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The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration

This study is currently recruiting participants.
Verified by The CORE Center, September 2005

Sponsored by: The CORE Center
Information provided by: The 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

MedlinePlus related topics:   AIDS    Post-Traumatic Stress Disorder    Stress   

ChemIDplus related topics:   Methadone    Methadone hydrochloride    Buprenorphine    Buprenorphine hydrochloride   

U.S. FDA Resources

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

Further study details as provided by The 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
The 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


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
 

Study ID Numbers:   1-H97HA03796-01-00
First Received:   September 27, 2005
Last Updated:   March 10, 2006
ClinicalTrials.gov Identifier:   NCT00227357
Health Authority:   United States: Institutional Review Board

Keywords provided by The CORE Center:
HIV  
AIDS  
Buprenorphine  
Methadone  
Primary care
dual diagnosis
ptsd

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Disorders of Environmental Origin
Stress
Opioid-Related Disorders
Stress Disorders, Traumatic
Immunologic Deficiency Syndromes
Naphazoline
Virus Diseases
Oxymetazoline
Methadone
Buprenorphine
Anxiety Disorders
Guaifenesin
Phenylephrine
HIV Infections
Mental Disorders
Sexually Transmitted Diseases
Substance-Related Disorders
Stress Disorders, Post-Traumatic
Phenylpropanolamine
Retroviridae Infections

Additional relevant MeSH terms:
Respiratory System Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Infection
Pharmacologic Actions
Sensory System Agents
Therapeutic Uses
Lentivirus Infections
Analgesics
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on October 10, 2008




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