The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration
Information source: Ruth M. Rothstein CORE Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; AIDS; Opiate Dependence; Post-Traumatic Stress Disorders
Intervention: On-site - buprenorphine (Suboxone) (Drug); Off-site - methadone or no agonist (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Ruth M. Rothstein CORE Center Official(s) and/or principal investigator(s):
Jeffrey D. Watts, M.D., Principal Investigator, Affiliation: The CORE Center and John H. Stroger, Jr. Hospital of Cook County, Affiliates of the Cook County Bureau of Health Services
Overall contact:
Mary Jo Tozzi, M.S., Phone: (312) 572-4818, Email: mtozzi@corecenter.org
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.
Clinical Details
Official title: SPNS - An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Abuse Treatment in HIV Primary Care
Study design: Natural History, Longitudinal, Defined Population, Prospective Study
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Mary Jo Tozzi, M.S., Phone: (312) 572-4818, Email: mtozzi@corecenter.org
The CORE Center, Chicago, Illinois 60612, United States; Recruiting
Mary Jo Tozzi, M.S., Phone: 312-572-4818, Email: mtozzi@corecenter.org
Jeffrey D. Watts, M.D., Phone: (312) 572-4550, Email: jwatts@corecenter.org
Jeffrey D. Watts, M.D., Principal Investigator
Additional Information
Click here for more information about The CORE Center. Evaluation and Support Center for the Mult-site Buprenorphine Study
Starting date: July 2005
Ending date: December 2008
Last updated: March 10, 2006
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