The purpose of this study is the use of Nefazodone in the treatment of cocaine dependence and depression comorbidity...
Date First Received: April 18, 2001
Last Updated: August 28, 2008
Verified by: National Institute on Drug Abuse (NIDA), August 2008
Clinical Trial Phase: Phase 2 | Start Date: February 1997
Overall Status: Completed
Estimated Enrollment: 0
Brief Summary
Official Title: “Efficacy of Nefazodone in Cocaine Dependent Subjects”
Condition Keyword(s):
Intervention(s):
The purpose of this study is the use of Nefazodone in the treatment of cocaine dependence and depression comorbidity.
Study Type: Interventional
Study Design: Treatment, Placebo Control
Detailed Clinical Trial Description
The objective of this study is to determine the safety and efficacy of nefazodone (Serzone ) in depressed cocaine dependent subjects. This is a hypothesis-testing study which will explore whether cocaine usage will be reduced in the nefazodone treatment group compared to a placebo control group.
Intervention(s) in this Clinical Trial
- Drug: Nefazodone
Outcome Measures for this Clinical Trial
Primary Measures
- Retention
- Comparison of nefazodone group and placebo
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- DSM-IV diagnosis of cocaine dependence, Depression score of 12 or above and history of depression. Males and non-pregnant, non-nursing females 21-55 years of age.
Exclusion Criteria:
- Axis I diagnosis other than substance use disorder, major depression, anxiety of dysthymic disorder. Physiological dependence on alcohol. Significant medical or neurological history.
- Abnormal UA, CBC or Chem 23 (LFT's may be up to 3 times normal). Enrollment in an opiate-substitution treatment program within 45 days of enrollment in the present study.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 21 Years
Maximum Age for this Clinical Trial: 55 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: National Institute on Drug Abuse (NIDA)
Overall Clinical Trial Officials and Contacts
John Rotrosen, M.D. Principal Investigator New York MDRU
Related Publications
References
Ciraulo DA, Knapp C, Rotrosen J, Sarid-Segal O, Ciraulo AM, LoCastro J, Greenblatt DJ, Leiderman D. Nefazodone treatment of cocaine dependence with comorbid depressive symptoms. Addiction. 2005 Mar;100 Suppl 1:23-31.
Additional Information
Information obtained from ClinicalTrials.gov on January 06, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00015210
Study ID Number: NIDA-5-0013-4
ClinicalTrials.gov Identifier: NCT00015210
Health Authority: United States: Federal Government
Clinical Trials Authorship and Review
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