NCT05389930

Cannabis' Impact on Alcohol Consumption

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This study employs a repeated measures experimental design to examine the effect of THC-dominant (9.53% THC and 0.09% CBD) dose of cannabis and CBD-dominant (0.35% THC and 11.27% CBD) 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 to obtain the final sample of 200 with complete data. Participants will be tested at a baseline session, during three experimental sessions, and then during a subsequent 4-week period in the natural environment using a smart-phone application. Findings have important implications for cannabis regulatory science and alcohol use disorder treatment by addressing the relative impact of specific cannabinoids as well as contextual risk in cannabis-alcohol co-use.

Conditions

• Alcohol Drinking
• Cannabis Use
• Cannabis
• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	THC-dominant cannabis	Smoked cannabis with 9.53% THC and 0.09% CBD
DRUG	CBD-dominant cannabis	Smoked cannabis with 0.35% THC and 11.27% CBD
DRUG	Cannabis placebo	Smoked placebo cannabis plant material
DRUG	Alcohol	Drink containing 0.3 g/kg of alcohol
DRUG	Alcohol placebo	Placebo beverage contains only juice and a negligible trace of alcohol for masking

Timeline

• Start date: 2023-03-16
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2022-05-25
• Last updated: 2024-08-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study