Clinical trial

Effects of Aspirin on Emotional Reactivity, Memory, and Risk-taking

Name
2019H0262
Description
The aim of this study is to determine whether the drug aspirin has effects on emotional reactivity, emotional memory, and risk-taking behaviors.
Trial arms
Trial start
2019-10-08
Estimated PCD
2022-04-15
Trial end
2022-04-15
Status
Completed
Phase
Early phase I
Treatment
Aspirin 500 MG
Single 500mg aspirin capsule.
Arms:
Aspirin 500MG
Other names:
actelysalicylic acid
Placebo
Single 500mg placebo capsule.
Arms:
Placebo
Size
268
Primary endpoint
Emotional Reactivity
1.5 hours
Memory
1.5 hours
Risk-Taking
1.5 hours
Eligibility criteria
Inclusion Criteria: At least 18 years old and biologically male Exclusion Criteria: Due 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 Participants will also be excluded for the following medical reasons: 1. Having an allergy to aspirin, other salicylates, or any other pain reliever/fever reducer. 2. Having or recovering from a viral infection such as the chicken pox or flu. 3. 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. 4. Having more than three drinks of alcohol in the 8 hours after completion of the study. 5. Having asthma, hay fever, nasal polyps, or chronic respiratory disease. 6. Impaired liver/kidney or impaired cardiovascular circulation (renal vascular disease, congestive heart failure, volume depletion, major surgery, sepsis or major hemorrhagic events) 7. Active or severe liver or kidney disease. 8. An ulcer, history of ulcers or are prone to bleeding. 9. A history of blood clotting defects. 10. Severe anemia. 11. 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) 12. Have had stomach ulcers or bleeding problems. 13. Have stomach problems such as heartburn, upset stomach, or stomach pain that does not go away or reoccurs. 14. Surgery in the last week or will have a surgery in the next week. 15. High blood pressure. 16. Diabetes, gout, or arthritis. 17. Low uric acid or Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', '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.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 268, 'type': 'ACTUAL'}}
Updated at
2024-06-03

1 organization

1 product

1 drug

1 indication

Product
Aspirin
Indication
Healthy Adults