FDA Cigarette Warning Labels: Eye Tracking Study

NCT ID: NCT04936724

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-22
• Study Completion Date: 2021-11-19

Brief Summary

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.

Detailed 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.

Conditions

Smoking, Cigarette

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Condition A (Lesser-known harms)

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

Group Type: EXPERIMENTAL

Pictorial Warning Labels

Intervention Type: OTHER

Participants will be randomized to one of two conditions and will view 4 pictorial warning labels from the assigned group for an eye-tracking task.

Condition B (Well-known harms)

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

Group Type: EXPERIMENTAL

Pictorial Warning Labels

Intervention Type: OTHER

Participants will be randomized to one of two conditions and will view 4 pictorial warning labels from the assigned group for an eye-tracking task.

Interventions

Pictorial Warning Labels

Participants will be randomized to one of two conditions and will view 4 pictorial warning labels from the assigned group for an eye-tracking task.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Andrew Strasser

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Strasser, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U54CA229973

Identifier Type: NIH

Identifier Source: secondary_id

View Link

843703

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 04021

Identifier Type: -

Identifier Source: org_study_id