Effects of THC on Alcohol Consumption and Neural Correlates of Reward
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Change in alcohol cue-elicited brain activation (fMRI) between medication periods
Study Overview
Brief Summary
Alcohol and cannabis are often used together such that their effects overlap, but little is known about the neural mechanisms that underlie simultaneous use. High doses of THC have not been well-studied in the laboratory, and it is unclear how high doses of THC may impact alcohol consumption patterns. The proposed study will explore the effects of oral THC (20mg dronabinol) vs. placebo on neural reward, alcohol self-administration and naturalistic co-use patterns.
Detailed Description
Participants will undergo a screening assessment, baseline session and two laboratory visits. The laboratory visits will involve an MRI scan and the opportunity to consume alcohol in our BAR lab. Prior to the MRI, participants will consume, a placebo (0mg) or high (20mg) dose of oral THC (dronabinol). Visits will be separated by 7 to 14 days. Dronabinol is an FDA-approved product that will be dispensed by our on-campus pharmacy
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Drink alcohol
- •Use cannabis
- •Contact site for additional details
Exclusion Criteria
- •MRI contraindications (implanted metal, weight > 315 lb, etc.).
- •Contact site for additional details
Arms & Interventions
Placebo first, Dronabinol second
This arm will receive placebo on the first visit, and dronabinol on the second visit
Intervention: Dronabinol Pill (Drug)
Placebo first, Dronabinol second
This arm will receive placebo on the first visit, and dronabinol on the second visit
Intervention: Placebo (Drug)
Dronabinol first, Placebo second
This arm will receive dronabinol on the first visit, and placebo on the second visit.
Intervention: Dronabinol Pill (Drug)
Dronabinol first, Placebo second
This arm will receive dronabinol on the first visit, and placebo on the second visit.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change in alcohol cue-elicited brain activation (fMRI) between medication periods
Time Frame: 1 hour after administration of a single dose of study medication at 7 days, 14 days.
Alcohol cue reactivity task BOLD signal to alcohol cues, relative to neutral beverage cues
Change in cannabis cue-elicited brain activation (fMRI) between medication periods
Time Frame: 1 hour after administration of a single dose of study medication at 7 days, 14 days.
Cannabis cue reactivity task BOLD signal to cannabis cues, relative to neutral cues
Alcohol self-administration
Time Frame: 3-4 hours after administration of a single dose of study medication at 7 days, 14 days.
Number of drinks self-administered
Self-reported cannabis use
Time Frame: One report per day for the 14 days after the final laboratory visit on day 14
Amount of cannabis consumed per day
Self-reported alcoholic drinks consumed
Time Frame: one report per day for the 14 days after the final laboratory visit on day 14.
# of drinks consumed per day
Self-reported cannabis and alcohol co-use
Time Frame: One report per day for the 14 days after the final laboratory visit on day 14.
Number of days in which cannabis and alcohol were both used
Secondary Outcomes
No secondary outcomes reported