Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

450

participants targeted

Target at P75+ for not_applicable

Timeline

28mo left

Started Mar 2024

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.5 years study duration

Study Progress48%

Mar 2024Sep 2028

First Submitted

Initial submission to the registry

December 13, 2023

Completed

23 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed

2 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed

4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2028

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2028

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

4.5 years

First QC Date

December 13, 2023

Last Update Submit

February 3, 2026

Conditions

Behavior, Risk

Keywords

oral nicotine pouchcancer controlcancer prevention

Outcome Measures

Primary Outcomes (9)

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.
1 day (Single Time Point: During Exposure)
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.
1 day (Single Time Point: During Exposure)
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.
1 day (Single Time Point: During Exposure)
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.
1 day (Single Time Point: During Exposure)
Arousal
Arousal is an indicator of physiological activation of the sympathetic nervous system and will be measured by skin conductance using Shimmer3 Galvanic Skin Response EDA sensors sampled at 128 Hz
1 day (Single Time Point: During Exposure)
Recall
We will capture unaided recall, a measure of storage in memory, via 3 open ended questions on a questionnaire pertaining to nicotine concentration, brand names, and source information corresponding to conditions to which participants are randomized. Responses will be coded, and coding reliability will be established, to create a score with higher values reflecting better recall of information about nicotine dimensions in the stimuli.
1 day (Single Time Point: During Exposure)
ONP Perceptions
We will capture perceptions of ONPs with 7 items that align with expert recommendations for assessing cognitive and affective aspects of tobacco risk perceptions. Items will assess perceived risk of health harm from ONPs, perceived risk of addiction from ONPs, worry about harm, and worry about addiction. The items are on a 1-7 response scale, have excellent reliability, and are averaged to create an overall score.
1 day (Single Time Point: During Exposure)
ONP Perceptions Relative to Other Products
We will also capture perceived harm and addictiveness of ONPs relative to cigarettes, smokeless tobacco, and electronic cigarettes using valid items on a 1-5 response scale.
1 day (Single Time Point: During Exposure)
ONP Intentions
We will assess curiosity, interest, and likelihood of using ONPs post-exposure. These are valid predictors of future use of novel tobacco and nicotine products among never users. Items are on a 1-7 scale, have excellent reliability, and are combined to create an overall ONP intentions score.
1 day (Single Time Point: During Exposure)

Other Outcomes (1)

ONP Trial (Lapse Task)
Single Time Point for 25 Minutes