Effects of THC on Alcohol Consumption and Neural Correlates of Reward

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.

Study Overview

• Status: Recruiting
• Conditions: Cannabis Use Disorder
• Intervention / Treatment: Drug: Placebo; Drug: Dronabinol Pill

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 Type: Interventional
• Enrollment (Estimated): 28
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Elnaz Nourollahimoghadam; Phone Number: 3037246020; Email: elnaz.nourollahimoghadam@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus
      • Contact: Elnaz Nourollahimoghadam, MD; Phone Number: 303-724-6020; Email: elnaz.nourollahimoghadam@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo first, Dronabinol second; This arm will receive placebo on the first visit, and dronabinol on the second visit	Drug: Placebo; placebo; Drug: Dronabinol Pill; Dronabinol 20 mg
Experimental: Dronabinol first, Placebo second; This arm will receive dronabinol on the first visit, and placebo on the second visit.	Drug: Placebo; placebo; Drug: Dronabinol Pill; Dronabinol 20 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in alcohol cue-elicited brain activation (fMRI) between medication periods	Alcohol cue reactivity task BOLD signal to alcohol cues, relative to neutral beverage cues	1 hour after administration of a single dose of study medication at 7 days, 14 days.
Change in cannabis cue-elicited brain activation (fMRI) between medication periods	Cannabis cue reactivity task BOLD signal to cannabis cues, relative to neutral cues	1 hour after administration of a single dose of study medication at 7 days, 14 days.
Alcohol self-administration	Number of drinks self-administered	3-4 hours after administration of a single dose of study medication at 7 days, 14 days.
Self-reported alcoholic drinks consumed	# of drinks consumed per day	one report per day for the 14 days after the final laboratory visit on day 14.
Self-reported cannabis use	Amount of cannabis consumed per day	One report per day for the 14 days after the final laboratory visit on day 14
Self-reported cannabis and alcohol co-use	Number of days in which cannabis and alcohol were both used	One report per day for the 14 days after the final laboratory visit on day 14.

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); Colorado State University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Psychotropic Drugs; Hallucinogens; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Dronabinol
• Other Study ID Numbers: 22-1314

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No