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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:

Study Description
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.

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Drug: Modafinil Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Primary Purpose: Diagnostic
Official Title: Modafinil for the Treatment of Cocaine Dependence
Study Start Date : October 2004
Estimated Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Cocaine abstinence

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
RHD Professional Plaza 4
Dallas, Texas, United States, 75234
UTHSCSA
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Domenic Ciraulo, M.D. Boston University
More Information

Responsible Party: Liza Gorgon, National Institute on Drug Abuse
ClinicalTrials.gov Identifier: NCT00100100     History of Changes
Other Study ID Numbers: NIDA-MDS-0004-1
First Posted: December 23, 2004    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: July 2008

Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine dependence

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Modafinil
Armodafinil
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers