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

NCT03386487 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2024-02-14

Study results available
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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)

Conditions

  • Cannabis Use Disorder

Interventions

DRUG

PF 04457845

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

DRUG

Placebo Oral Tablet

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

Sponsors & Collaborators

  • Columbia University

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • Medical University of South Carolina

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Deepak C D'Souza, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-14
Primary Completion
2022-07-25
Completion
2022-07-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03386487 on ClinicalTrials.gov