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Modafinil for the Treatment of Cocaine Dependence - 1

This study has been completed.
Information provided by:
National Institute on Drug Abuse (NIDA) Identifier:
First received: December 22, 2004
Last updated: July 21, 2008
Last verified: July 2008
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 2

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Modafinil for the Treatment of Cocaine Dependence

Resource links provided by NLM:

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00100100

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
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Principal Investigator: Domenic Ciraulo, M.D. Boston University
  More Information

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

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics, Local
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Neurotransmitter Agents processed this record on December 07, 2016