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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 24, 2014
Last verified: September 2014

June 5, 2012
September 24, 2014
June 2012
December 2016   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01618656 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal
FAAH-Inhibitor for Cannabis Dependence

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cannabis Dependence
  • Drug: PF-04457845
    Study medication will be administered at 4mg by mouth daily for four weeks.
  • Drug: Placebo
    Sugar pill
  • Active Comparator: PF-04457845
    2/3 of subjects will be randomized to fatty acid amide hydrolase (FAAH) inhibitor 4mg
    Intervention: Drug: PF-04457845
  • Placebo Comparator: Placebo (sugar pill)
    1/3 of subjects will be randomized to placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2016
December 2016   (final data collection date for primary outcome measure)

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
Male
18 Years to 50 Years
No
Contact: Gina Creatura, BA 203-974-7544 gina.creatura@yale.edu
United States
 
NCT01618656
1202009714, U01DA033267
Yes
Deepak C. D'Souza, Yale University
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Deepak C D'Souza, MD Yale University
Yale University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP