Aspirin Effects on Emotional Reactions

NCT04146532 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 2019H0262
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adults

Keywords

Aspirin; Acetylsalicylic acid; Emotional reactivity; Memory; Risk-taking; Inflammation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Risk-Taking

  We will measure the adjusted average number of pumps on the Balloon Analogue Risk Task.

  1.5 hours

Secondary Outcomes (1)

• Individual Differences

  1.5 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Single dose of a 500mg placebo tablet.

Drug: Placebo

Aspirin 500MG

ACTIVE COMPARATOR

Single dose of a 500 mg aspirin tablet.

Drug: Aspirin 500 MG

Interventions

Aspirin 500 MG DRUG

Single 500mg aspirin capsule.

Also known as: actelysalicylic acid

Aspirin 500MG

Placebo DRUG

Single 500mg placebo capsule.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Must be biologically male to participate in study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old and biologically male

You may not qualify if:

• 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:
• Having an allergy to aspirin, other salicylates, or any other pain reliever/fever reducer.
• Having or recovering from a viral infection such as the chicken pox or flu.
• 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.
• Having more than three drinks of alcohol in the 8 hours after completion of the study.
• Having asthma, hay fever, nasal polyps, or chronic respiratory disease.
• Impaired liver/kidney or impaired cardiovascular circulation (renal vascular disease, congestive heart failure, volume depletion, major surgery, sepsis or major hemorrhagic events)
• Active or severe liver or kidney disease.
• An ulcer, history of ulcers or are prone to bleeding.
• A history of blood clotting defects.
• Severe anemia.
• 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)
• Have had stomach ulcers or bleeding problems.
• Have stomach problems such as heartburn, upset stomach, or stomach pain that does not go away or reoccurs.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Psychology Building

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Risk-Taking; Inflammation

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 31, 2019
• Study Start: October 8, 2019
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The dataset and annotation will be made available by 7/1/2023

Locations

US (1)