FDA Cigarette Warning Labels: Eye Tracking Study (FLT)

Abramson Cancer Center at Penn Medicine

Status: Completed

Conditions: Smoking, Cigarette

Treatments: Other: Pictorial Warning Labels

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04936724

UPCC 04021

U54CA229973 (U.S. NIH Grant/Contract)

843703

Details and patient eligibility

About

The purpose of this study is to examine the effect of cigarette pictorial warning label content (lesser-known vs well-known risks) on visual engagement, recall, and knowledge of tobacco use harms.

Full description

This laboratory-based study will aim to enroll 120 current cigarette users to complete a 1-day randomized, parallel design protocol.

The participants will be randomized to one of two conditions, pictorial warning labels (PWLs) with well-known or lesser-known tobacco harms. After completing a baseline questionnaire, the participants will view 4 warning labels from the assigned group and complete a follow-up questionnaire. Eye-tracking will provide data on visual processing of the warning labels and the effect of these labels on knowledge, attitudes, and beliefs about smoking will be supplemented by self-report.

Enrollment: 70 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Current cigarette smokers using only filtered commercially manufactured cigarettes; smoking at least 5 cigarettes daily and smoking for at least last 1 year.
• Participants must physically present a pack of their preferred brand of cigarettes at the lab session to confirm their status as a cigarette smoker.
• Not currently undergoing smoking cessation treatment or planning to quit smoking currently or in the next month.
• Plan to live in the area for the duration of the study.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined Informed Consent and HIPAA form.
• Able to communicate fluently in English (i.e., speaking, writing, and reading) as determined by the research assistant.

Exclusion criteria

• Use of any nicotine-containing products other than cigarettes. Participants reporting isolated use of other nicotine-containing products less than 5 times per month are eligible to participate.
• Not actively trying to quit smoking currently and had not made a quit attempt in the past month.
• Self-report current alcohol consumption that exceeds 25 standard drinks/week.
• Self-report current pregnancy or breastfeeding.
• Any self-reported impairment - visual (colorblindness or impairments such as glass eye), physical, and/or neurological impairments preventing the proper completion of the study procedures.
• Serious or unstable medical condition.
• Lifetime history of schizophrenia, psychosis, and/or bipolar disorder.
• Current use or discontinuation of anti-psychotic medications within the last 6 months.
• Current diagnosis of active major depression. Participants who maintain a diagnosis of major depression who have not experienced any major depressive episodes in the past 6 months and are stable on antidepressant medication(s) are eligible to participate.
• Inability to provide informed consent or complete any of the study tasks as determined by the principal investigator.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Condition A (Lesser-known harms)

Experimental group

Description:

Participants randomized to this condition will view cigarette warning labels highlighting lesser-known harms of tobacco use.

Treatment:

Other: Pictorial Warning Labels

Condition B (Well-known harms)

Experimental group

Description:

Participants randomized to this condition will view cigarette warning labels highlighting the well-known harms of tobacco use.

Treatment:

Other: Pictorial Warning Labels