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

Yale University

Status and phase: Completed; Phase 2

Conditions: Cannabis Dependence

Treatments: Drug: PF-04457845; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01618656

1202009714

U01DA033267 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

PF-04457845

Active Comparator group

Description:

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

Treatment:

Drug: PF-04457845

Placebo (sugar pill)

Placebo Comparator group

Description:

1/3 of subjects will be randomized to placebo

Treatment:

Drug: Placebo