Effects of THC on Alcohol Consumption and Neural Correlates of Reward

Cannabis Use Disorder Clinical Trial

Official title:

Effects of THC on Alcohol Consumption and Neural Correlates of Reward

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06446479
• Other study ID #: 22-1314
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Cannabis Use Disorder

Intervention

Drug:
• Dronabinol Pill
Dronabinol 20 mg
• Placebo
placebo

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	Colorado State University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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
Primary	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.