Cannabis' Impact on Alcohol Consumption: Integrating Laboratory and Ecological Momentary Assessment Methods

2022003195

This study employs a repeated measures experimental design to examine the effect of THC-dominant dose of cannabis and CBD-dominant dose of cannabis, relative to placebo, on subsequent drinking in an alcohol choice task in which participants choose either to drink or receive monetary reinforcement for drinks not consumed. Cannabis will be administered simultaneously with an alcohol-priming dose or alcohol placebo. The study will enroll up to 350 nontreatment-seeking heavy episodic alcohol drinkers who use cannabis weekly.

2023-03-16

2027-03-31

2027-03-31

Recruiting

Early phase I

350

Inclusion Criteria: * Age 21 to 50 * English-speaking * cannabis smoking in past two months * heavy drinking in past two months * in good physical health and weighing \< 250 lbs * zero breath alcohol at each visit Exclusion Criteria: * positive pregnancy test * nursing * positive urine toxicology screen for drugs other than cannabis * interest to quit or receive treatment for cannabis or alcohol use

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Mixed factorial design will use a 3 (within-subjects; cannabinoid dose: 9.53% THC/0.06% CBD, 11.27% CBD/0.35% THC, placebo) X 2 (between-subjects; cannabis + an alcohol-priming dose (0.3 g/kg) versus cannabis + alcohol placebo)', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Participants are masked. Outcome assessors who have contact with participants are masked.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 350, 'type': 'ESTIMATED'}}

2024-08-06