NCT04573426

Pain and Acetaminophen in Women Study

Effects of Acetaminophen on Pain Response Among Overweight or Obese Women Exposed to Weight Stigmatization

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the influence of acetaminophen on pain response and inflammation.

Detailed description

The purpose of this study is to evaluate the influence of weight stigma on emotional functioning and biomarkers of inflammation among overweight and obese women; and to determine the degree to which acetaminophen moderates the stigma-related effects. Participants will provide blood spot and saliva samples upon arrival, and then be randomly assigned to consume either 1,000mg of acetaminophen in liquid form, or a placebo solution. Participants then will complete a series of questionnaires assessing a variety of relevant psychological and behavioral constructs. After this participants will be randomly assigned to read one of two shorts stories and answer a series of questions about their reaction to the story. Finally, participants will answer another series of questionnaires and provide a second saliva sample. Participants will first be adult women in the Columbus, Ohio and surrounding areas with body mass indices considered overweight or obese. A smaller cohort of women with normal weight will be recruited at a later time for purposes of comparison.

Conditions

• Overweight
• Obesity
• Healthy Adults

Interventions

Type	Name	Description
DRUG	Acetaminophen	1,000mg liquid acetaminophen
DRUG	Placebo	Liquid placebo solution
BEHAVIORAL	Weight stigma vignette	Short vignette meant to induce weight stigma by describing one's rejection for a promotion due to their weight
BEHAVIORAL	Control vignette	Short vignette meant to have no effect on emotion describing a generic promotion process

Timeline

• Start date: 2019-11-15
• Primary completion: 2021-05-02
• Completion: 2021-05-02
• First posted: 2020-10-05
• Last updated: 2021-09-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study