The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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SPNS - An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Abuse Treatment in HIV Primary Care

Conditions
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HIV Infections, AIDS, Opiate Dependence, Post-Traumatic Stress Disorders

Intervention / Treatment
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* Drug: On-site - buprenorphine/naloxone (Suboxone)
* Drug: Off-site - methadone or no agonist


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Buprenorphine<br>Study patients receiving buprenorphine treatment | Drug: On-site - buprenorphine/naloxone (Suboxone)<br>* Tablet, sub-lingual, 8/2 mg, 1-3 daily<br>|
| Comparison<br>Study patients receiving methadone or no agonist treatment | Drug: Off-site - methadone or no agonist<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, AIDS, Buprenorphine, Methadone, Primary care, dual diagnosis, ptsd