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The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration (BUP)

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ClinicalTrials.gov Identifier: NCT00227357
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : June 7, 2010
Sponsor:
Collaborators:
Health Resources and Services Administration (HRSA)
The New York Academy of Medicine
Information provided by:
Ruth M. Rothstein CORE Center

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The goal of this study is to develop and evaluate an innovative model of care to better serve patients who are both HIV-infected and opioid-dependent.

Condition or disease Intervention/treatment
HIV Infections AIDS Opiate Dependence Post-Traumatic Stress Disorders Drug: On-site - buprenorphine/naloxone (Suboxone) Drug: Off-site - methadone or no agonist

Detailed Description:

Hypothesis: HIV, opioid dependent patients provided agonist therapy at the site of their primary care will have better retention, utilization of services, health, social and quality of care measures and psychiatric treatment outcomes.

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.


Study Design
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Study Type : Observational
Actual Enrollment : 101 participants
Time Perspective: Prospective
Official Title: SPNS - An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Abuse Treatment in HIV Primary Care
Study Start Date : July 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Buprenorphine
Study patients receiving buprenorphine treatment
 Drug: On-site - buprenorphine/naloxone (Suboxone)
Tablet, sub-lingual, 8/2 mg, 1-3 daily
Comparison
Study patients receiving methadone or no agonist treatment
 Drug: Off-site - methadone or no agonist


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving buprenorphine treatment Patients not receiving buprenorphine treatment (methadone or none)
Criteria

Inclusion Criteria:

  • 18 years or older
  • 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:

  • Liver function tests (LFTs) (transaminase only) at 5 times or higher than normal
  • 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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00227357


Locations
United States, Illinois
The CORE Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Ruth M. Rothstein CORE Center
Health Resources and Services Administration (HRSA)
The New York Academy of Medicine
Investigators
Principal Investigator: Jeffrey D. Watts, M.D. The CORE Center and John H. Stroger, Jr. Hospital of Cook County, Affiliates of the Cook County Bureau of Health Services
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Jeffrey D. Watts, M.D., The Ruth M. Rothstein CORE Center
ClinicalTrials.gov Identifier: NCT00227357     History of Changes
Other Study ID Numbers: 1-H97HA03796-01-00
First Posted: September 28, 2005    Key Record Dates
Last Update Posted: June 7, 2010
Last Verified: September 2005

Keywords provided by Ruth M. Rothstein CORE Center:
HIV
AIDS
Buprenorphine
Methadone
 Primary care
dual diagnosis
ptsd

Additional relevant MeSH terms:
HIV Infections
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Opioid-Related Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Trauma and Stressor Related Disorders
Mental Disorders
Substance-Related Disorders
 Chemically-Induced Disorders
Buprenorphine
Methadone
Buprenorphine, Naloxone Drug Combination
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Antitussive Agents
Respiratory System Agents