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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
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 October 31, 2008




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