Marijuana's Impact on Alcohol Motivation and Consumption

NCT ID: NCT02983773

Last Updated: 2021-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-23

Study Completion Date

2021-07-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Alcohol Drinking Marijuana

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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High THC dose

1 marijuana cigarette (7.2% THC)

Group Type EXPERIMENTAL

THC 7.2%

Intervention Type DRUG

1 smoked marijuana cigarette with 7.2% THC

Low THC dose

1 marijuana cigarette (3.0% THC)

Group Type EXPERIMENTAL

THC 3.0%

Intervention Type DRUG

1 smoked marijuana cigarette with 3.0% THC

Placebo

Placebo marijuana cigarette

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 smoked placebo marijuana cigarette

Interventions

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THC 7.2%

1 smoked marijuana cigarette with 7.2% THC

Intervention Type DRUG

THC 3.0%

1 smoked marijuana cigarette with 3.0% THC

Intervention Type DRUG

Placebo

1 smoked placebo marijuana cigarette

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role lead

Responsible Party

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Jane Metrik

Associate Professor (research)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jane Metrik, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

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Brown University

Providence, Rhode Island, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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R01AA024091

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1511001372

Identifier Type: -

Identifier Source: org_study_id

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