Nefazodone in the Treatment of Cocaine Dependence and Depression - 4

This study has been completed.

First Received on April 18, 2001. Last Updated on August 28, 2008 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	New York MDRU
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00015210

Purpose

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

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

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Efficacy of Nefazodone in Cocaine Dependent Subjects

Resource links provided by NLM:

MedlinePlus related topics: Depression Drug Abuse

Drug Information available for: Cocaine hydrochloride Nefazodone hydrochloride Nefazodone

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Retention
Comparison of nefazodone group and placebo

Estimated Enrollment:	0
Study Start Date:	February 1997

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

Ages Eligible for Study:	21 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00015210

Locations

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

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

New York MDRU

Investigators

Principal Investigator:

John Rotrosen, M.D.

New York MDRU

More Information

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.

ClinicalTrials.gov Identifier:	NCT00015210 History of Changes
Other Study ID Numbers:	NIDA-5-0013-4, Y01-5-0013-4
Study First Received:	April 18, 2001
Last Updated:	August 28, 2008
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Additional relevant MeSH terms:

Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Nefazodone
Antidepressive Agents, Second-Generation

Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012