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Fatty Acid Amide Hydrolase (FAAH) Inhibitor Treatment of Cannabis Use Disorder (CUD) (FAAH-I MULTI)

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ClinicalTrials.gov Identifier: NCT03386487
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : August 16, 2019
Sponsor:
Collaborators:
Columbia University
Johns Hopkins University
Medical University of South Carolina
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University

Brief Summary:
A Phase 2B, 8-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of the Fatty Acid Amide Hydrolase (FAAH) Inhibitor PF-04457845 in Adults with DSM-5 Current Cannabis Use Disorder (CUD)

Condition or disease Intervention/treatment Phase
Cannabis Use Disorder Drug: PF 04457845 Drug: Placebo Oral Tablet Phase 2

Detailed Description:
The efficacy, safety and tolerability of the FAAH Inhibitor PF-0447845 in reducing cannabis use will be studied in a 4-site randomized, double-blind, placebo-controlled, parallel-group, outpatient clinical trial comparing PF-04457845 (4mg) and placebo in DSM-5 CUD individuals. Participants will be randomized in a 1:1 ratio to either PF-04457845 or placebo using random block sizes of 2 and 4, stratified by site and degree of cannabis use. Participants will receive motivational interviewing for 2 weeks before being randomized to receive study medication to make a quit attempt within the first week of treatment. Participants will receive active or placebo PF-04457845 for 8 weeks during which time they will be evaluated weekly in face to face visits. In addition, daily assessment of adherence to study medication and cannabinoid use will be conducted daily by cellphone. Measures of cannabinoid exposure (self-reported and urine toxicology), and problems related to the use of cannabis, will be assessed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 237 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase 2B
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2B, 8-week, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate Efficacy, Safety and Tolerability of the Fatty Acid Amide Hydrolase (FAAH) Inhibitor PF-04457845 in Adults With DSM5 Current Cannabis Use Disorder (CUD)
Actual Study Start Date : January 14, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Active Comparator: PF-04457845
Subjects will be randomized to Fatty Acid Amide Hydrolase (FAAH) Inhibitor; 4 mg PF-04457845 QD x 8 weeks
Drug: PF 04457845
Study medication will be administered at 4mg by mouth daily for eight weeks.

Placebo Comparator: Placebo
Subjects will be randomized to placebo
Drug: Placebo Oral Tablet
Placebo comparator will be administered by mouth daily for eight weeks.




Primary Outcome Measures :
  1. Time Line Follow Back (TLFB) for cannabis use [ Time Frame: Change from baseline in weekly self reported cannabis use as measured by the TLFB at baseline and then weekly over 8 weeks ]
    Change in the average number of times per day of self-reported cannabis consumption measured by the 7 day Timeline Follow Back approach for Cannabis Use in which participants quantify and report their frequency of cannabis use prior to study participation and throughout the study.

  2. Urinary levels of THC-COOH (ng/ml) [ Time Frame: Change from baseline in weekly levels of urinary THC-COOH levels over 8 weeks from urine samples collected at baseline and each weekly visit ]
    Assay of the levels of the principal metabolite of THC (THC-COOH) in urine samples collected from the participants at each weekly visit.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ages 18-60 years, inclusive.
  2. Male or Female.
  3. Individuals with DSM-V criteria for Cannabis Use Disorder .
  4. Positive for urinary THC-COOH at both screening visits.
  5. Must express a willingness at screening to set a date within the first week of randomization to attempt to quit using cannabis.

Exclusion Criteria:

  1. Clinically significant unstable medical disorders (as determined by the site investigator).
  2. Laboratory tests with clinically significant abnormalities (as determined by the site investigator)
  3. Pregnancy by history and or laboratory confirmation (serum HCG).
  4. Lactation.
  5. Physiological dependence on another substance.

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): NCT03386487


Contacts
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Contact: Christina Luddy, BS 203-932-5711 ext 4549 christina.luddy@yale.edu

Locations
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United States, Connecticut
Connecticut Mental Health Center Recruiting
New Haven, Connecticut, United States, 06519
Contact: Alex Selloni, BA    203-974-7544    alexandria.selloni@yale.edu   
Contact: Kimberlee Forselius-Bielen, BS    203-974-7540    kimberlee.forselius@yale.edu   
Principal Investigator: Deepak C D'Souza, MD         
Sub-Investigator: Mohini Ranganathan, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21224
Contact: Elia Goffi, BS    410-550-0050    egoffi2@jhmi.edu   
Principal Investigator: Ryan Vandrey, PhD         
Sub-Investigator: Dustin Lee, PhD         
United States, New York
Columbia University Medical College / New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Amy Mahony, LMHC       amy.mahony@nyspi.columbia.edu   
Principal Investigator: Frances Levin, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Amanda Wagner, MA, LPC    843-792-0484    wagne@musc.edu   
Principal Investigator: Kevin Gray, MD         
Principal Investigator: Aimee McRae-Clark, MD         
Sponsors and Collaborators
Yale University
Columbia University
Johns Hopkins University
Medical University of South Carolina
Investigators
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Principal Investigator: Deepak C D'Souza, MD Yale University

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Responsible Party: Deepak C. D'Souza, Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT03386487     History of Changes
Other Study ID Numbers: 2000022450
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Marijuana Abuse
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders