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Nefazodone in the Treatment of Cocaine Dependence and Depression - 4

This study has been completed.
Sponsor:
Collaborator:
Boston University
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00015210
First received: April 18, 2001
Last updated: October 17, 2012
Last verified: August 2008
History of Changes
  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 2

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
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, Massachusetts
Boston University
Boston, Massachusetts, United States
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Boston University
Investigators
Principal Investigator: Dom Ciraulo, M.D. Boston University
  More Information

Publications:

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: October 17, 2012
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 May 23, 2013