Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cannabis Dependence |
Drug: PF-04457845 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | FAAH-Inhibitor for Cannabis Dependence |
- Marijuana Withdrawal Checklist [ Time Frame: Completed each time subject seen over approximately 16 weeks ] [ Designated as safety issue: Yes ]32-item checklist evaluating potential symptoms of cannabis withdrawal
- Self reported cannabis use [ Time Frame: Evaluated each time subject seen over approximately 16 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Subjects provide urine samples to quantify levels of THC
- Marijuana Craving Scale [ Time Frame: 15 times over approximately 16 weeks ] [ Designated as safety issue: No ]Scale to assess severity of craving for marijuana
- Relapse Rates [ Time Frame: After one week of abstinence ] [ Designated as safety issue: No ]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.
- Polysomnography [ Time Frame: Two nights prior to study treatment, three nights during study treatment and two nights at the end of study treatment (four weeks later) ] [ Designated as safety issue: No ]Measurement of sleeping patterns
- Cognitive Testing [ Time Frame: Once pre-treatment, twice during treatment (within 4 weeks) and once during the non-treatment follow up (within 8 weeks) ] [ Designated as safety issue: No ]Various computerized tests of memory, attention and learning
| Estimated Enrollment: | 75 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: PF-04457845
2/3 of subjects will be randomized to fatty acid amide hydrolase (FAAH) inhibitor 4mg
|
Drug: PF-04457845
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
|
Drug: Placebo
Sugar pill
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male
- Ages 18-50 (inclusive)
- Cannabis Dependence
Exclusion Criteria:
- Allergies or intolerance to FAAH-Inhibitors
- Current significant medical or other comorbidities
Contacts and Locations| Contact: Halle Thurnauer, BS | 203-974-7489 | halle.thurnauer@yale.edu |
| United States, Connecticut | |
| Yale University School of Medicine | Recruiting |
| New Haven, Connecticut, United States, 06511 | |
| Contact: Halle Thurnauer, BS 203-974-7489 halle.thurnauer@yale.edu | |
| Principal Investigator: Deepak C D'Souza, MD | |
| Principal Investigator: | Deepak C D'Souza, MD | Yale University |
More Information
No publications provided
| Responsible Party: | Deepak C. D'Souza, Associate Professor of Psychiatry, Yale University |
| ClinicalTrials.gov Identifier: | NCT01618656 History of Changes |
| Other Study ID Numbers: | 1202009714, U01DA033267 |
| Study First Received: | June 5, 2012 |
| Last Updated: | March 18, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board United States: Data and Safety Monitoring Board |
Additional relevant MeSH terms:
|
Marijuana Abuse Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013