Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT05672667
Status:
COMPLETED
Last Update Posted:
2025-02-17
First Post:
2022-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Pharmacokinetic Study of Intravenous and Intranasal Oxytocin in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jimeisenach@gmail.com', 'phone': '336-716-4182', 'title': 'Dr. James Eisenach', 'organization': 'Wake Forest University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Generalizability is limited by the single center design, lack of severely obese subjects, and, despite recruitment efforts, lack of race and ethnic diversity.'}}, 'adverseEventsModule': {'timeFrame': '1 week after intravenous oxytocin and 1 week after intranasal oxytocin.', 'eventGroups': [{'id': 'EG000', 'title': 'Intravenous Oxytocin Infusion Study Day', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 4, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intranasal Oxytocin Spray Study Day', 'description': 'Oxytocin 102 micrograms by intranasal spray on second study day.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 3, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Feeling of warmth after intravenous oxytocin', 'notes': 'Feeling of warmth which was neither painful nor unpleasant, beginning 2 min after start of oxytocin infusion, lasting 2 minutes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Red face after intravenous oxytocin', 'notes': 'Facial redness and flushing which was neither painful nor unpleasant, beginning 1 min after starting oxytocin infusion, lasting 1 min.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Rhinorrhea after intranasal oxytocin', 'notes': 'Clear rhinorrhea lasting 4 min in one case and 6 hr in another after intranasal oxytocin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Sternutation after intranasal oxytocin', 'notes': 'Single sneeze occuring one min after intranasal spray', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Plasma Oxytocin Concentration 2 Minutes After Infusion Initiated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Administration (Intravenous, Then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.'}], 'classes': [{'categories': [{'measurements': [{'value': '105', 'spread': '47', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 minutes after oxytocin infusion initiated', 'description': 'Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration', 'unitOfMeasure': 'picograms/ml of oxytocin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Plasma Oxytocin Concentration 5 Minutes After Infusion Initiated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Administration (Intravenous, Then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.'}], 'classes': [{'categories': [{'measurements': [{'value': '257', 'spread': '80', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 minutes after oxytocin infusion initiated', 'description': 'Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration', 'unitOfMeasure': 'picograms/ml of oxytocin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Plasma Oxytocin Concentration 10 Minutes After Infusion Initiated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Administration (Intravenous, Then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.'}], 'classes': [{'categories': [{'measurements': [{'value': '365', 'spread': '77', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes after oxytocin infusion initiated', 'description': 'Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration', 'unitOfMeasure': 'picograms/ml of oxytocin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Plasma Oxytocin Concentration 20 Minutes After Infusion Initiated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Administration (Intravenous, Then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.'}], 'classes': [{'categories': [{'measurements': [{'value': '452', 'spread': '89', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 minutes after oxytocin infusion initiated', 'description': 'Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration', 'unitOfMeasure': 'picograms/ml of oxytocin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Plasma Oxytocin Concentration 30 Minutes After Infusion Initiated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Administration (Intravenous, Then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.'}], 'classes': [{'categories': [{'measurements': [{'value': '462', 'spread': '139', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes after oxytocin infusion initiated', 'description': 'Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration', 'unitOfMeasure': 'picograms/ml of oxytocin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Plasma Oxytocin Concentration 40 Minutes After Infusion Initiated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Administration (Intravenous, Then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.'}], 'classes': [{'categories': [{'measurements': [{'value': '193', 'spread': '79', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '40 minutes after oxytocin infusion initiated', 'description': 'Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration', 'unitOfMeasure': 'picograms/ml of oxytocin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Plasma Oxytocin Concentration 50 Minutes After Infusion Initiated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Administration (Intravenous, Then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.'