The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration (BUP)
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ClinicalTrials.gov Identifier: NCT00227357 |
Recruitment Status
:
Completed
First Posted
: September 28, 2005
Last Update Posted
: June 7, 2010
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Condition or disease | Intervention/treatment |
---|---|
HIV Infections AIDS Opiate Dependence Post-Traumatic Stress Disorders | Drug: On-site - buprenorphine/naloxone (Suboxone) Drug: Off-site - methadone or no agonist |
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.
Study Type : | Observational |
Actual Enrollment : | 101 participants |
Time Perspective: | Prospective |
Official Title: | SPNS - An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Abuse Treatment in HIV Primary Care |
Study Start Date : | July 2005 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | December 2008 |

Group/Cohort | Intervention/treatment |
---|---|
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 |

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00227357
United States, Illinois | |
The CORE Center | |
Chicago, Illinois, United States, 60612 |
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 |
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 |
First Posted: | September 28, 2005 Key Record Dates |
Last Update Posted: | June 7, 2010 |
Last Verified: | September 2005 |
Keywords provided by Ruth M. Rothstein CORE Center:
HIV AIDS Buprenorphine Methadone |
Primary care dual diagnosis ptsd |
Additional relevant MeSH terms:
HIV Infections Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Opioid-Related Disorders Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Trauma and Stressor Related Disorders Mental Disorders Substance-Related Disorders |
Chemically-Induced Disorders Buprenorphine Methadone Buprenorphine, Naloxone Drug Combination Naloxone Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists Antitussive Agents Respiratory System Agents |