Modafinil for the Treatment of Cocaine Dependence - 1

This study has been completed.

First Received: December 22, 2004 Last Updated: July 21, 2008 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00100100

Purpose

The purpose of this study is to evaluate the efficacy and safety of modafinil in reducing cocaine use in subjects with cocaine dependence.

Condition	Intervention	Phase
Cocaine-Related Disorders	Drug: Modafinil	Phase II

Study Type:	Interventional
Study Design:	Diagnostic, Placebo Control
Official Title:	Modafinil for the Treatment of Cocaine Dependence

Resource links provided by NLM:

Drug Information available for: Cocaine hydrochloride Modafinil

U.S. FDA Resources

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

Primary Outcome Measures:

Cocaine abstinence

Estimated Enrollment:	210
Study Start Date:	October 2004
Estimated Study Completion Date:	December 2006

Detailed Description:

This is a double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of modafinil in reducing cocaine use in subjects with cocaine dependence.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Participant must have DSM-IV diagnosis of cocaine dependence as determined by SCID.
Must be seeking treatment for cocaine dependence.
Must be able to understand and provide written informed consent.

Exclusion Criteria:

Please contact the study site for more information.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100100

Locations

United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02215
United States, New York
New York VA Medical Center
New York, New York, United States, 10010
United States, Ohio
Cincinnati Addiction Research Center
Cincinnati, Ohio, United States, 45220 2272
United States, Pennsylvania
Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania, United States, 15213 2593
United States, Texas
UTHSCSA
San Antonio, Texas, United States, 78229
RHD Professional Plaza 4
Dallas, Texas, United States, 75234

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Domenic Ciraulo, M.D.

Boston University

More Information

No publications provided

Responsible Party:	National Institute on Drug Abuse ( Liza Gorgon )
Study ID Numbers:	NIDA-MDS-0004-1
Study First Received:	December 22, 2004
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00100100 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Cocaine-Related Disorders
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs
Substance-Related Disorders
Disorders of Environmental Origin

Central Nervous System Stimulants
Protective Agents
Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Modafinil

ClinicalTrials.gov processed this record on February 08, 2010