Marijuana's Impact on Alcohol Motivation and Consumption

• Sponsor: Brown University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02983773
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 131
• Location: 1
• Arms: 3
• Actual Duration (Months): 53.9
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 131 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: Jan 23, 2017
• Actual Primary Completion Date: Jul 21, 2021
• Actual Study Completion Date: Jul 21, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. change in alcohol craving [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) [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 [post-smoking during two-hour alcohol choice task during the experimental session]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 44 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brown University	Providence	Rhode Island	United States	02912

Sponsors and Collaborators

• Brown University
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Jane Metrik, PhD, Brown University

Study Documents (Full-Text)

• Informed Consent Form - Jun 20, 2020

More Information

Publications

None provided.

• Responsible Party: Jane Metrik, Associate Professor (research), Brown University
• ClinicalTrials.gov Identifier: NCT02983773
• Other Study ID Numbers: 1511001372; R01AA024091
• First Posted: Dec 6, 2016
• Last Update Posted: Sep 28, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Marijuana Abuse; Alcohol Drinking; Dronabinol

Study Results

No Results Posted as of Sep 28, 2021