Aspirin Effects on Emotional Reactions

The Ohio State University

Status and phase: Completed; Early Phase 1

Conditions: Healthy Adults

Treatments: Drug: Placebo; Drug: Aspirin 500 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04146532

2019H0262

Details and patient eligibility

About

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

Full 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.

Enrollment: 268 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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268 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Single dose of a 500mg placebo tablet.

Treatment:

Drug: Placebo

Aspirin 500MG

Active Comparator group

Description:

Single dose of a 500 mg aspirin tablet.

Treatment:

Drug: Aspirin 500 MG