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Clinical trial

Effects of THC on Alcohol Consumption and Neural Correlates of Reward

ID
Name
22-1314
Description
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.
Trial arms
Trial start
2024-07-01
Estimated PCD
2026-06-30
Trial end
2026-06-30
Status
Not yet recruiting
Phase
Early phase I
Treatment
Dronabinol Pill
Dronabinol 20 mg
Arms:
Dronabinol first, Placebo second, Placebo first, Dronabinol second
Placebo
placebo
Arms:
Dronabinol first, Placebo second, Placebo first, Dronabinol second
Size
28
Primary endpoint
Change in alcohol cue-elicited brain activation (fMRI) between medication periods
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
1 hour after administration of a single dose of study medication at 7 days, 14 days.
Alcohol self-administration
3-4 hours after administration of a single dose of study medication at 7 days, 14 days.
Self-reported alcoholic drinks consumed
one report per day for the 14 days after the final laboratory visit on day 14.
Self-reported cannabis use
One report per day for the 14 days after the final laboratory visit on day 14
Self-reported cannabis and alcohol co-use
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 28, 'type': 'ESTIMATED'}}
Updated at
2024-06-06

1 organization

2 products

1 indication

Organization
University of Colorado Denver
Product
Dronabinol
Indication
Cannabis Use Disorder
Product
Placebo