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)
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
228
Study medication will be administered at 4mg by mouth daily for eight weeks.
Placebo comparator will be administered by mouth daily for eight weeks.
Connecticut Mental Health Center
New Haven, Connecticut, United States
Johns Hopkins University
Baltimore, Maryland, United States
Columbia University Medical College / New York State Psychiatric Institute
New York, New York, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Time Line Follow Back (TLFB) for Cannabis Use
Change in the average number of times per day of self-reported cannabis consumption measured by the 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. Differences between groups in the change from baseline use (2 weeks prior to randomization) in the average number of times per day of self-reported consumption of cannabis or a cannabis containing product in the last 4 weeks of treatment captured using the daily TLFB data collected during CAROMA calls.
Time frame: 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.
Urinary Levels of THC-COOH (ng/ml)
Assay of the levels of the principal metabolite of THC (THC-COOH) in urine samples at baseline and bi-weekly over 8 weeks.
Time frame: baseline, week 1, week 3, week 5, week 7, and week 9 visits
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