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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02983773
Other study ID # 1511001372
Secondary ID R01AA024091
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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