Recruiting
Phase 2

THC

Sponsor:

University of Colorado, Denver

Code:

NCT06446479

Conditions

Cannabis Use Disorder

Eligibility Criteria

Sex: All

Age: 21 - 40

Healthy Volunteers: Accepted

Interventions

Dronabinol Pill

Placebo

Study Details

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

Study ID

NCT06446479

Start date

Jul 1, 2024

Status verified date

Aug, 2024

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 40

Healthy Volunteers: Accepted

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 Design

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Placebo first, Dronabinol second

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

experimental: Dronabinol first, Placebo second

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

Interventions

Dronabinol Pill

Dronabinol 20 mg

Placebo

placebo

Primary outcome measure

  • 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. ]
  • 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. ]
  • Alcohol self-administration [ Time Frame: 3-4 hours after administration of a single dose of study medication at 7 days, 14 days. ]
  • Self-reported alcoholic drinks consumed [ Time Frame: one report per day for the 14 days after the final laboratory visit on day 14. ]
  • Self-reported cannabis use [ Time Frame: One report per day for the 14 days after the final laboratory visit on day 14 ]
  • 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. ]

Central Contacts and Locations

Central contacts

Elnaz Nourollahimoghadam

3037246020elnaz.nourollahimoghadam@cuanschutz.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Elnaz Nourollahimoghadam, MD

303-724-6020elnaz.nourollahimoghadam@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Aug 19, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-08-19.