Subjects will be randomized to Fatty Acid Amide Hydrolase (FAAH) Inhibitor; 4 mg PF-04457845 QD x 8 weeks

Cannabis Use Disorder

Study medication will be administered at 4mg by mouth daily for eight weeks.

PF 04457845

Placebo comparator will be administered by mouth daily for eight weeks.

Placebo Oral Tablet

Connecticut Mental Health Center

Johns Hopkins University

Columbia University Medical College / New York State Psychiatric Institute

Medical University of South Carolina

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

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)

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.

Assay of the levels of the principal metabolite of THC (THC-COOH) in urine samples collected from the participants at each weekly visit.

Deepak C. D'Souza

Professor of Psychiatry

Yale University

Columbia University

2/3 of subjects will be randomized to fatty acid amide hydrolase (FAAH) inhibitor 4mg

1/3 of subjects will be randomized to placebo

Cannabis Dependence

Study medication will be administered at 4mg by mouth daily for four weeks.

PF-04457845

Placebo

Yale University School of Medicine

Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal

FAAH-Inhibitor for Cannabis Dependence

32-item checklist evaluating potential symptoms of cannabis withdrawal

Subject quantifies and reports frequency of cannabis use prior to study participation and during

Subjects provide urine samples to quantify levels of THC

Various computerized tests of memory, attention and learning

Visual analog scale for feeling states (depression, anxiety, irritability)

Measurement of circulating plasma Anandamide

Associate Professor of Psychiatry

National Institute on Drug Abuse (NIDA)

Dronabinol 2.5 mg will be taken orally with water twice per day for two days.

Dronabinol 5 mg will be taken orally with water twice per day for two days.

Placebo will be taken orally with water twice per day for two days.

Dronabinol 2.5 mg Bid

Dronabinol 5 mg Bid

Total

Sex: Female, Male

Region of Enrollment

Body Mass Index (BMI)

The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.

Colonic Transit Geometric Center

The time for half of the ingested solids or liquids to leave the stomach.

Gastric Emptying Half-Time (t1/2)

Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.

Colonic Filling at 6 Hours

Ascending colon emptying t1/2 will be estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. The primary data for this analysis will be the proportion of decay and depth-corrected counts in the ascending colon on the hourly scans on the first day of transit measurement and the 48 hour data.

Ascending Colon Emptying T 1/2

Proportion of stomach contents emptied at a 2 and 4 hours.

Gastric Emptying at 2 and 4 Hours

Colonic Transit Geometric Center at 24 Hours

Overall Study

Dr. Michael Camilleri

Irritable Bowel Syndrome

Dronabinol is a synthetic delta-9-tetrahydrocannabinol, a nonselective cannabinoid agonist. Subjects will receive either 2.5 mg bid, or 5 mg bid, taken orally with water for 2 days.

Dronabinol

Placebo will match study drug; taken orally with water twice per day for two days.

hydrolase/kanapė

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

Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal

Effect of Cannabinoid Agonist on Gastrointestinal and Colonic Motor Functions in Patients With Irritable Bowel Syndrome (IBS)

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