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COMPLETED
NCT04501874
PHASE2

A Study to Evaluate EMB 001 in Subjects With Cocaine Use Disorder

Sponsor: Embera NeuroTherapeutics, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

EMB-001

720 mg metyrapone/24 mg oxazepam mg BID

DRUG

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