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Modafinil for the Treatment of Cocaine Dependence - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00100100
Recruitment Status : Completed
First Posted : December 23, 2004
Last Update Posted : January 12, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

Tracking Information
First Submitted Date  ICMJE December 22, 2004
First Posted Date  ICMJE December 23, 2004
Last Update Posted Date January 12, 2017
Study Start Date  ICMJE October 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Cocaine abstinence
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Diagnostic
Condition  ICMJE Cocaine-Related Disorders
Intervention  ICMJE Drug: Modafinil
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
210
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2006
Primary Completion Date Not Provided
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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00100100
Other Study ID Numbers  ICMJE NIDA-MDS-0004-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Liza Gorgon, National Institute on Drug Abuse
Study Sponsor  ICMJE National Institute on Drug Abuse (NIDA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Domenic Ciraulo, M.D. Boston University
PRS Account 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