N/A N=70 Randomized Single-blind Other

FDA Cigarette Warning Labels: Eye Tracking Study

Smoking, Cigarette

Bottom Line

View on ClinicalTrials.gov: NCT04936724 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Apr 2024

Primary outcome: Primary: Attention: Latency (Time Until First Fixation) for Image — 2612; 978 ms

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Pictorial Warning Labels (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Abramson Cancer Center at Penn Medicine
Primary completion: Nov 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Attention: Latency (Time Until First Fixation) for Image	2612; 978	—
PRIMARY Attention: Latency (Time Until First Fixation) for Text	1001; 798	—
PRIMARY Attention: Latency Duration (Time of Fixation) for Image	160; 183	—
PRIMARY Attention: Latency Duration (Time of Fixation) for Text	150; 165	—
PRIMARY Attention: Total Fixation Time for Image	3532; 7887	—
PRIMARY Attention: Total Fixation Time for Text	4889; 3643	—
PRIMARY Recall: Participants Ability to Recall Condition Image	98.6; 95.7	—
PRIMARY Recall: Participants Ability to Recall Condition Text	82.9; 86.5	—
PRIMARY Knowledge of Smoking Harms	1.4; 3.0; 3.3; 3.9; 1.3; 1.3	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04936724). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.