Phase 2
Completed N=228
Fatty Acid Amide Hydrolase (FAAH) Inhibitor Treatment of Cannabis Use Disorder (CUD)
Source: ClinicalTrials.gov NCT03386487 ↗Enrolled (actual)
228
Serious AEs
0.9%
Results posted
Feb 2024
Primary outcomePrimary: Time Line Follow Back (TLFB) for Cannabis Use — 1.921; 1.768; 1.201; 1.066 times/day of self-reported cannabis use
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Line Follow Back (TLFB) for Cannabis Use |
1.921; 1.768; 1.201; 1.066; 1.308; 1.06 | — |
| PRIMARY Urinary Levels of THC-COOH (ng/ml) |
5.959; 5.571; 5.077; 5.747; 3.069; 3.92 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03386487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.