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

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ClinicalTrials.gov Identifier: NCT01618656
Recruitment Status : Active, not recruiting
First Posted : June 13, 2012
Last Update Posted : January 10, 2019
Sponsor:
Collaborator:
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. 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.

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

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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 2019
Estimated Study Completion Date : December 2019

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: Administered on Day 0, Day 1, Day 2, Day 3, and Day 4 (during the inpatient phase when withdrawal peaks) to assess change from baseline (Day 0) ]
    32-item checklist evaluating potential symptoms of cannabis withdrawal

  2. Self reported cannabis use at the end of 4 weeks [ Time Frame: Administered weekly for 4 weeks to assess change from baseline (Day 0) ]
    Subject quantifies and reports frequency of cannabis use prior to study participation and during

  3. THC-COOH Quantification at the end of 4 weeks [ Time Frame: Samples obtained weekly for 4 weeks to assess change from baseline (Day 0) ]
    Subjects provide urine samples to quantify levels of THC


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), to assess change from baseline (Day 0) ]
    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) to assess change from baseline (Day 0) ]
    Various computerized tests of memory, attention and learning


Other Outcome Measures:
  1. Feeling States [ Time Frame: Administered on Day 0, Day 1, Day 2, Day 3, and Day 4 (Once pre-treatment and during the inpatient phase 'acute abstinence') to assess change from baseline (Day 0) ]
    Visual analog scale for feeling states (depression, anxiety, irritability)

  2. Plasma endocannabinoid levels [ Time Frame: Samples obtained at the following study visits: Day -1, Day 0, Day 2, Day 4, Week 2, Week 3, Week 4 to assess change from baseline (Day 0) ]
    Measurement of circulating plasma Anandamide



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

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 ClinicalTrials.gov identifier (NCT number): NCT01618656


Locations
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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)
Investigators
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Principal Investigator: Deepak C D'Souza, MD Yale University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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 ( U.S. NIH Grant/Contract )
First Posted: June 13, 2012    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

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