FearNCT05396677
The Effects of Acetaminophen on Fear
A study testing Acetaminophen in people with Fear, run by University of Guelph at 1 site in Canada.
Trial summary
This study investigates the effects of acetaminophen on behavioral, physiological, and self-report fear responses. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fear
- What is being tested?
- Acetaminophen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 1 siteCanada
- Study dates
- 30 Mar 2022to 12 Jun 2023
- Phase
- Interventional
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Literate
- Speaks English
- Does not have any risk factors associated with acetaminophen (history of liver or kidney disease, taking other products with acetaminophen, has any allergies to acetaminophen, taking blood-thinning medications, drinks more than 12 alcoholic drinks per week for females, or more than 15 alcoholic drinks per week for males, are/ could be pregnant)
- Has taken acetaminophen in the past without any adverse reactions
- Is not diabetic
Show all 9Show fewer
- Did not have anything to eat within three hours of study time
- Did not have any acetaminophen or alcohol in the 48 hours prior to study
- Has never had an adverse reaction to virtual reality before, such as headaches or nausea
Who cannot join
- Younger than 18
- Non-literate
- Does not speak English
- Has at least one risk factor associated with acetaminophen (history of liver or kidney disease, taking other products with acetaminophen, has any allergies to acetaminophen, taking blood-thinning medications, drinks more than 12 alcoholic drinks per week for females, or more than 15 alcoholic drinks per week for males, are/ could be pregnant)
- Has never taken acetaminophen before
- Diabetic
Show all 9Show fewer
- Had something to eat within three hours of scheduled study time
- Has had acetaminophen or alcohol in the past 48 hours
- Has had an adverse reaction to virtual reality in the past, such as headaches or nausea
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavioral Consequences of Blunting Fear With Acetaminophen
This study investigates the effects of acetaminophen on behavioral, physiological, and self-report fear responses.
Read the detailed description
As acetaminophen blunts the experience of physical, social, and empathic pain, it is important to investigate whether there are other aversive states that the drug also provides relief from. If there are others, this may suggest overlapping mechanisms involved in these affective evaluations, all of which are interrupted by acetaminophen. The emotion of fear is aversive, yet it is distinct from both physical and social pain.
The present study will investigate the effects of acetaminophen on the subjective experience of fear as well as its behavioral outcomes. While blocking adaptive behavioral responses to fear could potentially be problematic in some dangerous situations, it may also be helpful for those with anxiety-related disorders. If individuals on acetaminophen can step farther away from safety on a virtual plank 80 stories above the ground, then perhaps acetaminophen can allow anxious individuals to step farther from their comfort zone in real life. Importantly, if acetaminophen blunts the fear response, this would mean that the drug blocks aversive feelings beyond emotional and physical pain. The extent of its effects will warrant further investigation for a greater understanding of emotional evaluations.
- Conditions
- Fear
- Being tested
- Acetaminophen, Placebo
- Keywords
- acetaminophen, fear, analgesics, virtual reality, emotions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
2 x 500 mg acetaminophen (one time)
PlaceboOther
2 x 500 mg microcrystalline cellulose (one time)
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen Condition | Experimental | 1000 mg acetaminophen Receives: Drug: Acetaminophen |
| Placebo Condition | Placebo comparator | 1000 mg microcrystalline cellulose Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed on plank in virtual reality
Farthest distance reached on plank / time to get there
Measured: 1 hour after taking acetaminophen or placebo
Distance walked on plank
(Unless there are ceiling effects in which >90% of people make it to the end.) Measured in cm walked on a 2 m wooden plank before deciding to turn around and walk back.
Measured: 1 hour after taking acetaminophen or placebo
Proportion of time spent looking down at the plank
We will record what participants see in virtual reality while doing the plank walk, and then code the footage to calculate the proportion of time on the plank participants spent looking down at the plank (indicating more anxiety about falling off).
Measured: 1 hour after taking acetaminophen or placebo
Decision on whether to do the plank walk again with virtual spiders
After doing the plank walk, participants will be offered an optional second chance to try the same plank walk again but this time with virtual giant spiders around them.
Measured: 1 hour after taking acetaminophen or placebo
Verbal Self-Report Fear
While participants are in virtual reality, we will ask them to rate their fear verbally twice, once when they first step onto the plank, and once when they have changed direction (during which the plank tends to shake). They will answer from 0 (no fear or anxiety) to 10 (extreme fear or anxiety). For those who decide to do the plank walk again with virtual giant spiders, they will also rate their self-reported fear in the same manner twice, once when the spiders first appear, and once when they are on their way back to the virtual elevator while surrounded by giant spiders.
Measured: 1 hour after taking acetaminophen or placebo
Written Self-Report Fear
After taking off the headset, participants will answer two survey questions. The first is, "How scary do you think most people would agree the act of walking on a virtual plank is?" They will answer on an 11-point scale (0 = Not at all scary, 5 = Moderately scary, 10 = Extremely scary). They will also be asked "How fearful, scared, nervous, or anxious did you personally feel when walking on the virtual plank?" (0 = Not at all fearful or anxious, 5 = Moderately fearful or anxious, 10 = Extremely fearful or anxious). Those who choose to do the second optional plank walk with virtual spiders will answer the same questions about that experience afterwards.
Measured: 1 hour after taking acetaminophen or placebo
Heart rate
Average heart rate while on the plank walk, measured with a Polar Verity Sense optical heart rate sensor on forearm.
Measured: 1 hour after taking acetaminophen or placebo
Secondary outcomes (3)
Time to take first step onto plank
Number of seconds it takes participants to leave the virtual elevator for the plank overlooking a virtual 80-story drop.
Measured: 1 hour after taking acetaminophen or placebo
Speed towards virtual elevator after turning around on plank,
Amount of time it takes them to make it back to the starting point after turning around on the plank. It is not clear whether someone who walks faster would be doing so to get back to the feeling safety quicker or because they are less cautious due to less fear, and so this is a secondary measure.
Measured: 1 hour after taking acetaminophen or placebo
Time before needing a break or quitting the virtual reality plank walk
(Unless there are ceiling effects in which >90% of participants do not quit early or need a break). Amount of time before a participant takes their headset off early, to quit or for a break, due to being overwhelmed.
Measured: 1 hour after taking acetaminophen or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start30 Mar 2022
- Primary completion12 Jun 2023
- Study completion12 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FearStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Responsible party
- Principal investigator, Patrick Barclay, University of Guelph
- Investigators
- Pat Barclay, Ph.D., Principal investigator, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396677
- Sponsor's protocol ID
- 21-07-024
- Status last verified
- Sep 2024
- First submitted
- 11 May 2022
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Open Science Framework
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Consequences of Blunting Fear With Acetaminophen
- ClinicalTrials.gov ID
- NCT05396677
- Acronym / sponsor ID
- 21-07-024
- Conditions
- Fear
- Keywords
- acetaminophen, fear, analgesics, virtual reality, emotions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 31 May 2022 (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.
This study investigates the effects of acetaminophen on behavioral, physiological, and self-report fear responses.
Detailed description
As acetaminophen blunts the experience of physical, social, and empathic pain, it is important to investigate whether there are other aversive states that the drug also provides relief from. If there are others, this may suggest overlapping mechanisms involved in these affective evaluations, all of which are interrupted by acetaminophen. The emotion of fear is aversive, yet it is distinct from both physical and social pain.
