The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration

Completed

• Conditions: Post-Traumatic Stress Disorders; HIV Infections; AIDS; Opiate Dependence
• Interventions: Drug: Off-site - methadone or no agonist; Drug: On-site - buprenorphine/naloxone (Suboxone)

• Registration Number: NCT00227357
• Lead Sponsor: Ruth M. Rothstein CORE Center

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.

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 Timeline

• Study Start: 2005-07
• Status Verified: 2005-09
• Study First Submitted: 2005-09-27
• Study First Submitted QC: 2005-09-27
• Study First Posted: 2005-09-28
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Last Update Submitted: 2010-06-04
• Last Update Posted: 2010-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Comparison	Off-site - methadone or no agonist	Study patients receiving methadone or no agonist treatment
Buprenorphine	On-site - buprenorphine/naloxone (Suboxone)	Study patients receiving buprenorphine treatment

Trial Locations

Locations (1)

The CORE Center; 🇺🇸 Chicago, Illinois, United States