Cannabis' Impact on Alcohol Consumption
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: THC-dominant cannabis, CBD-dominant cannabis, Cannabis placebo, Alcohol.
- Who it may be relevant to
- Registry conditions: Alcohol Drinking, Cannabis Use, Cannabis, Alcohol Use Disorder. Basic parameters: 21 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cannabis' Impact on Alcohol Consumption: Integrating Laboratory and Ecological Momentary Assessment Methods
Overview
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.
Interventions
- 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
Primary outcome measures
- ml of alcohol consumed [Time frame: post-smoking during two-hours of the alcohol choice task]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Brown University — Providence
Identifiers
NCT: NCT05389930 · 2022003195 · R01AA029711