Aspirin Effects on Emotional Reactions

NCT ID: NCT04146532

Last Updated: 2024-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-08

Study Completion Date

2022-04-15

Brief Summary

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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

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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.

Conditions

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Healthy Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Placebo

Single dose of a 500mg placebo tablet.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single 500mg placebo capsule.

Aspirin 500MG

Single dose of a 500 mg aspirin tablet.

Group Type ACTIVE_COMPARATOR

Aspirin 500 MG

Intervention Type DRUG

Single 500mg aspirin capsule.

Interventions

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Aspirin 500 MG

Single 500mg aspirin capsule.

Intervention Type DRUG

Placebo

Single 500mg placebo capsule.

Intervention Type DRUG

Other Intervention Names

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actelysalicylic acid

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Baldwin Way

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Psychology Building

Columbus, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2019H0262

Identifier Type: -

Identifier Source: org_study_id

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