}], 'classes': [{'categories': [{'measurements': [{'value': '118', 'spread': '73', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '50 minutes after oxytocin infusion initiated', 'description': 'Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration', 'unitOfMeasure': 'picograms/ml of oxytocin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Plasma Oxytocin Concentration 65 Minutes After Infusion Initiated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Administration (Intravenous, Then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'spread': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '65 minutes after oxytocin infusion initiated', 'description': 'Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration', 'unitOfMeasure': 'picograms/ml of oxytocin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Plasma Oxytocin Concentration 90 Minutes After Infusion Initiated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Administration (Intravenous, Then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'spread': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 minutes after oxytocin infusion initiated', 'description': 'Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration', 'unitOfMeasure': 'picograms/ml of oxytocin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Plasma Oxytocin Concentration 120 Minutes After Infusion Initiated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Administration (Intravenous, Then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'spread': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '120 minutes after oxytocin infusion initiated', 'description': 'Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration', 'unitOfMeasure': 'picograms/ml of oxytocin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Plasma Oxytocin Concentration 1 Minute After First Intranasal Puffs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Administration (Intravenous, Then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '1.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute after intranasal oxytocin administration', 'description': 'Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration', 'unitOfMeasure': 'picograms/ml of oxytocin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Samples were obtained from 24 subjects, but only 9 had oxytocin concentrations above the limit of detection of the assay (2 pg/mL).'}, {'type': 'PRIMARY', 'title': 'Plasma Oxytocin Concentration 2 Minutes After First Intranasal Puffs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Administration (Intravenous, Then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'spread': '6.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 minutes after intranasal oxytocin administration', 'description': 'Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration', 'unitOfMeasure': 'picograms/ml of oxytocin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Samples were obtained from 24 subjects, but only 14 had oxytocin concentrations above the limit of detection of the assay (2 pg/mL).'}, {'type': 'PRIMARY', 'title': 'Plasma Oxytocin Concentration 5 Minutes After First Intranasal Puffs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Administration (Intravenous, Then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.2', 'spread': '11.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 minutes after intranasal oxytocin administration', 'description': 'Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration', 'unitOfMeasure': 'picograms/ml of oxytocin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Plasma Oxytocin Concentration 7 Minutes After First Intranasal Puffs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Administration (Intravenous, Then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.5', 'spread': '15.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 minutes after intranasal oxytocin administration', 'description': 'Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration', 'unitOfMeasure': 'picograms/ml of oxytocin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Plasma Oxytocin Concentration 10 Minutes After First Intranasal Puffs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Administration (Intravenous, Then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.5', 'spread': '15.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes after intranasal oxytocin administration', 'description': 'Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration', 'unitOfMeasure': 'picograms/ml of oxytocin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Plasma Oxytocin Concentration 15 Minutes After First Intranasal Puffs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Administration (Intravenous, Then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.5', 'spread': '17.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 minutes after intranasal oxytocin administration', 'description': 'Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration', 'unitOfMeasure': 'picograms/ml of oxytocin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Plasma Oxytocin Concentration 20 Minutes After First Intranasal Puffs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Administration (Intravenous, Then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'spread': '15.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 minutes after intranasal oxytocin administration', 'description': 'Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration', 'unitOfMeasure': 'picograms/ml of oxytocin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Plasma Oxytocin Concentration 25 Minutes After First Intranasal Puffs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Administration (Intravenous, Then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'spread': '14.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '25 minutes after intranasal oxytocin administration', 'description': 'Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration', 'unitOfMeasure': 'picograms/ml of oxytocin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Plasma Oxytocin Concentration 35 Minutes After First Intranasal Puffs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Administration (Intravenous, Then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.1', 'spread': '32.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '35 minutes after intranasal oxytocin administration', 'description': 'Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration', 'unitOfMeasure': 'picograms/ml of oxytocin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Samples were obtained from 24 subjects, but only 23 had oxytocin concentrations above the limit of detection of the assay (2 pg/mL).'}, {'type': 'PRIMARY', 'title': 'Plasma Oxytocin Concentration 45 Minutes After First Intranasal Puffs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Administration (Intravenous, Then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'spread': '8.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '45 minutes after intranasal oxytocin administration', 'description': 'Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration', 'unitOfMeasure': 'picograms/ml of oxytocin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Samples were obtained from 24 subjects, but only 22 had oxytocin concentrations above the limit of detection of the assay (2 pg/mL).'}, {'type': 'PRIMARY', 'title': 'Plasma Oxytocin Concentration 60 Minutes After First Intranasal Puffs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Administration (Intravenous, Then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '5.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '60 minutes after intranasal oxytocin administration', 'description': 'Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration', 'unitOfMeasure': 'picograms/ml of oxytocin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Samples were obtained from 24 subjects, but only 21 had oxytocin concentrations above the limit of detection of the assay (2 pg/mL).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oxytocin Administration (Intravenous, Then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Vasovagal reaction with IV cannulation. Oxytocin was not infused and subject was withdrawn.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were enrolled between February, 2023 and August, 2023, and were recruited by IRB approved advertisements in the local community as well as direct contacting in a list of subjects who requested they be contacted regarding new research studies.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Oxytocin Administration (Intravenous, Then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40', 'spread': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', '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': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '25 subjects consented to participate and provided baseline data, but one individual was withdrawn after a vasovagal event on insertion of IV cannula and did not receive oxytocin IV or intranasally.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-27', 'size': 525181, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-18T11:12', 'hasProtocol': True}, {'date': '2023-02-06', 'size': 199144, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-01-05T13:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Each subject will receive 14 micrograms of oxytocin intravenously over 30 minutes and 102 micrograms of oxytocin intranasally.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2022-12-20', 'resultsFirstSubmitDate': '2024-06-18', 'studyFirstSubmitQcDate': '2022-12-20', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-10', 'studyFirstPostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Oxytocin Concentration 2 Minutes After Infusion Initiated', 'timeFrame': '2 minutes after oxytocin infusion initiated', 'description': 'Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration'}, {'measure': 'Plasma Oxytocin Concentration 5 Minutes After Infusion Initiated', 'timeFrame': '5 minutes after oxytocin infusion initiated', 'description': 'Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration'}, {'measure': 'Plasma Oxytocin Concentration 10 Minutes After Infusion Initiated', 'timeFrame': '10 minutes after oxytocin infusion initiated', 'description': 'Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration'}, {'measure': 'Plasma Oxytocin Concentration 20 Minutes After Infusion Initiated', 'timeFrame': '20 minutes after oxytocin infusion initiated', 'description': 'Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration'}, {'measure': 'Plasma Oxytocin Concentration 30 Minutes After Infusion Initiated', 'timeFrame': '30 minutes after oxytocin infusion initiated', 'description': 'Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration'}, {'measure': 'Plasma Oxytocin Concentration 40 Minutes After Infusion Initiated', 'timeFrame': '40 minutes after oxytocin infusion initiated', 'description': 'Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration'}, {'measure': 'Plasma Oxytocin Concentration 50 Minutes After Infusion Initiated', 'timeFrame': '50 minutes after oxytocin infusion initiated', 'description': 'Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration'}, {'measure': 'Plasma Oxytocin Concentration 65 Minutes After Infusion Initiated', 'timeFrame': '65 minutes after oxytocin infusion initiated', 'description': 'Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration'}, {'measure': 'Plasma Oxytocin Concentration 90 Minutes After Infusion Initiated', 'timeFrame': '90 minutes after oxytocin infusion initiated', 'description': 'Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration'}, {'measure': 'Plasma Oxytocin Concentration 120 Minutes After Infusion Initiated', 'timeFrame': '120 minutes after oxytocin infusion initiated', 'description': 'Blood will be sampled at specified intervals during and after the infusion. