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Completed

NCT Number: NCT00567814

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

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.

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Key information

Conditions

Cocaine Dependence Behavior Behavior, Addictive Chemically-Induced Disorders Cocaine Addiction Cocaine-Related Disorders Compulsive Behavior Impulsive Behavior Mental Disorders Substance-Related Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, Psychopharmacology Research Clinic

Shreveport, Louisiana, 71103, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metyrapone

Drug

Twice daily

Other names: Metopirone

Oxazepam

Drug

Twice Daily

Other names: Serax

Placebo

Drug

Twice daily

Primary outcomes

  1. Reduction or elimination of cocaine craving as evidenced by the Cocaine Craving Questionnaire

    Time frame: 6 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Embera NeuroTherapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 5, 2007
Registry last updated
Dec 31, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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