Alcohol Drinking, Alcohol Use Disorder, Cannabis, Cannabis Use
Conditions
Keywords
alcohol, cannabis, marijuana, addiction, cannabinoid, tetrahydrocannabinol, cannabidiol
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.
Interventions
DRUGTHC-dominant cannabis
Smoked cannabis with 9.53% THC and 0.09% CBD
DRUGCBD-dominant cannabis
Smoked cannabis with 0.35% THC and 11.27% CBD
DRUGCannabis placebo
Smoked placebo cannabis plant material
DRUGAlcohol
Drink containing 0.3 g/kg of alcohol
DRUGAlcohol placebo
Placebo beverage contains only juice and a negligible trace of alcohol for masking
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants are masked. Outcome assessors who have contact with participants are masked.
Intervention model description
Mixed factorial design will use a 3 (within-subjects; cannabinoid dose: 9.53% THC/0.06% 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)
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ml of alcohol consumed | post-smoking during two-hours of the alcohol choice task | ml of alcohol consumed during the alcohol choice task |
Countries
United States
Contacts
Primary ContactJane Metrik, PhD
Outcome results
None listed