Expired Study
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Minneapolis, Minnesota 55455


Purpose:

The purpose of this study is to determine the effects of nefazedone on cocaine self-administration in depressed and non-depressed female cocaine users.


Study summary:

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.


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


Study is Available At:


Original ID:

NIDA-09259-3


NCT ID:

NCT00000286


Secondary ID:

P50-09259-3


Study Acronym:


Brief Title:

Effects of Nefazodone on Treatment of Female Cocaine Abusers - 3


Official Title:

Effects of Nefazodone on Treatment of Female Cocaine Abusers


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute on Drug Abuse (NIDA)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Masking: Double-Blind, Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Dorothy Hatsukami, Ph.D.
Principal Investigator
University of Minnesota - Clinical and Translational Science Institute

Study Dates

Start Date:December 1996
Completion Date:December 2001
Verification Date:October 2016
Last Changed Date:January 11, 2017
First Received Date:September 20, 1999

Study Outcomes

Outcome Type:Primary Outcome
Measure:HIV risk behaviors
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Life functioning
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Depression
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Drug use
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Craving
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Nefazodone

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute on Drug Abuse (NIDA)
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of Minnesota - Clinical and Translational Science Institute

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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