The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration
NCT ID: NCT00227357
Last Updated: 2010-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
101 participants
OBSERVATIONAL
2005-07-31
2008-12-31
Brief Summary
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Detailed Description
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The Buprenorphine Project is an examination of two methods of service delivery. The purpose of this study is to assess the feasibility, cost and effectiveness of an intervention designed to integrate buprenorphine treatment for opioid dependence into HIV primary care at the CORE Center. For this project we will provide buprenorphine to 60 opioid dependent patients at any one time and will compare this on-site treatment group to 60 opioid dependent HIV+ patients who select off-site methadone or no agonist treatment at the time of enrollment.
Conditions
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Study Design
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PROSPECTIVE
Study Groups
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Buprenorphine
Study patients receiving buprenorphine treatment
On-site - buprenorphine/naloxone (Suboxone)
Tablet, sub-lingual, 8/2 mg, 1-3 daily
Comparison
Study patients receiving methadone or no agonist treatment
Off-site - methadone or no agonist
Interventions
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On-site - buprenorphine/naloxone (Suboxone)
Tablet, sub-lingual, 8/2 mg, 1-3 daily
Off-site - methadone or no agonist
Eligibility Criteria
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Inclusion Criteria
* Patient of the CORE Center
* HIV-infected (confirmed by HIV assay results)
* Opioid-dependent (by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision \[DSM-IV-TR\] criteria)
* Fluent in English or Spanish
* Planning to stay in Chicago area for the next 12 months
Exclusion Criteria
* DSM-IV-TR criteria for benzodiazepine abuse or dependence within the past 6 months
* DSM-IV-TR criteria for alcohol dependence within the past 6 months or actively suicidal
* Psychiatric impairment that impedes ability to consent
* Methadone dose exceeds level allowing for safe transition to buprenorphine
* Pregnant women or women actively trying to become pregnant
* Clinical judgement that patient is inappropriate for medical or psychiatric reasons
18 Years
ALL
No
Sponsors
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Health Resources and Services Administration (HRSA)
FED
The New York Academy of Medicine
OTHER
Ruth M. Rothstein CORE Center
OTHER
Responsible Party
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The Ruth M. Rothstein CORE Center
Principal Investigators
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Jeffrey D. Watts, M.D.
Role: PRINCIPAL_INVESTIGATOR
The CORE Center and John H. Stroger, Jr. Hospital of Cook County, Affiliates of the Cook County Bureau of Health Services
Locations
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The CORE Center
Chicago, Illinois, United States
Countries
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Related Links
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Click here for more information about The CORE Center.
Other Identifiers
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1-H97HA03796-01-00
Identifier Type: -
Identifier Source: org_study_id
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