The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration

HIV Infections Clinical Trial

— BUP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00227357
• Other study ID #: 1-H97HA03796-01-00
• Status: Completed
• Phase: N/A
• First received: September 27, 2005
• Last updated: June 4, 2010
• Start date: July 2005
• Est. completion date: December 2008

Study information

• Verified date: September 2005
• Source: Ruth M. Rothstein CORE Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Drug:
• On-site - buprenorphine/naloxone (Suboxone)
Tablet, sub-lingual, 8/2 mg, 1-3 daily
• Off-site - methadone or no agonist

Locations

Country	Name	City	State
United States	The CORE Center	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Ruth M. Rothstein CORE Center	Health Resources and Services Administration (HRSA), The New York Academy of Medicine

Country where clinical trial is conducted

United States, 

External Links

•   Click here for more information about The CORE Center.