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Aspirin Effects on Emotional Reactions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04146532
Recruitment Status : Suspended (The study was suspended due to COVID-19 cessation of research activities in March of 2020)
First Posted : October 31, 2019
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Baldwin Way, Ohio State University

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.

Condition or disease Intervention/treatment Phase
Healthy Adults Drug: Aspirin 500 MG Drug: Placebo Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Official Title: Effects of Aspirin on Emotional Reactivity, Memory, and Risk-taking
Actual Study Start Date : October 8, 2019
Estimated Primary Completion Date : October 8, 2021
Estimated Study Completion Date : October 8, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
Drug Information available for: Aspirin

Arm Intervention/treatment
Placebo Comparator: Placebo
Single dose of a 500mg placebo tablet.
Drug: Placebo
Single 500mg placebo capsule.

Active Comparator: Aspirin 500MG
Single dose of a 500 mg aspirin tablet.
Drug: Aspirin 500 MG
Single 500mg aspirin capsule.
Other Name: actelysalicylic acid




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Risk-Taking [ Time Frame: 1.5 hours ]
    We will measure the adjusted average number of pumps on the Balloon Analogue Risk Task.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Must be biologically male to participate in study.
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04146532


Locations
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United States, Ohio
Psychology Building
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
  Study Documents (Full-Text)

Documents provided by Baldwin Way, Ohio State University:
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Responsible Party: Baldwin Way, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT04146532    
Other Study ID Numbers: 2019H0262
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified data will be made available online for responses to the tasks.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: The dataset and annotation will be made available by 7/1/2023

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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
Keywords provided by Baldwin Way, Ohio State University:
Aspirin
Acetylsalicylic acid
Emotional reactivity
Memory
Risk-taking
Inflammation
Additional relevant MeSH terms:
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Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics