About this trial
This study evaluates knowledge, feelings and thoughts regarding nicotine products among young adults who are susceptible to but do not use tobacco/nicotine and adults who use tobacco/nicotine.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
combustible tobacco only (cigarettes, cigars, waterpipe)
non-combustible tobacco only (ST, ECs, heated tobacco products)
or both combustible and non-combustible tobacco (i.e., dual susceptibility)
exclusive combustible tobacco users
Disqualifiers
Age < 18 or > 65
Are not susceptible non-users or current tobacco users
Are unwilling or unable to complete and in person lab visit.
Have used ONPs within the past 3 months
Trial design
Parallel
Treatments tested in this trial
3x3 between-subjects experimental exposure
BehavioralParticipants will be randomly assigned to conditions in a 3 (Nicotine Concentration: None on label, Low, High) x 3 (Nicotine Source Claim: None, "Tobacco Free," "Synthetic Nicotine") between-subjects design. We will stratify randomization by young adult susceptible non-users and adult tobacco users for balance across the conditions. Participants will view 16 oral nicotine pouch pack images in random order that correspond to the nicotine concentration and source claim condition they are randomized to. Within each condition, pack images will vary by 4 brands and 4 flavors per brand. While viewing the images, we will collect psychophysiological data including heart rate, galvanic skin response, and eye tracking.
Treatment groups
9
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Visual Attention - Dwell Time
Visual attention will be measured via eye movements using SmartEye AI-X eye tracker with a 60 Hz sampling rate. Areas of interest (AOIs) will be predefined for each pack image including: 1) Full pack image; 2) Nicotine concentration; 3) Nicotine source claim; 4) Branding (i.e., brand name, flavors); 5) Warning label. A primary outcome for visual attention will be dwell time on AOIs.
Visual Attention - Time to First Fixation
Visual attention will be measured via eye movements using SmartEye AI-X eye tracker with a 60 Hz sampling rate. Areas of interest (AOIs) will be predefined for each pack image including: 1) Full pack image; 2) Nicotine concentration; 3) Nicotine source claim; 4) Branding (i.e., brand name, flavors); 5) Warning label. A primary outcome for visual attention will be time to first fixation on AOIs.
Visual Attention - Number of Fixations
Visual attention will be measured via eye movements using SmartEye AI-X eye tracker with a 60 Hz sampling rate. Areas of interest (AOIs) will be predefined for each pack image including: 1) Full pack image; 2) Nicotine concentration; 3) Nicotine source claim; 4) Branding (i.e., brand name, flavors); 5) Warning label. A primary outcome for visual attention will be number of fixations (i.e., saccades) to AOIs.
Cognitive Attention
Conceptualized as the cognitive resources allocated to encode a message into working memory, attention will be operationalized as the difference in heart rate (HR) between a baseline period prior to each pack image and during each second of the pack image exposure assessed with ECG. Beats per minute (BPM) will be collected with the Shimmer3 sampled at 512 Hz. This is an established psychophysiological measure of cognitive resources devoted to stimuli processing.
Other outcomes
ONP Trial (Lapse Task)
This is a valid behavioral measure that was originally developed for smoking cue reactivity research and used in prior work by others and our team. The lapse task will assess ONP trial, time to trial, and ONP product selection.
Sponsors and contacts
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Ohio State University Comprehensive Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator