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Buprenorphine and Integrated HIV Care Evaluation

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00124358
Enrollment
1350
Registered
2005-07-27
Start date
2005-08-31
Completion date
2008-12-31
Last updated
2007-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS, HIV Infections, Opioid-Related Disorders

Keywords

Drug Abuse, Drug Addiction, Drug Dependence, Drug Use Disorders, Drug Use Disorder, Substance Abuse, Substance Use Disorder, Buprenorphine, Opiate Addiction, Substance-related disorders, HIV

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.

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.

Interventions

DRUGBuprenorphine
BEHAVIORALIntegrated HIV care and office-based opioid dependence treatment

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Quality of life at 1, 3, 6, 9, and 12 months
HIV-related health outcomes at 1, 3, 6, 9, and 12 months

Countries

United States

Contacts

Primary ContactRuth Finkelstein, ScD
rfinkelstein@nyam.org212.822.7266
Backup ContactJames E Egan, MPH
jegan@nyam.org212.822.7347

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026