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Phase 2 N=228 Randomized Quadruple-blind Treatment

Fatty Acid Amide Hydrolase (FAAH) Inhibitor Treatment of Cannabis Use Disorder (CUD)

Cannabis Use Disorder

Bottom Line

View on ClinicalTrials.gov: NCT03386487 ↗
Enrolled (actual)
228
Serious AEs
0.9%
Results posted
Feb 2024
Primary outcome: Primary: Time Line Follow Back (TLFB) for Cannabis Use — 1.921; 1.768; 1.201; 1.066 times/day of self-reported cannabis use

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
PF 04457845 (Drug); Placebo Oral Tablet (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Yale University
Primary completion
Jul 2022

Outcome Measures

OutcomeResultp-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 —

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)

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.
View full record on ClinicalTrials.gov →

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.

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