Clinical trial NCT00227357: The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration
Official title: SPNS - An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Abuse Treatment in HIV Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
AIDS
Opiate Dependence
Post-Traumatic Stress Disorders
Keywords: HIV
AIDS
Buprenorphine
Methadone
Primary care
dual diagnosis
ptsd
Lead sponsor: Ruth M. Rothstein CORE Center
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
name: The New York Academy of Medicine
First posted: 2005-09-28
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving buprenorphine treatment Patients not receiving buprenorphine treatment (methadone or none)

Brief summary: The goal of this study is to develop and evaluate an innovative model of care to better serve patients who are both HIV-infected and opioid-dependent.

Detailed description: Hypothesis: HIV, opioid dependent patients provided agonist therapy at the site of their primary care will have better retention, utilization of services, health, social and quality of care measures and psychiatric treatment outcomes.

The Buprenorphine Project is an examination of two methods of service delivery. The purpose of this study is to assess the feasibility, cost and effectiveness of an intervention designed to integrate buprenorphine treatment for opioid dependence into HIV primary care at the CORE Center. For this project we will provide buprenorphine to 60 opioid dependent patients at any one time and will compare this on-site treatment group to 60 opioid dependent HIV+ patients who select off-site methadone or no agonist treatment at the time of enrollment.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Patient of the CORE Center
* HIV-infected (confirmed by HIV assay results)
* Opioid-dependent (by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision \[DSM-IV-TR\] criteria)
* Fluent in English or Spanish
* Planning to stay in Chicago area for the next 12 months

Exclusion Criteria:

* Liver function tests (LFTs) (transaminase only) at 5 times or higher than normal
* DSM-IV-TR criteria for benzodiazepine abuse or dependence within the past 6 months
* DSM-IV-TR criteria for alcohol dependence within the past 6 months or actively suicidal
* Psychiatric impairment that impedes ability to consent
* Methadone dose exceeds level allowing for safe transition to buprenorphine
* Pregnant women or women actively trying to become pregnant
* Clinical judgement that patient is inappropriate for medical or psychiatric reasons

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The CORE Center
state: Illinois
Study officials:
affiliation: The CORE Center and John H. Stroger, Jr. Hospital of Cook County, Affiliates of the Cook County Bureau of Health Services
name: Jeffrey D. Watts, M.D.
role: PRINCIPAL_INVESTIGATOR
References: