Buprenorphine and Integrated HIV Care Evaluation

March 23, 2007 updated by: The New York Academy of Medicine

An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Treatment in HIV Primary Care Settings

The purpose of this study is to assess the feasibility, cost and effectiveness of interventions designed to integrate buprenorphine treatment for opioid dependence into HIV primary care in ten HIV care centers in the U.S.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Programs that integrate medical care and drug treatment have shown great promise in improving health and substance use related outcomes. The overlap in the epidemics of HIV (with its complex medical needs) and drug abuse makes HIV-infected drug users a population likely to benefit from the integration of primary care and drug treatment. The Drug Addiction Treatment Act of 2000 and the approval of buprenorphine for the office-based treatment of opioid addiction provide a new opportunity to integrate addiction treatment and medical care for people with HIV. Research has demonstrated the effectiveness of buprenorphine in reducing illicit drug use among opioid dependent people. However, little is known about implementing such programs in HIV care settings, their cost, what effect they have on the health outcomes and substance use behavior of PLWH/A, or their broader impact on providers, institutions, and local systems.

Through this study, approximately 1,350 HIV-infected individuals who meet criteria for opioid dependence will be selected by eleven model demonstration projects located in ten HIV care centers across the U.S. Information on patients' drug use, HIV health status, service utilization, quality of life, and satisfaction with services as well as information about providers' practices and attitudes towards treating drug dependent patients will be collected through face-to-face interviews, audio computer-assisted self-interviewing, written surveys, and chart abstractions. These data will be used to help replicate effective programs that integrated HIV care and drug treatment and to improve the care of HIV-infected opioid dependent individuals.

Comparisons: All eleven programs will compare a group of patients who receive integrated buprenorphine treatment and HIV care to a group of patients who receive an alternate intervention. However, the program designs and comparison group interventions vary across the sites and are locally determined. Some sites will implement randomized control designs, while others will use observational methods.

Study Type

Interventional

Enrollment

1350

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: James E Egan, MPH
  • Phone Number: 212.822.7347
  • Email: jegan@nyam.org

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85745
        • Recruiting
        • El Rio Santa Cruz Neighborhood Health Center
        • Contact:
        • Principal Investigator:
          • Kevin Carmichael, MD
    • California
      • Oakland, California, United States, 94612
        • Recruiting
        • Organization to Achieve Solutions in Substance Abuse
        • Contact:
          • Laphyne Barrett, MA
          • Phone Number: 510-834-5442
        • Principal Investigator:
          • Diana Sylvestre
      • San Francisco, California, United States, 94110
        • Recruiting
        • University of California San Francisco
        • Contact:
        • Principal Investigator:
          • Paula Lum, MD, MPH
        • Principal Investigator:
          • Jacqueline Tulsky, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University School of Medicine AIDS Program
        • Contact:
        • Principal Investigator:
          • Frederick Altice, MD
        • Principal Investigator:
          • Lynn Sullivan, MD
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami School of Medicine
        • Contact:
        • Principal Investigator:
          • Margaret Fischl, MD
        • Principal Investigator:
          • Lisa Metsch, PhD
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • The CORE Center
        • Contact:
        • Principal Investigator:
          • Jeffrey Watts, MD
        • Sub-Investigator:
          • David Barker, MD
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University
        • Contact:
        • Principal Investigator:
          • Greg Lucas, MD, PhD
        • Sub-Investigator:
          • Yngveld Olsen, MD
        • Sub-Investigator:
          • William Ruby, DO
        • Sub-Investigator:
          • Jeffrey Hsu, MD
        • Sub-Investigator:
          • Jeanne Keruly, CRNP
        • Sub-Investigator:
          • Richard Moore, MD
    • New York
      • New York, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
        • Principal Investigator:
          • Chinazo Cunningham, MD
        • Sub-Investigator:
          • Nancy Sohler, PhD, MPH
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
          • Catherine Pedersen, MPA
          • Phone Number: 503-494-6770
        • Principal Investigator:
          • P. Todd Korthuis, MD, MPH
        • Sub-Investigator:
          • Dennis McCarty, PhD
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • The Miriam Hospital
        • Contact:
        • Principal Investigator:
          • Timothy Flanigan, MD
        • Sub-Investigator:
          • Peter Friedman, MD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HIV-infected
  • Clinical diagnosis of opioid dependence
  • Fluent in English or Spanish
  • 18 years or older

Exclusion Criteria:

  • Liver function tests (transaminase only) at five times or higher than normal level;
  • Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for benzodiazepine abuse or dependence within the past 6 months;
  • DSM-IV criteria for alcohol dependence within the past 6 months;
  • Actively suicidal;
  • Psychiatric impairment that impedes ability to consent (dementia, delusional, actively psychotic);
  • Methadone dose exceeding levels allowing for safe transition to buprenorphine;
  • Pregnant women and women actively trying to become pregnant;
  • Clinical judgment of local site principal investigator that patient is inappropriate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Substance use outcomes at 1, 3 and 6 months measured by self-report
Urine toxicology results at 1, 3, 6, and 12 months
Retention in and adherence to HIV care at 1, 3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure
Quality of life at 1, 3, 6, 9, and 12 months
HIV-related health outcomes at 1, 3, 6, 9, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The New York Academy of Medicine

Collaborators

Johns Hopkins University
University of Miami
Yale University
Brown University
Montefiore Medical Center
Oregon Health and Science University
University of California, San Francisco
Health Resources and Services Administration (HRSA)
Organization to Achieve Solutions in Substance Abuse (OASIS)
El Rio Santa Cruz Neighborhood Health Center
CORE Center, Cook County Bureau of Health Services

Investigators

  • Principal Investigator: David Fiellin, MD, Yale University
  • Principal Investigator: Ruth Finkelstein, ScD, New York Academy of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

July 25, 2005

First Submitted That Met QC Criteria

July 26, 2005

First Posted (Estimate)

July 27, 2005

Study Record Updates

Last Update Posted (Estimate)

March 27, 2007

Last Update Submitted That Met QC Criteria

March 23, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 063005
  • H97HA03795

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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