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

September 27, 2005
June 4, 2010
July 2005
December 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00227357 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • HIV Infections
  • AIDS
  • Opiate Dependence
  • Post-Traumatic Stress Disorders
  • Drug: On-site - buprenorphine/naloxone (Suboxone)
    Tablet, sub-lingual, 8/2 mg, 1-3 daily
  • Drug: Off-site - methadone or no agonist
  • Buprenorphine
    Study patients receiving buprenorphine treatment
    Intervention: Drug: On-site - buprenorphine/naloxone (Suboxone)
  • Comparison
    Study patients receiving methadone or no agonist treatment
    Intervention: Drug: Off-site - methadone or no agonist
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00227357
1-H97HA03796-01-00
No
Jeffrey D. Watts, M.D., The Ruth M. Rothstein CORE Center
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
Ruth M. Rothstein CORE Center
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP