Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-01-03 @ 10:31 AM
Study NCT ID:
NCT03174067
Status:
COMPLETED
Last Update Posted:
2017-06-02
First Post:
2017-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Buprenorphine in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-11-02', 'releaseDate': '2017-10-06'}], 'estimatedResultsFirstSubmitDate': '2017-10-06'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002047', 'term': 'Buprenorphine'}, {'id': 'D003000', 'term': 'Clonidine'}], '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': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-30', 'studyFirstSubmitDate': '2017-05-24', 'studyFirstSubmitQcDate': '2017-05-30', 'lastUpdatePostDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants attending the rapid access clinic', 'timeFrame': '2-5 days', 'description': 'The number of participants who attend a rapid access clinic assessment after initial enrollment'}], 'secondaryOutcomes': [{'measure': 'Number of participants who are on opioid agonist treatment', 'timeFrame': '30 days', 'description': 'The number of participants who are maintained on some form of opioid agonist treatment at the one-month mark'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['buprenorphine', 'emergency department'], 'conditions': ['Opioid Withdrawal', 'Opioid-use Disorder']}, 'referencesModule': {'references': [{'pmid': '31088887', 'type': 'DERIVED', 'citation': 'Srivastava A, Kahan M, Njoroge I, Sommer LZ. Buprenorphine in the emergency department: Randomized clinical controlled trial of clonidine versus buprenorphine for the treatment of opioid withdrawal. Can Fam Physician. 2019 May;65(5):e214-e220.'}]}, 'descriptionModule': {'briefSummary': 'This is a pilot randomized control trial randomizing patients presenting in opioid withdrawal to the emergency department to receive either one of clonidine (usual standard of care) or buprenorphine for their opioid withdrawal. Primary treatment outcome is attendance at a rapid access addiction medicine clinic within a few days of emergency room presentation. Secondary treatment outcome is treatment status with respect to opioid agonist treatment at one month post emergency room visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Presenting to the ED in opioid withdrawal or soon to be in withdrawal\n2. Minimum age 16\n3. English speaking\n4. Active phone number\n5. Ontario Health Insurance Program card\n\nExclusion Criteria:\n\n1. Pregnant\n2. Currently enrolled in a methadone or buprenorphine maintenance\n3. Benzodiazepine addiction (or taking \\>50mg of valium equivalent/day)\n4. Acute hepatitis or liver failure'}, 'identificationModule': {'nctId': 'NCT03174067', 'acronym': 'BED', 'briefTitle': 'Buprenorphine in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': "St. Joseph's Health Centre Toronto"}, 'officialTitle': 'Buprenorphine in the Emergency Department: Buprenorphine Versus Clonidine for Opioid Withdrawal', 'orgStudyIdInfo': {'id': 'BED2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Buprenorphine', 'description': 'Patient receives buprenorphine in the emergency room based on a clinical trial protocol as well as a take home prescription for buprenorphine', 'interventionNames': ['Drug: Buprenorphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clonidine', 'description': 'Patient receives clonidine in the emergency room based on a clinical trial protocol and also receives a take home prescription for clonidine', 'interventionNames': ['Drug: Clonidine']}], 'interventions': [{'name': 'Buprenorphine', 'type': 'DRUG', 'description': 'The participant receives buprenorphine', 'armGroupLabels': ['Buprenorphine']}, {'name': 'Clonidine', 'type': 'DRUG', 'description': 'The participant receives clonidine', 'armGroupLabels': ['Clonidine']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anita Srivastava, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Joseph's Health Centre Toronto", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Physician and Associate Professor', 'investigatorFullName': 'Anita Srivastava', 'investigatorAffiliation': "St. Joseph's Health Centre Toronto"}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-10-06', 'type': 'RELEASE'}, {'date': '2017-11-02', 'type': 'RESET'}], 'unpostedResponsibleParty': "Anita Srivastava, Associate Professor, Department of Family and Community Medicine, St. Joseph's Health Centre Toronto"}}}}