The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration (BUP)
This study has been completed.
Sponsor:
Ruth M. Rothstein CORE Center
Collaborators:
Health Resources and Services Administration (HRSA)
The New York Academy of Medicine
Information provided by:
Ruth M. Rothstein CORE Center
ClinicalTrials.gov Identifier:
NCT00227357
First received: September 27, 2005
Last updated: June 4, 2010
Last verified: September 2005
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections AIDS Opiate Dependence Post-Traumatic Stress Disorders |
Drug: On-site - buprenorphine/naloxone (Suboxone) Drug: Off-site - methadone or no agonist |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | SPNS - An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Abuse Treatment in HIV Primary Care |
Resource links provided by NLM:
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Methadone
Methadone hydrochloride
Buprenorphine
Buprenorphine hydrochloride
U.S. FDA Resources
Further study details as provided by Ruth M. Rothstein CORE Center:
| Enrollment: | 101 |
| Study Start Date: | July 2005 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Buprenorphine
Study patients receiving buprenorphine treatment
|
Drug: On-site - buprenorphine/naloxone (Suboxone)
Tablet, sub-lingual, 8/2 mg, 1-3 daily
|
|
Comparison
Study patients receiving methadone or no agonist treatment
|
Drug: Off-site - methadone or no agonist |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients receiving buprenorphine treatment Patients not receiving buprenorphine treatment (methadone or none)
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227357
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227357
Locations
| United States, Illinois | |
| The CORE Center | |
| Chicago, Illinois, United States, 60612 | |
Sponsors and Collaborators
Ruth M. Rothstein CORE Center
Health Resources and Services Administration (HRSA)
The New York Academy of Medicine
Investigators
| Principal Investigator: | Jeffrey D. Watts, M.D. | The CORE Center and John H. Stroger, Jr. Hospital of Cook County, Affiliates of the Cook County Bureau of Health Services |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jeffrey D. Watts, M.D., The Ruth M. Rothstein CORE Center |
| ClinicalTrials.gov Identifier: | NCT00227357 History of Changes |
| Other Study ID Numbers: | 1-H97HA03796-01-00 |
| Study First Received: | September 27, 2005 |
| Last Updated: | June 4, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ruth M. Rothstein CORE Center:
|
HIV AIDS Buprenorphine Methadone |
Primary care dual diagnosis ptsd |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders Buprenorphine Analgesics Analgesics, Opioid Central Nervous System Agents |
Central Nervous System Depressants Narcotic Antagonists Narcotics Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015