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Buprenorphine and Integrated HIV Care Evaluation

This study is currently recruiting participants.
Verified by The New York Academy of Medicine, March 2007

Sponsors and Collaborators: The New York Academy of Medicine
Health Resources & Services Administration
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
  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 IV

MedlinePlus related topics:   AIDS    Ataxia Telangiectasia   

ChemIDplus related topics:   Buprenorphine    Buprenorphine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Treatment in HIV Primary Care Settings

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

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 & Services Administration
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

Click here for more information about this study: Buprenorphine and Integrated HIV Care Evaluation and Support Center (BHIVES).  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   063005, H97HA03795
First Received:   July 25, 2005
Last Updated:   March 23, 2007
ClinicalTrials.gov Identifier:   NCT00124358
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

Study placed in the following topic categories:
Behavior, Addictive
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Disorders of Environmental Origin
Opioid-Related Disorders
Immunologic Deficiency Syndromes
Virus Diseases
Buprenorphine
HIV Infections
Mental Disorders
Sexually Transmitted Diseases
Substance-Related Disorders
Retroviridae Infections

Additional relevant MeSH terms:
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
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on September 05, 2008




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