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

Cocaine Dependence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567814
• Other study ID #: ECA-001
• Status: Completed
• Phase: N/A
• First received: December 3, 2007
• Last updated: December 30, 2008
• Start date: December 2007
• Est. completion date: November 2008

Study information

• Verified date: December 2008
• Source: Embera NeuroTherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Behavior, Addictive
• Cocaine Addiction
• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Drug:
• Metyrapone
Twice daily
• Oxazepam
Twice Daily
• Placebo
Twice daily

Locations

Country	Name	City	State
United States	Department of Psychiatry, Psychopharmacology Research Clinic	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Embera NeuroTherapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction or elimination of cocaine craving as evidenced by the Cocaine Craving Questionnaire		6 weeks	No
Secondary	Reduction or elimination of cocaine use as evidenced by self-report and urine toxicology		6 weeks	No
Secondary	Improvement in anxiety and depression symptoms		6 weeks	No