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Recruiting NCT06446479

Effects of THC on Alcohol Consumption and Neural Correlates of Reward

Phase II Interventional Cannabis Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dronabinol Pill, Placebo.
Who it may be relevant to
Registry conditions: Cannabis Use Disorder. Basic parameters: 21 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Drug Dronabinol Pill
    Dronabinol 20 mg
  • Drug Placebo
    placebo

Primary outcome measures

  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Colorado Anschutz Medical Campus — Aurora

Identifiers

NCT: NCT06446479 · 22-1314

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