Aspirin Effects on Emotional Reactions

October 10, 2022 updated by: Baldwin Way, Ohio State University

Effects of Aspirin on Emotional Reactivity, Memory, and Risk-taking

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

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Interventional

Enrollment (Anticipated)

270

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Columbus, Ohio, United States, 43210
        • Psychology Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Single dose of a 500mg placebo tablet.
Single 500mg placebo capsule.
Active Comparator: Aspirin 500MG
Single dose of a 500 mg aspirin tablet.
Single 500mg aspirin capsule.
Other Names:
  • actelysalicylic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotional Reactivity
Time Frame: 1.5 hours
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
Time Frame: 1.5 hours
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
Time Frame: 1.5 hours
We will measure the adjusted average number of pumps on the Balloon Analogue Risk Task.
1.5 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual Differences
Time Frame: 1.5 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2019

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

October 29, 2019

First Posted (Actual)

October 31, 2019

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Deidentified data will be made available online for responses to the tasks.

IPD Sharing Time Frame

The dataset and annotation will be made available by 7/1/2023

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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