Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-29 @ 3:03 PM
Study NCT ID:
NCT00124358
Status:
UNKNOWN
Last Update Posted:
2007-03-27
First Post:
2005-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Buprenorphine and Integrated HIV Care Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002047', 'term': 'Buprenorphine'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 1350}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-03-23', 'studyFirstSubmitDate': '2005-07-25', 'studyFirstSubmitQcDate': '2005-07-26', 'lastUpdatePostDateStruct': {'date': '2007-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Substance use outcomes at 1, 3 and 6 months measured by self-report'}, {'measure': 'Urine toxicology results at 1, 3, 6, and 12 months'}, {'measure': 'Retention in and adherence to HIV care at 1, 3, 6, and 12 months'}], 'secondaryOutcomes': [{'measure': 'Quality of life at 1, 3, 6, 9, and 12 months'}, {'measure': 'HIV-related health outcomes at 1, 3, 6, 9, and 12 months'}]}, 'conditionsModule': {'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'], 'conditions': ['Opioid-Related Disorders', 'HIV Infections', 'AIDS']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bhives.org', 'label': 'Click here for more information about this study: Buprenorphine and Integrated HIV Care Evaluation and Support Center (BHIVES).'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThrough 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.\n\nComparisons: 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-infected\n* Clinical diagnosis of opioid dependence\n* Fluent in English or Spanish\n* 18 years or older\n\nExclusion Criteria:\n\n* Liver function tests (transaminase only) at five times or higher than normal level;\n* Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) criteria for benzodiazepine abuse or dependence within the past 6 months;\n* DSM-IV criteria for alcohol dependence within the past 6 months;\n* Actively suicidal;\n* Psychiatric impairment that impedes ability to consent (dementia, delusional, actively psychotic);\n* Methadone dose exceeding levels allowing for safe transition to buprenorphine;\n* Pregnant women and women actively trying to become pregnant;\n* Clinical judgment of local site principal investigator that patient is inappropriate'}, 'identificationModule': {'nctId': 'NCT00124358', 'briefTitle': 'Buprenorphine and Integrated HIV Care Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'The New York Academy of Medicine'}, 'officialTitle': 'An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Treatment in HIV Primary Care Settings', 'orgStudyIdInfo': {'id': '063005'}, 'secondaryIdInfos': [{'id': 'H97HA03795'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Buprenorphine', 'type': 'DRUG'}, {'name': 'Integrated HIV care and office-based opioid dependence treatment', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85745', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeff Thomas, ACSW', 'role': 'CONTACT', 'email': 'jefft@elrio.org', 'phone': '520-629-2888'}, {'name': 'Kevin Carmichael, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'El Rio Santa Cruz Neighborhood Health Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94612', 'city': 'Oakland', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laphyne Barrett, MA', 'role': 'CONTACT', 'phone': '510-834-5442'}, {'name': 'Diana Sylvestre', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Organization to Achieve Solutions in Substance Abuse', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bob Thawley', 'role': 'CONTACT', 'email': 'rthawley@php.ucsf.edu', 'phone': '415-476-9296', 'phoneExt': '311'}, {'name': 'Paula Lum, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jacqueline Tulsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Declan Barry, PhD', 'role': 'CONTACT', 'email': 'declan.barry@yale.edu', 'phone': '203-781-4650', 'phoneExt': '250'}, {'name': 'Frederick Altice, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lynn Sullivan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yale University School of Medicine AIDS Program', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leslie Thompson, RN, BSN', 'role': 'CONTACT', 'email': 'lthomps@gate.net', 'phone': '305-243-3838'}, {'name': 'Margaret Fischl, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lisa Metsch, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Miami School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mary Jo Tozzi', 'role': 'CONTACT', 'email': 'mtozzi@corecenter.org', 'phone': '312-572-4818'}, {'name': 'Jeffrey Watts, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David Barker, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The CORE Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Greg Lucas, MD, PhD', 'role': 'CONTACT', 'email': 'glucas@jhmi.edu', 'phone': '410-614-0560'}, {'name': 'Greg Lucas, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yngveld Olsen, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'William Ruby, DO', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jeffrey Hsu, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jeanne Keruly, CRNP', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Richard Moore, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '10467', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Galit Sacajiu, MD', 'role': 'CONTACT', 'email': 'gsacajiu@montefiore.org'}, {'name': 'Chinazo Cunningham, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nancy Sohler, PhD, MPH', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Catherine Pedersen, MPA', 'role': 'CONTACT', 'phone': '503-494-6770'}, {'name': 'P. Todd Korthuis, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dennis McCarty, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Helen Loewenthal, MSW', 'role': 'CONTACT', 'email': 'hloewenthal@lifespan.org', 'phone': '401-793-4824'}, {'name': 'Timothy Flanigan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Peter Friedman, MD, MPH', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Miriam Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'centralContacts': [{'name': 'Ruth Finkelstein, ScD', 'role': 'CONTACT', 'email': 'rfinkelstein@nyam.org', 'phone': '212.822.7266'}, {'name': 'James E Egan, MPH', 'role': 'CONTACT', 'email': 'jegan@nyam.org', 'phone': '212.822.7347'}], 'overallOfficials': [{'name': 'Ruth Finkelstein, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Academy of Medicine'}, {'name': 'David Fiellin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The New York Academy of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Health Resources and Services Administration (HRSA)', 'class': 'FED'}, {'name': 'El Rio Santa Cruz Neighborhood Health Center', 'class': 'UNKNOWN'}, {'name': 'Organization to Achieve Solutions in Substance Abuse (OASIS)', 'class': 'OTHER'}, {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, {'name': 'University of Miami', 'class': 'OTHER'}, {'name': 'Brown University', 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'CORE Center, Cook County Bureau of Health Services', 'class': 'UNKNOWN'}, {'name': 'Yale University', 'class': 'OTHER'}]}}}