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

Yale University

Status and phase: Completed; Phase 2

Conditions: Cannabis Use Disorder

Treatments: Drug: PF 04457845; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03386487

2000022450

1U01DA045372-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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)

Full 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.

Enrollment: 228 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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228 participants in 2 patient groups, including a placebo group

PF-04457845

Active Comparator group

Description:

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

Treatment:

Drug: PF 04457845

Placebo

Placebo Comparator group

Description:

Subjects will be randomized to placebo

Treatment:

Drug: Placebo Oral Tablet