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A Study of Metyrapone and Oxazepam Combination Product (EMB-001) and Cocaine

NCT02856854 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-08-01

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 Phase 1b cocaine interaction study is being conducted in order to assess the safety and PK of EMB-001 and cocaine in combination.

Conditions

  • Cocaine Use Disorder

Interventions

DRUG

EMB-001

EMB-001 is a combination of metyrapone (720mg per dose in this study) and oxazepam (24mg per dose in this study)

DRUG

Placebo

EMB-001 matched placebo

DRUG

Cocaine IV

Cocaine administered at doses of 20 and 40mg

DRUG

Saline IV

Cocaine matched placebo

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Embera NeuroTherapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Debra Kelsh, MD · Vince & Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-02-17
Completion
2017-07-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02856854 on ClinicalTrials.gov