Back to resultsEffect of Nefazodone on Relapse in Females With Cocaine Abuse - 10
Primary Purpose
Cocaine-Related Disorders
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Nefazodone
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring cocaine dependence
Eligibility 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.
Sites / Locations
- University of Minnesota
Outcomes
Primary Outcome Measures
Retention
Primary drug use
Depression (secondary)
Relapse
Secondary Outcome Measures
Full Information
NCT ID
NCT00000293
First Posted
September 20, 1999
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT00000293
Brief Title
Effect of Nefazodone on Relapse in Females With Cocaine Abuse - 10
Official Title
Effect of Nefazodone on Relapse in Females With Cocaine Abuse
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Minnesota
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
Keywords
cocaine dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Enrollment
0 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Nefazodone
Primary Outcome Measure Information:
Title
Retention
Title
Primary drug use
Title
Depression (secondary)
Title
Relapse
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorothy Hatsukami, Ph.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
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Effect of Nefazodone on Relapse in Females With Cocaine Abuse - 10
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