- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04146532
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
Intervention / Treatment
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:
- 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.
- Surgery in the last week or will have a surgery in the next week.
- High blood pressure.
- Diabetes, gout, or arthritis.
- 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:
|
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.
Sponsor
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
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- 2019H0262
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.
Clinical Trials on Healthy Adults
-
KU LeuvenCompletedHealthy Older Adults | Ill Older AdultsBelgium
-
Samsung Medical CenterTerminatedHealthy Aging | Healthy AdultsKorea, Republic of
-
King Abdulaziz UniversityUniversity College Dublin; Royal College of Surgeons, IrelandRecruitingHealthy Adults | Healthy NutritionSaudi Arabia
-
Shirley Ryan AbilityLabNot yet recruiting
-
National Institute of Allergy and Infectious Diseases...RecruitingHealthy AdultsUnited States
-
Arizona State UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingHealthy AdultsUnited States
-
Marian NeuhouserDuke University; University of Washington; University of Nebraska; United States...Recruiting
-
Mirati Therapeutics Inc.CompletedHealthy AdultsUnited States
-
Ohio State UniversityActive, not recruitingHealthy AdultsUnited States
-
Ohio State UniversityActive, not recruitingHealthy AdultsUnited States
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States