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Clinical Trials/NCT00227357
NCT00227357
Completed
Not Applicable

SPNS - An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Abuse Treatment in HIV Primary Care

Ruth M. Rothstein CORE Center1 site in 1 country101 target enrollmentJuly 2005

Overview

Phase
Not Applicable
Intervention
On-site - buprenorphine/naloxone (Suboxone)
Conditions
HIV Infections
Sponsor
Ruth M. Rothstein CORE Center
Enrollment
101
Locations
1
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2005
End Date
December 2008
Last Updated
15 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Ruth M. Rothstein CORE Center

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

Arms & Interventions

Buprenorphine

Study patients receiving buprenorphine treatment

Intervention: On-site - buprenorphine/naloxone (Suboxone)

Comparison

Study patients receiving methadone or no agonist treatment

Intervention: Off-site - methadone or no agonist

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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