Status:
COMPLETED
Fatty Acid Amide Hydrolase (FAAH) Inhibitor Treatment of Cannabis Use Disorder (CUD)
Lead Sponsor:
Yale University
Collaborating Sponsors:
Columbia University
Johns Hopkins University
Conditions:
Cannabis Use Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
A Phase 2B, 8-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of the Fatty Acid Amide Hydrolase (FAAH) Inhibitor PF-04457845 ...
Detailed Description
The efficacy, safety and tolerability of the FAAH Inhibitor PF-0447845 in reducing cannabis use will be studied in a 4-site randomized, double-blind, placebo-controlled, parallel-group, outpatient cli...
Eligibility Criteria
Inclusion
- Ages 18-60 years, inclusive.
- Male or Female.
- Individuals with DSM-V criteria for Cannabis Use Disorder .
- Positive for urinary THC-COOH at both screening visits.
- Must express a willingness at screening to set a date within the first week of randomization to attempt to quit using cannabis.
Exclusion
- Clinically significant unstable medical disorders (as determined by the site investigator).
- Laboratory tests with clinically significant abnormalities (as determined by the site investigator)
- Pregnancy by history and or laboratory confirmation (serum HCG).
- Lactation.
- Physiological dependence on another substance.
Key Trial Info
Start Date :
January 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2022
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT03386487
Start Date
January 14 2019
End Date
July 25 2022
Last Update
February 14 2024
Active Locations (4)
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1
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
2
Johns Hopkins University
Baltimore, Maryland, United States, 21224
3
Columbia University Medical College / New York State Psychiatric Institute
New York, New York, United States, 10032
4
Medical University of South Carolina
Charleston, South Carolina, United States, 29425