Pain and Acetaminophen in Women Study (PAWS)

The Ohio State University

Status: Completed

Conditions: Overweight; Healthy Adults; Obesity

Treatments: Behavioral: Weight stigma vignette; Drug: Acetaminophen; Drug: Placebo; Behavioral: Control vignette

Study type: Observational

Funder types: Other

Identifiers

NCT04573426

2019H0381

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

The following are additional exclusion criteria:

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.

Trial design

200 participants in 5 patient groups

Overweight/Obese+Drug+Stigma

Description:

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.

Treatment:

Drug: Acetaminophen

Behavioral: Weight stigma vignette

Overweight/Obese+Drug+Control

Description:

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.

Treatment:

Drug: Acetaminophen

Behavioral: Control vignette

Overweight/Obese+Placebo+Stigma

Description:

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.

Treatment:

Behavioral: Weight stigma vignette

Drug: Placebo

Overweight/Obese+Placebo+Control

Description:

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.

Treatment:

Drug: Placebo

Behavioral: Control vignette

Normal Weight+Placebo+Stigma

Description:

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.

Treatment:

Behavioral: Weight stigma vignette

Drug: Placebo