Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT03802227
Status:
TERMINATED
Last Update Posted:
2021-07-08
First Post:
2018-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study Using fMRI Imaging to Evaluate the Effect of NKTR-181 on Brain Activity in Healthy, Non-physically Dependent Recreational Opioid Users.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000623152', 'term': 'NKTR-181'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medicalaffairs@nektar.com', 'phone': '415-482-5416', 'title': 'Study Director', 'organization': 'Nektar Therapeutics'}, 'certainAgreement': {'otherDetails': "There are restrictions to the PI's rights to discuss or publish trial results.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was originally planned for 24 patients. However enrollment was stopped due to the CDP being stopped at 8 and therefore limits the generalizability of this data.'}}, 'adverseEventsModule': {'timeFrame': '19 days post-dose of NKTR-181 or Oxycodone IR 40 mg', 'description': 'All adverse events and their duration were listed. Adverse events that occurred on or after study dose administration were summarized. Verbatim terms were mapped to PTs and system organ classes (SOC) using the Medical Dictionary for Regulatory Activities (MedDRA).', 'eventGroups': [{'id': 'EG000', 'title': 'NKTR-181', 'description': 'Two 200 mg NKTR-181 tablets and 1 placebo capsule for oxycodone IR', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Oxycodone IR 40 mg', 'description': 'One capsule of Oxycodone IR 40 mg and 2 placebo tablets for NKTR-181', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Back Pain', 'notes': 'One subject experienced back pain that was treated with paracetamol and resolved within 1-2 days. The back pain was deemed not related to the study drug (NKTR-181).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Insomnia', 'notes': 'One subject experienced insomnia that was treated with trazodone and resolved within 1-2 days. The insomnia was deemed not related to the study drug (NKTR-181)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Brain Activity Measured Via fMRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-181', 'description': 'Two 200 mg NKTR-181 tablets and 1 placebo capsule for oxycodone IR'}, {'id': 'OG001', 'title': 'Oxycodone IR 40 mg', 'description': 'One capsule of Oxycodone IR 40 mg and 2 placebo tablets for NKTR-181'}], 'classes': [{'title': 'Effective Connectivity between ACC and R Hippocampus at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.34', 'groupId': 'OG001'}]}]}, {'title': 'Effective Connectivity between ACC and R Hippocampus after 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Effective Connectivity between ACC and R Hippocampus after 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Effective Connectivity between ACC and R Hippocampus after 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.48', 'groupId': 'OG001'}]}]}, {'title': 'Effective Connectivity between ACC and R Hippocampus after 8 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Effective Connectivity between R Amygdala and mPFC at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Effective Connectivity between R Amygdala and mPFC after 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.34', 'groupId': 'OG001'}]}]}, {'title': 'Effective Connectivity between R Amygdala and mPFC after 2 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.51', 'groupId': 'OG001'}]}]}, {'title': 'Effective Connectivity between R Amygdala and mPFC after 4 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Effective Connectivity between R Amygdala and mPFC after 8 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hour period following dose of NKTR-181', 'description': 'The primary objective of the study was to evaluate the effects of NKTR-181 on brain activity. Functional MRI assessments in subjects administered opioids such as morphine, buprenorphine, and nalbuphine have shown drug-induced signaling changes in reward structures such as the nucleus accumbens, orbitofrontal cortex, and hippocampus, as well as changes in the functional connectivity of reward circuitry (Becerra, 2006; Gear, 2013; Upadhyay, 2012).', 'unitOfMeasure': 'Correlation Coefficient', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who had sufficient MRI data for NKTR-181 or oxycodone IR treatment to allow for analysis of modulation of brain circuitry.'}, {'type': 'SECONDARY', 'title': 'Change in Pupil Diameter Via Pupillometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-181', 'description': 'Two 200 mg NKTR-181 tablets and 1 placebo capsule for oxycodone IR'}, {'id': 'OG001', 'title': 'Oxycodone IR 40 mg', 'description': 'One capsule of Oxycodone IR 40 mg and 2 placebo tablets for NKTR-181'}], 'classes': [{'title': 'Baseline Pupil Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.45', 'spread': '1.198', 'groupId': 'OG000'}, {'value': '4.81', 'spread': '1.717', 'groupId': 'OG001'}]}]}, {'title': 'Pupil Diameter After 1 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.03', 'spread': '0.443', 'groupId': 'OG000'}, {'value': '4.87', 'spread': '1.624', 'groupId': 'OG001'}]}]}, {'title': 'Pupil Diameter After 2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.82', 'spread': '1.550', 'groupId': 'OG000'}, {'value': '4.97', 'spread': '1.747', 'groupId': 'OG001'}]}]}, {'title': 'Pupil Diameter After 4 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.34', 'spread': '0.985', 'groupId': 'OG000'}, {'value': '5.32', 'spread': '1.723', 'groupId': 'OG001'}]}]}, {'title': 'Pupil Diameter After 6 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.99', 'spread': '2.213', 'groupId': 'OG000'}, {'value': '5.01', 'spread': '1.086', 'groupId': 'OG001'}]}]}, {'title': 'Pupil Diameter After 8 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.28', 'spread': '1.161', 'groupId': 'OG000'}, {'value': '5.07', 'spread': '1.115', 'groupId': 'OG001'}]}]}, {'title': 'Pupil Diameter After 12 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.91', 'spread': 'NA', 'comment': 'There is only one participant', 'groupId': 'OG000'}, {'value': '3.87', 'spread': 'NA', 'comment': 'There is only one participant', 'groupId': 'OG001'}]}]}, {'title': 'Pupil Diameter After 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.61', 'spread': '0.403', 'groupId': 'OG000'}, {'value': '4.20', 'spread': '0.191', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hour period following dose administration Day 1 to 2', 'description': 'Analysis of change in pupil diameter after administration of NKTR-181 or Oxycodone IR.', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received at least one dose of NKTR-181 or oxycodone IR and did not have unexpected pupillary dilation as a result of technical issues during the procedure.'}, {'type': 'SECONDARY', 'title': 'Plasma Drug Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-181', 'description': 'Two 200 mg NKTR-181 tablets and 1 placebo capsule for oxycodone IR'}, {'id': 'OG001', 'title': 'Oxycodone IR 40 mg', 'description': 'One capsule of Oxycodone IR 40 mg and 2 placebo tablets for NKTR-181'}], 'classes': [{'title': 'Plasma Drug Concentration at Hour 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1970', 'spread': '477', 'groupId': 'OG000'}, {'value': '35.7', 'spread': '33.9', 'groupId': 'OG001'}]}]}, {'title': 'Plasma Drug Concentration at Hour 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2360', 'spread': '1230', 'groupId': 'OG000'}, {'value': '54.1', 'spread': '13.1', 'groupId': 'OG001'}]}]}, {'title': 'Plasma Drug Concentration at Hour 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1350', 'spread': '656', 'groupId': 'OG000'}, {'value': '46.7', 'spread': '15.3', 'groupId': 'OG001'}]}]}, {'title': 'Plasma Drug Concentration at Hour 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '388', 'spread': '230', 'groupId': 'OG000'}, {'value': '27.1', 'spread': '7.47', 'groupId': 'OG001'}]}]}, {'title': 'Plasma Drug Concentration at Hour 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '185', 'spread': '30.4', 'groupId': 'OG000'}, {'value': '14.8', 'spread': 'NA', 'comment': 'Only one sample was collected for this measurement', 'groupId': 'OG001'}]}]}, {'title': 'Plasma Drug Concentration at Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.5', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '3.9', 'spread': 'NA', 'comment': 'Only one sample was collected for this measurement', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hour period following dose administration Day 1 to 2', 'description': 'Plasma drug concentration for NKTR-181 and Oxycodone IR over 24 hours.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Consisted of all subjects who had sufficient plasma concentration data to facilitate the calculation of maximum plasma drug concentration as determined by the pharmacokineticist.'