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A Study to Evaluate EMB 001 in Subjects With Cocaine Use Disorder
Sponsor: Embera NeuroTherapeutics, Inc.
Summary
EMB-001 is a combination of 2 drugs: the cortisol synthesis inhibitor, metyrapone (Metopirone®), and the benzodiazepine receptor agonist, oxazepam (original trade name Serax®; now marketed as oxazepam (generic) only). This is a Phase 2 study in approximately 80 adult subjects with moderate-to-severe Cocaine Use Disorder (CUD).
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Safety and Efficacy of EMB 001 in Subjects With Moderate-to-Severe Cocaine Use Disorder
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
82
Start Date
2020-07-29
Completion Date
2022-10-15
Last Updated
2026-09-21
Healthy Volunteers
No
Conditions
Interventions
EMB-001
720 mg metyrapone/24 mg oxazepam mg BID
EMB-001 Placebo
Inactive comparator
Locations (4)
Pacific Treatment and Research Center, Department of Psychiatry, University of California, San Diego, School of Medicine
San Diego, California, United States
Segal Trials
Miami, Florida, United States
U PENN- Perelman School of Medicine
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States