Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-01-01 @ 12:50 AM
Study NCT ID:
NCT03977012
Status:
UNKNOWN
Last Update Posted:
2023-04-14
First Post:
2019-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuroimaging Study on the Effect of Transdermal Buprenorphine in Complex Regional Pain Syndrome Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020918', 'term': 'Complex Regional Pain Syndromes'}], 'ancestors': [{'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002047', 'term': 'Buprenorphine'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-13', 'studyFirstSubmitDate': '2019-05-23', 'studyFirstSubmitQcDate': '2019-06-05', 'lastUpdatePostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in neuroinflammation', 'timeFrame': 'baseline, 8 weeks', 'description': '\\[11C\\]-(R)-PK11195 PET distribution volume ratio (DVR)'}], 'secondaryOutcomes': [{'measure': 'Morphine equivalent', 'timeFrame': 'baseline, 8 weeks', 'description': 'narcotic analgesic dosage'}, {'measure': 'Physical test(1)', 'timeFrame': 'baseline, 8 weeks', 'description': 'blood test'}, {'measure': 'Physical test(2)', 'timeFrame': 'baseline, 8 weeks', 'description': 'urine test'}, {'measure': 'Physical test(3)', 'timeFrame': 'baseline, 8 weeks', 'description': 'Electrocardiogram(ECG) test (pulse rate)'}, {'measure': 'Physical test(4)', 'timeFrame': 'baseline, 8 weeks', 'description': 'pulse measurement'}, {'measure': 'Physical test(5)', 'timeFrame': 'baseline, 8 weeks', 'description': 'blood pressure measurement'}, {'measure': 'Self-reported questionnaire(1)', 'timeFrame': 'baseline, 8 weeks', 'description': 'Beck Depression Index(BDI)/ total score: 0\\~63, The higher the score, the more depressed'}, {'measure': 'Self-reported questionnaire(2)', 'timeFrame': 'baseline, 8 weeks', 'description': 'Beck Anxiety Index(BAI)/ total score: 0\\~63, The higher the score, the more anxiety'}, {'measure': 'Self-reported questionnaire(3)', 'timeFrame': 'baseline, 8 weeks', 'description': "Short Form McGill Pain Questionnaire(SF-MPQ)/ 'a' subscale score: 0\\~45, The higher the score, the more painful/ 'b' subscale score, 0\\~10, The higher the score, the more painful/ 'c' subscale score, 0\\~5, The higher the score, the more painful"}, {'measure': 'Self-reported questionnaire(4)', 'timeFrame': 'baseline, 8 weeks', 'description': 'Pain Catastrophizing Scale/ total score: 0\\~52, The higher the score, the more pain Catastrophizing'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complex Regional Pain Syndromes']}, 'descriptionModule': {'briefSummary': 'In the present study, we aim to investigate the effect of buprenorphine on neuroinflammation in patients with complex regional pain syndrome, using \\[11C\\]-(R)-PK11195 PET.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with complex regional pain syndrome Type I (Budapest Criteria)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients diagnosed with complex regional pain syndrome Type I (Budapest Criteria) and persistent back pain (VAS ≥ 4).\n2. Patients who can stop benzodiazepine treatment 2 weeks before study\n3. Patients who initially decided to use buprenorphine according to clinical judgment\n4. Patients who are able to understand the purpose and procedure of the study\n\nExclusion Criteria:\n\n1. Patients with an impaired cognitive function such as psychosis, dementia, or mental retardation\n2. Patients with neurologic disease, cerebrovascular disease, history of brain tumor, history of severe head trauma, history of convulsive disease\n3. Patients with cardiovascular disease, liver, respiratory or renal dysfunction\n4. Patients with biliary disease\n5. Patients who could not undergo the PET/magnetic resonance imaging (MRI) process.\n6. Patients who have a risk of suicide or show aggressive behavior\n7. Patients who have drug dependence (DSM-IV criteria) or history (past 6 months or older)\n8. Employees of researchers or clinical research institutes\n9. Patients with hypersensitivity or contraindication to buprenorphine'}, 'identificationModule': {'nctId': 'NCT03977012', 'briefTitle': 'Neuroimaging Study on the Effect of Transdermal Buprenorphine in Complex Regional Pain Syndrome Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Neuroimaging Study on the Effect of Transdermal Buprenorphine in Complex Regional Pain Syndrome(CRPS) Patients With Chronic Lower Back Pain: A Pilot Study', 'orgStudyIdInfo': {'id': 'NOR17-KR-IIT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with CRPS Type I', 'description': 'Patients diagnosed with Complex Regional Pain Syndrome Type I who are anticipated to recieve a 8 weeks regime of buprenorphine as a part of routine medical care.\n\n-drug name: norspan patch 5\\~20 mcg dosage form: patch frequency: every weeks duration: 8 weeks', 'interventionNames': ['Drug: Buprenorphine']}], 'interventions': [{'name': 'Buprenorphine', 'type': 'DRUG', 'otherNames': ['norspan patch'], 'description': '5\\~20 mcg', 'armGroupLabels': ['Patients with CRPS Type I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'state': 'Jongno-gu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Soo-Hee Choi, MD,PhD', 'role': 'CONTACT'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Soo-Hee Choi, MD,PhD', 'role': 'CONTACT', 'email': 'soohchoi@snu.ac.kr', 'phone': '+82 2-2072-2302'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Soo-Hee Choi', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}