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

Study Overview
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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.

Official Title
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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

Conditions
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Cocaine Dependence, Cocaine Addiction

Intervention / Treatment
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* Drug: Metyrapone
* Drug: Oxazepam
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Lower dose combination of metyrapone with oxazepam | Drug: Metyrapone<br>* Twice daily<br>* Other names: Metopirone;Drug: Oxazepam<br>* Twice Daily<br>* Other names: Serax;|
| Active Comparator: 2<br>Higher dose combination of metyrapone with oxazepam | Drug: Metyrapone<br>* Twice daily<br>* Other names: Metopirone;Drug: Oxazepam<br>* Twice Daily<br>* Other names: Serax;|
| Placebo Comparator: 3<br> | Drug: Placebo<br>* Twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction or elimination of cocaine craving as evidenced by the Cocaine Craving Questionnaire |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction or elimination of cocaine use as evidenced by self-report and urine toxicology |  | 6 weeks | 
| Improvement in anxiety and depression symptoms |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cocaine, Dependence, Addiction, Cortisol, GABA