Official Title: “Effect of Nefazodone on Relapse in Females With Cocaine Abuse”

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.

Study Type: Interventional

Study Design: Treatment, Double-Blind, Placebo Control

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.

Intervention(s) in this Clinical Trial

• Drug: Nefazodone

Primary Measures

• Retention
• Primary drug use
• Depression (secondary)
• Relapse

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 Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Dorothy Hatsukami, Ph.D. Principal Investigator University of Minnesota  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00000293

Study ID Number: NIDA-09259-10

ClinicalTrials.gov Identifier: NCT00000293

Health Authority: United States: Federal Government