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

This study has been completed.
Sponsor:
Information provided by:
Embera NeuroTherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00567814
First received: December 3, 2007
Last updated: December 30, 2008
Last verified: December 2008
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Chemically-Induced Disorders
Compulsive Behavior
Impulsive Behavior
Mental Disorders
Substance-Related Disorders
Cocaine
Metyrapone
Oxazepam
Anesthetics
Anesthetics, Local
Anti-Anxiety Agents
Antimetabolites
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Uptake Inhibitors
Enzyme Inhibitors
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs

ClinicalTrials.gov processed this record on November 25, 2014