Modafinil for the Treatment of Cocaine Dependence - 1 - Tabular View

Tracking Information

First Received Date ^ICMJE

December 22, 2004

Last Updated Date

July 21, 2008

Start Date ^ICMJE

October 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Cocaine abstinence

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00100100 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Modafinil for the Treatment of Cocaine Dependence - 1

Official Title ^ICMJE

Modafinil for the Treatment of Cocaine Dependence

Brief Summary

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

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Placebo Control

Condition ^ICMJE

Cocaine-Related Disorders

Intervention ^ICMJE

Drug: Modafinil

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

210

Completion Date

December 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00100100

Responsible Party

Liza Gorgon, National Institute on Drug Abuse

Study ID Numbers ^ICMJE

NIDA-MDS-0004-1

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Domenic Ciraulo, M.D.

Boston University

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP