Nefazodone in the Treatment of Cocaine Dependence and Depression - 4

Official Title: “Efficacy of Nefazodone in Cocaine Dependent Subjects”

The purpose of this study is the use of Nefazodone in the treatment of cocaine dependence and depression comorbidity.

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

Primary Measures

• Retention
• Comparison of nefazodone group and placebo

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

Lead Investigator: National Institute on Drug Abuse (NIDA) NIH

Overall Clinical Trial Officials and Contacts

John Rotrosen, M.D. Principal Investigator New York MDRU  

Information obtained from ClinicalTrials.gov on February 02, 2012

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