A Placebo-Controlled Study of a Combination of Metyrapone and Oxazepam in Cocaine Addiction
This study has been completed.
Sponsor:
Embera NeuroTherapeutics, Inc.
Information provided by:
Embera NeuroTherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00567814
First received: December 3, 2007
Last updated: December 30, 2008
Last verified: December 2008
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cocaine Dependence Cocaine Addiction |
Drug: Metyrapone Drug: Oxazepam Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Embera NeuroTherapeutics, Inc.:
Primary Outcome Measures:
- Reduction or elimination of cocaine craving as evidenced by the Cocaine Craving Questionnaire [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Reduction or elimination of cocaine use as evidenced by self-report and urine toxicology [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Improvement in anxiety and depression symptoms [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 45 |
| Study Start Date: | December 2007 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Lower dose combination of metyrapone with oxazepam
|
Drug: Metyrapone
Twice daily
Other Name: Metopirone
Drug: Oxazepam
Twice Daily
Other Name: Serax
|
|
Active Comparator: 2
Higher dose combination of metyrapone with oxazepam
|
Drug: Metyrapone
Twice daily
Other Name: Metopirone
Drug: Oxazepam
Twice Daily
Other Name: Serax
|
| Placebo Comparator: 3 |
Drug: Placebo
Twice daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567814
Locations
| United States, Louisiana | |
| Department of Psychiatry, Psychopharmacology Research Clinic | |
| Shreveport, Louisiana, United States, 71103 | |
Sponsors and Collaborators
Embera NeuroTherapeutics, Inc.
Investigators
| Principal Investigator: | Anita S Kablinger, MD | LSU Health Sciences Center - Shreveport |
More Information
No publications provided
| Responsible Party: | Marie Lindner, MD/Medical Monitor, Embera NeuroTherapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00567814 History of Changes |
| Other Study ID Numbers: | ECA-001 |
| Study First Received: | December 3, 2007 |
| Last Updated: | December 30, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Embera NeuroTherapeutics, Inc.:
|
Cocaine Dependence Addiction Cortisol GABA |
Additional relevant MeSH terms:
|
Behavior, Addictive Cocaine-Related Disorders Compulsive Behavior Impulsive Behavior Substance-Related Disorders Mental Disorders Cocaine Oxazepam Metyrapone Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Anesthetics, Local Anesthetics Central Nervous System Depressants Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Antimetabolites Enzyme Inhibitors Hypnotics and Sedatives Anti-Anxiety Agents Tranquilizing Agents |
ClinicalTrials.gov processed this record on May 23, 2013