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Effects of THC on Alcohol Consumption and Neural Correlates of Reward

Effects of THC on Alcohol Consumption and Neural Correlates of Reward

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06446479
Enrollment
28
Registered
2024-06-06
Start date
2024-07-01
Completion date
2026-06-30
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cannabis Use Disorder

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.

Detailed 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

Interventions

DRUGDronabinol Pill

Dronabinol 20 mg

DRUGPlacebo

placebo

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Colorado State University
CollaboratorOTHER
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in alcohol cue-elicited brain activation (fMRI) between medication periods1 hour after administration of a single dose of study medication at 7 days, 14 days.Alcohol cue reactivity task BOLD signal to alcohol cues, relative to neutral beverage cues
Change in cannabis cue-elicited brain activation (fMRI) between medication periods1 hour after administration of a single dose of study medication at 7 days, 14 days.Cannabis cue reactivity task BOLD signal to cannabis cues, relative to neutral cues
Alcohol self-administration3-4 hours after administration of a single dose of study medication at 7 days, 14 days.Number of drinks self-administered
Self-reported alcoholic drinks consumedone report per day for the 14 days after the final laboratory visit on day 14.\# of drinks consumed per day
Self-reported cannabis useOne report per day for the 14 days after the final laboratory visit on day 14Amount of cannabis consumed per day
Self-reported cannabis and alcohol co-useOne report per day for the 14 days after the final laboratory visit on day 14.Number of days in which cannabis and alcohol were both used

Countries

United States

Contacts

Primary ContactElnaz Nourollahimoghadam
elnaz.nourollahimoghadam@cuanschutz.edu3037246020

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026