Cannabis' Impact on Alcohol Consumption
- Conditions
- Alcohol DrinkingCannabis UseCannabisAlcohol Use Disorder
- Interventions
- Registration Number
- NCT05389930
- Lead Sponsor
- Brown University
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
- 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
- positive pregnancy test
- nursing
- positive urine toxicology screen for drugs other than cannabis
- interest to quit or receive treatment for cannabis or alcohol use
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Alcohol priming dose THC-dominant cannabis Alcohol: 0.3 g/kg. Alcohol priming drink is designed to raise blood alcohol levels to 0.03 g/dl and be consumed in 5 minutes. The drink is mixed using 80-proof liquor and juice. Participants are randomized to receive either the experimental alcohol priming dose or alcohol placebo. THC-dominant cannabis dose Alcohol 367 mg of cannabis plant material with 9.53% THC and 0.09% CBD and 217 mg of placebo cannabis plant material will be mixed and smoked in a handheld pipe THC-dominant cannabis dose Alcohol placebo 367 mg of cannabis plant material with 9.53% THC and 0.09% CBD and 217 mg of placebo cannabis plant material will be mixed and smoked in a handheld pipe Alcohol priming dose Cannabis placebo Alcohol: 0.3 g/kg. Alcohol priming drink is designed to raise blood alcohol levels to 0.03 g/dl and be consumed in 5 minutes. The drink is mixed using 80-proof liquor and juice. Participants are randomized to receive either the experimental alcohol priming dose or alcohol placebo. Alcohol placebo dose Cannabis placebo Placebo beverage contains only juice and a negligible trace of alcohol for masking. The weight and sex-adjusted volume of alcohol and non-alcohol containing beverages will be equal. Participants are randomized to receive either the experimental alcohol priming dose or alcohol placebo. CBD-dominant cannabis dose Alcohol placebo 367 mg of cannabis plant material with 11.27% CBD and 0.35% THC and 217 mg of placebo cannabis plant material will be mixed and smoked in a handheld pipe Placebo Alcohol placebo 584 mg of cannabis plant material will be smoked in a handheld pipe Alcohol priming dose CBD-dominant cannabis Alcohol: 0.3 g/kg. Alcohol priming drink is designed to raise blood alcohol levels to 0.03 g/dl and be consumed in 5 minutes. The drink is mixed using 80-proof liquor and juice. Participants are randomized to receive either the experimental alcohol priming dose or alcohol placebo. Alcohol placebo dose THC-dominant cannabis Placebo beverage contains only juice and a negligible trace of alcohol for masking. The weight and sex-adjusted volume of alcohol and non-alcohol containing beverages will be equal. Participants are randomized to receive either the experimental alcohol priming dose or alcohol placebo. Alcohol placebo dose CBD-dominant cannabis Placebo beverage contains only juice and a negligible trace of alcohol for masking. The weight and sex-adjusted volume of alcohol and non-alcohol containing beverages will be equal. Participants are randomized to receive either the experimental alcohol priming dose or alcohol placebo. CBD-dominant cannabis dose Alcohol 367 mg of cannabis plant material with 11.27% CBD and 0.35% THC and 217 mg of placebo cannabis plant material will be mixed and smoked in a handheld pipe Placebo Alcohol 584 mg of cannabis plant material will be smoked in a handheld pipe
- Primary Outcome Measures
Name Time Method ml of alcohol consumed post-smoking during two-hours of the alcohol choice task ml of alcohol consumed during the alcohol choice task
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Brown University
🇺🇸Providence, Rhode Island, United States