Healthy AdultsEarly Phase 1NCT04146532
Aspirin Effects on Emotional Reactions
A Early Phase 1 study testing Aspirin 500 MG in people with Healthy Adults, run by Ohio State University at 1 site in United States.
Trial summary
The aim of this study is to determine whether the drug aspirin has effects on emotional reactivity, emotional memory, and risk-taking behaviors. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Aspirin 500 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 268 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2019to 15 Apr 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old and biologically male
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Adults
- Being tested
- Aspirin 500 MG, Placebo
- Keywords
- Aspirin, Acetylsalicylic acid, Emotional reactivity, Memory, Risk-taking, Inflammation
- Medical subject headings
- Risk-Taking, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 500 MGDrug
Also called actelysalicylic acid
Single 500mg aspirin capsule.
PlaceboDrug
Single 500mg placebo capsule.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Single dose of a 500mg placebo tablet. Receives: Drug: Placebo |
| Aspirin 500MG | Active comparator | Single dose of a 500 mg aspirin tablet. Receives: Drug: Aspirin 500 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1.5 hours
Risk-Taking
We will measure the adjusted average number of pumps on the Balloon Analogue Risk Task.
Measured: 1.5 hours
Secondary outcomes (1)
Individual Differences
Self-reported political ideology will be examined as a moderator of the self-reported ratings of the images as well as memory for them.
Measured: 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start8 Oct 2019
- Primary completion15 Apr 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baldwin Way, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146532
- Sponsor's protocol ID
- 2019H0262
- Status last verified
- May 2024
- First submitted
- 28 Oct 2019
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be made available online for responses to the tasks.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aspirin on Emotional Reactivity, Memory, and Risk-taking
- ClinicalTrials.gov ID
- NCT04146532
- Acronym / sponsor ID
- 2019H0262
- Conditions
- Healthy Adults
- Keywords
- Aspirin, Acetylsalicylic acid, Emotional reactivity, Memory, Risk-taking, Inflammation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSingle dose of a 500mg placebo tablet. |
| Aspirin 500MG | Active comparator | Drug: Aspirin 500 MGSingle dose of a 500 mg aspirin tablet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- At least 18 years old and biologically male
Key exclusion criteria (19 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 500 MGAlso: actelysalicylic acidSingle 500mg aspirin capsule. | Drug | Aspirin 500MG |
| PlaceboSingle 500mg placebo capsule. | Drug | Placebo |
Primary outcome
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.
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.
Risk-Taking
Time frame: 1.5 hours
We will measure the adjusted average number of pumps on the Balloon Analogue Risk Task.
1 secondary outcome
Individual Differences
Time frame: 1.5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: Yes. Deidentified data will be made available online for responses to the tasks.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Aspirin 500 MG in people with Healthy Adults, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional Reactivity (time frame: 1.5 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.