A Phase 2 interventional study of Dronabinol Pill and Placebo in Cannabis Use Disorder, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 21 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-19.
Sponsored by University of Colorado, Denver · Phase 2, Interventional, and Basic science
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.
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
925 studies on the registry are indexed under Alcohol Drinking; 172 are open to participants now.
This study's planned enrollment of 28 is below the median of 108 across 802 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This arm will receive placebo on the first visit, and dronabinol on the second visit
Drug: Dronabinol Pill · Drug: Placebo
This arm will receive dronabinol on the first visit, and placebo on the second visit.
Drug: Dronabinol Pill · Drug: Placebo
Dronabinol 20 mg
placebo
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
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
Cannabis cue reactivity task BOLD signal to cannabis cues, relative to neutral cues
Time frame: 1 hour after administration of a single dose of study medication at 7 days, 14 days.
Alcohol self-administration
Number of drinks self-administered
Time frame: 3-4 hours after administration of a single dose of study medication at 7 days, 14 days.
Self-reported alcoholic drinks consumed
# of drinks consumed per day
Time frame: one report per day for the 14 days after the final laboratory visit on day 14.
Self-reported cannabis use
Amount of cannabis consumed per day
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
Number of days in which cannabis and alcohol were both used
Time frame: One report per day for the 14 days after the final laboratory visit on day 14.
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University of Colorado, Denver