Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT03302416
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2017-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
CRF - Nociceptin Receptor Interactions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006854', 'term': 'Hydrocortisone'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'narendranr@upmc.edu', 'phone': '412-647-5176', 'title': 'Rajesh Narendran', 'organization': 'Univesity of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '< 7 days', 'eventGroups': [{'id': 'EG000', 'title': '[C-11]NOP-1A PET Scan Conditions', 'description': 'Baseline condition and Post-hydrocortisone (1 mg/Kg, intravenous) condition\n\nHydrocortisone\n\n\\[C-11\\]NOP-1A', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline Participants', 'description': 'Healthy Controls'}], 'classes': [{'title': 'Amygdala/baseline', 'categories': [{'measurements': [{'value': '16.3', 'spread': '1.9', 'groupId': 'OG000'}]}]}, {'title': 'Amygdala/post-hydrocortisone', 'categories': [{'measurements': [{'value': '18.7', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'Hippocampus/baseline', 'categories': [{'measurements': [{'value': '11.6', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Hippocampus/post-hydrocortisone', 'categories': [{'measurements': [{'value': '13.3', 'spread': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'Midbrain/baseline', 'categories': [{'measurements': [{'value': '9.4', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Midbrain/post-hydrocortisone', 'categories': [{'measurements': [{'value': '10.6', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'Vental striatum/baseline', 'categories': [{'measurements': [{'value': '15.1', 'spread': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'Ventral striatum/post-hydrocortisone', 'categories': [{'measurements': [{'value': '17.1', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Caudate/baseline', 'categories': [{'measurements': [{'value': '12.7', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Caudate/post-hydrocortisone', 'categories': [{'measurements': [{'value': '14.0', 'spread': '1.9', 'groupId': 'OG000'}]}]}, {'title': 'Putamen/baseline', 'categories': [{'measurements': [{'value': '14.3', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'Putamen/post-hydrocortisone', 'categories': [{'measurements': [{'value': '16.0', 'spread': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'dorsolateralPFC/baseline', 'categories': [{'measurements': [{'value': '14.4', 'spread': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'dorsolateralPFC/post-hydrocortisone', 'categories': [{'measurements': [{'value': '16.4', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Orbital frontal cortex/baseline', 'categories': [{'measurements': [{'value': '14.9', 'spread': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Orbital frontal cortex/post-hydrocortisone', 'categories': [{'measurements': [{'value': '17.1', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'MedialPFC/baseline', 'categories': [{'measurements': [{'value': '14.3', 'spread': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'MedialPFC/post-hydrocortisone', 'categories': [{'measurements': [{'value': '16.2', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'anterior cigulate/baseline', 'categories': [{'measurements': [{'value': '14.6', 'spread': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'anterior cingulate/post-hydrocortisone', 'categories': [{'measurements': [{'value': '16.6', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Cerebellum/baseline', 'categories': [{'measurements': [{'value': '8.2', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Cerebellum/post-hydrocortisone', 'categories': [{'measurements': [{'value': '9.3', 'spread': '1.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000'], 'statisticalMethod': 'Linear mixed model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Baseline scan VT vs. Post-hydrocortisone scan VT'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3.5 hours post-hydrocortisone', 'description': 'VT is the volume of distribution expressed relative to total plasma concentration. This is defined consistent with that reported in Consensus nomenclature for in vivo imaging of reversibly binding radioligands (Reference: J Cereb Blood Flow Metab 2007 Sep;27(9):1533-9. doi: 10.1038/sj.jcbfm.9600493)', 'unitOfMeasure': 'mL/cm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '[C-11]NOP-1A