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| Sponsors and Collaborators: |
The New York Academy of Medicine Health Resources & Services Administration 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 |
|---|---|
| Information provided by: | The New York Academy of Medicine |
| ClinicalTrials.gov Identifier: | NCT00124358 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Opioid-Related Disorders HIV Infections AIDS |
Drug: Buprenorphine Behavioral: Integrated HIV care and office-based opioid dependence treatment |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Treatment in HIV Primary Care Settings |
| Estimated Enrollment: | 1350 |
| Study Start Date: | August 2005 |
| Estimated Study Completion Date: | December 2008 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ruth Finkelstein, ScD | 212.822.7266 | rfinkelstein@nyam.org |
| Contact: James E Egan, MPH | 212.822.7347 | jegan@nyam.org |
| United States, Arizona | |
| El Rio Santa Cruz Neighborhood Health Center | Recruiting |
| Tucson, Arizona, United States, 85745 | |
| Contact: Jeff Thomas, ACSW 520-629-2888 jefft@elrio.org | |
| Principal Investigator: Kevin Carmichael, MD | |
| United States, California | |
| Organization to Achieve Solutions in Substance Abuse | Recruiting |
| Oakland, California, United States, 94612 | |
| Contact: Laphyne Barrett, MA 510-834-5442 | |
| Principal Investigator: Diana Sylvestre | |
| University of California San Francisco | Recruiting |
| San Francisco, California, United States, 94110 | |
| Contact: Bob Thawley 415-476-9296 ext 311 rthawley@php.ucsf.edu | |
| Principal Investigator: Paula Lum, MD, MPH | |
| Principal Investigator: Jacqueline Tulsky, MD | |
| United States, Connecticut | |
| Yale University School of Medicine AIDS Program | Recruiting |
| New Haven, Connecticut, United States, 06510 | |
| Contact: Declan Barry, PhD 203-781-4650 ext 250 declan.barry@yale.edu | |
| Principal Investigator: Frederick Altice, MD | |
| Principal Investigator: Lynn Sullivan, MD | |
| United States, Florida | |
| University of Miami School of Medicine | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Leslie Thompson, RN, BSN 305-243-3838 lthomps@gate.net | |
| Principal Investigator: Margaret Fischl, MD | |
| Principal Investigator: Lisa Metsch, PhD | |
| United States, Illinois | |
| The CORE Center | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Mary Jo Tozzi 312-572-4818 mtozzi@corecenter.org | |
| Principal Investigator: Jeffrey Watts, MD | |
| Sub-Investigator: David Barker, MD | |
| United States, Maryland | |
| Johns Hopkins University | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Greg Lucas, MD, PhD 410-614-0560 glucas@jhmi.edu | |
| Principal Investigator: Greg Lucas, MD, PhD | |
| Sub-Investigator: Yngveld Olsen, MD | |
| Sub-Investigator: William Ruby, DO | |
| Sub-Investigator: Jeffrey Hsu, MD | |
| Sub-Investigator: Jeanne Keruly, CRNP | |
| Sub-Investigator: Richard Moore, MD | |
| United States, New York | |
| Montefiore Medical Center | Recruiting |
| New York, New York, United States, 10467 | |
| Contact: Galit Sacajiu, MD gsacajiu@montefiore.org | |
| Principal Investigator: Chinazo Cunningham, MD | |
| Sub-Investigator: Nancy Sohler, PhD, MPH | |
| United States, Oregon | |
| Oregon Health & Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Catherine Pedersen, MPA 503-494-6770 | |
| Principal Investigator: P. Todd Korthuis, MD, MPH | |
| Sub-Investigator: Dennis McCarty, PhD | |
| United States, Rhode Island | |
| The Miriam Hospital | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Contact: Helen Loewenthal, MSW 401-793-4824 hloewenthal@lifespan.org | |
| Principal Investigator: Timothy Flanigan, MD | |
| Sub-Investigator: Peter Friedman, MD, MPH | |
| Principal Investigator: | Ruth Finkelstein, ScD | New York Academy of Medicine |
| Principal Investigator: | David Fiellin, MD | Yale University |
More Information
| Study ID Numbers: | 063005, H97HA03795 |
| Study First Received: | July 25, 2005 |
| Last Updated: | March 23, 2007 |
| ClinicalTrials.gov Identifier: | NCT00124358 |
| Health Authority: | United States: Institutional Review Board |
|
Drug Abuse Drug Addiction Drug Dependence Drug Use Disorders Drug Use Disorder Substance Abuse |
Substance Use Disorder Buprenorphine Opiate Addiction Substance-related disorders HIV |
|
Behavior, Addictive Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Disorders of Environmental Origin Opioid-Related Disorders Immunologic Deficiency Syndromes Virus Diseases |
Buprenorphine HIV Infections Mental Disorders Sexually Transmitted Diseases Substance-Related Disorders Retroviridae Infections |
|
RNA Virus Infections Slow Virus Diseases Immune System Diseases Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Narcotics Infection |
Pharmacologic Actions Sensory System Agents Therapeutic Uses Lentivirus Infections Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |
