Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal
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|ClinicalTrials.gov Identifier: NCT01618656|
Recruitment Status : Completed
First Posted : June 13, 2012
Results First Posted : February 23, 2023
Last Update Posted : February 23, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Cannabis Dependence||Drug: PF-04457845 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||FAAH-Inhibitor for Cannabis Dependence|
|Actual Study Start Date :||September 12, 2012|
|Actual Primary Completion Date :||March 11, 2016|
|Actual Study Completion Date :||March 11, 2016|
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
- Change in Marijuana Withdrawal Checklist (MWC) [ Time Frame: 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. ]
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
- Change in Self Reported Cannabis Use at the End of 4 Weeks [ Time Frame: 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. ]
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.
- Change in THC-COOH Quantification at the End of 4 Weeks [ Time Frame: 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. ]Subjects provide urine samples to quantify levels of THC.
- Change in Polysomnography [ Time Frame: 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). ]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.
- Feeling States [ Time Frame: 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) ]Visual analog scale for feeling states (depression, anxiety, irritability)
- Plasma Endocannabinoid Levels [ Time Frame: 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) ]Measurement of circulating plasma Anandamide
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|Ages Eligible for Study:||18 Years to 55 Years (Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- Ages 18-55 (inclusive)
- Cannabis Dependence
- Allergies or intolerance to FAAH-Inhibitors
- Current significant medical or other comorbidities
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01618656
|United States, Connecticut|
|Yale University School of Medicine|
|New Haven, Connecticut, United States, 06511|
|Principal Investigator:||Deepak C D'Souza, MD||Yale University|
|Responsible Party:||Deepak C. D'Souza, Associate Professor of Psychiatry, Yale University|
|Other Study ID Numbers:||
U01DA033267 ( U.S. NIH Grant/Contract )
|First Posted:||June 13, 2012 Key Record Dates|
|Results First Posted:||February 23, 2023|
|Last Update Posted:||February 23, 2023|
|Last Verified:||January 2023|