Recruiting

Nicotine Product

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT06192316

Conditions

Behavior, Risk

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

3x3 between-subjects experimental exposure

Study Details

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.

Conditions

Behavior, Risk

Study ID

NCT06192316

Start date

Mar 1, 2024

Status verified date

Feb, 2026

Completion date

Sep 14, 2028

Anticipated

Primary completion date

Sep 14, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Nicotine Concentration: None Displayed; Nicotine Source Claim 1

Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.

experimental: Nicotine Concentration: None Displayed; Nicotine Source Claim 2

Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.

experimental: Nicotine Concentration: None Displayed; Nicotine Source Claim 3

Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.

experimental: Nicotine Concentration: Low; Nicotine Source Claim 1

Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.

experimental: Nicotine Concentration: Low; Nicotine Source Claim 2

Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.

experimental: Nicotine Concentration: Low; Nicotine Source Claim 3

Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.

experimental: Nicotine Concentration: High; Nicotine Source Claim 1

Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.

experimental: Nicotine Concentration: High; Nicotine Source Claim 2

Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.

experimental: Nicotine Concentration: High; Nicotine Source Claim 3

Participants view randomized images of nicotine-containing product packaging and complete a lapse task test on study. Participants also complete questionnaires on study.

Interventions

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.

Primary outcome measure

  • Visual Attention - Dwell Time [ Time Frame: 1 day (Single Time Point: During Exposure) ]
  • Visual Attention - Time to First Fixation [ Time Frame: 1 day (Single Time Point: During Exposure) ]
  • Visual Attention - Number of Fixations [ Time Frame: 1 day (Single Time Point: During Exposure) ]
  • Cognitive Attention [ Time Frame: 1 day (Single Time Point: During Exposure) ]
  • Arousal [ Time Frame: 1 day (Single Time Point: During Exposure) ]
  • Recall [ Time Frame: 1 day (Single Time Point: During Exposure) ]
  • ONP Perceptions [ Time Frame: 1 day (Single Time Point: During Exposure) ]
  • ONP Perceptions Relative to Other Products [ Time Frame: 1 day (Single Time Point: During Exposure) ]
  • ONP Intentions [ Time Frame: 1 day (Single Time Point: During Exposure) ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Darren Mays, MPH, PhD

614-366-2953

Principal Investigator:

Darren Mays, MPH, PhD

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Keywords

  • oral nicotine pouch
  • cancer control
  • cancer prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-02-05.