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-181', 'description': 'Two 200 mg NKTR-181 tablets and 1 placebo capsule for oxycodone IR'}, {'id': 'OG001', 'title': 'Oxycodone IR 40 mg', 'description': 'One capsule of Oxycodone IR 40 mg and 2 placebo tablets for NKTR-181'}], 'classes': [{'title': 'Plasma Drug Concentration at Hour 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1970', 'spread': '477', 'groupId': 'OG000'}, {'value': '35.7', 'spread': '33.9', 'groupId': 'OG001'}]}]}, {'title': 'Plasma Drug Concentration at Hour 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2360', 'spread': '1230', 'groupId': 'OG000'}, {'value': '54.1', 'spread': '13.1', 'groupId': 'OG001'}]}]}, {'title': 'Plasma Drug Concentration at Hour 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1350', 'spread': '656', 'groupId': 'OG000'}, {'value': '46.7', 'spread': '15.3', 'groupId': 'OG001'}]}]}, {'title': 'Plasma Drug Concentration at Hour 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '388', 'spread': '230', 'groupId': 'OG000'}, {'value': '27.1', 'spread': '7.47', 'groupId': 'OG001'}]}]}, {'title': 'Plasma Drug Concentration at Hour 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '185', 'spread': '30.4', 'groupId': 'OG000'}, {'value': '14.8', 'spread': 'NA', 'comment': 'There is only one participant', 'groupId': 'OG001'}]}]}, {'title': 'Plasma Drug Concentration at Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.5', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '3.9', 'spread': 'NA', 'comment': 'There is only one participant', 'groupId': 'OG001'}]}]}, {'title': 'Time to Maximum Concentration (Tmax) measured in hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.54', 'spread': '0.676', 'groupId': 'OG000'}, {'value': '2.21', 'spread': '1.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hour period following dose administration Day 1 to 2', 'description': 'The amount of time needed for maximum drug concentration to be reached.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Consisted of all subjects who had sufficient plasma concentration data to facilitate the calculation of the time to maximum plasma drug concentration as determined by the pharmacokineticist.'}, {'type': 'SECONDARY', 'title': 'Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-181', 'description': 'NKTR-181 400 mg and placebo for oxycodone IR one tablet of each once'}, {'id': 'OG001', 'title': 'Oxycodone IR 40 mg', 'description': 'Oxycodone IR 40 mg and placebo for NKTR-181 one tablet of each once'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '19 days', 'description': 'Number of patients who experienced any type of adverse event as a result of one of the treatments.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Consisted of all subjects who received at least 1 dose of NKTR-181 or Oxycodone IR.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NKTR-181', 'description': 'Two 200 mg NKTR-181 tablets and 1 placebo capsule for oxycodone IR'}, {'id': 'FG001', 'title': 'Oxycodone IR 40 mg', 'description': 'Once capsule of Oxycodone IR 40 mg and 2 placebo tablets for NKTR-181'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Treatment assignments were based on a computer-generated randomization scheduled prepared by SynteractHCR Inc. prior to study start'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NKTR-181', 'description': 'Two 200 mg NKTR-181 tablets and 1 placebo capsule for oxycodone IR oxycodone IR'}, {'id': 'BG001', 'title': 'Oxycodone IR 40 mg', 'description': 'One capsule of Oxycodone IR 40 mg and 2 placebo tablets for NKTR-181'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'spread': '7.42', 'groupId': 'BG000'}, {'value': '43.5', 'spread': '3.42', 'groupId': 'BG001'}, {'value': '41.0', 'spread': '5.98', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height (cm)', 'classes': [{'categories': [{'measurements': [{'value': '166.3', 'spread': '5.94', 'groupId': 'BG000'}, {'value': '182.0', 'spread': '2.44', 'groupId': 'BG001'}, {'value': '174.1', 'spread': '9.39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '81.5', 'spread': '21.30', 'groupId': 'BG000'}, {'value': '83.8', 'spread': '5.93', 'groupId': 'BG001'}, {'value': '82.7', 'spread': '14.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI (kg/m2)', 'classes': [{'categories': [{'measurements': [{'value': '29.7', 'spread': '8.83', 'groupId': 'BG000'}, {'value': '25.3', 'spread': '2.12', 'groupId': 'BG001'}, {'value': '27.5', 'spread': '6.39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms per meter squared', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic Blood Pressure (mm Hg)', 'classes': [{'categories': [{'measurements': [{'value': '143.5', 'spread': '11.47', 'groupId': 'BG000'}, {'value': '127.3', 'spread': '12.74', 'groupId': 'BG001'}, {'value': '135.4', 'spread': '14.19', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimeters of Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic Blood Pressure (mm Hg)', 'classes': [{'categories': [{'measurements': [{'value': '91.3', 'spread': '18.63', 'groupId': 'BG000'}, {'value': '74.5', 'spread': '12.66', 'groupId': 'BG001'}, {'value': '82.9', 'spread': '17.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimeters of Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pulse Rate (bpm)', 'classes': [{'categories': [{'measurements': [{'value': '74.5', 'spread': '6.40', 'groupId': 'BG000'}, {'value': '74.3', 'spread': '4.35', 'groupId': 'BG001'}, {'value': '74.4', 'spread': '5.07', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Respiratory Rate (breaths per minute)', 'classes': [{'categories': [{'measurements': [{'value': '14.0', 'spread': '2.31', 'groupId': 'BG000'}, {'value': '17.5', 'spread': '1.00', 'groupId': 'BG001'}, {'value': '15.8', 'spread': '2.49', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'breaths per minute', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'SpO2 (%)', 'classes': [{'categories': [{'measurements': [{'value': '97.3', 'spread': '0.96', 'groupId': 'BG000'}, {'value': '97.5', 'spread': '1.91', 'groupId': 'BG001'}, {'value': '97.4', 'spread': '1.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Temperature (degrees Celsius)', 'classes': [{'categories': [{'measurements': [{'value': '36.7', 'spread': '0.37', 'groupId': 'BG000'}, {'value': '36.8', 'spread': '0.27', 'groupId': 'BG001'}, {'value': '36.7', 'spread': '0.30', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'degrees Celsius', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-24', 'size': 667160, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-05-03T12:18', 'hasProtocol': True}, {'date': '2019-08-25', 'size': 906855, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-05-03T12:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A double-blind, double-dummy, parallel-group, randomized, positive control study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Sponsor Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-06', 'studyFirstSubmitDate': '2018-11-15', 'resultsFirstSubmitDate': '2020-12-23', 'studyFirstSubmitQcDate': '2019-01-10', 'lastUpdatePostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-03', 'studyFirstPostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain Activity Measured Via fMRI', 'timeFrame': '8 hour period following dose of NKTR-181', 'description': 'The primary objective of the study was to evaluate the effects of NKTR-181 on brain activity. Functional MRI assessments in subjects administered opioids such as morphine, buprenorphine, and nalbuphine have shown drug-induced signaling changes in reward structures such as the nucleus accumbens, orbitofrontal cortex, and hippocampus, as well as changes in the functional connectivity of reward circuitry (Becerra, 2006; Gear, 2013; Upadhyay, 2012).'}], 'secondaryOutcomes': [{'measure': 'Change in Pupil Diameter Via Pupillometry', 'timeFrame': '24 hour period following dose administration Day 1 to 2', 'description': 'Analysis of change in pupil diameter after administration of NKTR-181 or Oxycodone IR.'}, {'measure': 'Plasma Drug Concentration', 'timeFrame': '24 hour period following dose administration Day 1 to 2', 'description': 'Plasma drug concentration for NKTR-181 and Oxycodone IR over 24 hours.'}, {'measure': 'Time to Maximum Concentration (Tmax)', 'timeFrame': '24 hour period following dose administration Day 1 to 2', 'description': 'The amount of time needed for maximum drug concentration to be reached.'}, {'measure': 'Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': '19 days', 'description': 'Number of patients who experienced any type of adverse event as a result of one of the treatments.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Moderate to Severe Chronic Pain']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the effect of NKTR-181 on brain activity in healthy, non-physically dependent recreational opioid users. This study will last about 88 days for each participant.', 'detailedDescription': 'This study is a single-center study in which approximately 24 subjects will be randomized to one of two treatment groups. Subjects will enter a screening period between Day -28 and Day -2. Upon meeting all criteria for enrollment, on Day -1 subjects will enter the clinical research study unit (CRSU) for an overnight confinement. On Day 1, subjects will undergo a baseline MRI and will then be randomized to NKTR-181 or oxycodone immediate release (IR). Once randomized, subjects will receive a single dose of study drug (NKTR-181 or oxycodone IR) and matched alternate-treatment placebo. Subjects will undergo a series of three fMRIs (functional magnetic resonance imaging) post dose (at hours 1, 2, and 4). At post-dose hours 0.5, 1, 2, 3, 4, 5, 6, and 8, pupillometry will be performed and PK blood samples will be drawn. Following a 14- to 17-day safety follow-up period, subjects will return to the research facility clinic for the End of Study (EOS) visit (Day 16-19).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Healthy male and female recreational opioid users, 18-65 years of age inclusive.\n* Body Mass Index (BMI) between 19.0 to 45.0kg/m2\n* Have at least one urine drug screen positive for opioids during Screening to confirm recreational opioid use. Subjects testing positive for methadone or buprenorphine prescribed for treatment will be excluded.\n* Subjects must agree to practice adequate contraception as outlined in the protocol.\n\nKey Exclusion Criteria:\n\n* Any metal fragments or other bodily metal that would pose a risk to subjects during MRI scanning as determined by the MRI technologist and/or MRI physicist\n* Any clinically significant disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, central nervous, or gastrointestinal systems or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of the study drug or would place the subject at increased risk\n* History of clinically significant acute asthma or other obstructive airway disease requiring daily controller medication or any condition that may increase the risk for respiratory depression\n* Current neurologic conditions such as convulsive disorders, or history of severe head injury.\n* Any current DSM-5 axis I psychiatric disorder or neurological disorder requiring ongoing treatment\n* Current substance use disorder (moderate to severe), other than Opioid, Nicotine, THC (tetrahydrocannabinol), cocaine, or caffeine as defined by DSM-5\n* Physical dependence of opioids\n* History of claustrophobia or any other psychiatric disorder that would preclude subject tolerance of MRI procedures.\n* Current use of any medication that could affect central nervous system blood flow (e.g. certain cardiovascular medications, triptan migraine medications)\n* Clinical Opiate Withdrawal Scale (COWS) score of greater than 5 during screening or prior to first scan.\n* Positive urine drug screen for buprenorphine or methadone immediately prior to the first scan.'}, 'identificationModule': {'nctId': 'NCT03802227', 'briefTitle': 'A Study Using fMRI Imaging to Evaluate the Effect of NKTR-181 on Brain Activity in Healthy, Non-physically Dependent Recreational Opioid Users.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nektar Therapeutics'}, 'officialTitle': 'A Phase 1 Double-Blind, Double-Dummy, Parallel-Group, Randomized, Positive Control Study Using fMRI to Evaluate the Effect of NKTR-181 on Brain Activity in Healthy, Non-physically Dependent Recreational Opioid Users', 'orgStudyIdInfo': {'id': '18-181-26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'NKTR-181 400 mg and oxycodone IR placebo', 'interventionNames': ['Drug: NKTR-181']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Oxycodone IR 40 mg and NKTR-181 placebo', 'interventionNames': ['Drug: Oxycodone IR']}], 'interventions': [{'name': 'NKTR-181', 'type': 'DRUG', 'description': 'A combination of NKTR-181 and oxycodone IR placebo', 'armGroupLabels': ['Group 1']}, {'name': 'Oxycodone IR', 'type': 'DRUG', 'description': 'A combination of oxycodone IR and NKTR-181 placebo', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Investigator Site - Richmond', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nektar Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nektar Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}