Cannabis' Impact on Alcohol Consumption

Sponsor

Brown University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05389930

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

350

Enrollment

Location

Arms

53.9

Anticipated Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Drinking Cannabis Use Cannabis Alcohol Use Disorder	Drug: THC-dominant cannabis Drug: CBD-dominant cannabis Drug: Cannabis placebo Drug: Alcohol Drug: Alcohol placebo	Phase 2

Detailed Description

This study employs a repeated measures experimental design to examine the effect of THC-dominant (12.13% 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

350 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

Mixed factorial design will use a 3 (within-subjects; cannabinoid dose: 12.13% THC/0.09% 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)Mixed factorial design will use a 3 (within-subjects; cannabinoid dose: 12.13% THC/0.09% 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)

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Participants are masked. Outcome assessors who have contact with participants are masked.

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2027

Anticipated Study Completion Date :

Mar 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: THC-dominant cannabis dose 292 mg of cannabis plant material with 12.13% THC and 0.09% CBD and 292 mg of placebo cannabis plant material will be mixed and smoked in a handheld pipe	Drug: Alcohol Drink containing 0.3 g/kg of alcohol Drug: Alcohol placebo Placebo beverage contains only fruit juice and a negligible trace of alcohol for masking
Experimental: CBD-dominant cannabis dose 292 mg of cannabis plant material with 11.27% CBD and 0.35% THC and 292 mg of placebo cannabis plant material will be mixed and smoked in a handheld pipe	Drug: Alcohol Drink containing 0.3 g/kg of alcohol Drug: Alcohol placebo Placebo beverage contains only fruit juice and a negligible trace of alcohol for masking
Placebo Comparator: Placebo 584 mg of cannabis plant material will be smoked in a handheld pipe	Drug: Alcohol Drink containing 0.3 g/kg of alcohol Drug: Alcohol placebo Placebo beverage contains only fruit juice and a negligible trace of alcohol for masking
Experimental: Alcohol priming dose 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 fruit juice. Participants are randomized to receive either the experimental alcohol priming dose or alcohol placebo.	Drug: THC-dominant cannabis Smoked cannabis with 12.13% 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
Placebo Comparator: Alcohol placebo dose Placebo beverage contains only fruit 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.	Drug: THC-dominant cannabis Smoked cannabis with 12.13% 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