Trial | NCT00567814  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    45
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.
Study Started
Dec 31
2007
Primary Completion
Nov 30
2008
Study Completion
Nov 30
2008
Last Update
Dec 31
2008
Estimate

Drug Metyrapone

Twice daily

  • Other names: Metopirone

Drug Oxazepam

Twice Daily

  • Other names: Serax

Drug Placebo

Twice daily

3 Placebo Comparator

1 Active Comparator

Lower dose combination of metyrapone with oxazepam

2 Active Comparator

Higher dose combination of metyrapone with oxazepam

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
No Results Posted