Effects of THC on Alcohol Consumption and Neural Correlates of Reward

Phase 2

Recruiting

• Conditions: Cannabis Use Disorder
• Interventions: Drug: Dronabinol Pill; Drug: Placebo

• Registration Number: NCT06446479
• Lead Sponsor: University of Colorado, Denver

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-06-04
• Study First Posted: 2024-06-06
• Study Start: 2024-07-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Drink alcohol
• Use cannabis
• Contact site for additional details

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Exclusion Criteria

• MRI contraindications (implanted metal, weight > 315 lb, etc.).
• Contact site for additional details

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dronabinol first, Placebo second	Dronabinol Pill	This arm will receive dronabinol on the first visit, and placebo on the second visit.
Dronabinol first, Placebo second	Placebo	This arm will receive dronabinol on the first visit, and placebo on the second visit.
Placebo first, Dronabinol second	Placebo	This arm will receive placebo on the first visit, and dronabinol on the second visit
Placebo first, Dronabinol second	Dronabinol Pill	This arm will receive placebo on the first visit, and dronabinol on the second visit

Primary Outcome Measures

Name	Time	Method
Change in alcohol cue-elicited brain activation (fMRI) between medication periods	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	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	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	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	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	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

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States