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

This study has been completed.
Health Resources and Services Administration (HRSA)
The New York Academy of Medicine
Information provided by:
Ruth M. Rothstein CORE Center Identifier:
First received: September 27, 2005
Last updated: June 4, 2010
Last verified: September 2005
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 Intervention
HIV Infections
Opiate Dependence
Post-Traumatic Stress Disorders
Drug: On-site - buprenorphine/naloxone (Suboxone)
Drug: Off-site - methadone or no agonist

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: SPNS - An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Abuse Treatment in HIV Primary Care

Resource links provided by NLM:

Further study details as provided by Ruth M. Rothstein CORE Center:

Enrollment: 101
Study Start Date: July 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Study patients receiving buprenorphine treatment
Drug: On-site - buprenorphine/naloxone (Suboxone)
Tablet, sub-lingual, 8/2 mg, 1-3 daily
Study patients receiving methadone or no agonist treatment
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving buprenorphine treatment Patients not receiving buprenorphine treatment (methadone or none)

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
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Please refer to this study by its identifier: NCT00227357

United States, Illinois
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
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
  More Information

Additional Information:
Responsible Party: Jeffrey D. Watts, M.D., The Ruth M. Rothstein CORE Center Identifier: NCT00227357     History of Changes
Other Study ID Numbers: 1-H97HA03796-01-00
Study First Received: September 27, 2005
Last Updated: June 4, 2010

Keywords provided by Ruth M. Rothstein CORE Center:
Primary care
dual diagnosis

Additional relevant MeSH terms:
HIV Infections
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Opioid-Related Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Trauma and Stressor Related Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Buprenorphine, Naloxone Drug Combination
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Antitussive Agents
Respiratory System Agents processed this record on April 28, 2017