PET Scan Conditions', 'description': 'Baseline condition and Post-hydrocortisone (1 mg/Kg, intravenous) condition\n\nHydrocortisone\n\n\\[C-11\\]NOP-1A'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '45 subjects screened, 19 assigned to interventions'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '[C-11]NOP-1A PET Scan Conditions', 'description': 'Baseline condition and Post-hydrocortisone (1 mg/Kg, intravenous) condition\n\nHydrocortisone\n\n\\[C-11\\]NOP-1A'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25', 'spread': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '77', 'spread': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-13', 'size': 477095, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-08T12:56', 'hasProtocol': True}, {'date': '2018-11-13', 'size': 318936, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-09-08T12:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Baseline \\[C-11\\]NOP-1A scan Post-hydrocortisone \\[C-11\\]NOP-1A scan'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-02', 'studyFirstSubmitDate': '2017-09-29', 'resultsFirstSubmitDate': '2020-09-05', 'studyFirstSubmitQcDate': '2017-10-03', 'lastUpdatePostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-02', 'studyFirstPostDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '[C-11]NOP-1A Volume of Distribution Expressed Relative to Total Plasma Concentration', 'timeFrame': 'Baseline and 3.5 hours post-hydrocortisone', 'description': 'VT is the volume of distribution expressed relative to total plasma concentration. This is defined consistent with that reported in Consensus nomenclature for in vivo imaging of reversibly binding radioligands (Reference: J Cereb Blood Flow Metab 2007 Sep;27(9):1533-9. doi: 10.1038/sj.jcbfm.9600493)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '31706582', 'type': 'RESULT', 'citation': 'Flanigan M, Tollefson S, Himes ML, Jordan R, Roach K, Stoughton C, Lopresti B, Mason NS, Ciccocioppo R, Narendran R. Acute Elevations in Cortisol Increase the In Vivo Binding of [11C]NOP-1A to Nociceptin Receptors: A Novel Imaging Paradigm to Study the Interaction Between Stress- and Antistress-Regulating Neuropeptides. Biol Psychiatry. 2020 Mar 15;87(6):570-576. doi: 10.1016/j.biopsych.2019.09.013. Epub 2019 Sep 25.'}]}, 'descriptionModule': {'briefSummary': 'To determine if \\[C-11\\]NOP-1A receptor binding (VT) can be altered by an intravenous hydrocortisone (cortisol) challenge through CRF-NOP interactions', 'detailedDescription': 'Examines changes in \\[C-11\\]NOP-1A pharmacokinetics caused by an intravenous hydrocortisone challenge (1 mg/kg)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females between 18 and 40 years old\n\nExclusion Criteria:\n\n* Current DSM-5 psychiatric disorders\n* Binge drinking as defined in NIAAA criteria in the past month\n* Recreational abuse of opiates, sedative-hypnotics, cocaine, amphetamines, MDMA, and PCP, as well as cannabis use\n* Currently on any prescription medical or psychotropic medication;\n* Current or past severe medical, endocrine, cardiovascular, immunological or neurological illnesses\n* Currently pregnant or breast-feeding;\n* History of radioactivity exposure via prior nuclear medicine studies or occupational exposure in past twelve months\n* Metallic objects in the body that are contraindicated for MRI;\n* First-degree relative with psychosis or mood disorders'}, 'identificationModule': {'nctId': 'NCT03302416', 'briefTitle': 'CRF - Nociceptin Receptor Interactions', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'In Vivo Imaging of Corticotropin-releasing Factor - Nociceptin Receptor Interactions', 'orgStudyIdInfo': {'id': 'PRO16030242'}, 'secondaryIdInfos': [{'id': 'R21DA042633', 'link': 'https://reporter.nih.gov/quickSearch/R21DA042633', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[C-11]NOP-1A PET Scan conditions', 'description': 'Baseline condition and Post-hydrocortisone (1 mg/Kg, intravenous) condition', 'interventionNames': ['Drug: Hydrocortisone', 'Radiation: [C-11]NOP-1A']}], 'interventions': [{'name': 'Hydrocortisone', 'type': 'DRUG', 'armGroupLabels': ['[C-11]NOP-1A PET Scan conditions']}, {'name': '[C-11]NOP-1A', 'type': 'RADIATION', 'armGroupLabels': ['[C-11]NOP-1A PET Scan conditions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Visiting Professor in Radiology', 'investigatorFullName': 'Rajesh Narendran', 'investigatorAffiliation': 'University of Pittsburgh'}}}}