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Buprenorphine and Integrated HIV Care Evaluation

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ClinicalTrials.gov Identifier: NCT00124358
Recruitment Status : Unknown
Verified March 2007 by The New York Academy of Medicine.
Recruitment status was:  Recruiting
First Posted : July 27, 2005
Last Update Posted : March 27, 2007
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders HIV Infections AIDS Drug: Buprenorphine Behavioral: Integrated HIV care and office-based opioid dependence treatment Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1350 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Treatment in HIV Primary Care Settings
Study Start Date : August 2005
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

Secondary Outcome Measures :
  1. Quality of life at 1, 3, 6, 9, and 12 months
  2. HIV-related health outcomes at 1, 3, 6, 9, and 12 months

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00124358

Contact: Ruth Finkelstein, ScD 212.822.7266 rfinkelstein@nyam.org
Contact: James E Egan, MPH 212.822.7347 jegan@nyam.org

United States, Arizona
El Rio Santa Cruz Neighborhood Health Center Recruiting
Tucson, Arizona, United States, 85745
Contact: Jeff Thomas, ACSW    520-629-2888    jefft@elrio.org   
Principal Investigator: Kevin Carmichael, MD         
United States, California
Organization to Achieve Solutions in Substance Abuse Recruiting
Oakland, California, United States, 94612
Contact: Laphyne Barrett, MA    510-834-5442      
Principal Investigator: Diana Sylvestre         
University of California San Francisco Recruiting
San Francisco, California, United States, 94110
Contact: Bob Thawley    415-476-9296 ext 311    rthawley@php.ucsf.edu   
Principal Investigator: Paula Lum, MD, MPH         
Principal Investigator: Jacqueline Tulsky, MD         
United States, Connecticut
Yale University School of Medicine AIDS Program Recruiting
New Haven, Connecticut, United States, 06510
Contact: Declan Barry, PhD    203-781-4650 ext 250    declan.barry@yale.edu   
Principal Investigator: Frederick Altice, MD         
Principal Investigator: Lynn Sullivan, MD         
United States, Florida
University of Miami School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Leslie Thompson, RN, BSN    305-243-3838    lthomps@gate.net   
Principal Investigator: Margaret Fischl, MD         
Principal Investigator: Lisa Metsch, PhD         
United States, Illinois
The CORE Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Mary Jo Tozzi    312-572-4818    mtozzi@corecenter.org   
Principal Investigator: Jeffrey Watts, MD         
Sub-Investigator: David Barker, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Greg Lucas, MD, PhD    410-614-0560    glucas@jhmi.edu   
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         
United States, New York
Montefiore Medical Center Recruiting
New York, New York, United States, 10467
Contact: Galit Sacajiu, MD       gsacajiu@montefiore.org   
Principal Investigator: Chinazo Cunningham, MD         
Sub-Investigator: Nancy Sohler, PhD, MPH         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Catherine Pedersen, MPA    503-494-6770      
Principal Investigator: P. Todd Korthuis, MD, MPH         
Sub-Investigator: Dennis McCarty, PhD         
United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Helen Loewenthal, MSW    401-793-4824    hloewenthal@lifespan.org   
Principal Investigator: Timothy Flanigan, MD         
Sub-Investigator: Peter Friedman, MD, MPH         
Sponsors and Collaborators
The New York Academy of Medicine
Health Resources and Services Administration (HRSA)
El Rio Santa Cruz Neighborhood Health Center
Organization to Achieve Solutions in Substance Abuse (OASIS)
Oregon Health and Science University
Montefiore Medical Center
University of Miami
Brown University
University of California, San Francisco
Johns Hopkins University
CORE Center, Cook County Bureau of Health Services
Yale University
Principal Investigator: Ruth Finkelstein, ScD New York Academy of Medicine
Principal Investigator: David Fiellin, MD Yale University
More Information

ClinicalTrials.gov Identifier: NCT00124358     History of Changes
Other Study ID Numbers: 063005
First Posted: July 27, 2005    Key Record Dates
Last Update Posted: March 27, 2007
Last Verified: March 2007

Keywords provided by The New York Academy of Medicine:
Drug Abuse
Drug Addiction
Drug Dependence
Drug Use Disorders
Drug Use Disorder
Substance Abuse
Substance Use Disorder
Opiate Addiction
Substance-related disorders

Additional relevant MeSH terms:
HIV Infections
Opioid-Related Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists