Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT07278518
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Patient Decision Aid for Emergency Department Initiated Buprenorphine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-12-03', 'studyFirstSubmitQcDate': '2025-12-03', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability of Intervention Measure (AIM)', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'Knowledge about MOUD', 'timeFrame': 'pre and post intervention on day 1, and at 7 days', 'description': 'This is a multiple choice knowledge quiz'}, {'measure': 'Treatment selection', 'timeFrame': 'Day 1'}, {'measure': 'Decisional Conflict Scale', 'timeFrame': 'Day 1'}, {'measure': 'Receipt of buprenorphine', 'timeFrame': 'Day 1, 7'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['buprenorphine', 'patient decision aid', 'emergency department'], 'conditions': ['Opioid Use Disorder']}, 'descriptionModule': {'briefSummary': 'This study aims to develop and pilot test a patient decision aid (PtDA) for emergency department (ED)-initiated buprenorphine treatment for opioid use disorder (OUD). The PtDA will be evaluated for acceptability, impact on patient knowledge, decisional conflict, and buprenorphine uptake compared to treatment as usual (TAU).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18\n* DSM-5 criteria for moderate-to-severe OUD\n* Speaks and reads English\n* Not currently prescribed MOUD\n* Post-ED discharge patients with access to video/email\n\nExclusion Criteria:\n\n\\- Prisoners'}, 'identificationModule': {'nctId': 'NCT07278518', 'briefTitle': 'Evaluation of a Patient Decision Aid for Emergency Department Initiated Buprenorphine', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'CTN-0156: Pilot Development and Evaluation of a Patient Decision Aid for Emergency Department Initiated Buprenorphine', 'orgStudyIdInfo': {'id': 'Pro00145434'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient Decision Aid', 'description': 'This arm will receive the patient decision aid', 'interventionNames': ['Behavioral: Patient Decision Aid for Opioid Use Disorder']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as Usual', 'description': 'This will be treatment as usual without the patient decision aid'}], 'interventions': [{'name': 'Patient Decision Aid for Opioid Use Disorder', 'type': 'BEHAVIORAL', 'description': 'This will include information structured for patients about buprenorphine as a treatment options in the emergency department.', 'armGroupLabels': ['Patient Decision Aid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'contacts': [{'name': 'Lindsey Jennings, MD', 'role': 'CONTACT', 'email': 'jennil@musc.edu', 'phone': '843-792-2300'}], 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'centralContacts': [{'name': 'Lindsey Jennings, MD, MPH', 'role': 'CONTACT', 'email': 'jennil@musc.edu', 'phone': '(843) 876-8023'}], 'overallOfficials': [{'name': 'Lindsey Jennings, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'De-identified data will be shared via the NIDA data repository in accordance with NIH Data Management and Sharing Policy.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor-Faculty', 'investigatorFullName': 'Lindsey Jennings', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}