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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00227357

Acronym

BUP

Enrollment

101

Registered

2005-09-28

Start date

2005-07-31

Completion date

2008-12-31

Last updated

2010-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

HIV, AIDS, Buprenorphine, Methadone, Primary care, dual diagnosis, ptsd

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.

Interventions

DRUGOn-site - buprenorphine/naloxone (Suboxone)

Tablet, sub-lingual, 8/2 mg, 1-3 daily

DRUGOff-site - methadone or no agonist

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026