Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03386487
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : February 10, 2022
Columbia University
Johns Hopkins University
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
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.

Layout table for study information
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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT03386487

Layout table for location contacts
Contact: Christina Luddy, BS 203-932-5711 ext 4549

Layout table for location information
United States, Connecticut
Connecticut Mental Health Center Recruiting
New Haven, Connecticut, United States, 06519
Contact: Alex Selloni, BA    203-974-7544   
Contact: Kimberlee Forselius-Bielen, BS    203-974-7540   
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   
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   
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   
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
National Institute on Drug Abuse (NIDA)
Layout table for investigator information
Principal Investigator: Deepak C D'Souza, MD Yale University
Layout table for additonal information
Responsible Party: Deepak C. D'Souza, Professor of Psychiatry, Yale University Identifier: NCT03386487    
Other Study ID Numbers: 2000022450
1U01DA045372-01 ( U.S. NIH Grant/Contract )
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: February 10, 2022
Last Verified: February 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders