Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal
This study is ongoing, but not recruiting participants.
First Posted: June 13, 2012
Last Update Posted: June 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University
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 and a 8 week follow-up phase. Abstinence and relapse will be measured at various times during this 12 week study.
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||FAAH-Inhibitor for Cannabis Dependence
Primary Outcome Measures:
- Marijuana Withdrawal Checklist [ Time Frame: Completed each time subject seen over approximately 16 weeks ]
32-item checklist evaluating potential symptoms of cannabis withdrawal
- Self reported cannabis use [ Time Frame: Evaluated each time subject seen over approximately 16 weeks ]
Subject quantifies and reports frequency of cannabis use prior to study participation and during
- THC-COOH Quantification [ Time Frame: 12 times over approximately 16 weeks ]
Subjects provide urine samples to quantify levels of THC
- Marijuana Craving Scale [ Time Frame: 15 times over approximately 16 weeks ]
Scale to assess severity of craving for marijuana
- Relapse Rates [ Time Frame: After one week of abstinence ]
Subjects will frequently be evaluated to determine if they are able to maintain abstinence after one week of study treatment, at the end of the treatment period as well as at the end of the non-treatment follow up period.
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2017 (Final data collection date for primary outcome measure)
Active Comparator: PF-04457845
2/3 of subjects will be randomized to fatty acid amide hydrolase (FAAH) inhibitor 4mg
Study medication will be administered at 4mg by mouth daily for four weeks.
Placebo Comparator: Placebo (sugar pill)
1/3 of subjects will be randomized to placebo