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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Yale University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University
ClinicalTrials.gov Identifier:
NCT01618656
First received: June 5, 2012
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Cannabis Dependence
Drug: PF-04457845
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: FAAH-Inhibitor for Cannabis Dependence

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Marijuana Withdrawal Checklist [ Time Frame: Completed each time subject seen over approximately 16 weeks ] [ Designated as safety issue: Yes ]
    32-item checklist evaluating potential symptoms of cannabis withdrawal

  • Self reported cannabis use [ Time Frame: Evaluated each time subject seen over approximately 16 weeks ] [ Designated as safety issue: No ]
    Subject quantifies and reports frequency of cannabis use prior to study participation and during

  • THC-COOH Quantification [ Time Frame: 12 times over approximately 16 weeks ] [ Designated as safety issue: No ]
    Subjects provide urine samples to quantify levels of THC

  • Marijuana Craving Scale [ Time Frame: 15 times over approximately 16 weeks ] [ Designated as safety issue: No ]
    Scale to assess severity of craving for marijuana

  • Relapse Rates [ Time Frame: After one week of abstinence ] [ Designated as safety issue: No ]
    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:
  • 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) ] [ Designated as safety issue: No ]
    Measurement of sleeping patterns

  • Cognitive Testing [ Time Frame: Once pre-treatment, twice during treatment (within 4 weeks) and once during the non-treatment follow up (within 8 weeks) ] [ Designated as safety issue: No ]
    Various computerized tests of memory, attention and learning


Estimated Enrollment: 120
Study Start Date: June 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male
  2. Ages 18-50 (inclusive)
  3. Cannabis Dependence

Exclusion Criteria:

  1. Allergies or intolerance to FAAH-Inhibitors
  2. Current significant medical or other comorbidities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618656

Contacts
Contact: Halle Thurnauer, BS 203-974-7489 halle.thurnauer@yale.edu

Locations
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06511
Contact: Grai Bluez, MA    203-974-7435    grai.bluez@yale.edu   
Principal Investigator: Deepak C D'Souza, MD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Deepak C D'Souza, MD Yale University
  More Information

No publications provided

Responsible Party: Deepak C. D'Souza, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT01618656     History of Changes
Other Study ID Numbers: 1202009714, U01DA033267
Study First Received: June 5, 2012
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Data and Safety Monitoring Board

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

ClinicalTrials.gov processed this record on July 23, 2014