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

Information source: Embera NeuroTherapeutics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cocaine Dependence; Cocaine Addiction

Intervention: Metyrapone (Drug); Oxazepam (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Embera NeuroTherapeutics, Inc.

Official(s) and/or principal investigator(s):
Anita S Kablinger, MD, Principal Investigator, Affiliation: LSU Health Sciences Center - Shreveport

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.

Clinical Details

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

Primary outcome: Reduction or elimination of cocaine craving as evidenced by the Cocaine Craving Questionnaire

Secondary outcome:

Reduction or elimination of cocaine use as evidenced by self-report and urine toxicology

Improvement in anxiety and depression symptoms

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

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

Locations and Contacts

Department of Psychiatry, Psychopharmacology Research Clinic, Shreveport, Louisiana 71103, United States
Additional Information

Starting date: December 2007
Last updated: December 30, 2008

Page last updated: August 23, 2015

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