Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal

NCT ID: NCT01618656

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-12
• Study Completion Date: 2016-03-11

Brief Summary

Cannabis dependence is associated with changes in the brain's cannabinoid system. When cannabis dependent individuals try to quit using cannabis, some of them experience problems that make it difficult for them to achieve and maintain abstinence. Therefore, reducing the problems related to quitting cannabis may facilitate abstinence. One way to do this is by harnessing the brain's capacity to make its own cannabis-like substances - endocannabinoids. One of the main endocannabinoids is anandamide. The study is based on the hypothesis that the problems related to quitting cannabis use will be reduced by increasing the brain levels of anandamide. Furthermore, by reducing the problems related to quitting cannabis, people will be less likely to relapse. Brain anandamide levels will be increased by blocking the breakdown of anandamide using a fatty acid amide hydrolase inhibitor (FAAH-I). The effects of a novel FAAH-I cannabis withdrawal and relapse in cannabis dependent subjects will be studied in a double-blind, randomized, controlled, proof-of-concept study. Cannabis-dependent subjects will receive placebo or the FAAH-inhibitor PF-04457845 in a 2:1 randomization. The trial consists of a 1 week inpatient stay to achieve abstinence, a 3 week outpatient treatment phase. Cannabis withdrawal will be measured during the inpatient phase. Cannabis use and urinary THC-COOH levels will be measured during the entire study. The treatment phase will be followed by a safety follow up phase of 8 weeks.

Conditions

Cannabis Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PF-04457845

2/3 of subjects will be randomized to fatty acid amide hydrolase (FAAH) inhibitor 4mg

Group Type: ACTIVE_COMPARATOR

PF-04457845

Intervention Type: DRUG

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

Placebo (sugar pill)

1/3 of subjects will be randomized to placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sugar pill

Interventions

PF-04457845

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

Intervention Type: DRUG

Placebo

Sugar pill

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male

2. Ages 18-55 (inclusive)

3. Cannabis Dependence

Exclusion Criteria

1. Allergies or intolerance to FAAH-Inhibitors

2. Current significant medical or other comorbidities

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Deepak C. D'Souza

Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deepak C D'Souza, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

Countries

United States

References

D'Souza DC, Cortes-Briones J, Creatura G, Bluez G, Thurnauer H, Deaso E, Bielen K, Surti T, Radhakrishnan R, Gupta A, Gupta S, Cahill J, Sherif MA, Makriyannis A, Morgan PT, Ranganathan M, Skosnik PD. Efficacy and safety of a fatty acid amide hydrolase inhibitor (PF-04457845) in the treatment of cannabis withdrawal and dependence in men: a double-blind, placebo-controlled, parallel group, phase 2a single-site randomised controlled trial. Lancet Psychiatry. 2019 Jan;6(1):35-45. doi: 10.1016/S2215-0366(18)30427-9. Epub 2018 Dec 6.

Reference Type: DERIVED

PMID: 30528676 (View on PubMed)

Other Identifiers

U01DA033267

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1202009714

Identifier Type: -

Identifier Source: org_study_id