Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-29 @ 10:08 PM
Study NCT ID:
NCT05854303
Status:
RECRUITING
Last Update Posted:
2025-10-16
First Post:
2023-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Opioid Cessation on Opioid-Induced Esophageal Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-15', 'studyFirstSubmitDate': '2023-05-03', 'studyFirstSubmitQcDate': '2023-05-03', 'lastUpdatePostDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects to have opioid-induced esophageal dysfunction resolution', 'timeFrame': '4 weeks', 'description': 'Number of subjects to have resolution of opioid-induced esophageal dysfunction'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with dysphagia', 'timeFrame': '4 weeks', 'description': 'Number of subjects that are chronic opioid users presenting to an opioid cessation clinic to have dysphagia'}, {'measure': 'Number of subjects with chest pain', 'timeFrame': '4 weeks', 'description': 'Number of subjects that are chronic opioid users presenting to an opioid cessation clinic to have chest pain'}, {'measure': 'Number of subjects with opioid-induced esophageal dysfunction', 'timeFrame': '4 weeks', 'description': 'Number of subjects that are chronic opioid users presenting to an opioid cessation clinic to have opioid-induced esophageal dysfunction'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid-Induced Esophageal Dysfunction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of opioid cessation on opioid-induced esophageal dysfunction (OIED).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients being seen in the Pain Rehabilitation Center for opioid cessation at Mayo Clinic Rochester.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients enrolled in the Pain Rehabilitation Center for opioid cessation, with or without esophageal symptoms.\n\nExclusion Criteria:\n\n* Inability to provide informed consent.\n* Patients with previous gastroesophageal surgery or pneumatic dilation.\n* Esophageal botulinum toxin injection within the prior 12 months.\n* Esophageal stricture\n* Achalasia types I and II\n* Allergy to Lidocaine or other local anesthetics\n* Subjects on anticoagulation\n* Bilateral nasal obstruction\n* Pregnancy or breast feeding'}, 'identificationModule': {'nctId': 'NCT05854303', 'briefTitle': 'Effect of Opioid Cessation on Opioid-Induced Esophageal Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Prospective Evaluation of the Effect of Opioid Cessation on Opioid-Induced Esophageal Dysfunction (OIED)', 'orgStudyIdInfo': {'id': '23-001879'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Opioid Cessation', 'description': 'Subjects able to complete opioid cessation.', 'interventionNames': ['Behavioral: Opioid cessation']}, {'label': 'Non-Opioid Cessation', 'description': 'Subjects unable to complete opioid cessation.', 'interventionNames': ['Other: No opioid cessation']}], 'interventions': [{'name': 'Opioid cessation', 'type': 'BEHAVIORAL', 'description': 'opioid cessation will occur during pain rehabilitative program over approximately 3 weeks', 'armGroupLabels': ['Opioid Cessation']}, {'name': 'No opioid cessation', 'type': 'OTHER', 'description': 'Subjects will not stop taking opioids', 'armGroupLabels': ['Non-Opioid Cessation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic Minnesota', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Mariah Robran', 'role': 'CONTACT', 'email': 'robran.mariah@mayo.edu', 'phone': '507-266-3595'}], 'overallOfficials': [{'name': 'Diana Snyder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Diana L. Snyder', 'investigatorAffiliation': 'Mayo Clinic'}}}}