The Effects of Acetaminophen on Fear

NCT05396677 | Completed

• 1 other identifier: 21-07-024
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effects of acetaminophen on behavioral, physiological, and self-report fear responses.

Conditions

Fear

Keywords

acetaminophen; fear; analgesics; virtual reality; emotions

Outcome Measures

Primary Outcomes (7)

• Walking speed on plank in virtual reality

  Farthest distance reached on plank / time to get there

  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.

  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).

  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.

  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.

  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.

  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.

  1 hour after taking acetaminophen or placebo

Secondary Outcomes (3)

• Time to take first step onto plank

  1 hour after taking acetaminophen or placebo

• Speed towards virtual elevator after turning around on plank,

  1 hour after taking acetaminophen or placebo

• Time before needing a break or quitting the virtual reality plank walk

  1 hour after taking acetaminophen or placebo

Study Arms (2)

Acetaminophen Condition

EXPERIMENTAL

1000 mg acetaminophen

Drug: Acetaminophen

Placebo Condition

PLACEBO COMPARATOR

1000 mg microcrystalline cellulose

Other: Placebo

Interventions

Acetaminophen DRUG

2 x 500 mg acetaminophen (one time)

Acetaminophen Condition

Placebo OTHER

2 x 500 mg microcrystalline cellulose (one time)

Placebo Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Guelph: lead
• Natural Sciences and Engineering Research Council, Canada: collaborator

Study Sites (1)

University of Guelph

Guelph, Ontario, N1G 2W1, Canada

Location

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Pat Barclay, Ph.D.

  University of Guelph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind placebo study
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 31, 2022
• Study Start: March 30, 2022
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Upon publication or within two years
• Access Criteria: Open Access

Locations

CA (1)