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NCT01618656 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal
A Phase 2 study of Cannabis Dependence, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT01618656: Completed Phase 2 study of Cannabis Dependence, sponsored by Yale University.
NCT01618656 is a Phase 2 study of Cannabis Dependence that has completed, run by Yale University. The registered enrollment target is 70 participants, below the 125-participant average among 12 other Cannabis Dependence trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01618656, a Phase 2 study of Cannabis Dependence, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG PF-04457845
Study Locations (1)
Connecticut
- Yale University School of Medicine - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2012-09-12 |
| Est. Completion | 2016-03-11 |
| Phase | Phase 2 |
What the finished NCT01618656 record still lists
NCT01618656 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 125-participant average among 12 other Cannabis Dependence trials with a reported enrollment target (44% lower).
The record links to 1 condition, with Cannabis Dependence appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01618656 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT01618656 about?
NCT01618656 is a clinical study titled "Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal". 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 ...
What is the current status of trial NCT01618656?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2012-09-12. Estimated completion is 2016-03-11.
What conditions does trial NCT01618656 study?
This clinical trial studies the following conditions: Cannabis Dependence.
What interventions are being tested in trial NCT01618656?
The interventions under investigation include: Placebo (DRUG), PF-04457845 (DRUG).
Who is sponsoring clinical trial NCT01618656?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01618656 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01618656's enrollment target sits among peer trials
70 6th of 12 higher than 6 of 12 other Cannabis Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cannabis Dependence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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