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration'}, {'measure': 'Plasma Oxytocin Concentration 1 Minute After First Intranasal Puffs', 'timeFrame': '1 minute after intranasal oxytocin administration', 'description': 'Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration'}, {'measure': 'Plasma Oxytocin Concentration 2 Minutes After First Intranasal Puffs', 'timeFrame': '2 minutes after intranasal oxytocin administration', 'description': 'Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration'}, {'measure': 'Plasma Oxytocin Concentration 5 Minutes After First Intranasal Puffs', 'timeFrame': '5 minutes after intranasal oxytocin administration', 'description': 'Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration'}, {'measure': 'Plasma Oxytocin Concentration 7 Minutes After First Intranasal Puffs', 'timeFrame': '7 minutes after intranasal oxytocin administration', 'description': 'Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration'}, {'measure': 'Plasma Oxytocin Concentration 10 Minutes After First Intranasal Puffs', 'timeFrame': '10 minutes after intranasal oxytocin administration', 'description': 'Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration'}, {'measure': 'Plasma Oxytocin Concentration 15 Minutes After First Intranasal Puffs', 'timeFrame': '15 minutes after intranasal oxytocin administration', 'description': 'Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration'}, {'measure': 'Plasma Oxytocin Concentration 20 Minutes After First Intranasal Puffs', 'timeFrame': '20 minutes after intranasal oxytocin administration', 'description': 'Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration'}, {'measure': 'Plasma Oxytocin Concentration 25 Minutes After First Intranasal Puffs', 'timeFrame': '25 minutes after intranasal oxytocin administration', 'description': 'Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration'}, {'measure': 'Plasma Oxytocin Concentration 35 Minutes After First Intranasal Puffs', 'timeFrame': '35 minutes after intranasal oxytocin administration', 'description': 'Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration'}, {'measure': 'Plasma Oxytocin Concentration 45 Minutes After First Intranasal Puffs', 'timeFrame': '45 minutes after intranasal oxytocin administration', 'description': 'Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration'}, {'measure': 'Plasma Oxytocin Concentration 60 Minutes After First Intranasal Puffs', 'timeFrame': '60 minutes after intranasal oxytocin administration', 'description': 'Blood will be sampled at specified intervals after the intranasal administration of oxytocin. Plasma will be separated, rapidly frozen, and later analyzed for oxytocin concentration'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Pain', 'Chronic Pain', 'Intravenous Oxytocin', 'Intranasal Oxytocin'], 'conditions': ['Healthy Volunteer Study']}, 'referencesModule': {'references': [{'pmid': '40121179', 'type': 'DERIVED', 'citation': 'Shafer SL, Ririe DG, Miller S, Curry RS, Hsu DT, Sullivan GM, Eisenach JC. Plasma pharmacokinetics of intravenous and intranasal oxytocin in nonpregnant adults. Br J Anaesth. 2025 May;134(5):1513-1522. doi: 10.1016/j.bja.2024.12.046. Epub 2025 Mar 21.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to sample blood and model the plasma pharmacokinetics (PK) of a single dose of intravenous (IV) oxytocin and a single dose of intranasal (i.n.) oxytocin.\n\nThis is an unblinded study of subjects, all of whom will receive an intravenous (IV) infusion and intranasal (i.n.) dose of oxytocin (a naturally occurring hormone that is made in the brain) with blood samples taken thereafter in order to create a formula to describe the concentrations of oxytocin in the blood over time (pharmacokinetics).\n\nIn this study healthy volunteers and people are recruited for a two day study. Each study participant will have 2 IV catheters placed (one in each arm) for the day of IV oxytocin dosing and 1 IV catheter on the day of i.n. oxytocin dosing. After placement of the IV catheters, an infusion of oxytocin will be given over a 30 minute period. Blood samples will be taken after the infusion begins and several times during and after the infusion. The blood will be drawn through the IV catheter not used for the oxytocin infusion. For the intranasal oxytocin administration day, 1 IV catheter will be placed and several blood samples will be taken after administration.', 'detailedDescription': 'This is an unblinded, sequential study of subjects; all participants will receive an infusion of oxytocin and intranasal administration of oxytocin with blood samples taken thereafter in order to create a formula to describe the concentrations of oxytocin in the blood over time (pharmacokinetics). In this study healthy volunteers. Participants will come to the Clinical Research Unit (CRU) on study day 1 and have two IVs inserted; one in each arm. Participants will get a 30 minute infusion through one of the IV catheters of oxytocin and blood will be taken several times over the next 120 minutes, plasma separated, and the amount of oxytocin measured in the plasma samples. Participants will come to the CRU on study day 2 and have one IV inserted; in the arm. Participants will self administer intranasal oxytocin and blood will be taken several times over the next 60 minutes and the amount of oxytocin measured in the plasma samples. This information will be analyzed by another group at Stanford University under a data sharing agreement between the institutions and funded by a grant from the National Institutes of Health. Compartmental modeling will be performed using NONMEM to describe the change in oxytocin concentrations over time. The effect of subject age, sex, race, ethnicity and weight on the pharmacokinetics of oxytocin will be examined, since these factors can affect pharmacokinetics and are important to better adjust the dose of drug to the individual.