Buprenorphine and Integrated HIV Care Evaluation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by The New York Academy of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
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
Information provided by:
The New York Academy of Medicine
ClinicalTrials.gov Identifier:
NCT00124358
First received: July 25, 2005
Last updated: March 23, 2007
Last verified: March 2007
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Treatment in HIV Primary Care Settings

Resource links provided by NLM:


Further study details as provided by The New York Academy of Medicine:

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

Estimated Enrollment: 1350
Study Start Date: August 2005
Estimated Study Completion Date: December 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124358

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

Locations
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
Investigators
Principal Investigator: Ruth Finkelstein, ScD New York Academy of Medicine
Principal Investigator: David Fiellin, MD Yale University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00124358     History of Changes
Other Study ID Numbers: 063005, H97HA03795
Study First Received: July 25, 2005
Last Updated: March 23, 2007
Health Authority: United States: Institutional Review Board

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
Buprenorphine
Opiate Addiction
Substance-related disorders
HIV

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

ClinicalTrials.gov processed this record on August 20, 2014