Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
Study NCT ID:
NCT00317460
Status:
COMPLETED
Last Update Posted:
2020-04-03
First Post:
2006-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Buprenorphine and Integrated HIV Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'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': 'D012897', 'term': 'Slow 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': 'D000079524', 'term': 'Narcotic-Related Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020399', 'term': 'Practice Management'}, {'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-01', 'studyFirstSubmitDate': '2006-04-20', 'studyFirstSubmitQcDate': '2006-04-21', 'lastUpdatePostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment retention', 'timeFrame': '52 weeks'}, {'measure': 'Reductions in illicit opioid use', 'timeFrame': '52 weeks'}, {'measure': 'Adherence to antiretroviral medications', 'timeFrame': '52 weeks'}], 'secondaryOutcomes': [{'measure': 'T-lymphocyte CD4 cell count', 'timeFrame': '52 weeks'}, {'measure': 'HIV-1 RNA levels', 'timeFrame': '52 weeks'}, {'measure': 'Reduction in HIV transmission risk behaviors', 'timeFrame': '52 weeks'}, {'measure': 'Improved health status', 'timeFrame': '52 weeks'}, {'measure': 'Patient satisfaction', 'timeFrame': '52 weeks'}, {'measure': 'Provider satisfaction', 'timeFrame': '52 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug Abuse', 'Drug Addiction', 'Drug Dependence', 'Drug Use Disorders', 'Drug Use Disorder', 'Substance Abuse', 'Substance Use Disorder', 'Buprenorphine', 'Opiate Addiction'], 'conditions': ['Substance-related Disorders', 'Drug Addiction', 'Human Immunodeficiency Virus', 'AIDS', 'HIV Infections']}, '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 examine the efficacy of providing two levels of psychosocial support along with buprenorphine/naloxone (BUP) maintenance to opioid dependent patients receiving their care in an HIV clinical care setting.', 'detailedDescription': 'The purpose of this study is to examine the efficacy of providing two levels of psychosocial support along with buprenorphine/naloxone (BUP) maintenance to opioid dependent patients receiving their care in an HIV clinical care setting. The proposed study will compare Physician Management (PM), a manual-guided brief intervention that approximates the usual counseling provided by primary care practitioners to patients with chronic medical conditions vs. an enhanced strategy of PM with the addition of a combined drug counseling and adherence management strategy (PM+DC/AM). DC is designed to educate the patient about the recovery process and provide additional advice about lifestyle changes including HIV transmission risk reduction and 12-step participation. Adherence Management (AM) is a counseling strategy focusing on HIV medication adherence, adapted from Sorensen et al1. This research will build on pilot work that is being completed in order to further develop and refine these counseling interventions, determine what other psychosocial interventions might be required, and to evaluate this model of integrated care in terms of its effects on opioid agonist therapy retention, decreasing illicit drug use, and increasing adherence to highly active antiretroviral therapy (HAART). Finally, it will provide data that will aid in the formulation of guidelines and the creation of practical manuals for optimizing the provision of this novel therapy to individuals with HIV disease and opioid dependence, as well as provide data for future funded randomized clinical trials.\n\nFrom September 2005 (start date) to December 1, 2007, the study was conducted as part of a multi-site project that was overseen by the New York Academy of Medicine (NYAM), which is in charge of data analysis. Following December 1, 2007, the study will continue as a local, single-site project without further collaboration from NYAM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV disease\n* DSM-IV criteria for opioid dependence, as assessed by SCID\n* Documented opioid positive urine toxicology testing\n\nExclusion criteria:\n\n* Desire to remain enrolled in opioid agonist treatment at an opioid treatment program\n* Current dependence on alcohol, benzodiazepines or sedatives (patients who are receiving benzodiazepines under the care of a psychiatrist for the treatment of an anxiety disorder will not be excluded)\n* Current suicide or homicide risk\n* Current psychotic disorder or major depression\n* Inability to read or understand English\n* Dementia\n* Life-threatening or unstable medical problems requiring inpatient medical care or nursing home placement\n* Currently enrolled in other studies involving the provision of psychosocial treatment.'}, 'identificationModule': {'nctId': 'NCT00317460', 'briefTitle': 'Buprenorphine and Integrated HIV Care', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'On-Site Addiction Treatment With Buprenorphine in HIV Clinical Care Settings', 'orgStudyIdInfo': {'id': '0510000681'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Physician Management', 'interventionNames': ['Other: Physician Management']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Physician Management and counseling (drug counseling and medication adherence)', 'interventionNames': ['Behavioral: Counseling']}], 'interventions': [{'name': 'Physician Management', 'type': 'OTHER', 'description': 'Standard physician care', 'armGroupLabels': ['1']}, {'name': 'Counseling', 'type': 'BEHAVIORAL', 'description': 'Physician Management and Counseling', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Christopher J Cutter, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The New York Academy of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}