Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-29 @ 10:59 AM
Study NCT ID:
NCT04019093
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2019-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acute Effects of Alcohol Use on Chronic Orofacial Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jboissoneault@phhp.ufl.edu', 'phone': '352-273-6147', 'title': 'Jeff Boissoneault, PhD', 'organization': 'University of Florida'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Duration of study participation (4-8 hours per study session, with at least 48 hours separating each session)', 'eventGroups': [{'id': 'EG000', 'title': 'Jaw Pain Patients: Ethanol', 'description': "Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.", 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Controls: Ethanol', 'description': "Healthy social drinkers without jaw pain recruited as a comparison group.\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.", 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 1, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Jaw Pain Patients: Placebo', 'description': "Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.", 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Healthy Controls: Placebo', 'description': "Healthy social drinkers without jaw pain recruited as a comparison group.\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.", 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea and vomiting', 'notes': "Approximately 2.5 hours after consuming the study beverage, while metabolizing alcohol dose prior to transport home, participant reported feeling nauseous and vomited. Participant's BrAC was 0.04.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pressure Pain Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Jaw Pain Patients: Ethanol', 'description': "Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL."}, {'id': 'OG001', 'title': 'Healthy Controls: Ethanol', 'description': "Healthy social drinkers without jaw pain recruited as a comparison group.\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration."}, {'id': 'OG002', 'title': 'Jaw Pain Patients: Placebo', 'description': 'Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.'}, {'id': 'OG003', 'title': 'Healthy Controls: Placebo', 'description': 'Healthy social drinkers without jaw pain recruited as a comparison group.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.56', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '5.27', 'spread': '1.37', 'groupId': 'OG001'}, {'value': '3.81', 'spread': '0.84', 'groupId': 'OG002'}, {'value': '4.51', 'spread': '1.21', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.99', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': '2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) mixed general linear model on pressure threshold. Here we report the results of the analysis of the beverage condition X group interaction.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'F(1,46) = .001'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': '2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) mixed general linear model on pressure threshold. Here we report the results of the analysis of the main effect of beverage condition.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'F(1,46)=12.55'}, {'pValue': '.015', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': '2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) mixed general linear model on pressure threshold. Here we report the results of the analysis of the main effect of group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'F(1,46)=6.32'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)', 'description': 'Pressure at which stimulation at the masseter insertion becomes painful, in lbf. Positive values represent higher pain thresholds.', 'unitOfMeasure': 'lbf', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pressure Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '28', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '28', 'groupId': 'OG009'}, {'value': '17', 'groupId': 'OG010'}, {'value': '28', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Jaw Pain Patients: Ethanol, 4lbf', 'description': "Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.\n\n4lbf: Pressure applied to masseter insertion"}, {'id': 'OG001', 'title': 'Healthy Controls: Ethanol, 4lbf', 'description': "Healthy social drinkers without jaw pain recruited as a comparison group.\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.\n\n4lbf: Pressure applied to masseter insertion"}, {'id': 'OG002', 'title': 'Jaw Pain Patients: Placebo, 4lbf', 'description': 'Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.\n\n4lbf: Pressure applied to masseter insertion'}, {'id': 'OG003', 'title': 'Healthy Controls: Placebo, 4lbf', 'description': 'Healthy social drinkers without jaw pain recruited as a comparison group.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.\n\n4lbf: Pressure applied to masseter insertion'}, {'id': 'OG004', 'title': 'Jaw Pain Patients: Ethanol, 5lbf', 'description': "Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.\n\n5lbf: Pressure applied to masseter insertion"}, {'id': 'OG005', 'title': 'Healthy Controls: Ethanol, 5lbf', 'description': "Healthy social drinkers without jaw pain recruited as a comparison group.\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.\n\n5lbf: Pressure applied to masseter insertion"}, {'id': 'OG006', 'title': 'Jaw Pain Patients: Placebo, 5lbf', 'description': 'Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.\n\n5lbf: Pressure applied to masseter insertion'}, {'id': 'OG007', 'title': 'Healthy Controls: Placebo, 5lbf', 'description': 'Healthy social drinkers without jaw pain recruited as a comparison group.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.\n\n5lbf: Pressure applied to masseter insertion'}, {'id': 'OG008', 'title': 'Jaw Pain Patients: Ethanol, 6lbf', 'description': "Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.\n\n6lbf: Pressure applied to masseter insertion"}, {'id': 'OG009', 'title': 'Healthy Controls: Ethanol, 6lbf', 'description': "Healthy social drinkers without jaw pain recruited as a comparison group.\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.\n\n6lbf: Pressure applied to masseter insertion"}, {'id': 'OG010', 'title': 'Jaw Pain Patients: Placebo, 6lbf', 'description': 'Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.\n\n6lbf: Pressure applied to masseter insertion'}, {'id': 'OG011', 'title': 'Healthy Controls: Placebo, 6lbf', 'description': 'Healthy social drinkers without jaw pain recruited as a comparison group.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.\n\n6lbf: Pressure applied to masseter insertion'}], 'classes': [{'categories': [{'measurements': [{'value': '23.96', 'spread': '28.03', 'groupId': 'OG000'}, {'value': '12.76', 'spread': '13.44', 'groupId': 'OG001'}, {'value': '32.39', 'spread': '19.95', 'groupId': 'OG002'}, {'value': '22.05', 'spread': '17.72', 'groupId': 'OG003'}, {'value': '35.43', 'spread': '19.67', 'groupId': 'OG004'}, {'value': '20.92', 'spread': '17.02', 'groupId': 'OG005'}, {'value': '41.81', 'spread': '20.28', 'groupId': 'OG006'}, {'value': '29.98', 'spread': '23.89', 'groupId': 'OG007'}, {'value': '37.19', 'spread': '23.90', 'groupId': 'OG008'}, {'value': '26.95', 'spread': '23.06', 'groupId': 'OG009'}, {'value': '46.10', 'spread': '22.97', 'groupId': 'OG010'}, {'value': '34.03', 'spread': '22.94', 'groupId': 'OG011'}]}]}], 'analyses': [{'pValue': '.76', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG008', 'OG009', 'OG010', 'OG011'], 'groupDescription': '2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the pressure level X group interaction.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'F(2,82)=.20'}, {'pValue': '.52', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG008', 'OG009', 'OG010', 'OG011'], 'groupDescription': '2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the pressure level X beverage condition interaction.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'F(2,82)=.66'}, {'pValue': '.04', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG008', 'OG009', 'OG010', 'OG011'], 'groupDescription': '2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of beverage condition.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'F(1,41)=4.53, p=.04'}, {'pValue': '.017', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG008', 'OG009', 'OG010', 'OG011'], 'groupDescription': '2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'F(1,41)=6.24'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG008', 'OG009', 'OG010', 'OG011'], 'groupDescription': '2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of pressure level.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'F(2,82)=48.41'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)', 'description': 'Pain ratings associated with 4, 5, or 6 pound-feet (lbf) of pressure applied to the insertion of the masseter. VAS (visual analogue scale) pain intensity ratings anchored from 0 ("no pain at all") to 100 ("most intense imaginable") were collected. Higher values represent higher pain intensity.', 'unitOfMeasure': 'VAS units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Participant ratings from stimuli that were not within 0.5 lbf of the target pressure were excluded from analyses. This resulted in exclusion of 3 participants' data from this analysis."}, {'type': 'PRIMARY', 'title': 'Perceived Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}, {'value': '19', 'groupId': 'OG006'}, {'value': '28', 'groupId': 'OG007'}, {'value': '19', 'groupId': 'OG008'}, {'value': '28', 'groupId': 'OG009'}, {'value': '19', 'groupId': 'OG010'}, {'value': '28', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Jaw Pain Patients: Ethanol, 4lbf', 'description': "Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.\n\n4lbf: Pressure applied to masseter insertion"}, {'id': 'OG001', 'title': 'Healthy Controls: Ethanol, 4lbf', 'description': "Healthy social drinkers without jaw pain recruited as a comparison group.