
First Submitted
November 15, 2016
First Submitted That Met QC Criteria
December 5, 2016
First Posted (Estimated)
December 6, 2016
Study Record Updates
Last Update Posted (Actual)
April 21, 2026
Last Update Submitted That Met QC Criteria
March 31, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Substance-Related Disorders
- Chemically-Induced Disorders
- Drinking Behavior
- Behavior
- Alcohol Drinking
- Marijuana Abuse
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Psychotropic Drugs
- Hallucinogens
- Cannabinoid Receptor Agonists
- Cannabinoid Receptor Modulators
- Dronabinol
Other Study ID Numbers
- 1511001372
- R01AA024091 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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