Fatty Acid Amide Hydrolase (FAAH) Inhibitor Treatment of Cannabis Use Disorder (CUD) (FAAH-I MULTI)
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| ClinicalTrials.gov Identifier: NCT03386487 |
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Recruitment Status :
Recruiting
First Posted : December 29, 2017
Last Update Posted : January 8, 2021
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Sponsor:
Yale University
Collaborators:
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
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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 |
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.
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: PF-04457845
Subjects will be randomized to Fatty Acid Amide Hydrolase (FAAH) Inhibitor; 4 mg PF-04457845 QD x 8 weeks
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Drug: PF 04457845
Study medication will be administered at 4mg by mouth daily for eight weeks. |
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Placebo Comparator: Placebo
Subjects will be randomized to placebo
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Drug: Placebo Oral Tablet
Placebo comparator will be administered by mouth daily for eight weeks. |
Primary Outcome Measures :
- 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.
- 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:
- Ages 18-60 years, inclusive.
- Male or Female.
- Individuals with DSM-V criteria for Cannabis Use Disorder .
- Positive for urinary THC-COOH at both screening visits.
- Must express a willingness at screening to set a date within the first week of randomization to attempt to quit using cannabis.
Exclusion Criteria:
- Clinically significant unstable medical disorders (as determined by the site investigator).
- Laboratory tests with clinically significant abnormalities (as determined by the site investigator)
- Pregnancy by history and or laboratory confirmation (serum HCG).
- Lactation.
- 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
| Contact: Christina Luddy, BS | 203-932-5711 ext 4549 | christina.luddy@yale.edu |
Locations
| 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
National Institute on Drug Abuse (NIDA)
Investigators
| Principal Investigator: | Deepak C D'Souza, MD | Yale University |
| Responsible Party: | Deepak C. D'Souza, Professor of Psychiatry, Yale University |
| ClinicalTrials.gov 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: | January 8, 2021 |
| Last Verified: | January 2021 |
| 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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Marijuana Abuse Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |