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
  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 3

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Nefazodone on Relapse in Females With Cocaine Abuse

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Dorothy Hatsukami, Ph.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

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

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nefazodone
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014