Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT05425420
Status:
COMPLETED
Last Update Posted:
2025-02-10
First Post:
2022-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Single Dose IV Methadone for Post-Op Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008691', 'term': 'Methadone'}], 'ancestors': [{'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kanecia.zimmerman@duke.edu', 'phone': '919-668-8651', 'title': 'Kanecia Zimmerman', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 96 hours (4 days)', 'eventGroups': [{'id': 'EG000', 'title': 'Open Label Methadone IV', 'description': 'All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.\n\nMethadone hydrochloride 0.1mg/kg: Single dose of methadone hydrochloride administered via intravenous (IV)', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 10, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Blood pressure diastolic abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK) in Adults - Systemic Clearance (CL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Methadone IV', 'description': 'All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.\n\nMethadone hydrochloride 0.1mg/kg: Single dose of methadone hydrochloride administered via intravenous (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '6.14', 'spread': '1.42', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after dosing', 'unitOfMeasure': 'liters/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with samples collected at 96 hours.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK) in Adults - Volume of Distribution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Methadone IV', 'description': 'All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.\n\nMethadone hydrochloride 0.1mg/kg: Single dose of methadone hydrochloride administered via intravenous (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '318.95', 'spread': '42.04', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after dosing', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with samples collected at 96 hours.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK) in Adults - Elimination Half-life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Methadone IV', 'description': 'All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.\n\nMethadone hydrochloride 0.1mg/kg: Single dose of methadone hydrochloride administered via intravenous (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '39.66', 'spread': '9.95', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after dosing', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with samples collected at 96 hours.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK) in Adults - Plasma AUC0-96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Methadone IV', 'description': 'All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.\n\nMethadone hydrochloride 0.1mg/kg: Single dose of methadone hydrochloride administered via intravenous (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '1088.9', 'spread': '311.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after dosing', 'description': 'Plasma AUC0-96 is the area under the plasma concentration versus time curve from time zero to 96 hours post-dose.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with samples collected at 96 hours.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK) in Adults - AUC0-inf', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Methadone IV', 'description': 'All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.\n\nMethadone hydrochloride 0.1mg/kg: Single dose of methadone hydrochloride administered via intravenous (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '1363.3', 'spread': '515.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after dosing', 'description': 'AUC0-inf is the area under the curve from time 0 extrapolated to infinite time.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with samples collected at 96 hours.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK) in Adults - Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Methadone IV', 'description': 'All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.\n\nMethadone hydrochloride 0.1mg/kg: Single dose of methadone hydrochloride administered via intravenous (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '90.92', 'spread': '38.14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after dosing', 'description': 'Cmax: A pharmacokinetic measure used to determine drug dosing. Cmax is the highest concentration of a drug in the blood, cerebrospinal fluid, or target organ after a dose is given.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with samples collected at 96 hours.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK) in Adults - Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Methadone IV', 'description': 'All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.\n\nMethadone hydrochloride 0.1mg/kg: Single dose of methadone hydrochloride administered via intravenous (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.116', 'spread': '0.095', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after dosing', 'description': 'Tmax is the time corresponding to maximum concentration post-dose.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with samples collected at 96 hours.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK) in Adults - Cmin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Methadone IV', 'description': 'All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.\n\nMethadone hydrochloride 0.1mg/kg: Single dose of methadone hydrochloride administered via intravenous (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.35', 'spread': '2.41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after dosing', 'description': 'Cmin is the observed minimum concentration post-dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with samples collected at 96 hours.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK) in Adults - Elimination Rate Constant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Methadone IV', 'description': 'All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.\n\nMethadone hydrochloride 0.1mg/kg: Single dose of methadone hydrochloride administered via intravenous (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.018', 'spread': '0.004', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after dosing', 'description': 'Elimination rate constant (ke)-s a value used in pharmacokinetics to describe the rate at which a drug is removed from the human system.', 'unitOfMeasure': 'h^-1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with samples collected at 96 hours.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics (PD) in Adults - Dark-adapted Pupillometry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Methadone IV', 'description': 'All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.\n\nMethadone hydrochloride 0.1mg/kg: Single dose of methadone hydrochloride administered via intravenous (IV)'}], 'classes': [{'title': 'Left pupil', 'categories': [{'measurements': [{'value': '6.95', 'spread': '1.30', 'groupId': 'OG000'}]}]}, {'title': 'Right pupil', 'categories': [{'measurements': [{'value': '7.57', 'spread': '1.29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after dosing', 'description': 'Dark-adapted pupillometry measured pupil diameter using a goggle-based, camera-like device. A goggle-based system effectively allowed the participant to be in the dark while room lights were on for research staff.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics (PD) in Adults - Thermal Pain Tolerance Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Methadone IV', 'description': 'All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.\n\nMethadone hydrochloride 0.1mg/kg: Single dose of methadone hydrochloride administered via intravenous (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '46.58', 'spread': '1.87', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after dosing', 'description': "The thermal pain tolerance threshold is the highest tolerated temperature change. Thermal pain tolerance was measured by a 3 cm2 computer-controlled Peltier-type thermal stimulator. The stimulator delivered painful heat stimuli to the volar side of the forearm. The thermode system's baseline temperature was set at 32°C. The computer-controlled thermode system was programmed to gradually increase the stimulus (0.8°C/sec) until participants pressed a stop button, which indicates maximum tolerable temperature was reached and initiated immediate thermode cooling. The maximum tolerable temperature was recorded.", 'unitOfMeasure': 'degrees Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Alertness/Sedation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Methadone IV', 'description': 'All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.\n\nMethadone hydrochloride 0.1mg/kg: Single dose of methadone hydrochloride administered via intravenous (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '91.60', 'spread': '16.33', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after dosing', 'description': 'Subjective self-assessment of methadone effects using a visual analog scale (VAS). The score for alertness/sedation ranges from 0 (almost asleep) to 100 (wide awake).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Energy Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Methadone IV', 'description': 'All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.\n\nMethadone hydrochloride 0.1mg/kg: Single dose of methadone hydrochloride administered via intravenous (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '89.60', 'spread': '18.01', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after dosing', 'description': 'Subjective self-assessment of methadone effects using a visual analog scale (VAS). The score for energy level ranges from 0 (no energy) to 100 (full of energy).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Confusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Methadone IV', 'description': 'All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.\n\nMethadone hydrochloride 0.1mg/kg: Single dose of methadone hydrochloride administered via intravenous (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.60', 'spread': '3.36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after dosing', 'description': 'Subjective self-assessment of methadone effects using a visual analog scale (VAS). The score for confusion ranges from 0 (clear headed) to 100 (confused).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Clumsiness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Methadone IV', 'description': 'All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.\n\nMethadone hydrochloride 0.1mg/kg: Single dose of methadone hydrochloride administered via intravenous (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.60', 'spread': '5.37', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after dosing', 'description': 'Subjective self-assessment of methadone effects using a visual analog scale (VAS). The score for clumsiness ranges from 0 (well-coordinated) to 100 (extremely clumsy).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Methadone IV', 'description': 'All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.\n\nMethadone hydrochloride 0.1mg/kg: Single dose of methadone hydrochloride administered via intravenous (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.50', 'spread': '3.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after dosing', 'description': 'Subjective self-assessment of methadone effects using a visual analog scale (VAS). The score for anxiety ranges from 0 (calm/relaxed) to 100 (extremely nervous).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Methadone IV', 'description': 'All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.\n\nMethadone hydrochloride 0.1mg/kg: Single dose of methadone hydrochloride administered via intravenous (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after dosing', 'description': 'Subjective self-assessment of methadone effects using a visual analog scale (VAS). The score for nausea ranges from 0 (no nausea) to 100 (worst nausea).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics (PD) in Adults - Maximum End-expired CO2 Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Methadone IV', 'description': 'All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.\n\nMethadone hydrochloride 0.1mg/kg: Single dose of methadone hydrochloride administered via intravenous (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '37.40', 'spread': '1.91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after dosing', 'description': 'Measured in mmHg', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics (PD) in Adults - Maximum Sedation Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open Label Methadone IV', 'description': 'All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.\n\nMethadone hydrochloride 0.1mg/kg: Single dose of methadone hydrochloride administered via intravenous (IV)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 hours after dosing', 'description': 'Maximum sedation score obtained via the Modified Observer\'s Assessment of Alertness/Sedation (MOAA/S). The MOAA/S has a scale of 0 to 5, where 0 = "Does not respond to painful trapezius squeeze" and 5 = "Responds readily to name spoken in normal tone".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Open Label Methadone IV', 'description': 'All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.\n\nMethadone hydrochloride 0.1mg/kg: Single dose of methadone hydrochloride administered via intravenous (IV)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Failure to Meet Continuation Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Open Label Methadone IV', 'description': 'All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.\n\nMethadone hydrochloride 0.1mg/kg: Single dose of methadone hydrochloride administered via intravenous (IV)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.4', 'spread': '5.05', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', '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': '21', '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': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', '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': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-27', 'size': 1221596, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-13T09:37', 'hasProtocol': True}, {'date': '2023-10-18', 'size': 6254834, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-03-20T15:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Subjects will be studied on one occasion in the Early Phase Research Unit at Duke University Medical Center for administration of drug, collection of blood samples, and measurements of drug effect. Study drug is intravenous methadone hydrochloride Plasma samples collections are obtained up to 96 hr after dosing. Dark-adapted pupil diameter is measured by infrared camera. Responses to thermal skin stimulation are recorded. Respiratory rate and end-tidal carbon dioxide concentrations are measured. Subject self-assessment of methadone effect is performed using verbal analog scales. Blood samples obtained during the study will be analyzed for plasma concentrations of methadone.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-11', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-18', 'studyFirstSubmitDate': '2022-04-15', 'resultsFirstSubmitDate': '2025-01-18', 'studyFirstSubmitQcDate': '2022-06-16', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-18', 'studyFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK) in Adults - Systemic Clearance (CL)', 'timeFrame': '96 hours after dosing'}, {'measure': 'Pharmacokinetics (PK) in Adults - Volume of Distribution', 'timeFrame': '96 hours after dosing'}, {'measure': 'Pharmacokinetics (PK) in Adults - Elimination Half-life', 'timeFrame': '96 hours after dosing'}, {'measure': 'Pharmacokinetics (PK) in Adults - Plasma AUC0-96', 'timeFrame': '96 hours after dosing', 'description': 'Plasma AUC0-96 is the area under the plasma concentration versus time curve from time zero to 96 hours post-dose.'}, {'measure': 'Pharmacokinetics (PK) in Adults - AUC0-inf', 'timeFrame': '96 hours after dosing', 'description': 'AUC0-inf is the area under the curve from time 0 extrapolated to infinite time.'}, {'measure': 'Pharmacokinetics (PK) in Adults - Cmax', 'timeFrame': '96 hours after dosing', 'description': 'Cmax: A pharmacokinetic measure used to determine drug dosing. Cmax is the highest concentration of a drug in the blood, cerebrospinal fluid, or target organ after a dose is given.'}, {'measure': 'Pharmacokinetics (PK) in Adults - Tmax', 'timeFrame': '96 hours after dosing', 'description': 'Tmax is the time corresponding to maximum concentration post-dose.'}, {'measure': 'Pharmacokinetics (PK) in Adults - Cmin', 'timeFrame': '96 hours after dosing', 'description': 'Cmin is the observed minimum concentration post-dose.'}, {'measure': 'Pharmacokinetics (PK) in Adults - Elimination Rate Constant', 'timeFrame': '96 hours after dosing', 'description': 'Elimination rate constant (ke)-s a value used in pharmacokinetics to describe the rate at which a drug is removed from the human system.'}], 'secondaryOutcomes': [{'measure': 'Pharmacodynamics (PD) in Adults - Dark-adapted Pupillometry', 'timeFrame': '96 hours after dosing', 'description': 'Dark-adapted pupillometry measured pupil diameter using a goggle-based, camera-like device. A goggle-based system effectively allowed the participant to be in the dark while room lights were on for research staff.'}, {'measure': 'Pharmacodynamics (PD) in Adults - Thermal Pain Tolerance Threshold', 'timeFrame': '96 hours after dosing', 'description': "The thermal pain tolerance threshold is the highest tolerated temperature change. Thermal pain tolerance was measured by a 3 cm2 computer-controlled Peltier-type thermal stimulator. The stimulator delivered painful heat stimuli to the volar side of the forearm. The thermode system's baseline temperature was set at 32°C. The computer-controlled thermode system was programmed to gradually increase the stimulus (0.8°C/sec) until participants pressed a stop button, which indicates maximum tolerable temperature was reached and initiated immediate thermode cooling. The maximum tolerable temperature was recorded."}, {'measure': 'Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Alertness/Sedation', 'timeFrame': '96 hours after dosing', 'description': 'Subjective self-assessment of methadone effects using a visual analog scale (VAS). The score for alertness/sedation ranges from 0 (almost asleep) to 100 (wide awake).'}, {'measure': 'Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Energy Level', 'timeFrame': '96 hours after dosing', 'description': 'Subjective self-assessment of methadone effects using a visual analog scale (VAS). The score for energy level ranges from 0 (no energy) to 100 (full of energy).'}, {'measure': 'Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Confusion', 'timeFrame': '96 hours after dosing', 'description': 'Subjective self-assessment of methadone effects using a visual analog scale (VAS). The score for confusion ranges from 0 (clear headed) to 100 (confused).'}, {'measure': 'Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Clumsiness', 'timeFrame': '96 hours after dosing', 'description': 'Subjective self-assessment of methadone effects using a visual analog scale (VAS). The score for clumsiness ranges from 0 (well-coordinated) to 100 (extremely clumsy).'}, {'measure': 'Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Anxiety', 'timeFrame': '96 hours after dosing', 'description': 'Subjective self-assessment of methadone effects using a visual analog scale (VAS). The score for anxiety ranges from 0 (calm/relaxed) to 100 (extremely nervous).'}, {'measure': 'Pharmacodynamics (PD) in Adults - Subjective Self-assessment of Methadone Effects - Nausea', 'timeFrame': '96 hours after dosing', 'description': 'Subjective self-assessment of methadone effects using a visual analog scale (VAS). The score for nausea ranges from 0 (no nausea) to 100 (worst nausea).'}, {'measure': 'Pharmacodynamics (PD) in Adults - Maximum End-expired CO2 Concentration', 'timeFrame': '96 hours after dosing', 'description': 'Measured in mmHg'}, {'measure': 'Pharmacodynamics (PD) in Adults - Maximum Sedation Score', 'timeFrame': '96 hours after dosing', 'description': 'Maximum sedation score obtained via the Modified Observer\'s Assessment of Alertness/Sedation (MOAA/S). The MOAA/S has a scale of 0 to 5, where 0 = "Does not respond to painful trapezius squeeze" and 5 = "Responds readily to name spoken in normal tone".'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'Single-center, open label, single-session study to evaluate methadone pharmacokinetics and pharmacodynamic in adults.', 'detailedDescription': 'The Adult Methadone study will be conducted at a single site, Duke Early Phase Research Unity (DEPRU), to enroll 24 participants. Participants will be treated/monitored overnight with Methadone hydrochloride IV (FDA approved and commercially available), with daily follow-up visits for 1 week total. The study aims to provide information on the disposition and clinical effects of intravenous methadone to update the drug label.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 to \\< 40 years of age at the time of enrollment\n2. Provide informed consent\n\nExclusion Criteria:\n\n1. History of cardiac dysfunction\n2. History of or current QTc prolongation, defined as \\> 470 ms in males and \\> 480 ms in females\n3. Known hypersensitivity to methadone hydrochloride or any other ingredient in the methadone hydrochloride injection\n4. Known acute bronchial asthma or hypercarbia (known history of known PaCO2 above 45 mm HG)\n5. Receipt of a serotonergic drug or buproprion within 7 days prior to study enrollment\n6. Receipt of benzodiazepines, muscle relaxants, or other opioids within 7 days prior to study enrollment\n7. Receipt of a moderate or strong CYP2B6 inhibitor or inducer - either prescription or non-prescription medications, herbals,34 or foods known to be metabolized by or affecting CYP2B6 - within 30 days prior to study enrollment\n\n 1. CYP2B6 inhibitors include clopidogrel, prasugrel, thioTEPA, ticlopidine, voriconazole, macrolide antibiotics, azole-antifungal agents, fluconazole, Alstonia boonei, Mangifera indica, and Picralima nitida\n 2. CYP2B6 inducers include artemisinin antimalarials, barbiturates, carbamazepine, cyclophosphamide, efavirenz, lopinavir, methimazole, nelfinavir, phenobarbital, phenytoin, primidone, rifampicin/rifampin, ritonavir, abacavir, amprenavir, nevirapine, telaprevir\n8. Receipt of zidovudine, desipramine, or other drugs that may increase serum concentration when combined with methadone within 30 days prior to study enrollment\n9. Known or suspected gastrointestinal obstruction, including paralytic ileus\n10. Significant respiratory depression (respiratory rate less than 8 breaths/min or oxygen saturation (SpO2) \\<95%)\n11. BMI ≥ 33 and BMI ≤ 17\n12. Known history of moderate-to-severe liver (Child Class B or C) or kidney disease (serum creatinine \\> 1.5)\n13. Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction)\n14. Females who are pregnant or nursing'}, 'identificationModule': {'nctId': 'NCT05425420', 'acronym': 'MTH02', 'briefTitle': 'Single Dose IV Methadone for Post-Op Pain', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Pharmacokinetics, Pharmacodynamics, and Safety of a Single Dose Intravenous Methadone in Healthy Adult Volunteers (MTH02)', 'orgStudyIdInfo': {'id': 'Pro00113821'}, 'secondaryIdInfos': [{'id': 'Pro00106216', 'type': 'OTHER', 'domain': 'Duke site IRB#'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm, Open label Methadone IV', 'description': 'All participants will be treated with Methadone Hydrochloride IV (over 10 minutes) and monitored overnight.', 'interventionNames': ['Drug: methadone hydrochloride 0.1mg/kg']}], 'interventions': [{'name': 'methadone hydrochloride 0.1mg/kg', 'type': 'DRUG', 'description': 'Single dose of methadone hydrochloride administered via intravenous (IV)', 'armGroupLabels': ['Single arm, Open label Methadone IV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Early Phase Unit (DEPRU', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Kanecia Zimmerman, MD, MPH,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DUMC, DCRI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanecia Obie Zimmerman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Kanecia Obie Zimmerman', 'investigatorAffiliation': 'Duke University'}}}}