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

Not Applicable

Completed

• Conditions: Cocaine Dependence; Cocaine Addiction
• Interventions: Drug: Metyrapone; Drug: Placebo; Drug: Oxazepam

• Registration Number: NCT00567814
• Lead Sponsor: Embera NeuroTherapeutics, Inc.

Brief Summary

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

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-03
• Study First Submitted QC: 2007-12-03
• Study First Posted: 2007-12-05
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-30
• Last Update Posted: 2008-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Metyrapone	Lower dose combination of metyrapone with oxazepam
3	Placebo	-
2	Metyrapone	Higher dose combination of metyrapone with oxazepam
1	Oxazepam	Lower dose combination of metyrapone with oxazepam
2	Oxazepam	Higher dose combination of metyrapone with oxazepam

Primary Outcome Measures

Name	Time	Method
Reduction or elimination of cocaine craving as evidenced by the Cocaine Craving Questionnaire	6 weeks

Secondary Outcome Measures

Name	Time	Method
Reduction or elimination of cocaine use as evidenced by self-report and urine toxicology	6 weeks
Improvement in anxiety and depression symptoms	6 weeks

Trial Locations

Locations (1)

Department of Psychiatry, Psychopharmacology Research Clinic; 🇺🇸 Shreveport, Louisiana, United States