BUP: The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration

Sponsor

Ruth M. Rothstein CORE Center (Other)

Overall Status

Completed

CT.gov ID

NCT00227357

Collaborator

Health Resources and Services Administration (HRSA) (U.S. Fed), The New York Academy of Medicine (Other)

101

Enrollment

Location

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections AIDS Opiate Dependence Post-Traumatic Stress Disorders	Drug: On-site - buprenorphine/naloxone (Suboxone) Drug: Off-site - methadone or no agonist

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 Design

Study Type:

Observational

Actual Enrollment :

101 participants

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 2005

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

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

Arm

Intervention/Treatment

Buprenorphine

Study patients receiving buprenorphine treatment

Drug: On-site - buprenorphine/naloxone (Suboxone)

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

Comparison

Study patients receiving methadone or no agonist treatment

Drug: Off-site - methadone or no agonist

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The CORE Center	Chicago	Illinois	United States	60612

Sponsors and Collaborators

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

Investigators

Principal Investigator: Jeffrey D. Watts, M.D., The CORE Center and John H. Stroger, Jr. Hospital of Cook County, Affiliates of the Cook County Bureau of Health Services