Effects of THC on Alcohol Consumption and Neural Correlates of Reward

University of Colorado Denver (CU Denver)

Status and phase: Enrolling; Phase 2

Conditions: Cannabis Use Disorder

Treatments: Drug: Placebo; Drug: Dronabinol Pill

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06446479

22-1314

Details and patient eligibility

About

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.

Full 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

Enrollment: 28 estimated patients

Sex: All

Ages: 21 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

28 participants in 2 patient groups

Placebo first, Dronabinol second

Experimental group

Description:

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

Treatment:

Drug: Dronabinol Pill

Drug: Placebo

Dronabinol first, Placebo second

Experimental group

Description:

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

Treatment:

Drug: Dronabinol Pill

Drug: Placebo