Fatty Acid Amide Hydrolase (FAAH) Inhibitor Treatment of Cannabis Use Disorder (CUD) (FAAH-I MULTI)
- Study HIC#:2000022450
- Last Updated:01/01/0001
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 in Adults with DSM-5 Current Cannabis Use Disorder (CUD)
- Age18 years - 60 years
- GenderBoth
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Trial Purpose and Description
The effects of PF-04457845 (4 mg QD) will be studied in treatment-seeking subjects with a cannabis use disorder (n= 260) in a placebo-controlled, double-blind, randomized, multicenter, 8-week long parallel-group outpatient study funded by the National Institute of Drug Abuse (NIDA).
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
