Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
Health Resources and Services Administration (HRSA)
The New York Academy of Medicine
Information provided by:
Ruth M. Rothstein CORE Center
ClinicalTrials.gov Identifier:
NCT00227357
First received: September 27, 2005
Last updated: June 4, 2010
Last verified: September 2005
  Purpose

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
AIDS
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients receiving buprenorphine treatment Patients not receiving buprenorphine treatment (methadone or none)

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227357

Locations
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
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
  More Information

Additional Information:
No publications provided

Responsible Party: Jeffrey D. Watts, M.D., The Ruth M. Rothstein CORE Center
ClinicalTrials.gov Identifier: NCT00227357     History of Changes
Other Study ID Numbers: 1-H97HA03796-01-00
Study First Received: September 27, 2005
Last Updated: June 4, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Ruth M. Rothstein CORE Center:
HIV
AIDS
Buprenorphine
Methadone
Primary care
dual diagnosis
ptsd

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Mental Disorders
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Buprenorphine
Methadone
Naloxone
Analgesics
Analgesics, Opioid
Antitussive Agents
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents

ClinicalTrials.gov processed this record on November 20, 2014