Clinical trial NCT05396677: The Effects of Acetaminophen on Fear
Official title: Behavioral Consequences of Blunting Fear With Acetaminophen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear
Keywords: acetaminophen
fear
analgesics
virtual reality
emotions
Lead sponsor: University of Guelph
Sponsor class: OTHER
Collaborators: name: Natural Sciences and Engineering Research Council, Canada
First posted: 2022-05-31
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Walking speed on plank in virtual reality
timeFrame: 1 hour after taking acetaminophen or placebo
measure: Distance walked on plank
timeFrame: 1 hour after taking acetaminophen or placebo
measure: Proportion of time spent looking down at the plank
timeFrame: 1 hour after taking acetaminophen or placebo
measure: Decision on whether to do the plank walk again with virtual spiders
timeFrame: 1 hour after taking acetaminophen or placebo
measure: Verbal Self-Report Fear
timeFrame: 1 hour after taking acetaminophen or placebo
measure: Written Self-Report Fear
timeFrame: 1 hour after taking acetaminophen or placebo
measure: Heart rate
timeFrame: 1 hour after taking acetaminophen or placebo
Secondary outcomes:
measure: Time to take first step onto plank
timeFrame: 1 hour after taking acetaminophen or placebo
measure: Speed towards virtual elevator after turning around on plank,
timeFrame: 1 hour after taking acetaminophen or placebo
measure: Time before needing a break or quitting the virtual reality plank walk
timeFrame: 1 hour after taking acetaminophen or placebo
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: University of Guelph
state: Ontario
Study officials:
affiliation: University of Guelph
name: Pat Barclay, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: