Nefazodone in the Treatment of Cocaine Dependence and Depression - 4
Information source: National Institute on Drug Abuse (NIDA)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cocaine-Related Disorders; Substance-Related Disorders
Intervention: Nefazodone (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: National Institute on Drug Abuse (NIDA) Official(s) and/or principal investigator(s):
John Rotrosen, M.D., Principal Investigator, Affiliation: New York MDRU
Summary
The purpose of this study is the use of Nefazodone in the treatment of cocaine dependence and
depression comorbidity.
Clinical Details
Official title: Efficacy of Nefazodone in Cocaine Dependent Subjects
Study design: Treatment, Placebo Control
Primary outcome: RetentionComparison of nefazodone group and placebo
Detailed 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.
Eligibility
Minimum age: 21 Years.
Maximum age: 55 Years.
Gender(s): 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.
Locations and Contacts
New York MDRU, New York, New York 10010, United States
Additional Information
Starting date: February 1997
Last updated: November 3, 2005
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