Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-24 @ 12:15 PM
Study NCT ID:
NCT00987961
Status:
COMPLETED
Last Update Posted:
2015-11-11
First Post:
2009-09-30
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Linking Hospitalized Injection Drug Users to Buprenorphine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008040', 'term': 'Genetic Linkage'}], 'ancestors': [{'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-10', 'studyFirstSubmitDate': '2009-09-30', 'studyFirstSubmitQcDate': '2009-09-30', 'lastUpdatePostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'opioid use', 'timeFrame': 'baseline, 1-month, 3-months, 6-months'}, {'measure': 'HIV risk behavior', 'timeFrame': 'baseline, 1-month, 3-months, 6-months'}], 'secondaryOutcomes': [{'measure': 'reduction in injection-related medical conditions', 'timeFrame': 'baseline, 1-month, 3-months, 6-months'}, {'measure': 'reduction in emergency department and hospital utilization', 'timeFrame': 'baseline, 1-month, 3-months, 6-months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['opioid dependence', 'suboxone', 'HIV risk behavior'], 'conditions': ['Opiate Dependence']}, 'referencesModule': {'references': [{'pmid': '25090173', 'type': 'DERIVED', 'citation': 'Liebschutz JM, Crooks D, Herman D, Anderson B, Tsui J, Meshesha LZ, Dossabhoy S, Stein M. Buprenorphine treatment for hospitalized, opioid-dependent patients: a randomized clinical trial. JAMA Intern Med. 2014 Aug;174(8):1369-76. doi: 10.1001/jamainternmed.2014.2556.'}, {'pmid': '24045030', 'type': 'DERIVED', 'citation': 'Meshesha LZ, Tsui JI, Liebschutz JM, Crooks D, Anderson BJ, Herman DS, Stein MD. Days of heroin use predict poor self-reported health in hospitalized heroin users. Addict Behav. 2013 Dec;38(12):2884-7. doi: 10.1016/j.addbeh.2013.08.002. Epub 2013 Aug 14.'}]}, 'descriptionModule': {'briefSummary': 'This study tests whether starting Suboxone (buprenorphine) during a medical hospitalization, and then providing an appointment (a "link") for after discharge to maintenance buprenorphine in an outpatient setting will reduce HIV risk behavior in individuals who inject opioids.', 'detailedDescription': 'In this randomized controlled trial, medically hospitalized opioid dependent patients will be assigned to a "treatment as usual" group, where they will receive a detox regiment of Suboxone during their hospital stay, or a "linkage" group, where they receive a maintenance course of Suboxone during their hospital stay, and appointment post-discharge with an outpatient Suboxone clinic/provider and a Suboxone prescription to use between discharge and this appointment. Study interviews are completed at baseline, and 1, 3- and 6-months post-baseline. Primary outcomes are opioid use and HIV risk behavior.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Current opioid injector, at least weekly in the past month\n* Current opioid dependence, SCID confirmed\n* Currently receiving an inpatient buprenorphine detoxification protocol.\n\nExclusion Criteria:\n\n* Patients unable to be interviewed due to acute illness or cognitive impairment\n* In police custody, expecting incarceration\n* Persons who cannot provide two contact persons (including shelters, parole officers, etc.) to verify location\n* Not able to complete assessments in English\n* Enrolled in a methadone maintenance program\n* Plans to leave the area within the next 6 months.'}, 'identificationModule': {'nctId': 'NCT00987961', 'briefTitle': 'Linking Hospitalized Injection Drug Users to Buprenorphine', 'organization': {'class': 'OTHER', 'fullName': 'Butler Hospital'}, 'officialTitle': 'Linking Hospitalized Injection Drug Users to Buprenorphine', 'orgStudyIdInfo': {'id': '1R01DA026223', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA026223', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Treatment as usual', 'description': 'Participants in this arm will receive the standard detox treatment for individuals hospitalized with opioid dependence.'}, {'type': 'EXPERIMENTAL', 'label': 'Linkage', 'description': 'Participants in this arm will receive a maintenance schedule of Suboxone during their hospital stay, and an appointment with an outpatient Suboxone provider for after their discharge.', 'interventionNames': ['Behavioral: Linkage']}], 'interventions': [{'name': 'Linkage', 'type': 'BEHAVIORAL', 'description': 'This intervention provides an outpatient appointment with a Suboxone provider for medically hospitalized opioid-dependent patients to attend post-discharge.', 'armGroupLabels': ['Linkage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Michael D Stein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Butler Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Butler Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael Stein, MD', 'investigatorAffiliation': 'Butler Hospital'}}}}