Behavior, RiskNCT06192316
Human Laboratory Study of the Effects of Nicotine Product Claims on Appeal, Perceptions, and Use Behavior
A study testing 3x3 between-subjects experimental exposure in people with Behavior, Risk, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior, Risk
- What is being tested?
- 3x3 between-subjects experimental exposure
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 14 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Young adult susceptible non-users aged 18-24 who have never used ONPs and have never used but are susceptible to using either:
- 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)
- 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:
- exclusive combustible tobacco users
Show all 10Show fewer
- exclusive non-combustible tobacco users
- dual users
- For adult tobacco users, we will define current use as use of combustible and/or non-combustible tobacco every day or some days for 6 months or longer
- Willing and able to complete an in-person lab visit.
Who cannot join
- 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
- Have used ONPs more than 10 times in their lifetime
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Darren Mays, MPH, PhD, 614-366-2953
Darren Mays, MPH, PhD
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Behavior, Risk
- Being tested
- 3x3 between-subjects experimental exposure
- Keywords
- oral nicotine pouch, cancer control, cancer prevention
- Medical subject headings
- Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3x3 between-subjects experimental exposureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Concentration: None Displayed; Nicotine Source Claim 1 | Experimental | Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study. Receives: Behavioral: 3x3 between-subjects experimental exposure |
| Nicotine Concentration: None Displayed; Nicotine Source Claim 2 | Experimental | Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study. Receives: Behavioral: 3x3 between-subjects experimental exposure |
| Nicotine Concentration: None Displayed; Nicotine Source Claim 3 | Experimental | Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study. Receives: Behavioral: 3x3 between-subjects experimental exposure |
| Nicotine Concentration: Low; Nicotine Source Claim 1 | Experimental | Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study. Receives: Behavioral: 3x3 between-subjects experimental exposure |
| Nicotine Concentration: Low; Nicotine Source Claim 2 | Experimental | Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study. Receives: Behavioral: 3x3 between-subjects experimental exposure |
| Nicotine Concentration: Low; Nicotine Source Claim 3 | Experimental | Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study. Receives: Behavioral: 3x3 between-subjects experimental exposure |
| Nicotine Concentration: High; Nicotine Source Claim 1 | Experimental | Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study. Receives: Behavioral: 3x3 between-subjects experimental exposure |
| Nicotine Concentration: High; Nicotine Source Claim 2 | Experimental | Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study. Receives: Behavioral: 3x3 between-subjects experimental exposure |
| Nicotine Concentration: High; Nicotine Source Claim 3 | Experimental | Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study. Receives: Behavioral: 3x3 between-subjects experimental exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 day (Single Time Point: During Exposure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Mar 2024
- Primary completion14 Sep 2028 (estimated)
- Study completion14 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, RiskStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Darren Mays, Ohio State University Comprehensive Cancer Center
- Investigators
- Darren Mays, MPH, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192316
- Sponsor's protocol ID
- OSU-23115
- Other IDs
- NCI-2023-08947, U54CA287392
- Status last verified
- Feb 2026
- First submitted
- 13 Dec 2023
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Laboratory Study of the Effects of Nicotine Product Claims on Appeal, Perceptions, and Use Behavior
- ClinicalTrials.gov ID
- NCT06192316
- Acronym / sponsor ID
- OSU-23115
- Conditions
- Behavior, Risk
- Keywords
- oral nicotine pouch, cancer control, cancer prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 14 Sep 2028 (estimated)
- Study completion
- 14 Sep 2028 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Nicotine Concentration: None Displayed; Nicotine Source Claim 1 | Experimental | Behavioral: 3x3 between-subjects experimental exposureParticipants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study. |
| Nicotine Concentration: None Displayed; Nicotine Source Claim 2 | Experimental | Behavioral: 3x3 between-subjects experimental exposureParticipants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study. |
| Nicotine Concentration: None Displayed; Nicotine Source Claim 3 | Experimental | Behavioral: 3x3 between-subjects experimental exposureParticipants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study. |
| Nicotine Concentration: Low; Nicotine Source Claim 1 | Experimental | Behavioral: 3x3 between-subjects experimental exposureParticipants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study. |
| Nicotine Concentration: Low; Nicotine Source Claim 2 | Experimental | Behavioral: 3x3 between-subjects experimental exposureParticipants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study. |
| Nicotine Concentration: Low; Nicotine Source Claim 3 | Experimental | Behavioral: 3x3 between-subjects experimental exposureParticipants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study. |
| Nicotine Concentration: High; Nicotine Source Claim 1 | Experimental | Behavioral: 3x3 between-subjects experimental exposureParticipants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study. |
| Nicotine Concentration: High; Nicotine Source Claim 2 | Experimental | Behavioral: 3x3 between-subjects experimental exposureParticipants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study. |
| Nicotine Concentration: High; Nicotine Source Claim 3 | Experimental | Behavioral: 3x3 between-subjects experimental exposureParticipants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Willing and able to complete an in-person lab visit.
Key exclusion criteria (5 listed)
- 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
- Have used ONPs more than 10 times in their lifetime
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3x3 between-subjects experimental exposureParticipants 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. | Behavioural | Nicotine Concentration: High; Nicotine Source Claim 1, Nicotine Concentration: High; Nicotine Source Claim 2, Nicotine Concentration: High; Nicotine Source Claim 3, Nicotine Concentration: Low; Nicotine Source Claim 1, Nicotine Concentration: Low; Nicotine Source Claim 2, Nicotine Concentration: Low; Nicotine Source Claim 3, Nicotine Concentration: None Displayed; Nicotine Source Claim 1, Nicotine Concentration: None Displayed; Nicotine Source Claim 2, Nicotine Concentration: None Displayed; Nicotine Source Claim 3 |
Primary outcome
Visual Attention - Dwell Time
Time frame: 1 day (Single Time Point: During Exposure)
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
Time frame: 1 day (Single Time Point: During Exposure)
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
Time frame: 1 day (Single Time Point: During Exposure)
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
Time frame: 1 day (Single Time Point: During Exposure)
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.
Arousal
Time frame: 1 day (Single Time Point: During Exposure)
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
Recall
Time frame: 1 day (Single Time Point: During Exposure)
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.
ONP Perceptions
Time frame: 1 day (Single Time Point: During Exposure)
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.
ONP Perceptions Relative to Other Products
Time frame: 1 day (Single Time Point: During Exposure)
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.
ONP Intentions
Time frame: 1 day (Single Time Point: During Exposure)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Ohio State University Comprehensive Cancer Center contact
Darren Mays, MPH, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3x3 between-subjects experimental exposure in people with Behavior, Risk, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Attention - Dwell Time (time frame: 1 day (Single Time Point: During Exposure)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.