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Nefazodone in the Treatment of Cocaine Dependence and Depression - 4

Information source: Boston Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cocaine-Related Disorders; Substance-Related Disorders

Intervention: Nefazodone (Drug); Psychosocial Treatment (Behavioral)

Phase: Phase 2

Status: Completed

Sponsored by: Boston Medical Center

Official(s) and/or principal investigator(s):
Dom Ciraulo, M.D., Principal Investigator, Affiliation: Boston University


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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Urine benzoylecgonine (BE) concentration

Secondary outcome:

Hamilton Depression Scale (HAM-D)

Cocaine-Craving Scale

Adverse Events Self Report

Alcohol Drug Use Inventory

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.


Minimum age: 21 Years. Maximum age: 55 Years. Gender(s): Both.


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

Boston University, Boston, Massachusetts 02118, United States
Additional Information

Related publications:

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.

Starting date: February 1997
Last updated: July 29, 2015

Page last updated: August 23, 2015

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