Brown University
Providence, Rhode Island, 02912, United States
NCT Number: NCT02983773
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.
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Notify Me21 year–44 year
All sexes
Interventional
Phase 2
Providence, Rhode Island, 02912, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 smoked marijuana cigarette with 7.2% THC
1 smoked marijuana cigarette with 3.0% THC
1 smoked placebo marijuana cigarette
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.
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.
Brown University
Other
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