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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Cannabis Use Disorder

Intervention / Treatment
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* Drug: PF 04457845
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Phase 2B
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PF-04457845<br>Subjects will be randomized to Fatty Acid Amide Hydrolase (FAAH) Inhibitor; 4 mg PF-04457845 QD x 8 weeks | Drug: PF 04457845<br>* Study medication will be administered at 4mg by mouth daily for eight weeks.<br>|
| Placebo Comparator: Placebo<br>Subjects will be randomized to placebo | Drug: Placebo Oral Tablet<br>* Placebo comparator will be administered by mouth daily for eight weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline in self reported cannabis use as measured by the TLFB approach at baseline and then daily 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 collected from the participants at each weekly visit. | Change from baseline in weekly levels of urinary THC-COOH levels over 8 weeks from urine samples collected at baseline and each weekly visit |