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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04146532
Other study ID # 2019H0262
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date October 8, 2019
Est. completion date April 15, 2022

Study information

Verified date May 2024
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to determine whether the drug aspirin has effects on emotional reactivity, emotional memory, and risk-taking behaviors.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 268
Est. completion date April 15, 2022
Est. primary completion date April 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Aspirin 500 MG
Single 500mg aspirin capsule.
Placebo
Single 500mg placebo capsule.

Locations

Country Name City State
United States Psychology Building Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Emotional Reactivity Changes in self-reported evaluations of valence on a 1 to 7 scale and felt reactions to emotional images on a 1-7 scale. 1.5 hours
Primary Memory 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. 1.5 hours
Primary Risk-Taking We will measure the adjusted average number of pumps on the Balloon Analogue Risk Task. 1.5 hours
Secondary Individual Differences Self-reported political ideology will be examined as a moderator of the self-reported ratings of the images as well as memory for them. 1.5 hours
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