\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.\n\n4lbf: Pressure applied to masseter insertion"}, {'id': 'OG002', 'title': 'Jaw Pain Patients: Placebo, 4lbf', 'description': 'Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.\n\n4lbf: Pressure applied to masseter insertion'}, {'id': 'OG003', 'title': 'Healthy Controls: Placebo, 4lbf', 'description': 'Healthy social drinkers without jaw pain recruited as a comparison group.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.\n\n4lbf: Pressure applied to masseter insertion'}, {'id': 'OG004', 'title': 'Jaw Pain Patients: Ethanol, 5lbf', 'description': "Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.\n\n5lbf: Pressure applied to masseter insertion"}, {'id': 'OG005', 'title': 'Healthy Controls: Ethanol, 5lbf', 'description': "Healthy social drinkers without jaw pain recruited as a comparison group.\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.\n\n5lbf: Pressure applied to masseter insertion"}, {'id': 'OG006', 'title': 'Jaw Pain Patients: Placebo, 5lbf', 'description': 'Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.\n\n5lbf: Pressure applied to masseter insertion'}, {'id': 'OG007', 'title': 'Healthy Controls: Placebo, 5lbf', 'description': 'Healthy social drinkers without jaw pain recruited as a comparison group.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.\n\n5lbf: Pressure applied to masseter insertion'}, {'id': 'OG008', 'title': 'Jaw Pain Patients: Ethanol, 6lbf', 'description': "Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.\n\n6lbf: Pressure applied to masseter insertion"}, {'id': 'OG009', 'title': 'Healthy Controls: Ethanol, 6lbf', 'description': "Healthy social drinkers without jaw pain recruited as a comparison group.\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.\n\n6lbf: Pressure applied to masseter insertion"}, {'id': 'OG010', 'title': 'Jaw Pain Patients: Placebo, 6lbf', 'description': 'Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.\n\n6lbf: Pressure applied to masseter insertion'}, {'id': 'OG011', 'title': 'Healthy Controls: Placebo, 6lbf', 'description': 'Healthy social drinkers without jaw pain recruited as a comparison group.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration.\n\n6lbf: Pressure applied to masseter insertion'}], 'classes': [{'categories': [{'measurements': [{'value': '40.58', 'spread': '31.31', 'groupId': 'OG000'}, {'value': '39.79', 'spread': '30.58', 'groupId': 'OG001'}, {'value': '7.91', 'spread': '13.71', 'groupId': 'OG002'}, {'value': '5.51', 'spread': '11.36', 'groupId': 'OG003'}, {'value': '41.00', 'spread': '28.27', 'groupId': 'OG004'}, {'value': '42.75', 'spread': '30.14', 'groupId': 'OG005'}, {'value': '7.20', 'spread': '13.01', 'groupId': 'OG006'}, {'value': '5.57', 'spread': '11.13', 'groupId': 'OG007'}, {'value': '39.72', 'spread': '30.05', 'groupId': 'OG008'}, {'value': '43.65', 'spread': '29.61', 'groupId': 'OG009'}, {'value': '7.20', 'spread': '13.41', 'groupId': 'OG010'}, {'value': '5.89', 'spread': '13.11', 'groupId': 'OG011'}]}]}], 'analyses': [{'pValue': '.50', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG008', 'OG009', 'OG010', 'OG011'], 'groupDescription': '2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the beverage condition X pressure level X group interaction.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'F (2, 82) = 0.69'}, {'pValue': '.21', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG008', 'OG009', 'OG010', 'OG011'], 'groupDescription': '2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the beverage condition X pressure level interaction.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'F(2,82)=1.58'}, {'pValue': '.053', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG008', 'OG009', 'OG010', 'OG011'], 'groupDescription': '2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the pressure level X group interaction.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'F(2,82)=3.06'}, {'pValue': '.98', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG008', 'OG009', 'OG010', 'OG011'], 'groupDescription': '2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the beverage condition X group interaction.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'F(1,41)=.001'}, {'pValue': '.71', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG008', 'OG009', 'OG010', 'OG011'], 'groupDescription': '2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of pressure level.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'F(2,82)=.34'}, {'pValue': '.71', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG008', 'OG009', 'OG010', 'OG011'], 'groupDescription': '2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'F(1,41)=.14'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007', 'OG008', 'OG009', 'OG010', 'OG011'], 'groupDescription': '2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of beverage condition.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'F(1,41)=55.02'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)', 'description': 'Ratings of relief from pain associated with consumption of the study beverage following application of 4, 5, or 6 lbf stimuli. VAS (visual analogue scale) assessing perceived relief anchored from 0 ("No relief at all") to 100 ("Most profound relief imaginable"). Higher values represent greater perceived relief.', 'unitOfMeasure': 'VAS units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant had missing data on this measure, resulting from exclusion from analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Jaw Pain Patients: Ethanol First, Then Placebo', 'description': "Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD), randomized to receive ethanol first, followed by placebo.\n\nThe first laboratory session lasted 4-8 hours, followed by a minimum 48 hour gap, and the second laboratory session lasted 4-8 hours.\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration."}, {'id': 'FG001', 'title': 'Healthy Controls: Ethanol First, Then Placebo', 'description': "Healthy social drinkers without jaw pain recruited as a comparison group who received ethanol first, randomized to receive ethanol first, followed by placebo.\n\nThe first laboratory session lasted 4-8 hours, followed by a minimum 48 hour gap, and the second laboratory session lasted 4-8 hours.\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration."}, {'id': 'FG002', 'title': 'Jaw Pain Patients: Placebo First, Then Ethanol', 'description': "Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD), randomized to receive placebo first, followed by ethanol.\n\nThe first laboratory session lasted 4-8 hours, followed by a minimum 48 hour gap, and the second laboratory session lasted 4-8 hours.\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration."}, {'id': 'FG003', 'title': 'Healthy Controls: Placebo First, Then Ethanol', 'description': "Healthy social drinkers without jaw pain recruited as a comparison group who received ethanol first, randomized to receive placebo first, followed by ethanol.\n\nThe first laboratory session lasted 4-8 hours, followed by a minimum 48 hour gap, and the second laboratory session lasted 4-8 hours.\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Jaw Pain Patients', 'description': "Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration."}, {'id': 'BG001', 'title': 'Healthy Controls', 'description': "Healthy social drinkers without jaw pain recruited as a comparison group.\n\nEthanol: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.\n\nPlacebo: A beverage that does not meaningfully increase breath alcohol concentration."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.74', 'spread': '5', 'groupId': 'BG000'}, {'value': '25.72', 'spread': '4.12', 'groupId': 'BG001'}, {'value': '26.13', 'spread': '4.47', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '35', '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': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', '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': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Alcohol Use Disorders Identification Test (total score)', 'classes': [{'categories': [{'measurements': [{'value': '4.37', 'spread': '1.77', 'groupId': 'BG000'}, {'value': '4.31', 'spread': '1.67', 'groupId': 'BG001'}, {'value': '4.33', 'spread': '1.69', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Alcohol Use Disorders Identification Test (AUDIT) is a standardized assessment of drinking frequency and heaviness, as well as consequences associated with alcohol intake. Higher scores reflect heavier/more frequent drinking and more severe alcohol-related consequences. Items are summed to compute total score, which can range from 0-40.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Quantity-Frequency Index', 'classes': [{'categories': [{'measurements': [{'value': '.426', 'spread': '.35', 'groupId': 'BG000'}, {'value': '.551', 'spread': '.39', 'groupId': 'BG001'}, {'value': '.48', 'spread': '.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'oz. absolute ethanol consumed per day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Max Quantity (oz. abs. EtOH)', 'classes': [{'categories': [{'measurements': [{'value': '4.29', 'spread': '2.01', 'groupId': 'BG000'}, {'value': '3.74', 'spread': '1.41', 'groupId': 'BG001'}, {'value': '3.96', 'spread': '1.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'oz. absolute ethanol', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Oral Health Impact Profile - TMDs (total score)', 'classes': [{'categories': [{'measurements': [{'value': '31.79', 'spread': '14.74', 'groupId': 'BG000'}, {'value': '10.14', 'spread': '11.26', 'groupId': 'BG001'}, {'value': '18.71', 'spread': '16.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Oral Health Impact Profile - TMDs is a temporomandibular joint and muscle disorder (TMD) specific version of the Oral Health Impact Profile. Total scores are generated by summing each item and range from 0-88. Higher scores indicate more severe TMD-related symptoms and quality of life impacts.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-02', 'size': 212276, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-27T09:50', 'hasProtocol': True}, {'date': '2021-02-17', 'size': 244662, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-02-27T11:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'People with and without jaw pain, including temporomandibular joint and muscle disorder (TMD) will receive an active oral dose of alcohol or placebo in a counterbalanced manner.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-05', 'studyFirstSubmitDate': '2019-07-11', 'resultsFirstSubmitDate': '2023-02-27', 'studyFirstSubmitQcDate': '2019-07-11', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-05', 'studyFirstPostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pressure Pain Threshold', 'timeFrame': 'Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)', 'description': 'Pressure at which stimulation at the masseter insertion becomes painful, in lbf. Positive values represent higher pain thresholds.'}, {'measure': 'Pressure Pain Intensity', 'timeFrame': 'Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)', 'description': 'Pain ratings associated with 4, 5, or 6 pound-feet (lbf) of pressure applied to the insertion of the masseter. VAS (visual analogue scale) pain intensity ratings anchored from 0 ("no pain at all") to 100 ("most intense imaginable") were collected. Higher values represent higher pain intensity.'}, {'measure': 'Perceived Relief', 'timeFrame': 'Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)', 'description': 'Ratings of relief from pain associated with consumption of the study beverage following application of 4, 5, or 6 lbf stimuli. VAS (visual analogue scale) assessing perceived relief anchored from 0 ("No relief at all") to 100 ("Most profound relief imaginable"). Higher values represent greater perceived relief.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['alcohol effects'], 'conditions': ['Temporomandibular Joint Disorders']}, 'referencesModule': {'references': [{'pmid': '37358545', 'type': 'DERIVED', 'citation': 'Alexander C, Bush NJ, Neubert JK, Robinson M, Boissoneault J. Expectancy of alcohol analgesia moderates perception of pain relief following acute alcohol intake. Exp Clin Psychopharmacol. 2024 Apr;32(2):228-235. doi: 10.1037/pha0000664. Epub 2023 Jun 26.'}]}, 'descriptionModule': {'briefSummary': 'Self-medication of pain with alcohol is a common, yet risky, behavior among individuals with chronic orofacial pain. Chronic pain status may affect the degree to which alcohol use relieves pain, but the independent contributions of pain chronification and alcohol-related expectations and conditioning have not been previously studied. This project addresses this gap in knowledge and will inform further research and clinical/translational efforts for reducing risk associated with these behaviors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Positive diagnosis of jaw pain, including temporomandibular joint and muscle disorder (TMD) (jaw pain group only)\n* Consume at least 1 drink/month over the past 6 months\n\nExclusion Criteria:\n\n* History of chronic pain other than jaw pain or TMD\n* Current use of opioids\n* Current major depression\n* History of any psychotic disorder\n* Undercontrolled hypertension or diabetes\n* History of neurologic disease\n* History of serious medical illness\n* History of drug or alcohol dependence, including nicotine, or a pattern of hazardous alcohol use'}, 'identificationModule': {'nctId': 'NCT04019093', 'briefTitle': 'Acute Effects of Alcohol Use on Chronic Orofacial Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Acute Effects of Alcohol Use on Chronic Orofacial Pain', 'orgStudyIdInfo': {'id': 'IRB201801911-N'}, 'secondaryIdInfos': [{'id': 'R21AA026805', 'link': 'https://reporter.nih.gov/quickSearch/R21AA026805', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Jaw pain patients', 'description': 'Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD).', 'interventionNames': ['Drug: Ethanol', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy controls', 'description': 'Healthy social drinkers without jaw pain recruited as a comparison group.', 'interventionNames': ['Drug: Ethanol', 'Other: Placebo']}], 'interventions': [{'name': 'Ethanol', 'type': 'DRUG', 'description': "A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.", 'armGroupLabels': ['Healthy controls', 'Jaw pain patients']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'A beverage that does not meaningfully increase breath alcohol concentration.', 'armGroupLabels': ['Healthy controls', 'Jaw pain patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Pain Research and Behavioral Health at UF Health', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Jeff Boissoneault, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}