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

NCT04501874 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2023-08-08

No results posted yet for this study

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).

Conditions

  • Cocaine Use Disorder

Interventions

DRUG

EMB-001

720 mg metyrapone/24 mg oxazepam mg BID

DRUG

EMB-001 Placebo

Inactive comparator

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Embera NeuroTherapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Bruce McCarthy, MD · Embera NeuroTherapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-07-29
Primary Completion
2022-07-27
Completion
2022-10-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04501874 on ClinicalTrials.gov