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

July 25, 2005
March 23, 2007
August 2005
Not Provided
  • 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
  • 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.
Complete list of historical versions of study NCT00124358 on ClinicalTrials.gov Archive Site
  • Quality of life at 1, 3, 6, 9, and 12 months
  • HIV-related health outcomes at 1, 3, 6, 9, and 12 months
  • Quality of life at 1, 3, 6, 9, and 12 months.
  • HIV-related health outcomes at 1, 3, 6, 9, and 12 months.
Not Provided
Not Provided
 
Buprenorphine and Integrated HIV Care Evaluation
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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Opioid-Related Disorders
  • HIV Infections
  • AIDS
  • Drug: Buprenorphine
  • Behavioral: Integrated HIV care and office-based opioid dependence treatment
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1350
December 2008
Not Provided

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
Both
18 Years and older
No
Contact: Ruth Finkelstein, ScD 212.822.7266 rfinkelstein@nyam.org
Contact: James E Egan, MPH 212.822.7347 jegan@nyam.org
United States
 
NCT00124358
063005, H97HA03795
Not Provided
Not Provided
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
The New York Academy of Medicine
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP