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Effects of Nefazodone on Treatment of Female Cocaine Abusers - 3

Primary Purpose

Cocaine-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nefazodone
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring cocaine dependence

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Females, ages 18-55, minimum use of 8 days of the last 30, minimum of 8th grade education, current diagnosis of cocaine abuse/dependence Exclusion Criteria: Unstable medical illness, dx of MR, OBS, bipolar

Sites / Locations

  • University of Minnesota

Outcomes

Primary Outcome Measures

Craving
Drug use
Depression
Life functioning
HIV risk behaviors

Secondary Outcome Measures

Full Information

First Posted
September 20, 1999
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT00000286
Brief Title
Effects of Nefazodone on Treatment of Female Cocaine Abusers - 3
Official Title
Effects of Nefazodone on Treatment of Female Cocaine Abusers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 1996 (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 effects of nefazedone on cocaine self-administration in depressed and non-depressed female cocaine users.
Detailed Description
This study evaluated the effect of nefazodone on reducing cocaine use and craving in both depressed and nondepressed women and if there was a greater effect in depressed women.

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 2
Masking
Double
Enrollment
0 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nefazodone
Primary Outcome Measure Information:
Title
Craving
Title
Drug use
Title
Depression
Title
Life functioning
Title
HIV risk behaviors

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: Females, ages 18-55, minimum use of 8 days of the last 30, minimum of 8th grade education, current diagnosis of cocaine abuse/dependence Exclusion Criteria: Unstable medical illness, dx of MR, OBS, bipolar
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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Effects of Nefazodone on Treatment of Female Cocaine Abusers - 3

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