- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00100100
Modafinil for the Treatment of Cocaine Dependence - 1
January 11, 2017 updated by: National Institute on Drug Abuse (NIDA)
Modafinil for the Treatment of Cocaine Dependence
The purpose of this study is to evaluate the efficacy and safety of modafinil in reducing cocaine use in subjects with cocaine dependence.
Study Overview
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
Interventional
Enrollment
210
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Boston University Medical Center
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New York
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New York, New York, United States, 10010
- New York VA Medical Center
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Ohio
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Cincinnati, Ohio, United States, 45220 2272
- Cincinnati Addiction Research Center
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213 2593
- Western Psychiatric Institute & Clinic
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Texas
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Dallas, Texas, United States, 75234
- RHD Professional Plaza 4
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San Antonio, Texas, United States, 78229
- UTHSCSA
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Cocaine abstinence
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Domenic Ciraulo, M.D., Boston University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Study Completion
December 1, 2006
Study Registration Dates
First Submitted
December 22, 2004
First Submitted That Met QC Criteria
December 22, 2004
First Posted (Estimate)
December 23, 2004
Study Record Updates
Last Update Posted (Estimate)
January 12, 2017
Last Update Submitted That Met QC Criteria
January 11, 2017
Last Verified
July 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Cocaine-Related Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Central Nervous System Stimulants
- Wakefulness-Promoting Agents
- Modafinil
Other Study ID Numbers
- NIDA-MDS-0004-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cocaine-Related Disorders
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Baylor College of MedicineNational Institute on Drug Abuse (NIDA)CompletedSubstance Abuse | Cocaine Dependence | Cocaine Abuse | Cocaine AddictionUnited States
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Baylor College of MedicineNational Institute on Drug Abuse (NIDA)CompletedSubstance Abuse | Cocaine Dependence | Cocaine Abuse | Cocaine AddictionUnited States
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Baylor College of MedicineNational Institute on Drug Abuse (NIDA)CompletedSubstance Abuse | Cocaine Dependence | Cocaine Abuse | Cocaine AddictionUnited States
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-
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-
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