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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 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.

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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.

Conditions Studied

Cannabis Dependence

Interventions

  • DRUG Placebo
  • DRUG PF-04457845

Study Locations (1)

Connecticut

  • Yale University School of Medicine - New Haven

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2012-09-12
Est. Completion 2016-03-11
Phase Phase 2

Sponsor

Yale University

1,492 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01618656

The ClinicalTrials.gov registry entry for NCT01618656 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 125-participant average among 12 other Cannabis Dependence trials with a reported enrollment target (44% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.