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

Condition	Treatment or Intervention	Phase
Cocaine-Related Disorders Substance-Related Disorders	Drug: Nefazodone	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  21 Years   -   55 Years,  Genders Eligible for Study:  Both

Criteria

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.

New York
      New York MDRU, New York,  New York,  10010,  United States

Study chairs or principal investigators

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

Study ID Numbers:  NIDA-5-0013-4; Y01-5-0013-4
Record last reviewed:  February 1997
Last Updated:  February 16, 2005
Record first received:  April 18, 2001
ClinicalTrials.gov Identifier:  NCT00015210
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08