Clinical trial NCT04146532: Aspirin Effects on Emotional Reactions
Official title: Effects of Aspirin on Emotional Reactivity, Memory, and Risk-taking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy Adults
Keywords: Aspirin
Acetylsalicylic acid
Emotional reactivity
Memory
Risk-taking
Inflammation
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 268
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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

Detailed 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.

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.

Primary outcomes:
measure: Emotional Reactivity
timeFrame: 1.5 hours
measure: Memory
timeFrame: 1.5 hours
measure: Risk-Taking
timeFrame: 1.5 hours
Secondary outcomes:
measure: Individual Differences
timeFrame: 1.5 hours
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Psychology Building
state: Ohio
Study officials:
References: