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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00567814
Recruitment Status : Completed
First Posted : December 5, 2007
Last Update Posted : December 31, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Cocaine Addiction Drug: Metyrapone Drug: Oxazepam Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Reduction or elimination of cocaine craving as evidenced by the Cocaine Craving Questionnaire [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Reduction or elimination of cocaine use as evidenced by self-report and urine toxicology [ Time Frame: 6 weeks ]
  2. Improvement in anxiety and depression symptoms [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00567814

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United States, Louisiana
Department of Psychiatry, Psychopharmacology Research Clinic
Shreveport, Louisiana, United States, 71103
Sponsors and Collaborators
Embera NeuroTherapeutics, Inc.
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Principal Investigator: Anita S Kablinger, MD LSU Health Sciences Center - Shreveport

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Responsible Party: Marie Lindner, MD/Medical Monitor, Embera NeuroTherapeutics, Inc. Identifier: NCT00567814     History of Changes
Other Study ID Numbers: ECA-001
First Posted: December 5, 2007    Key Record Dates
Last Update Posted: December 31, 2008
Last Verified: December 2008

Keywords provided by Embera NeuroTherapeutics, Inc.:

Additional relevant MeSH terms:
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Behavior, Addictive
Cocaine-Related Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Enzyme Inhibitors
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators