Effects of THC on Alcohol Consumption and Neural Correlates of Reward

NCT06446479 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 22-1314
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Use Disorder

Outcome Measures

Primary Outcomes (6)

• 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.

Study Arms (2)

Placebo first, Dronabinol second

EXPERIMENTAL

This arm will receive placebo on the first visit, and dronabinol on the second visit

Drug: Dronabinol Pill; Drug: Placebo

Dronabinol first, Placebo second

EXPERIMENTAL

This arm will receive dronabinol on the first visit, and placebo on the second visit.

Drug: Dronabinol Pill; Drug: Placebo

Interventions

Dronabinol Pill DRUG

Dronabinol 20 mg

Dronabinol first, Placebo second; Placebo first, Dronabinol second

Placebo DRUG

placebo

Dronabinol first, Placebo second; Placebo first, Dronabinol second

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Colorado State University: collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Interventions

Dronabinol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Central Study Contacts

Elnaz Nourollahimoghadam

CONTACT

3037246020; elnaz.nourollahimoghadam@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: June 6, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

US (1)