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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 27, 2005

Last Updated Date

June 4, 2010

Start Date ^ICMJE

July 2005

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00227357 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration

Official Title ^ICMJE

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

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.

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

HIV Infections
AIDS
Opiate Dependence
Post-Traumatic Stress Disorders

Intervention ^ICMJE

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

Study Group/Cohort (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

101

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00227357

Other Study ID Numbers ^ICMJE

1-H97HA03796-01-00

Has Data Monitoring Committee

Responsible Party

Jeffrey D. Watts, M.D., The Ruth M. Rothstein CORE Center

Study Sponsor ^ICMJE

Ruth M. Rothstein CORE Center

Collaborators ^ICMJE

Health Resources and Services Administration (HRSA)
The New York Academy of Medicine

Investigators ^ICMJE

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

Information Provided By

Ruth M. Rothstein CORE Center

Verification Date

September 2005

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

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