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

Phase 2

Completed

• Conditions: Cannabis Use Disorder
• Interventions: Drug: PF 04457845; Drug: Placebo Oral Tablet

• Registration Number: NCT03386487
• Lead Sponsor: Yale University

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)

Detailed Description

The efficacy, safety and tolerability of the FAAH Inhibitor PF-0447845 in reducing cannabis use will be studied in a 4-site randomized, double-blind, placebo-controlled, parallel-group, outpatient clinical trial comparing PF-04457845 (4mg) and placebo in DSM-5 CUD individuals. Participants will be randomized in a 1:1 ratio to either PF-04457845 or placebo using random block sizes of 2 and 4, stratified by site and degree of cannabis use. Participants will receive motivational interviewing for 2 weeks before being randomized to receive study medication to make a quit attempt within the first week of treatment. Participants will receive active or placebo PF-04457845 for 8 weeks during which time they will be evaluated weekly in face to face visits. In addition, daily assessment of adherence to study medication and cannabinoid use will be conducted daily by cellphone. Measures of cannabinoid exposure (self-reported and urine toxicology), and problems related to the use of cannabis, will be assessed.

Study Timeline

• Study First Submitted: 2017-12-21
• Study First Submitted QC: 2017-12-21
• Study First Posted: 2017-12-29
• Study Start: 2019-01-14
• Primary Completion: 2022-07-25
• Study Completion: 2022-07-25
• Disposition First Submitted: 2023-07-24
• Results First Submitted: 2023-11-22
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-09
• Last Update Submitted: 2024-02-09
• Results First Posted: 2024-02-14
• Disposition First Posted: 2024-02-14
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-04457845	PF 04457845	Subjects will be randomized to Fatty Acid Amide Hydrolase (FAAH) Inhibitor; 4 mg PF-04457845 QD x 8 weeks
Placebo	Placebo Oral Tablet	Subjects will be randomized to placebo

Primary Outcome Measures

Name	Time	Method
Time Line Follow Back (TLFB) for Cannabis Use	Change from baseline in self reported cannabis use as measured by the TLFB approach at baseline and then weekly average daily use over 8 weeks.	Change in the average number of times per day of self-reported cannabis consumption measured by the Timeline Follow Back approach for Cannabis Use in which participants quantify and report their frequency of cannabis use prior to study participation and throughout the study. Differences between groups in the change from baseline use (2 weeks prior to randomization) in the average number of times per day of self-reported consumption of cannabis or a cannabis containing product in the last 4 weeks of treatment captured using the daily TLFB data collected during CAROMA calls.
Urinary Levels of THC-COOH (ng/ml)	baseline, week 1, week 3, week 5, week 7, and week 9 visits	Assay of the levels of the principal metabolite of THC (THC-COOH) in urine samples at baseline and bi-weekly over 8 weeks.

Trial Locations

Locations (4)

Connecticut Mental Health Center; 🇺🇸 New Haven, Connecticut, United States

Columbia University Medical College / New York State Psychiatric Institute; 🇺🇸 New York, New York, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States