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Cannabinoid
THC for Alcohol Consumption
Phase 2
Recruiting
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour after administration of a single dose of study medication at 7 days, 14 days.
Summary
This trial will investigate how taking high doses of a cannabis compound, THC, affects the way people consume alcohol. The study will look at how THC impacts the brain's reward system, alcohol consumption, and
Who is the study for?
This trial is for individuals who regularly drink alcohol and use cannabis. Participants should reach out to the study site for more detailed eligibility requirements.
What is being tested?
The study investigates how a high dose of oral THC (20mg dronabinol pill) versus a placebo affects brain reward systems, alcohol consumption, and real-world patterns of using both substances together.
What are the potential side effects?
Potential side effects may include typical reactions to THC such as altered senses, changes in mood, impaired body movement, difficulty with thinking and problem-solving, impaired memory, and an increased risk of addiction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 hour after administration of a single dose of study medication at 7 days, 14 days.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour after administration of a single dose of study medication at 7 days, 14 days.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Alcohol self-administration
Change in alcohol cue-elicited brain activation (fMRI) between medication periods
Change in cannabis cue-elicited brain activation (fMRI) between medication periods
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Placebo first, Dronabinol secondExperimental Treatment2 Interventions
This arm will receive placebo on the first visit, and dronabinol on the second visit
Group II: Dronabinol first, Placebo secondExperimental Treatment2 Interventions
This arm will receive dronabinol on the first visit, and placebo on the second visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Colorado State UniversityOTHER
132 Previous Clinical Trials
38,399 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,806 Previous Clinical Trials
2,822,378 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
836 Previous Clinical Trials
1,082,902 Total Patients Enrolled
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