\n\nThe main purpose of this study is to determine the amount of oxytocin in plasma after IV and i.n. administration.\n\nThe research participants will not benefit from this study, but the knowledge investigators get will be important to adjust oxytocin dose to individuals, and to be able to calculate plasma oxytocin concentrations after various doses in the future. The sample size chosen is needed to get an accurate estimate for the parameters in the pharmacokinetic model for the population, not just the subjects in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female \\> 18 and \\< 75 years of age, Body Mass Index (BMI) \\<40.\n* Generally in good health as determined by the Principal Investigator based on prior medical history, American Society of Anesthesiologists physical status 1 or 2.\n* For healthy volunteers, normal blood pressure (systolic 100-140 mmHg; diastolic 60-90 mmHg) resting heart rate 45-90 beats per minute) without medication. For those with hypertension, blood pressure controlled with anti-hypertensive medication and with a resting heart rate 45-100 beats per minute.\n* Female subjects of child-bearing potential and those \\< 1 year post-menopausal, must be practicing highly effective methods of birth control such as hormonal methods (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double barrier methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal jellies or cream), or total abstinence from heterosexual intercourse for a minimum of 1 full cycle before study drug administration.\n\nExclusion Criteria:\n\n* Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®\n* Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data\n* Women who are pregnant (positive result for urine pregnancy test at visit 1), women who are currently nursing or lactating, women that have been pregnant within 2 years\n* Subjects with neuropathy, chronic pain (being treated on a daily basis), diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.\n* Subjects with current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval.\n* Subjects with past or current history of hyponatremia or at risk for hyponatremia; anyone taking thiazide diuretics, loop diuretics, combination diuretics, lithium, carbamazepine, enalapril, Ramipril, celecoxib, temazepam, gliclazide, glimepiride, glibenclamide, glipizide, omeprazole, pantoprazole, desmopressin, Selective serotonin reuptake inhibitors (SSRI's) , Monoamine oxidase inhibitors (MAOI), or the recreational drug ecstasy.\n* Subjects with a known latex allergy.\n* History of chronic nasal obstruction or local pathology in nostril pathway which, in the opinion of the investigator, would prevent appropriate nasal administration of the study drug.\n* Use of over the counter nasal products (ie. Saline spray, Neti-Pot, etc.) or intranasal corticosteroid medications during the study."}, 'identificationModule': {'nctId': 'NCT05672667', 'briefTitle': 'A Pharmacokinetic Study of Intravenous and Intranasal Oxytocin in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'A Pharmacokinetic Study of Intravenous and Intranasal Oxytocin in Healthy Subjects', 'orgStudyIdInfo': {'id': 'IRB00089938'}, 'secondaryIdInfos': [{'id': '1P01NS119159-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1P01NS119159-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxytocin Administration (Intravenous, then Intranasal)', 'description': 'Oxytocin 14 micrograms infusion over 30 minutes on first study day. Oxytocin 102 micrograms by intranasal spray on second study day.', 'interventionNames': ['Drug: intravenous oxytocin', 'Drug: intranasal oxytocin']}], 'interventions': [{'name': 'intravenous oxytocin', 'type': 'DRUG', 'otherNames': ['Pitocin'], 'description': 'Oxytocin given by intravenous route', 'armGroupLabels': ['Oxytocin Administration (Intravenous, then Intranasal)']}, {'name': 'intranasal oxytocin', 'type': 'DRUG', 'otherNames': ['TNX-1900'], 'description': 'Oxytocin given by intranasal administration', 'armGroupLabels': ['Oxytocin Administration (Intravenous, then Intranasal)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Health', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'James C Eisenach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'url': 'https://github.com/StevenLShafer', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Data will become available upon publication or upon posting results in ClinicalTrials.gov, whichever comes first, with no expiration.', 'ipdSharing': 'YES', 'description': 'Plan Description: Statistical programs in the data analysis will be written in R. The software and anonymized data will be included both as digital supplements in the published papers and will be posted on GitHub under github.com/StevenLShafer. Interested investigators will be able to reproduce the published analyses from these files. Consistent with the posting of software and data to the OpenTCI initiative, the software and de-identified data will be made available with "no strings attached," enabling investigators to freely use the data to inform or supplement additional research without restriction. Data to be made available are oxytocin dose, times of sampling (relative to the start of dosing), plasma oxytocin concentrations at those times for each subject, and age, weight, and sex for each subject.', 'accessCriteria': 'These data are freely shared to all and will be posted at the URL below'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}