HIV InfectionsBUPNCT00227357
The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration
An observational study of HIV Infections and AIDS, run by Ruth M. Rothstein CORE Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, AIDS, Opiate Dependence
- What is being tested?
- On-site - buprenorphine/naloxone (Suboxone) and Off-site - methadone or no agonist
- Type of treatment
- Pill or oral medicine
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving buprenorphine treatment Patients not receiving buprenorphine treatment (methadone or none)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SPNS - An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Abuse Treatment in HIV Primary Care
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.
Read the 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.
- Being tested
- On-site - buprenorphine/naloxone (Suboxone), Off-site - methadone or no agonist
- Keywords
- HIV, AIDS, Buprenorphine, Methadone, Primary care, dual diagnosis, ptsd
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Opioid-Related Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-site - buprenorphine/naloxone (Suboxone)Drug
Tablet, sub-lingual, 8/2 mg, 1-3 daily
Off-site - methadone or no agonistDrug
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine | Study patients receiving buprenorphine treatment Receives: Drug: On-site - buprenorphine/naloxone (Suboxone) | |
| Comparison | Study patients receiving methadone or no agonist treatment Receives: Drug: Off-site - methadone or no agonist |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruth M. Rothstein CORE Center
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA), The New York Academy of Medicine
- Investigators
- Jeffrey D. Watts, M.D., Principal investigator, The CORE Center and John H. Stroger, Jr. Hospital of Cook County, Affiliates of the Cook County Bureau of Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00227357
- Sponsor's protocol ID
- 1-H97HA03796-01-00
- Acronym
- BUP
- Status last verified
- Sep 2005
- First submitted
- 27 Sep 2005
- Last updated
- 7 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPNS - An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Abuse Treatment in HIV Primary Care
- ClinicalTrials.gov ID
- NCT00227357
- Acronym / sponsor ID
- BUP / 1-H97HA03796-01-00
- Keywords
- HIV, AIDS, Buprenorphine, Methadone, Primary care, dual diagnosis, ptsd
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Ruth M. Rothstein CORE CenterUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA), The New York Academy of Medicine
- Study start
- Jul 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 28 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine | – | Drug: On-site - buprenorphine/naloxone (Suboxone)Study patients receiving buprenorphine treatment |
| Comparison | – | Drug: Off-site - methadone or no agonistStudy patients receiving methadone or no agonist treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving buprenorphine treatment Patients not receiving buprenorphine treatment (methadone or none)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On-site - buprenorphine/naloxone (Suboxone)Tablet, sub-lingual, 8/2 mg, 1-3 daily | Drug | Buprenorphine |
| Off-site - methadone or no agonist | Drug | Comparison |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2010.
- Click here for more information about The CORE Center.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey D. Watts, M.D. principal investigator
The CORE Center and John H. Stroger, Jr. Hospital of Cook County, Affiliates of the Cook County Bureau of Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and AIDS, run by Ruth M. Rothstein CORE Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2010.