Buprenorphine and Integrated HIV Care Evaluation - NCT00124358-33136 (Clinical Trial 126268)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy126268.aspx
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| City: |
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Miami |
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State:
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FL |
| Zip Code: |
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33136 |
| Conditions: |
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Opioid-Related Disorders - HIV Infections - AIDS |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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Inclusion Criteria:
- HIV-infected
- Clinical diagnosis of opioid dependence
- Fluent in English or Spanish
- 18 years or older
Exclusion Criteria:
- 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 |
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| Study is available at: |
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University of Miami School of Medicine
Miami, FL 33136
United States
Primary Contact:
Leslie Thompson, RN, BSN
Email: lthomps@gate.net
Phone: 305-243-3838
Secondary Contact:
Ruth Finkelstein, ScD
Email: rfinkelstein@nyam.org
Phone: 212.822.7266 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 15, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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