Cannabis' Impact on Alcohol Consumption

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Brown University
Study ID
NCT05389930
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 16, 2023
Status verified
Aug 2024
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: THC-dominant cannabis dose
    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
  • Experimental: CBD-dominant cannabis dose
    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 Comparator: Placebo
    584 mg of cannabis plant material will be smoked in a handheld pipe
  • 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 juice. Participants are randomized to receive either the experimental alcohol priming dose or alcohol placebo.
  • Placebo Comparator: Alcohol placebo dose
    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.

Primary Outcome Measure

ml of alcohol consumed [ Time Frame: post-smoking during two-hours of the alcohol choice task ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brown UniversityProvidenceRhode Island02912
Jane Metrik, PhD
[email protected]
401-863-6650

Find similar trials in Providence, RI

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Brown University· Providence, RI

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