Buprenorphine and Integrated HIV Care Evaluation

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00124358
• Other study ID #: 063005
• Secondary ID: H97HA03795
• Status: Recruiting
• Phase: Phase 4
• First received: July 25, 2005
• Last updated: March 23, 2007
• Start date: August 2005
• Est. completion date: December 2008

Study information

• Verified date: March 2007
• Source: The New York Academy of Medicine
• Contact: Ruth Finkelstein, ScD
• Phone: 212.822.7266
• Email: rfinkelstein[@]nyam.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1350
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AIDS
• HIV Infections
• Opioid-Related Disorders

Intervention

Drug:
• Buprenorphine

Behavioral:
• Integrated HIV care and office-based opioid dependence treatment

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	The CORE Center	Chicago	Illinois
United States	University of Miami School of Medicine	Miami	Florida
United States	Yale University School of Medicine AIDS Program	New Haven	Connecticut
United States	Montefiore Medical Center	New York	New York
United States	Organization to Achieve Solutions in Substance Abuse	Oakland	California
United States	Oregon Health & Science University	Portland	Oregon
United States	The Miriam Hospital	Providence	Rhode Island
United States	University of California San Francisco	San Francisco	California
United States	El Rio Santa Cruz Neighborhood Health Center	Tucson	Arizona

Sponsors (12)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Substance use outcomes at 1, 3 and 6 months measured by self-report
Primary	Urine toxicology results at 1, 3, 6, and 12 months
Primary	Retention in and adherence to HIV care at 1, 3, 6, and 12 months
Secondary	Quality of life at 1, 3, 6, 9, and 12 months
Secondary	HIV-related health outcomes at 1, 3, 6, 9, and 12 months