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The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration | Clinical Trials | Clareo Health

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The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration

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

NCT00227357•Ruth M. Rothstein CORE Center

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.

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 (1)

The CORE Center

Chicago, Illinois, United States

Key Dates

Start Date

July 1, 2005

Primary Completion Date

December 1, 2008

Completion Date

December 1, 2008

Last Updated

June 7, 2010

Enrollment

101

ACTUAL participants

Conditions

HIV InfectionsAIDSOpiate DependencePost-Traumatic Stress Disorders

Interventions

On-site - buprenorphine/naloxone (Suboxone)

DRUG

Off-site - methadone or no agonist

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 7, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration

Inclusion Criteria

Exclusion Criteria

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