Completed

A Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Two Dose Combinations of Metyrapone and Oxazepam in the Treatment of Cocaine Addiction

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What is being tested

Metyrapone

+ Oxazepam

+ Placebo

Drug
Who is being recruted

Behavior+5

+ Mental Disorders

+ Compulsive Behavior

From 18 to 50 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: December 2007
See protocol details

Summary

Principal SponsorEmbera NeuroTherapeutics, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2007

Actual date on which the first participant was enrolled.

Subjects will be randomly assigned to receive either one of the two potential dose combinations of the study medications or placebo over 6 weeks. The study will include twice weekly visits to the research clinic for laboratory studies, safety assessments and urine drug screens. Subjects will also be questioned regarding drug craving and mood symptoms.

Official TitleA Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Two Dose Combinations of Metyrapone and Oxazepam in the Treatment of Cocaine Addiction
NCT00567814
Principal SponsorEmbera NeuroTherapeutics, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior, AddictiveSubstance-Related DisordersCocaine-Related DisordersChemically-Induced Disorders

Criteria

7 inclusion criteria required to participate
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
Show More Criteria
15 exclusion criteria prevent from participating
Liver enzymes greater than two times normal
Any history of hepatitis
History of disorders requiring chronic treatment with steroids
Significantly abnormal ECG
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Lower dose combination of metyrapone with oxazepam

Group II

Active Comparator
Higher dose combination of metyrapone with oxazepam

Group III

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Department of Psychiatry, Psychopharmacology Research Clinic

Shreveport, United StatesOpen Department of Psychiatry, Psychopharmacology Research Clinic in Google Maps
CompletedOne Study Center