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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01618656
Recruitment Status : Active, not recruiting
First Posted : June 13, 2012
Last Update Posted : November 30, 2017
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University

Brief 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 and a 8 week follow-up phase. Abstinence and relapse will be measured at various times during this 12 week study.

Condition or disease Intervention/treatment Phase
Cannabis Dependence Drug: PF-04457845 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: FAAH-Inhibitor for Cannabis Dependence
Study Start Date : June 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Marijuana Withdrawal Checklist [ Time Frame: Completed each time subject seen over approximately 16 weeks ]
    32-item checklist evaluating potential symptoms of cannabis withdrawal

  2. Self reported cannabis use [ Time Frame: Evaluated each time subject seen over approximately 16 weeks ]
    Subject quantifies and reports frequency of cannabis use prior to study participation and during

  3. THC-COOH Quantification [ Time Frame: 12 times over approximately 16 weeks ]
    Subjects provide urine samples to quantify levels of THC

  4. Marijuana Craving Scale [ Time Frame: 15 times over approximately 16 weeks ]
    Scale to assess severity of craving for marijuana

  5. Relapse Rates [ Time Frame: After one week of abstinence ]
    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.

Secondary Outcome Measures :
  1. 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) ]
    Measurement of sleeping patterns

  2. Cognitive Testing [ Time Frame: Once pre-treatment, twice during treatment (within 4 weeks) and once during the non-treatment follow up (within 8 weeks) ]
    Various computerized tests of memory, attention and learning

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01618656

United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Deepak C D'Souza, MD Yale University

Responsible Party: Deepak C. D'Souza, Associate Professor of Psychiatry, Yale University Identifier: NCT01618656     History of Changes
Other Study ID Numbers: 1202009714
U01DA033267 ( U.S. NIH Grant/Contract )
First Posted: June 13, 2012    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders