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Phase IIB

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

  • Study HIC#:2000022450
  • Last Updated:07/15/2021

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
  • Start Date01/14/2019
  • End Date12/31/2022

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:

  1. Ages 18-60 years, inclusive.
  2. Male or Female.
  3. Individuals with DSM-V criteria for Cannabis Use Disorder .
  4. Positive for urinary THC-COOH at both screening visits.
  5. Must express a willingness at screening to set a date within the first week of randomization to attempt to quit using cannabis.

Exclusion Criteria:

  1. Clinically significant unstable medical disorders (as determined by the site investigator).
  2. Laboratory tests with clinically significant abnormalities (as determined by the site investigator)
  3. Pregnancy by history and or laboratory confirmation (serum HCG).
  4. Lactation.
  5. Physiological dependence on another substance.

Principal Investigator

Sub-Investigators

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