Clinical trial NCT05389930: Cannabis' Impact on Alcohol Consumption
Official title: Cannabis' Impact on Alcohol Consumption: Integrating Laboratory and Ecological Momentary Assessment Methods
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Alcohol Drinking
Cannabis Use
Cannabis
Alcohol Use Disorder
Keywords: alcohol
cannabis
marijuana
addiction
cannabinoid
tetrahydrocannabinol
cannabidiol
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-05-25
Enrollment: 350
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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)
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: ml of alcohol consumed
timeFrame: post-smoking during two-hours of the alcohol choice task
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Jane Metrik, PhD
role: PRINCIPAL_INVESTIGATOR
References: