Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-01 @ 9:30 AM
Study NCT ID:
NCT00227357
Status:
COMPLETED
Last Update Posted:
2010-06-07
First Post:
2005-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'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'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D000069479', 'term': 'Buprenorphine, Naloxone Drug Combination'}], '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'}, {'id': 'D002047', 'term': 'Buprenorphine'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-04', 'studyFirstSubmitDate': '2005-09-27', 'studyFirstSubmitQcDate': '2005-09-27', 'lastUpdatePostDateStruct': {'date': '2010-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'AIDS', 'Buprenorphine', 'Methadone', 'Primary care', 'dual diagnosis', 'ptsd'], 'conditions': ['HIV Infections', 'AIDS', 'Opiate Dependence', 'Post-Traumatic Stress Disorders']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.corecenter.org', 'label': 'Click here for more information about The CORE Center.'}, {'url': 'http://www.bhives.org', 'label': 'Evaluation and Support Center for the Mult-site Buprenorphine Study'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving buprenorphine treatment Patients not receiving buprenorphine treatment (methadone or none)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Patient of the CORE Center\n* HIV-infected (confirmed by HIV assay results)\n* Opioid-dependent (by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision \\[DSM-IV-TR\\] criteria)\n* Fluent in English or Spanish\n* Planning to stay in Chicago area for the next 12 months\n\nExclusion Criteria:\n\n* Liver function tests (LFTs) (transaminase only) at 5 times or higher than normal\n* DSM-IV-TR criteria for benzodiazepine abuse or dependence within the past 6 months\n* DSM-IV-TR criteria for alcohol dependence within the past 6 months or actively suicidal\n* Psychiatric impairment that impedes ability to consent\n* Methadone dose exceeds level allowing for safe transition to buprenorphine\n* Pregnant women or women actively trying to become pregnant\n* Clinical judgement that patient is inappropriate for medical or psychiatric reasons'}, 'identificationModule': {'nctId': 'NCT00227357', 'acronym': 'BUP', 'briefTitle': 'The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration', 'organization': {'class': 'OTHER', 'fullName': 'Ruth M. Rothstein CORE Center'}, 'officialTitle': 'SPNS - An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Abuse Treatment in HIV Primary Care', 'orgStudyIdInfo': {'id': '1-H97HA03796-01-00'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Buprenorphine', 'description': 'Study patients receiving buprenorphine treatment', 'interventionNames': ['Drug: On-site - buprenorphine/naloxone (Suboxone)']}, {'label': 'Comparison', 'description': 'Study patients receiving methadone or no agonist treatment', 'interventionNames': ['Drug: Off-site - methadone or no agonist']}], 'interventions': [{'name': 'On-site - buprenorphine/naloxone (Suboxone)', 'type': 'DRUG', 'description': 'Tablet, sub-lingual, 8/2 mg, 1-3 daily', 'armGroupLabels': ['Buprenorphine']}, {'name': 'Off-site - methadone or no agonist', 'type': 'DRUG', 'armGroupLabels': ['Comparison']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The CORE Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Jeffrey D. Watts, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The CORE Center and John H. Stroger, Jr. Hospital of Cook County, Affiliates of the Cook County Bureau of Health Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruth M. Rothstein CORE Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Health Resources and Services Administration (HRSA)', 'class': 'FED'}, {'name': 'The New York Academy of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Jeffrey D. Watts, M.D.', 'oldOrganization': 'The Ruth M. Rothstein CORE Center'}}}}