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

This study has been completed.

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) University of Minnesota
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000293

Purpose

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.

Condition	Intervention	Phase
Cocaine-Related Disorders	Drug: Nefazodone	Phase III

MedlinePlus related topics: Depression

Drug Information available for: 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride Nefazodone Nefazodone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Placebo Control
Official Title:	Effect of Nefazodone on Relapse in Females With Cocaine Abuse

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Retention
Primary drug use
Depression (secondary)
Relapse

Estimated Enrollment:	0
Study Start Date:	January 1999
Estimated Study Completion Date:	December 2001

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000293

Locations

United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

University of Minnesota

Investigators

Principal Investigator:

Dorothy Hatsukami, Ph.D.

University of Minnesota

More Information

Study ID Numbers:	NIDA-09259-10, P50-09259-10
Study First Received:	September 20, 1999
Last Updated:	August 16, 2005
ClinicalTrials.gov Identifier:	NCT00000293
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Cocaine-Related Disorders
Nefazodone
Mental Disorders

Substance-Related Disorders
Disorders of Environmental Origin
Cocaine

Additional relevant MeSH terms:

Therapeutic Uses
Psychotropic Drugs
Antidepressive Agents, Second-Generation

Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents

ClinicalTrials.gov processed this record on January 15, 2009