Actively Recruiting

Phase 2
Age: 21Years - 40Years
All Genders
Healthy Volunteers
ID06446479

Effects of THC on Alcohol Consumption and Neural Correlates of Reward

Led by University of Colorado, Denver · Updated on 2024-08-19

28

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

N

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to understand how high doses of oral THC (20 mg dronabinol) affect alcohol consumption, neural reward responses, and patterns of using alcohol and cannabis together. The study focuses on adults with cannabis use disorder who consume alcohol and cannabis. It addresses the limited knowledge about the brain mechanisms involved in simultaneous use and the impact of high THC doses on drinking behavior. Participants will be randomly assigned to receive either a placebo or 20 mg of dronabinol in two separate laboratory visits spaced 7 to 14 days apart. During each visit, they will take the assigned oral dose before undergoing an MRI scan and having the option to consume alcohol in a controlled laboratory setting. The study uses a triple-blind design to compare the effects of the active medication and placebo. Throughout the study, participants will complete a screening, baseline session, and two main visits. Researchers will measure brain activity related to alcohol and cannabis cues using fMRI one hour after medication, observe alcohol self-administration three to four hours post-dose, and collect daily self-reports on alcohol and cannabis use for 14 days following the final visit. Safety monitoring and adherence are included during the study period, which spans from the initial screening through the 14-day post-visit reporting phase.

CONDITIONS

Brief Title

Effects of THC on Alcohol Consumption and Neural Correlates of Reward

Who Can Participate

Age: 21Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Drink alcohol
  • Use cannabis
  • Contact site for additional details
Not Eligible

You will not qualify if you...

  • MRI contraindications such as implanted metal or weight over 315 pounds
  • Contact site for additional details

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Session

Duration - 1 day

Participants attend a baseline session before starting the intervention visits.

1 visit (in-person)

Treatment

Duration - Approximately 2 weeks

Participants receive either a placebo or 20 mg of oral THC (dronabinol) before undergoing an MRI scan and alcohol consumption in the lab. This is repeated in a crossover design with visits separated by 7 to 14 days.

2 laboratory visits each involving medication administration, MRI scan, and alcohol consumption

Follow-up

Duration - 14 days

Participants report daily alcohol and cannabis use for 14 days after the final laboratory visit.

Daily self-reports for 14 days

Trial Site Locations

Total: 1 location

1

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

Loading map...

Research Team

E

Elnaz Nourollahimoghadam

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

Similar Trials

Development of a Novel Cannabis Brief Intervention for Frequ...

Cannabis Use Disorder

Actively Recruiting

1 location

A Randomized, Placebo Controlled Study of Cannabidiol in You...

Cannabis Use Disorder

Actively Recruiting

1 location

Cannabidiol and Cannabis Concentrate Users: A Randomized, Pl...

Cannabis Use Disorder

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here