Pain and Acetaminophen in Women Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-15

Study Completion Date

2021-05-02

Brief Summary

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

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Detailed Description

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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

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Overweight Obesity Healthy Adults

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Overweight/Obese+Drug+Stigma

40 participants with overweight or obesity will consume 1,000mg of acetaminophen in a liquid vehicle briefly following the start of the appointment. After one hour, they will read a short vignette meant to induce weight stigma.

Acetaminophen

Intervention Type DRUG

1,000mg liquid acetaminophen

Weight stigma vignette

Intervention Type BEHAVIORAL

Short vignette meant to induce weight stigma by describing one's rejection for a promotion due to their weight

Overweight/Obese+Drug+Control

40 participants with overweight or obesity will consume 1,000mg of acetaminophen in a liquid vehicle briefly following the start of the appointment. After one hour, they will read a short control vignette meant to have no impact on their emotional state.

Acetaminophen

Intervention Type DRUG

1,000mg liquid acetaminophen

Control vignette

Intervention Type BEHAVIORAL

Short vignette meant to have no effect on emotion describing a generic promotion process

Overweight/Obese+Placebo+Stigma

40 participants with overweight or obesity will consume a placebo solution briefly following the start of the appointment. After one hour, they will read a short vignette meant to induce weight stigma.

Placebo

Intervention Type DRUG

Liquid placebo solution

Weight stigma vignette

Intervention Type BEHAVIORAL

Short vignette meant to induce weight stigma by describing one's rejection for a promotion due to their weight

Overweight/Obese+Placebo+Control

40 participants with overweight or obesity will consume a placebo solution briefly following the start of the appointment. After one hour, they will read a short control vignette meant to have no impact on their emotional state.

Placebo

Intervention Type DRUG

Liquid placebo solution

Control vignette

Intervention Type BEHAVIORAL

Short vignette meant to have no effect on emotion describing a generic promotion process

Normal Weight+Placebo+Stigma

40 participants with normal weight will consume a placebo solution briefly following the start of the appointment. After one hour, they will read a short vignette meant to induce weight stigma.

Placebo

Intervention Type DRUG

Liquid placebo solution

Weight stigma vignette

Intervention Type BEHAVIORAL

Short vignette meant to induce weight stigma by describing one's rejection for a promotion due to their weight

Interventions

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Acetaminophen

1,000mg liquid acetaminophen

Intervention Type DRUG

Placebo

Liquid placebo solution

Intervention Type DRUG

Weight stigma vignette

Short vignette meant to induce weight stigma by describing one's rejection for a promotion due to their weight

Intervention Type BEHAVIORAL

Control vignette

Short vignette meant to have no effect on emotion describing a generic promotion process

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* At least 18 years old and biologically female

Exclusion Criteria

* Due to the use of acetaminophen in this study, women who report current pregnancy will be excluded from the study due to potential negative effects on pregnancy.

1. Visual impairment that would impair one's ability to read to the extent that they could not read items on paper or a computer screen.
2. Stopping schooling prior to completing ninth grade.
3. A history of liver disorder and/or alcohol abuse.
4. A current prescription of a drug that contains acetaminophen.
5. Allergy to acetaminophen
6. A score on the Patient Health Questionnaire - 9 depressive symptom scale of 15 or greater.
7. For normal weight participants, a history of overweight or obesity.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes