Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-02-28 @ 10:37 PM
Study NCT ID:
NCT00348868
Status:
COMPLETED
Last Update Posted:
2008-03-18
First Post:
2006-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Buprenorphine HIV Care Integration Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}], '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': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-14', 'studyFirstSubmitDate': '2006-07-05', 'studyFirstSubmitQcDate': '2006-07-05', 'lastUpdatePostDateStruct': {'date': '2008-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The three primary outcomes are Cessation of illicit opioid use, Reduction in high risk behavior and Improved HIV therapy adherence', 'timeFrame': 'week 48'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV Infection', 'Opioid dependence', 'DSM-IV criteria for opioid dependence'], 'conditions': ['HIV Infection', 'Opioid-Related Disorders']}, 'descriptionModule': {'briefSummary': 'A007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction counseling with buprenorphine/naloxone to enhanced motivational drug counseling with buprenorphine/naloxone for the treatment for opioid addiction in an integrated and nonintegrated HIV care setting.', 'detailedDescription': 'DESIGN: A007 is a randomized, two-arm study evaluating the effectiveness of standard drug addiction counseling with buprenorphine/naloxone to enhanced motivational drug counseling with buprenorphine/naloxone for the treatment for opioid addiction in an integrated and nonintegrated HIV care setting.\n\nDURATION: Subjects will participate in this study for approximately 48 weeks. Chart abstractions will continue for up to four years.\n\nSAMPLE SIZE: This study will enroll 60 subjects (30 per arm) over 72 weeks.\n\nPOPULATION: HIV-1 infected opioid dependent men and women ≥18 years of age who initiate buprenorphine for the treatment of opioid dependence and who are receiving primary care for HIV-1 infection.\n\nSTRATIFICATION: Subjects will be stratified at screening based on HIV care setting (integrated HIV care vs. nonintegrated HIV care)\n\nINTERVENTON At entry subjects will be randomized to one of the following:\n\nARM A: Standard drug addiction counseling + buprenorphine / naloxone\n\nARM B: Enhanced behavioral motivation counseling + buprenorphine / naloxone\n\nThe three primary outcomes are:\n\n1. Cessation of illicit opioid use\n2. Reduction in high risk behavior\n3. Improved HIV therapy adherence'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV infection\n* Receiving or seeking outpatient HIV care\n* Seeking outpatient treatment for opioid dependence and be willing to take buprenorphine\n* Meets DSM-IV criteria for opioid dependence, and be willing to stop illicit opioid use and be experiencing early symptoms of opioid withdrawal at the time that buprenorphine is given\n* Men and women age ≥ 18 years\n* Women of reproductive potential must have a negative serum or urine pregnancy test result available within 7 days prior to initiating buprenorphine\n* Within 30 days: (SGOT), ALT (SGPT), and alkaline phosphatase \\<=5 X ULN, Total bilirubin \\<= 2.5 x ULN\n\nExclusion Criteria:\n\n* Serious medical problem\n* Acute and/or severe psychiatric conditions\n* High dose methadone (\\>30 mg/day)\n* Documented co-dependence on alcohol and/or benzodiazepines, barbiturates\n* Chronic pain management requiring opioids\n* Pregnancy or breast-feeding\n* Imprisonment or involuntary incarceration in a medical facility for psychiatric or physical'}, 'identificationModule': {'nctId': 'NCT00348868', 'briefTitle': 'Buprenorphine HIV Care Integration Project', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Miami Buprenorphine HIV Care Integration Project', 'orgStudyIdInfo': {'id': 'A007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'enhanced behavioral motivation counseling', 'interventionNames': ['Behavioral: enhanced behavioral motivation counseling', 'Behavioral: Motivational counseling']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Behavioral: Standard counseling']}], 'interventions': [{'name': 'enhanced behavioral motivation counseling', 'type': 'BEHAVIORAL', 'armGroupLabels': ['1']}, {'name': 'Motivational counseling', 'type': 'BEHAVIORAL', 'armGroupLabels': ['1']}, {'name': 'Standard counseling', 'type': 'BEHAVIORAL', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami AIDS Clinical Reserach Unit', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Margaret Fischl, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'HRSA/Maternal and Child Health Bureau', 'class': 'FED'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Margaret A. Fischl, M.D.', 'oldOrganization': 'Unversity of Miami'}}}}