Effect of Nefazodone on Relapse in Females With Cocaine Abuse - 10

This study has been completed.

Sponsor:

Collaborator:

University of Minnesota - Clinical and Translational Science Institute

Information provided by:

National Institute on Drug Abuse (NIDA)

ClinicalTrials.gov Identifier:

NCT00000293

First received: September 20, 1999

Last updated: August 16, 2005

Last verified: January 1999

History of Changes

Tracking Information

First Received Date ^ICMJE

September 20, 1999

Last Updated Date

August 16, 2005

Start Date ^ICMJE

January 1999

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Retention
Primary drug use
Depression (secondary)
Relapse

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00000293 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of Nefazodone on Relapse in Females With Cocaine Abuse - 10

Official Title ^ICMJE

Effect of Nefazodone on Relapse in Females With Cocaine Abuse

Brief Summary

The purpose of this study is to determine the effect of nefazodone on relapse to cocaine use in depressed and non-depressed females with cocaine abuse/dependence.

Detailed Description

The purpose of this study is to determine the effect of nefazodone on relapse to cocaine in women and if a greater effect will be seen in the dependent condition. A relapse and coping skills questionnaire will be utilized to determine the various factors important to the relapse process.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Cocaine-Related Disorders

Intervention ^ICMJE

Drug: Nefazodone

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2001

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Female, ages 18-55, cocaine abuse/dependence, use of cocaine 7 days of the last 30 days or of the 30 days prior to current abstinence, less than 90 days current abstinence, at least an 8th grade education.

Exclusion Criteria:

Unstable medical conditions; current use of Hismanal, Seldane, or Propulsid; dx of MR, OBS, bipolar, schizophrenia.

Gender

Female

Ages

18 Years to 55 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 Number ^ICMJE

NCT00000293

Other Study ID Numbers ^ICMJE

NIDA-09259-10, P50-09259-10

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

University of Minnesota - Clinical and Translational Science Institute

Investigators ^ICMJE

Principal Investigator:

Dorothy Hatsukami, Ph.D.

University of Minnesota - Clinical and Translational Science Institute

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

January 1999

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

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