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

NCT03386487 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 20000224501U01DA045372-01
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 4

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)

Conditions

Cannabis Use Disorder

Outcome Measures

Primary Outcomes (2)

• Time Line Follow Back (TLFB) for Cannabis Use

  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.

  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.

• Urinary Levels of THC-COOH (ng/ml)

  Assay of the levels of the principal metabolite of THC (THC-COOH) in urine samples at baseline and bi-weekly over 8 weeks.

  baseline, week 1, week 3, week 5, week 7, and week 9 visits

Study Arms (2)

PF-04457845

ACTIVE COMPARATOR

Subjects will be randomized to Fatty Acid Amide Hydrolase (FAAH) Inhibitor; 4 mg PF-04457845 QD x 8 weeks

Drug: PF 04457845

Placebo

PLACEBO COMPARATOR

Subjects will be randomized to placebo

Drug: Placebo Oral Tablet

Interventions

PF 04457845 DRUG

Study medication will be administered at 4mg by mouth daily for eight weeks.

PF-04457845

Placebo Oral Tablet DRUG

Placebo comparator will be administered by mouth daily for eight weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• Columbia University: collaborator
• Johns Hopkins University: collaborator
• Medical University of South Carolina: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (4)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Columbia University Medical College / New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Interventions

N-pyridazin-3-yl-4-(3-((5-(trifluoromethyl)pyridin-2-yl)oxy)benzylidene)piperidine-1-carboxamide

Results Point of Contact

• Title: Dr. Deepak Cyril D'Souza, M.D.
• Organization: Yale University

deepak.dsouza@yale.edu

203-932-5711

Study Officials

• Deepak C D'Souza, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Model Details: Phase 2B

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: December 29, 2017
• Study Start: January 14, 2019
• Primary Completion: July 25, 2022
• Study Completion: July 25, 2022
• Last Updated: February 14, 2024
• Results First Posted: February 14, 2024

Record last verified: 2024-02

Locations

US (4)