Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-05 @ 5:47 PM
Study NCT ID:
NCT04146532
Status:
COMPLETED
Last Update Posted:
2024-06-03
First Post:
2019-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aspirin Effects on Emotional Reactions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012309', 'term': 'Risk-Taking'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-28', 'size': 1060457, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-04-28T14:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Note. 135 of an originally intended 200 participants had been enrolled at the time of cessation of research activities due to COVID-19 research closures. Therefore, the intended sample was increased to 270 to allow comparison between pre-COVID and post-COVID participants.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 268}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-31', 'studyFirstSubmitDate': '2019-10-28', 'studyFirstSubmitQcDate': '2019-10-29', 'lastUpdatePostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Emotional Reactivity', 'timeFrame': '1.5 hours', 'description': 'Changes in self-reported evaluations of valence on a 1 to 7 scale and felt reactions to emotional images on a 1-7 scale.'}, {'measure': 'Memory', 'timeFrame': '1.5 hours', 'description': 'Changes in memory for emotional pictures. After rating the images, the participants will be shown them again as well as new pictures and asked to indicate whether they have seen the picture before or not.'}, {'measure': 'Risk-Taking', 'timeFrame': '1.5 hours', 'description': 'We will measure the adjusted average number of pumps on the Balloon Analogue Risk Task.'}], 'secondaryOutcomes': [{'measure': 'Individual Differences', 'timeFrame': '1.5 hours', 'description': 'Self-reported political ideology will be examined as a moderator of the self-reported ratings of the images as well as memory for them.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aspirin', 'Acetylsalicylic acid', 'Emotional reactivity', 'Memory', 'Risk-taking', 'Inflammation'], 'conditions': ['Healthy Adults']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine whether the drug aspirin has effects on emotional reactivity, emotional memory, and risk-taking behaviors.', 'detailedDescription': 'The goal of this study is to determine if aspirin (acetylsalicylic acid) alters emotional reactions to emotion evoking pictures as well as memory for them. Using a double-blind parallel arm study, participants will receive either placebo or a pain-relieving dose of aspirin (500mg). One hour later they will complete 30 minutes of tasks. This will include ratings of emotional pictures and memory for them. The paradigm is similar to previous experiments done in this lab using other cyclooxygenase inhibitors: ibuprofen and acetaminophen (Durso, Luttrell, \\& Way, 2015; Psychological Science, https://doi.org/10.1177/0956797615570366). Risk taking on the Balloon Analogue Risk Task will also be assessed. Participants will be healthy young adult males at Ohio State University.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Must be biologically male to participate in study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAt least 18 years old and biologically male\n\nExclusion Criteria:\n\nDue to the use of aspirin in this study, women will be excluded from the study due to potential negative effects it may have on pregnancy\n\nParticipants will also be excluded for the following medical reasons:\n\n1. Having an allergy to aspirin, other salicylates, or any other pain reliever/fever reducer.\n2. Having or recovering from a viral infection such as the chicken pox or flu.\n3. Having taken aspirin or another NSAID drug (aspirin, ibuprofen, naproxen, or others) within the last 8 hours or plan to take aspirin or another NSAID drug in the 8 hours after the end of the study.\n4. Having more than three drinks of alcohol in the 8 hours after completion of the study.\n5. Having asthma, hay fever, nasal polyps, or chronic respiratory disease.\n6. Impaired liver/kidney or impaired cardiovascular circulation (renal vascular disease, congestive heart failure, volume depletion, major surgery, sepsis or major hemorrhagic events)\n7. Active or severe liver or kidney disease.\n8. An ulcer, history of ulcers or are prone to bleeding.\n9. A history of blood clotting defects.\n10. Severe anemia.\n11. Taking any of the following drugs: A blood thinning anticoagulant (e.g. warfarin), Digoxin, An Angiotensin Converting Enzyme (ACE) Inhibitor, Methotrexate, An oral glucocorticoid (e.g. hydrocortisone),Valproic Acid, A Selective Serotonin Reuptake Inhibitor (SSRI; e.g. Prozac; Zoloft)\n12. Have had stomach ulcers or bleeding problems.\n13. Have stomach problems such as heartburn, upset stomach, or stomach pain that does not go away or reoccurs.\n14. Surgery in the last week or will have a surgery in the next week.\n15. High blood pressure.\n16. Diabetes, gout, or arthritis.\n17. Low uric acid or Glucose-6-phosphate dehydrogenase (G6PD) deficiency.'}, 'identificationModule': {'nctId': 'NCT04146532', 'briefTitle': 'Aspirin Effects on Emotional Reactions', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Effects of Aspirin on Emotional Reactivity, Memory, and Risk-taking', 'orgStudyIdInfo': {'id': '2019H0262'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Single dose of a 500mg placebo tablet.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aspirin 500MG', 'description': 'Single dose of a 500 mg aspirin tablet.', 'interventionNames': ['Drug: Aspirin 500 MG']}], 'interventions': [{'name': 'Aspirin 500 MG', 'type': 'DRUG', 'otherNames': ['actelysalicylic acid'], 'description': 'Single 500mg aspirin capsule.', 'armGroupLabels': ['Aspirin 500MG']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Single 500mg placebo capsule.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Psychology Building', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'The dataset and annotation will be made available by 7/1/2023', 'ipdSharing': 'YES', 'description': 'Deidentified data will be made available online for responses to the tasks.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Baldwin Way', 'investigatorAffiliation': 'Ohio State University'}}}}