The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration

NCT00227357 | Completed

• 1 other identifier: 1-H97HA03796-01-00
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; AIDS; Opiate Dependence; Post-Traumatic Stress Disorders

Keywords

HIV; AIDS; Buprenorphine; Methadone; Primary care; dual diagnosis; ptsd

Study Arms (2)

Buprenorphine

Study patients receiving buprenorphine treatment

Drug: On-site - buprenorphine/naloxone (Suboxone)

Comparison

Study patients receiving methadone or no agonist treatment

Drug: Off-site - methadone or no agonist

Interventions

On-site - buprenorphine/naloxone (Suboxone) DRUG

Tablet, sub-lingual, 8/2 mg, 1-3 daily

Buprenorphine

Off-site - methadone or no agonist DRUG

Comparison

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruth M. Rothstein CORE Center: lead
• Health Resources and Services Administration (HRSA): collaborator
• The New York Academy of Medicine: collaborator

Study Sites (1)

The CORE Center

Chicago, Illinois, 60612, United States

Location

Related Links

• Click here for more information about The CORE Center.
• Evaluation and Support Center for the Mult-site Buprenorphine Study

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; Opioid-Related Disorders; Stress Disorders, Post-Traumatic

Interventions

Naloxone; Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Buprenorphine; Drug Combinations; Pharmaceutical Preparations

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 27, 2005
• First Posted: September 28, 2005
• Study Start: July 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 7, 2010

Record last verified: 2005-09

Locations

US (1)