Clinical trial NCT03386487: Fatty Acid Amide Hydrolase (FAAH) Inhibitor Treatment of Cannabis Use Disorder (CUD)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cannabis Use Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Johns Hopkins University
name: Medical University of South Carolina
name: National Institute on Drug Abuse (NIDA)
First posted: 2017-12-29
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 2B
Primary purpose: TREATMENT

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)

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.

Eligibility 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.

Primary outcomes:
measure: Time Line Follow Back (TLFB) for Cannabis Use
timeFrame: Change from baseline in self reported cannabis use as measured by the TLFB approach at baseline and then weekly average daily use over 8 weeks.
measure: Urinary Levels of THC-COOH (ng/ml)
timeFrame: baseline, week 1, week 3, week 5, week 7, and week 9 visits
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: New York
country: United States
facility: Columbia University Medical College / New York State Psychiatric Institute
state: New York
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Yale University
name: Deepak C D'Souza, MD
role: PRINCIPAL_INVESTIGATOR
References: