Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2026-02-21 @ 7:58 AM
Study NCT ID:
NCT03771612
Status:
COMPLETED
Last Update Posted:
2025-02-25
First Post:
2018-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Inflammation and Daily Life Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009288', 'term': 'Naproxen'}], 'ancestors': [{'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'neisenbe@ucla.edu', 'phone': '3108494330', 'title': 'Naomi Eisenberger', 'organization': 'UCLA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Because the study occurred during the COVID pandemic, we had to change our protocol to run all subjects online (drug/placebo was mailed to subjects as were blood collection devices). In addition, due to both budgetary issues and IRB concerns during the COVID pandemic, we had to shorten the planned intervention from 4 to 2 weeks.'}}, 'adverseEventsModule': {'timeFrame': 'Data were collected while participants were taking naproxen/placebo (2 weeks) as well as in the 2 weeks following the end of the intervention (T1 to T3).', 'description': 'No adverse events', 'eventGroups': [{'id': 'EG000', 'title': 'Naproxen', 'description': 'Naproxen: Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebos: Half of the participants will be randomly assigned to receive a placebo pill twice daily', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Loneliness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen', 'description': 'Naproxen: Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebos: Half of the participants will be randomly assigned to receive a placebo pill twice daily'}], 'classes': [{'title': 'T1 Loneliness', 'categories': [{'measurements': [{'value': '47.9', 'spread': '10', 'groupId': 'OG000'}, {'value': '46.9', 'spread': '10.5', 'groupId': 'OG001'}]}]}, {'title': 'T2 Loneliness', 'categories': [{'measurements': [{'value': '46.8', 'spread': '9.43', 'groupId': 'OG000'}, {'value': '44.6', 'spread': '10.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'T1: Baseline, T2: post-intervention (2 weeks later)', 'description': 'Changes in self-report measures of loneliness (University of California, Los Angeles (UCLA) Loneliness Scale) Scale ranges from 20-80 (though participants were included based on higher levels of loneliness, \\> 41). Higher values represent higher levels of loneliness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Negative Picture Viewing Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen', 'description': 'Naproxen: Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebos: Half of the participants will be randomly assigned to receive a placebo pill twice daily'}], 'classes': [{'title': 'T1 Ratings of Pictures', 'categories': [{'measurements': [{'value': '-2.83', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '-2.60', 'spread': '1.59', 'groupId': 'OG001'}]}]}, {'title': 'T2 Ratings of Pictures', 'categories': [{'measurements': [{'value': '-2.90', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '-2.66', 'spread': '1.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'T1: Baseline, T2: post-intervention (2 weeks later)', 'description': 'Changes in ratings of negative pictures "To what extent is this picture positive or negative: from -5 (very negative) to +5 (very positive)" Lower scores indicate more negativity', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Social Reward Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen', 'description': 'Naproxen: Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebos: Half of the participants will be randomly assigned to receive a placebo pill twice daily'}], 'classes': [{'title': 'T1 RT to close other vs. control', 'categories': [{'measurements': [{'value': '-0.012', 'spread': '.056', 'groupId': 'OG000'}, {'value': '-.003', 'spread': '.025', 'groupId': 'OG001'}]}]}, {'title': 'T2 RT to close other vs. control', 'categories': [{'measurements': [{'value': '-.020', 'spread': '.112', 'groupId': 'OG000'}, {'value': '.002', 'spread': '.054', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'T1: Baseline, T2: post-intervention (2 weeks later)', 'description': 'Changes in reaction time to close others vs. control image (measures in seconds) Faster reaction times indicate greater sensitivity; so lower scores (fewer seconds) indicate greater sensitivity to close others vs. control images', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Inflammatory Gene Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen', 'description': 'Naproxen: Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebos: Half of the participants will be randomly assigned to receive a placebo pill twice daily'}], 'classes': [{'title': 'T1 Inflammatory Composite', 'categories': [{'measurements': [{'value': '.070', 'spread': '.352', 'groupId': 'OG000'}, {'value': '.057', 'spread': '.357', 'groupId': 'OG001'}]}]}, {'title': 'T2 Inflammatory Composite', 'categories': [{'measurements': [{'value': '.042', 'spread': '.292', 'groupId': 'OG000'}, {'value': '.001', 'spread': '.345', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'T1: Baseline, T2: post-intervention (2 weeks later)', 'description': 'Changes in inflammatory gene expression Values are the logged transformed values of a pre-specified composite of 19 representative proinflammatory genes (e.g., IL1B, IL6, COX2/PTGS2,TNF). Composite is in counts per million. Final scale is the logged value of this counts per million (logCPM). Higher numbers indicate greater inflammatory gene expression', 'unitOfMeasure': 'logCPM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Loneliness at Follow-up (2 Weeks Post-intervention)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen', 'description': 'Naproxen: Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebos: Half of the participants will be randomly assigned to receive a placebo pill twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '45.1', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '43.5', 'spread': '10.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'T3: 2 weeks after the end of the intervention (4 weeks after the start of the intervention)', 'description': 'Changes in self-report measures of loneliness (University of California, Los Angeles (UCLA) Loneliness Scale) at follow-up, 2 weeks after the end of the intervention Scale ranges from 20-80 (though participants were included based on higher levels of loneliness, \\> 41). Higher values represent higher levels of loneliness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Naproxen', 'description': 'Naproxen: Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebos: Half of the participants will be randomly assigned to receive a placebo pill twice daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '36'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Naproxen', 'description': 'Naproxen: Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebos: Half of the participants will be randomly assigned to receive a placebo pill twice daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.9', 'spread': '4.94', 'groupId': 'BG000'}, {'value': '51.9', 'spread': '5.11', 'groupId': 'BG001'}, {'value': '51.9', 'spread': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity/Race', 'categories': [{'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Hispanic/Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Middle Eastern', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline includes those subjects who completed the study'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-12-20', 'size': 50073, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-06T13:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2018-12-06', 'resultsFirstSubmitDate': '2024-11-29', 'studyFirstSubmitQcDate': '2018-12-07', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-03', 'studyFirstPostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Loneliness', 'timeFrame': 'T1: Baseline, T2: post-intervention (2 weeks later)', 'description': 'Changes in self-report measures of loneliness (University of California, Los Angeles (UCLA) Loneliness Scale) Scale ranges from 20-80 (though participants were included based on higher levels of loneliness, \\> 41). Higher values represent higher levels of loneliness.'}, {'measure': 'Negative Picture Viewing Task', 'timeFrame': 'T1: Baseline, T2: post-intervention (2 weeks later)', 'description': 'Changes in ratings of negative pictures "To what extent is this picture positive or negative: from -5 (very negative) to +5 (very positive)" Lower scores indicate more negativity'}, {'measure': 'Social Reward Task', 'timeFrame': 'T1: Baseline, T2: post-intervention (2 weeks later)', 'description': 'Changes in reaction time to close others vs. control image (measures in seconds) Faster reaction times indicate greater sensitivity; so lower scores (fewer seconds) indicate greater sensitivity to close others vs. control images'}], 'secondaryOutcomes': [{'measure': 'Inflammatory Gene Expression', 'timeFrame': 'T1: Baseline, T2: post-intervention (2 weeks later)', 'description': 'Changes in inflammatory gene expression Values are the logged transformed values of a pre-specified composite of 19 representative proinflammatory genes (e.g., IL1B, IL6, COX2/PTGS2,TNF). Composite is in counts per million. Final scale is the logged value of this counts per million (logCPM). Higher numbers indicate greater inflammatory gene expression'}, {'measure': 'Loneliness at Follow-up (2 Weeks Post-intervention)', 'timeFrame': 'T3: 2 weeks after the end of the intervention (4 weeks after the start of the intervention)', 'description': 'Changes in self-report measures of loneliness (University of California, Los Angeles (UCLA) Loneliness Scale) at follow-up, 2 weeks after the end of the intervention Scale ranges from 20-80 (though participants were included based on higher levels of loneliness, \\> 41). Higher values represent higher levels of loneliness.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immune system', 'Social psychology', 'Health psychology'], 'conditions': ['Inflammation']}, 'descriptionModule': {'briefSummary': 'UCLA researchers looking for healthy individuals (age 45-60) to participate in a study investigating whether an anti-inflammatory medication can impact daily life experiences.\n\nEveryday for two weeks, participants will take either an anti-inflammatory medication (naproxen) twice daily, or a placebo pill twice daily. Participants will also answer daily questions during the 2-week period. Participants will also fill out questionnaires and complete a few tasks on the computer: once prior to the 2-week period and once immediately after the 2-week period, both during online study sessions.', 'detailedDescription': 'Participants (ntotal=50) will be men and women, ages 45-60. All interested participants will first complete a structured telephone interview in order to assess eligibility.\n\nThe study will begin with filling out questionnaires, as well as an online session to complete some tasks. You will then be randomly assigned to take either an anti-inflammatory medication (naproxen) or placebo (inactive substance) to take twice daily everyday for the following two weeks. You will also be contacted by text message to remind you to take your pills, to ask if you have taken your pills, and to send you a link to fill out questionnaires once daily. After the two weeks are over, you will again complete questionnaires and the online study session with tasks. Finally, two weeks after the second session, you will receive an email to fill out questionnaires online.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy adults 45-60\n\nExclusion Criteria: Following a structured telephone interview, participants with the following conditions will not be able to participate:\n\n* certain active, uncontrolled medical disorders\n* use of certain medications (e.g., hypnotic and psychotropic medication, steroid use, opioid use)\n* psychiatric disorders (e.g., current major depression, bipolar disorder)\n\nOther exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT03771612', 'briefTitle': 'Inflammation and Daily Life Study', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Inflammation and Daily Life Study', 'orgStudyIdInfo': {'id': 'IDL'}, 'secondaryIdInfos': [{'id': '1R21AG058893-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21AG058893-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Naproxen', 'interventionNames': ['Drug: Naproxen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Naproxen', 'type': 'DRUG', 'description': 'Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)', 'armGroupLabels': ['Naproxen']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Half of the participants will be randomly assigned to receive a placebo pill twice daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Department of Psychology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Naomi I Eisenberger, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Naomi Eisenberger', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}