The present study will investigate the effects of acetaminophen on the subjective experience of fear as well as its behavioral outcomes. While blocking adaptive behavioral responses to fear could potentially be problematic in some dangerous situations, it may also be helpful for those with anxiety-related disorders. If individuals on acetaminophen can step farther away from safety on a virtual plank 80 stories above the ground, then perhaps acetaminophen can allow anxious individuals to step farther from their comfort zone in real life. Importantly, if acetaminophen blunts the fear response, this would mean that the drug blocks aversive feelings beyond emotional and physical pain. The extent of its effects will warrant further investigation for a greater understanding of emotional evaluations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen Condition | Experimental | Drug: Acetaminophen1000 mg acetaminophen |
| Placebo Condition | Placebo comparator | Other: Placebo1000 mg microcrystalline cellulose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years or older
- Literate
- Speaks English
- Does not have any risk factors associated with acetaminophen (history of liver or kidney disease, taking other products with acetaminophen, has any allergies to acetaminophen, taking blood-thinning medications, drinks more than 12 alcoholic drinks per week for females, or more than 15 alcoholic drinks per week for males, are/ could be pregnant)
- Has taken acetaminophen in the past without any adverse reactions
Key exclusion criteria (9 listed)
- Younger than 18
- Non-literate
- Does not speak English
- Has at least one risk factor associated with acetaminophen (history of liver or kidney disease, taking other products with acetaminophen, has any allergies to acetaminophen, taking blood-thinning medications, drinks more than 12 alcoholic drinks per week for females, or more than 15 alcoholic drinks per week for males, are/ could be pregnant)
- Has never taken acetaminophen before
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 |
|---|---|---|
| Acetaminophen2 x 500 mg acetaminophen (one time) | Drug | Acetaminophen Condition |
| Placebo2 x 500 mg microcrystalline cellulose (one time) | Other | Placebo Condition |
Primary outcome
Walking speed on plank in virtual reality
Time frame: 1 hour after taking acetaminophen or placebo
Farthest distance reached on plank / time to get there
Distance walked on plank
Time frame: 1 hour after taking acetaminophen or placebo
(Unless there are ceiling effects in which >90% of people make it to the end.) Measured in cm walked on a 2 m wooden plank before deciding to turn around and walk back.
Proportion of time spent looking down at the plank
Time frame: 1 hour after taking acetaminophen or placebo
We will record what participants see in virtual reality while doing the plank walk, and then code the footage to calculate the proportion of time on the plank participants spent looking down at the plank (indicating more anxiety about falling off).
Decision on whether to do the plank walk again with virtual spiders
Time frame: 1 hour after taking acetaminophen or placebo
After doing the plank walk, participants will be offered an optional second chance to try the same plank walk again but this time with virtual giant spiders around them.
Verbal Self-Report Fear
Time frame: 1 hour after taking acetaminophen or placebo
While participants are in virtual reality, we will ask them to rate their fear verbally twice, once when they first step onto the plank, and once when they have changed direction (during which the plank tends to shake). They will answer from 0 (no fear or anxiety) to 10 (extreme fear or anxiety). For those who decide to do the plank walk again with virtual giant spiders, they will also rate their self-reported fear in the same manner twice, once when the spiders first appear, and once when they are on their way back to the virtual elevator while surrounded by giant spiders.
Written Self-Report Fear
Time frame: 1 hour after taking acetaminophen or placebo
After taking off the headset, participants will answer two survey questions. The first is, "How scary do you think most people would agree the act of walking on a virtual plank is?" They will answer on an 11-point scale (0 = Not at all scary, 5 = Moderately scary, 10 = Extremely scary). They will also be asked "How fearful, scared, nervous, or anxious did you personally feel when walking on the virtual plank?" (0 = Not at all fearful or anxious, 5 = Moderately fearful or anxious, 10 = Extremely fearful or anxious). Those who choose to do the second optional plank walk with virtual spiders will answer the same questions about that experience afterwards.
Heart rate
Time frame: 1 hour after taking acetaminophen or placebo
Average heart rate while on the plank walk, measured with a Polar Verity Sense optical heart rate sensor on forearm.
3 secondary outcomes
Time to take first step onto plank
Time frame: 1 hour after taking acetaminophen or placebo
Speed towards virtual elevator after turning around on plank,
Time frame: 1 hour after taking acetaminophen or placebo
Time before needing a break or quitting the virtual reality plank walk
Time frame: 1 hour after taking acetaminophen or placebo
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 23 Sep 2024.
- Individual participant dataSharing planned: Yes. Open Science Framework
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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.
Pat Barclay, Ph.D. principal investigator
University of Guelph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetaminophen in people with Fear, run by University of Guelph at 1 site in Canada.
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 9 inclusion and 9 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 23 Sep 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 Canada. 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.
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?
Walking speed on plank in virtual reality (time frame: 1 hour after taking acetaminophen or placebo). The study lists 7 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 23 Sep 2024.