AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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

800-293-5066

OSUCCCClinicaltrials@osumc.edu

United States1 site, 1 recruiting
  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Darren Mays, MPH, PhD, 614-366-2953

    Darren Mays, MPH, PhD

    Recruiting

Other trials in United States

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:

  1. 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 groups in NCT06192316
Study groupRoleWhat they receive
Nicotine Concentration: None Displayed; Nicotine Source Claim 1ExperimentalParticipants 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 2ExperimentalParticipants 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 3ExperimentalParticipants 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 1ExperimentalParticipants 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 2ExperimentalParticipants 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 3ExperimentalParticipants 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 1ExperimentalParticipants 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 2ExperimentalParticipants 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 3ExperimentalParticipants 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.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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.

  1. First posted5 Jan 2024
  2. Study start1 Mar 2024
  3. Primary completion14 Sep 2028 (estimated)
  4. Study completion14 Sep 2028 (estimated)

Resources

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)
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.

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in