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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborators: Columbia University; Johns Hopkins University; Medical University of South Carolina; National Institute on Drug Abuse (NIDA)

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.