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

Cannabis Dependence Clinical Trial

Official title:

FAAH-Inhibitor for Cannabis Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618656
• Other study ID #: 1202009714
• Secondary ID: U01DA033267
• Status: Completed
• Phase: Phase 2
• Start date: September 12, 2012
• Est. completion date: March 11, 2016

Study information

• Verified date: January 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 11, 2016
• Est. primary completion date: March 11, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis Dependence
• Marijuana Abuse

Intervention

Drug:
• PF-04457845
Study medication will be administered at 4mg by mouth daily for four weeks.
• Placebo
Sugar pill

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feeling States	Visual analog scale for feeling states (depression, anxiety, irritability)	Administered on Day 0, Day 1, Day 2, Day 3, and Day 4 (Once pre-treatment and during the inpatient phase 'acute abstinence') to assess change from baseline (Day 0)
Other	Plasma Endocannabinoid Levels	Measurement of circulating plasma Anandamide	Samples obtained at the following study visits: Day -1, Day 0, Day 2, Day 4, Week 2, Week 3, Week 4 to assess change from baseline (Day 0)
Primary	Change in Marijuana Withdrawal Checklist (MWC)	32-item checklist evaluating potential symptoms of cannabis withdrawal, lower values reflect lesser severity of withdrawal symptoms (lower scores represent a better outcome).; Min: 0 Max: 96	The MWC was administered on Day 0, Day 1, Day 2, Day 3, and Day 4 (during the inpatient phase when withdrawal peaks) to assess change from baseline (Day 0). The scores from each time point and subject were calculated to report the mean score for each arm.
Primary	Change in Self Reported Cannabis Use at the End of 4 Weeks	Subject quantifies and reports frequency of cannabis use prior to study participation and during the 4 week period. Lower scores reflect less cannabis usage, while higher scores reflect more frequent usage.; Min: 0 Max: undeterminable, varies per patient and their usage.	Administered weekly for 4 weeks to assess change from baseline (Day 0). The scores from each time point and subject were calculated to report the mean score for each arm.
Primary	Change in THC-COOH Quantification at the End of 4 Weeks	Subjects provide urine samples to quantify levels of THC.	Samples obtained weekly for 4 weeks to assess change from baseline (Day 0). The results from each time point and subject were calculated to report the mean score for each arm.
Secondary	Change in Polysomnography	Polysomnography (PSG) is a comprehensive reading of biophysiological changes that occur during sleep, including identification of sleep stage. A mean and standard deviation of their data points during sleep stages were calculated to determine change from baseline to the end of study treatment.	Polysomnography was collected two nights prior to baseline visit, for three nights during study treatment and two nights after four weeks of study treatment. A mean was calculated to assess change from baseline (Day 0).