- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00015080
Naltrexone in Treatment of Cocaine Dependence - 5
January 13, 2017 updated by: National Institute on Drug Abuse (NIDA)
Naltrexone in Treatment of Cocaine Dependence
The purpose of this study is to determine the efficacy of naltrexone in the treatment of cocaine dependence as measured by: 1) decreased urine benzoylecgonine (BE) levels, 2) decreased cocaine use by self-report, 3) decreased cocaine craving, and 4) retention in treatment.
Study Overview
Detailed Description
Double-blind, placebo controlled study of the safety and efficacy of naltrexone in treating cocaine dependence in a patient sample that initiated the study while in an inpatient setting and were then followed-up for 3 months as outpatients.
Study Type
Interventional
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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Ohio
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Cincinnati, Ohio, United States, 45220
- Cincinnati MDRU
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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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Meet DSM-III-R criteria for cocaine dependency,
- 18 to 65 years of age,
- capable of understanding the study,
- voluntarily signed consent,
- male or non-pregnant female using approved form of birth control.
Exclusion Criteria:
- abnormal liver function tests (SGOT, SGPT, or GGT greater than twice the normal values),
- opioid use within the last 7 days,
- use of neuroleptics,
- having a severe acute medical problem,
- unable to complete psychiatric rating scales, or
- judged by the investigator to be unlikely to comply with the study protocol
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: Treatment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Depression
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Anxiety
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Retention
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Addiction severity
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Cocaine use
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Global improvement
|
Psychopathology
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Eugene Somoza, M.D., Ph.D., Cincinnati MDRU
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Somoza, E., et al. A Double-Blind,Placebo Controlled Clinical Trial of Naltrexone as a Treatment for Cocaine Dependence. NIDA Research Monograph, 1998, 179, p. 295.. None
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
May 1, 1995
Primary Completion (Actual)
June 1, 1996
Study Completion (Actual)
July 1, 1996
Study Registration Dates
First Submitted
April 18, 2001
First Submitted That Met QC Criteria
April 17, 2001
First Posted (Estimate)
April 18, 2001
Study Record Updates
Last Update Posted (Estimate)
January 16, 2017
Last Update Submitted That Met QC Criteria
January 13, 2017
Last Verified
December 1, 1996
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIDA-5-0012-5
- Y01-5-0012-5
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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University Hospital Center of MartiniqueUnknown
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Alkermes, Inc.Terminated
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Alkermes, Inc.Completed
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Alkermes, Inc.Completed
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Centre for Addiction and Mental HealthUnknown
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