Marijuana's Impact on Alcohol Motivation and Consumption

Alcohol Drinking Clinical Trial

Official title:

Marijuana's Impact on Alcohol Motivation and Consumption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983773
• Other study ID #: 1511001372
• Secondary ID: R01AA024091
• Status: Completed
• Phase: Phase 2
• Start date: January 23, 2017
• Est. completion date: July 21, 2021

Study information

• Verified date: September 2021
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: July 21, 2021
• Est. primary completion date: July 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 44 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Drinking
• Marijuana
• Marijuana Abuse

Intervention

Drug:
• THC 7.2%
1 smoked marijuana cigarette with 7.2% THC
• THC 3.0%
1 smoked marijuana cigarette with 3.0% THC
• Placebo
1 smoked placebo marijuana cigarette

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in alcohol craving	Alcohol Craving Questionnaire-Short Form-Revised (ACQ-SF-R)	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
Secondary	change in alcohol demand measured with Alcohol Purchase Task-State Version (APT-SV)	Alcohol demand curve is generated by estimating alcohol consumption (number of drinks) over the course of escalating prices.	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
Secondary	number of alcohol beverages consumed		post-smoking during two-hour alcohol choice task during the experimental session