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

Tracking Information

First Received Date ^ICMJE

December 3, 2007

Last Updated Date

December 30, 2008

Start Date ^ICMJE

December 2007

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Reduction or elimination of cocaine craving as evidenced by the Cocaine Craving Questionnaire [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00567814 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Cocaine Dependence
Cocaine Addiction

Intervention ^ICMJE

Drug: Metyrapone
Drug: Oxazepam
Drug: Placebo

Study Arms / Comparison Groups

Active Comparator: Lower dose combination of metyrapone with oxazepam
Active Comparator: Higher dose combination of metyrapone with oxazepam

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

November 2008

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00567814

Responsible Party

Marie Lindner, MD/Medical Monitor, Embera NeuroTherapeutics, Inc.

Study ID Numbers ^ICMJE

ECA-001

Study Sponsor ^ICMJE

Embera NeuroTherapeutics, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Anita S Kablinger, MD

LSU Health Sciences Center - Shreveport

Information Provided By

Embera NeuroTherapeutics, Inc.

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP