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Can a Two-Drug combo break cocaine addiction?

NCT ID NCT04501874

NEW Symptom relief Sponsor: Embera NeuroTherapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing EMB-001, a combination of metyrapone and oxazepam, in adults with moderate-to-severe cocaine use disorder. The trial aims to see if the drug helps people stay away from cocaine during the last three weeks of treatment. About 80 participants will take either EMB-001 or a placebo for several weeks, and researchers will check their cocaine use through self-reports and urine tests.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EMB-001, a combination of metyrapone and oxazepam
What this could lead to
If it works, this could offer the first medication-based option to help people with cocaine use disorder reduce or stop cocaine use.
What could go wrong
This is a mid-stage trial with about 80 participants, so results may not hold in larger groups. The drug combination can cause side effects, and addiction treatment is notoriously difficult to get right.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

82 people

The number who actually took part.

Started

Jul 2020

Finished

Oct 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Provide written informed consent prior to any study procedures * 18 to 65 years of age * DSM-5 diagnosis of moderate-to-severe CUD * Seeking treatment for CUD. Subjects with past rehabilitation attempts are eligible if the most recent rehabilitation attempt ended at least 30 days prior to Screening * Female subjects must be of non-childbearing potential * Male subjects must agree to use accepted contraceptive regimens during the study and for at least 90 days after the last dose of the study drug Key Exclusion Criteria: * Any significant current medical conditions * Known hypersensitivity to or intolerance of oxazepam, metyrapone, or any benzodiazepine, or severe hypersensitivity reaction (e.g., angioedema) to any drug * Heightened likelihood of having adrenal insufficiency in the investigator's or designees' opinion * Current court-mandated treatment requirement for a substance-use disorder * Current DSM-5 moderate-to-severe substance use disorder, other than CUD, tobacco or caffeine * Current DSM-5 opioid or benzodiazepine use disorder of any severity

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Conditions

The condition(s) this trial relates to.

cocaine dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cocaine use disorder

Contacts and locations

Locations

  • Medical University of South Carolina

    Charleston, South Carolina, 29403, United States

  • Pacific Treatment and Research Center, Department of Psychiatry, University of California, San Diego, School of Medicine

    San Diego, California, 92092, United States

  • Segal Trials

    Miami, Florida, 33161, United States

  • U PENN- Perelman School of Medicine

    Philadelphia, Pennsylvania, 19104, United States

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