The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration

This study is currently recruiting participants.

Verified by Ruth M. Rothstein CORE Center, September 2005

First Received: September 27, 2005 Last Updated: March 10, 2006 History of Changes

Sponsor:	Ruth M. Rothstein CORE Center
Information provided by:	Ruth M. Rothstein CORE Center
ClinicalTrials.gov Identifier:	NCT00227357

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 (Suboxone) Drug: Off-site - methadone or no agonist

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Prospective Study
Official Title:	SPNS - An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Abuse Treatment in HIV Primary Care

Resource links provided by NLM:

MedlinePlus related topics: AIDS Post-Traumatic Stress Disorder

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Methadone Methadone hydrochloride

U.S. FDA Resources

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

Estimated Enrollment:	120
Study Start Date:	July 2005
Estimated Study Completion Date:	December 2008

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

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

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

Contacts

Contact: Mary Jo Tozzi, M.S.	(312) 572-4818	mtozzi@corecenter.org
Contact: Jeffrey D. Watts, M.D.	(312) 572-4550	jwatts@corecenter.org

Locations

United States, Illinois
The CORE Center	Recruiting
Chicago, Illinois, United States, 60612
Contact: Mary Jo Tozzi, M.S. 312-572-4818 mtozzi@corecenter.org
Contact: Jeffrey D. Watts, M.D. (312) 572-4550 jwatts@corecenter.org
Principal Investigator: Jeffrey D. Watts, M.D.

Sponsors and Collaborators

Ruth M. Rothstein CORE Center

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:

Click here for more information about The CORE Center. This link exits the ClinicalTrials.gov site

Evaluation and Support Center for the Mult-site Buprenorphine Study This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	1-H97HA03796-01-00
Study First Received:	September 27, 2005
Last Updated:	March 10, 2006
ClinicalTrials.gov Identifier:	NCT00227357 History of Changes
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:

Respiratory System Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Narcotic Antagonists
Physiological Effects of Drugs
Disorders of Environmental Origin
Opioid-Related Disorders
Infection
Stress Disorders, Traumatic
Buprenorphine
Mental Disorders
Sensory System Agents
Therapeutic Uses
Substance-Related Disorders
Stress Disorders, Post-Traumatic

Analgesics
Retroviridae Infections
Analgesics, Opioid
RNA Virus Infections
Immune System Diseases
Acquired Immunodeficiency Syndrome
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
Methadone
Anxiety Disorders
HIV Infections
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on November 09, 2009