Human Laboratory Study of the Effects of Nicotine Product Claims on Appeal, Perceptions, and Use Behavior

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorOhio State University Comprehensive Cancer Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 3x3 between-subjects experimental exposure

    Behavioral

    Participants 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

450 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Nicotine Concentration: None Displayed; Nicotine Source Claim 1Experimental treatment 1 intervention
Group B: Nicotine Concentration: None Displayed; Nicotine Source Claim 2Experimental treatment 1 intervention
Group C: Nicotine Concentration: None Displayed; Nicotine Source Claim 3Experimental treatment 1 intervention
Group D: Nicotine Concentration: Low; Nicotine Source Claim 1Experimental treatment 1 intervention
Group E: Nicotine Concentration: Low; Nicotine Source Claim 2Experimental treatment 1 intervention
Group F: Nicotine Concentration: Low; Nicotine Source Claim 3Experimental treatment 1 intervention
Group G: Nicotine Concentration: High; Nicotine Source Claim 1Experimental treatment 1 intervention
Group H: Nicotine Concentration: High; Nicotine Source Claim 2Experimental treatment 1 intervention
Group I: Nicotine Concentration: High; Nicotine Source Claim 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 day (Single Time Point: During Exposure)
2

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.

Time frame
1 day (Single Time Point: During Exposure)
3

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.

Time frame
1 day (Single Time Point: During Exposure)
4

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.

Time frame
1 day (Single Time Point: During Exposure)

Secondary outcomes

Other outcomes

1

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.

Time frame
Single Time Point for 25 Minutes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University Comprehensive Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator