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Can a Two-Drug combo break Cocaine's grip?

NCT ID NCT00567814

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are testing whether two dose combinations of metyrapone and oxazepam can help adults with cocaine addiction. The study enrolls 45 people aged 18 to 50 who want treatment and have cocaine in their system. Participants take the drugs or a placebo twice daily for six weeks and visit the clinic twice a week for urine drug screens, safety checks, and questions about craving and mood. The main goal is to see whether the drugs reduce cocaine craving compared with placebo.

What this could mean

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

Active substance
a combination of metyrapone and oxazepam
What this could lead to
If it works, this could point toward a medication combination that helps people with cocaine addiction reduce craving and stay off the drug.
What could go wrong
This is a small, early study of 45 people over six weeks, so any benefit may not hold up in larger trials. Both drugs have side effects of their own, and treating addiction with medication often fails for many patients.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

45 people

The number who actually took part.

Start date

Dec 2007

Finished

Nov 2008

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.

Inclusion Criteria: * Male or female, 18 - 50 years of age * Requests treatment for cocaine addiction * Meets the DSM-IV criteria for cocaine dependency * Able to provide written informed consent and comply with the study * Females of childbearing potential must have a negative pregnancy test and must be using adequate birth control during the study * Test positive for cocaine on a urinary drug screen * Healthy and medically stable in the opinion of the Principal Investigator Exclusion Criteria: * Liver enzymes greater than two times normal * Any history of hepatitis * History of disorders requiring chronic treatment with steroids * Significantly abnormal ECG * Any prominent DSM-IV axis I disorders other than cocaine dependence * Any subject who presents as a danger to self or others in the opinion of the Principal Investigator * Concomitant use of methamphetamine as determined by self-reporting and verified by measurement of methamphetamine in urinary drug screen * Alcohol consumption greater than 4 drinks per day (1 Drink = 12 oz beer; 5 oz wine; 1.5 oz shot of liquor) * Any clinically significant laboratory test abnormalities * Use of any concomitant medication during the study that would interfere with study medications * Serum cortisol less than 3 µg/dl at any time before or during study * Treatment with an investigational product within 30 days prior to study enrollment * Currently seeking other forms of professional addiction treatment * Known allergic reaction to oxazepam or metyrapone * Lactose intolerance

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Conditions

The condition(s) this trial relates to.

Behavior, Addictive cocaine dependence Cocaine-Related Disorders

As listed by the trial registrant

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

Cocaine addiction Cocaine dependence

Contacts and locations

Locations

  • Department of Psychiatry, Psychopharmacology Research Clinic

    Shreveport, Louisiana, 71103, United States

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