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A Placebo-Controlled Study of a Combination of Metyrapone and Oxazepam in Cocaine Addiction

NCT ID: NCT00567814

Last Updated: 2008-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cocaine Dependence Cocaine Addiction

Keywords

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Cocaine Dependence Addiction Cortisol GABA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Lower dose combination of metyrapone with oxazepam

Group Type ACTIVE_COMPARATOR

Metyrapone

Intervention Type DRUG

Twice daily

Oxazepam

Intervention Type DRUG

Twice Daily

2

Higher dose combination of metyrapone with oxazepam

Group Type ACTIVE_COMPARATOR

Metyrapone

Intervention Type DRUG

Twice daily

Oxazepam

Intervention Type DRUG

Twice Daily

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Twice daily

Interventions

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Metyrapone

Twice daily

Intervention Type DRUG

Oxazepam

Twice Daily

Intervention Type DRUG

Placebo

Twice daily

Intervention Type DRUG

Other Intervention Names

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Metopirone Serax

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Embera NeuroTherapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Embera NeuroTherapeutics, Inc.

Principal Investigators

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Anita S Kablinger, MD

Role: PRINCIPAL_INVESTIGATOR

LSU Health Sciences Center - Shreveport

Locations

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Department of Psychiatry, Psychopharmacology Research Clinic

Shreveport, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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ECA-001

Identifier Type: -

Identifier Source: org_study_id