An interventional study of 3x3 between-subjects experimental exposure in Behavior, Risk, sponsored by Ohio State University Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Prevention
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.
PRIMARY OBJECTIVES:
I. Examine the effects of nicotine concentration and source claims on engagement with ONP packaging using laboratory-based psychophysiological assessment.
II. Examine the effects of nicotine concentration and source claims on participant self-reported ONP perceptions, behavioral intentions, and ONP trial.
This is an experimental behavioral study. Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
136 studies on the registry are indexed under Risk-Taking; 18 are open to participants now.
This study's planned enrollment of 450 is above the median of 255 across 117 interventional studies indexed under Risk-Taking.
Browse Risk-Taking studies →Ohio State University Comprehensive Cancer Center is the lead sponsor of 377 studies on the registry; 84 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Young adult susceptible non-users aged 18-24 who have never used ONPs and have never used but are susceptible to using either:
Adult tobacco users aged 18-65 who have never used ONPs OR have used ONPs >3 months ago and 10 times or less in their lifetime. All adult tobacco users must also be:
dual users
Exclusion Criteria:
Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
Behavioral: 3x3 between-subjects experimental exposure
Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
Behavioral: 3x3 between-subjects experimental exposure
Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
Behavioral: 3x3 between-subjects experimental exposure
Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
Behavioral: 3x3 between-subjects experimental exposure
Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
Behavioral: 3x3 between-subjects experimental exposure
Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
Behavioral: 3x3 between-subjects experimental exposure
Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
Behavioral: 3x3 between-subjects experimental exposure
Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
Behavioral: 3x3 between-subjects experimental exposure
Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.
Behavioral: 3x3 between-subjects experimental exposure
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.
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)
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)
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)
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)
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 day (Single Time Point: During Exposure)
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
Plan to share: No — We will consider requests to share de-identified individual participant data by request and according to the investigator's study protocol and institutional data sharing policy.
Started Mar 2024 (actual). Primary completion is estimated for Sep 2028, 54 months after the start.
Of 65 non-industry interventional studies with no phase under Risk-Taking, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 48. This study's planned 54 months is above that.
Counting every sponsor, half of 68 studies reached it within 28 months; a quarter within 7 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
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