Opioid-Related DisordersPhase 4NCT00124358
Buprenorphine and Integrated HIV Care Evaluation
A Phase 4 study testing Buprenorphine and Integrated HIV care and office-based opioid dependence treatment in people with Opioid-Related Disorders and HIV Infections, run by The New York Academy of Medicine at 10 sites in United States.
Trial summary
The purpose of this study is to assess the feasibility, cost and effectiveness of interventions designed to integrate buprenorphine treatment for opioid dependence into HIV primary care in ten HIV care centers in the U.S. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-Related Disorders, HIV Infections, AIDS
- What is being tested?
- Buprenorphine and Integrated HIV care and office-based opioid dependence treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,350 participants
- Where
- 10 sitesUnited States
- Study dates
- Aug 2005to Dec 2008
- Phase
- Phase 4
- 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
Who may be able to join
- HIV-infected
- Clinical diagnosis of opioid dependence
- Fluent in English or Spanish
- 18 years or older
Who cannot join
- Liver function tests (transaminase only) at five times or higher than normal level;
- Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for benzodiazepine abuse or dependence within the past 6 months;
- DSM-IV criteria for alcohol dependence within the past 6 months;
- Actively suicidal;
- Psychiatric impairment that impedes ability to consent (dementia, delusional, actively psychotic);
- Methadone dose exceeding levels allowing for safe transition to buprenorphine;
- Pregnant women and women actively trying to become pregnant;
- Clinical judgment of local site principal investigator that patient is inappropriate
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Greg Lucas, MD, PhD, 410-614-0560, glucas@jhmi.edu
Greg Lucas, MD, PhD
- Recruiting
The CORE Center
Chicago, Illinois, 60612
Mary Jo Tozzi, 312-572-4818, mtozzi@corecenter.org
Jeffrey Watts, MD
- Recruiting
University of Miami School of Medicine
Miami, Florida, 33136
Leslie Thompson, RN, BSN, 305-243-3838, lthomps@gate.net
Margaret Fischl, MD
- Recruiting
Yale University School of Medicine AIDS Program
New Haven, Connecticut, 06510
Declan Barry, PhD, 203-781-4650 ext. 250, declan.barry@yale.edu
Frederick Altice, MD
- Recruiting
Montefiore Medical Center
New York, New York, 10467
Galit Sacajiu, MD, gsacajiu@montefiore.org
Chinazo Cunningham, MD
- Recruiting
Organization to Achieve Solutions in Substance Abuse
Oakland, California, 94612
Laphyne Barrett, MA, 510-834-5442
Diana Sylvestre
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Catherine Pedersen, MPA, 503-494-6770
P. Todd Korthuis, MD, MPH
- Recruiting
The Miriam Hospital
Providence, Rhode Island, 02903
Helen Loewenthal, MSW, 401-793-4824, hloewenthal@lifespan.org
Timothy Flanigan, MD
- Recruiting
University of California San Francisco
San Francisco, California, 94110
Bob Thawley, 415-476-9296 ext. 311, rthawley@php.ucsf.edu
Paula Lum, MD, MPH
- Recruiting
El Rio Santa Cruz Neighborhood Health Center
Tucson, Arizona, 85745
Jeff Thomas, ACSW, 520-629-2888, jefft@elrio.org
Kevin Carmichael, MD
About this study
Official title: An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Treatment in HIV Primary Care Settings
The purpose of this study is to assess the feasibility, cost and effectiveness of interventions designed to integrate buprenorphine treatment for opioid dependence into HIV primary care in ten HIV care centers in the U.S.
Read the detailed description
Programs that integrate medical care and drug treatment have shown great promise in improving health and substance use related outcomes. The overlap in the epidemics of HIV (with its complex medical needs) and drug abuse makes HIV-infected drug users a population likely to benefit from the integration of primary care and drug treatment. The Drug Addiction Treatment Act of 2000 and the approval of buprenorphine for the office-based treatment of opioid addiction provide a new opportunity to integrate addiction treatment and medical care for people with HIV. Research has demonstrated the effectiveness of buprenorphine in reducing illicit drug use among opioid dependent people. However, little is known about implementing such programs in HIV care settings, their cost, what effect they have on the health outcomes and substance use behavior of PLWH/A, or their broader impact on providers, institutions, and local systems.
Through this study, approximately 1,350 HIV-infected individuals who meet criteria for opioid dependence will be selected by eleven model demonstration projects located in ten HIV care centers across the U.S. Information on patients' drug use, HIV health status, service utilization, quality of life, and satisfaction with services as well as information about providers' practices and attitudes towards treating drug dependent patients will be collected through face-to-face interviews, audio computer-assisted self-interviewing, written surveys, and chart abstractions. These data will be used to help replicate effective programs that integrated HIV care and drug treatment and to improve the care of HIV-infected opioid dependent individuals.
Comparisons: All eleven programs will compare a group of patients who receive integrated buprenorphine treatment and HIV care to a group of patients who receive an alternate intervention. However, the program designs and comparison group interventions vary across the sites and are locally determined. Some sites will implement randomized control designs, while others will use observational methods.
- Conditions
- Opioid-Related Disorders, HIV Infections, AIDS
- Being tested
- Buprenorphine, Integrated HIV care and office-based opioid dependence treatment
- Keywords
- Drug Abuse, Drug Addiction, Drug Dependence, Drug Use Disorders, Drug Use Disorder, Substance Abuse, Substance Use Disorder, Buprenorphine, Opiate Addiction, Substance-related disorders, HIV
- Medical subject headings
- Opioid-Related Disorders, HIV Infections, Acquired Immunodeficiency Syndrome, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuprenorphineDrug
Integrated HIV care and office-based opioid dependence treatmentBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance use outcomes at 1, 3 and 6 months measured by self-report
Urine toxicology results at 1, 3, 6, and 12 months
Retention in and adherence to HIV care at 1, 3, 6, and 12 months
Secondary outcomes (2)
Quality of life at 1, 3, 6, 9, and 12 months
HIV-related health outcomes at 1, 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2005 (estimated)
- Study startAug 2005
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Related DisordersStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,350 participants
Sponsor and investigators
- Lead sponsor
- The New York Academy of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA), El Rio Santa Cruz Neighborhood Health Center, Organization to Achieve Solutions in Substance Abuse (OASIS), Oregon Health and Science University, Montefiore Medical Center, University of Miami, Brown University, University of California, San Francisco, Johns Hopkins University, CORE Center, Cook County Bureau of Health Services, Yale University
- Investigators
- Ruth Finkelstein, ScD, Principal investigator, New York Academy of MedicineDavid Fiellin, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124358
- Sponsor's protocol ID
- 063005
- Other IDs
- H97HA03795
- Status last verified
- Mar 2007
- First submitted
- 25 Jul 2005
- Last updated
- 27 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Treatment in HIV Primary Care Settings
- ClinicalTrials.gov ID
- NCT00124358
- Acronym / sponsor ID
- 063005
- Conditions
- Opioid-Related Disorders, HIV Infections, AIDS
- Keywords
- Drug Abuse, Drug Addiction, Drug Dependence, Drug Use Disorders, Drug Use Disorder, Substance Abuse, Substance Use Disorder, Buprenorphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,350 participants
- Lead sponsor
- The New York Academy of MedicineUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA), El Rio Santa Cruz Neighborhood Health Center, Organization to Achieve Solutions in Substance Abuse (OASIS), Oregon Health and Science University, Montefiore Medical Center, University of Miami, Brown University, University of California, San Francisco, Johns Hopkins University, CORE Center, Cook County Bureau of Health Services, Yale University
- Study start
- Aug 2005
- Study completion
- Dec 2008 (estimated)
- First posted
- 27 Jul 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 purpose of this study is to assess the feasibility, cost and effectiveness of interventions designed to integrate buprenorphine treatment for opioid dependence into HIV primary care in ten HIV care centers in the U.S.
Detailed description
Programs that integrate medical care and drug treatment have shown great promise in improving health and substance use related outcomes. The overlap in the epidemics of HIV (with its complex medical needs) and drug abuse makes HIV-infected drug users a population likely to benefit from the integration of primary care and drug treatment. The Drug Addiction Treatment Act of 2000 and the approval of buprenorphine for the office-based treatment of opioid addiction provide a new opportunity to integrate addiction treatment and medical care for people with HIV. Research has demonstrated the effectiveness of buprenorphine in reducing illicit drug use among opioid dependent people. However, little is known about implementing such programs in HIV care settings, their cost, what effect they have on the health outcomes and substance use behavior of PLWH/A, or their broader impact on providers, institutions, and local systems.
Through this study, approximately 1,350 HIV-infected individuals who meet criteria for opioid dependence will be selected by eleven model demonstration projects located in ten HIV care centers across the U.S. Information on patients' drug use, HIV health status, service utilization, quality of life, and satisfaction with services as well as information about providers' practices and attitudes towards treating drug dependent patients will be collected through face-to-face interviews, audio computer-assisted self-interviewing, written surveys, and chart abstractions. These data will be used to help replicate effective programs that integrated HIV care and drug treatment and to improve the care of HIV-infected opioid dependent individuals.
Comparisons: All eleven programs will compare a group of patients who receive integrated buprenorphine treatment and HIV care to a group of patients who receive an alternate intervention. However, the program designs and comparison group interventions vary across the sites and are locally determined. Some sites will implement randomized control designs, while others will use observational methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV-infected
- Clinical diagnosis of opioid dependence
- Fluent in English or Spanish
- 18 years or older
Key exclusion criteria (8 listed)
- Liver function tests (transaminase only) at five times or higher than normal level;
- Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for benzodiazepine abuse or dependence within the past 6 months;
- DSM-IV criteria for alcohol dependence within the past 6 months;
- Actively suicidal;
- Psychiatric impairment that impedes ability to consent (dementia, delusional, actively psychotic);
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 |
|---|---|---|
| Buprenorphine | Drug | – |
| Integrated HIV care and office-based opioid dependence treatment | Behavioural | – |
Primary outcome
Substance use outcomes at 1, 3 and 6 months measured by self-report
Urine toxicology results at 1, 3, 6, and 12 months
Retention in and adherence to HIV care at 1, 3, 6, and 12 months
2 secondary outcomes
Quality of life at 1, 3, 6, 9, and 12 months
HIV-related health outcomes at 1, 3, 6, 9, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2007.
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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.
Ruth Finkelstein, ScD principal investigator
New York Academy of Medicine
David Fiellin, MD principal investigator
Yale University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Buprenorphine and Integrated HIV care and office-based opioid dependence treatment in people with Opioid-Related Disorders and HIV Infections, run by The New York Academy of Medicine at 10 sites 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 27 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruth Finkelstein, ScD (212.822.7266, rfinkelstein@nyam.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substance use outcomes at 1, 3 and 6 months measured by self-report. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 27 Mar 2007.