Oral Nicotine Product Messaging to Communicate Risk of Use for Young Adults

Message Effects on Perceptions of Oral Nicotine Products

This clinical trial tests the effect of different types of oral nicotine pouch (ONP) messaging to communicate risk of using these products for young adults. Tobacco use remains the leading preventable cause of death due to cancer and other outcomes in the U.S. Tobacco products vary in the health risks they pose to users. Combustible tobacco products such as cigarettes pose higher risks than noncombustible nicotine and tobacco products such as ONPs. Despite the lower harm potential of ONPs for those who use tobacco, there are potential risks to non-users, especially susceptible young adults. Different types of messaging that include information about absolute risk and addiction, risks of ONPs relative to cigarettes and e-cigarettes, ability to use ONPs instead of cigarettes/e-cigarettes (switching), and the potential benefits of doing so and potential benefits of switching to ONPs may be more or less effective in communicating risk for young adults.

Study Overview

• Status: Completed
• Conditions: Tobacco-Related Carcinoma
• Intervention / Treatment: Other: Survey Administration; Behavioral: Behavioral Intervention; Behavioral: Behavioral Intervention; Behavioral: Behavioral Intervention; Behavioral: Behavioral Intervention

Detailed Description

PRIMARY OBJECTIVES:

I. To test the effects of ONP messages on:

Ia. message response (e.g., perceived effectiveness) and Ib. ONP curiosity and intentions.

SECONDARY OBJECTIVE:

I. To test the effects of ONP messages on ONP harms beliefs and perceptions; and motivation to quit cigarettes/e-cigarettes.

OUTLINE: Participants are randomized to 1 of 5 arms.

ARM I: Participants receive messaging regarding absolute risk of ONPs. Participants engage with the content at their discretion.

ARM II: Participants receive messaging regarding self and response efficacy about ability to use ONPs. Participants engage with the content at their discretion.

ARM III: Participants receive messaging regarding relative risk about the risks of ONPs relative to cigarettes and e-cigarettes. Participants engage with the content at their discretion.

ARM IV: Participants receive messaging regarding switching to ONPs. Participants engage with the content at their discretion.

ARM V: Participants do not receive messaging.

• Study Type: Interventional
• Enrollment (Actual): 607
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• United States (U.S.) young adults aged 18 - 30 years
• Current cigarette smokers. Current smokers are those who smoked 100 lifetime cigarettes and now are smoking every day or some days
• Current e-cigarette users. Current e-cigarette users are those who have ever tried an e-cigarette or other electronic vaping product even once and are now using every day or some days

• Susceptible nonusers of cigarettes or e-cigarettes. Susceptible nonusers are those who have never tried cigarettes/e-cigarettes and respond with any response other than "definitely not" to any of the following items:

  • "Have you ever been curious about using cigarettes/e-cigarettes?"
  • "Do you think that you will try a(n) cigarette/e-cigarette soon?"
  • "If one of your best friends were to offer you a(n) cigarette/e-cigarette, would you use it?"
  • "Do you think you will use cigarettes/e-cigarettes in the next year?"

Exclusion Criteria:

• Participants who do not meet age and tobacco-related criteria, unable to complete study procedures online in English, or do not reside in the U.S. will be excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (absolute risk of ONPs); Participants receive messaging regarding absolute risk and addiction beliefs. Participants engage with the content at their discretion.	Other: Survey Administration; Ancillary studies; Behavioral: Behavioral Intervention; Receive messaging regarding addiction beliefs; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioural; Behavioral: Behavioral Intervention; Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioural; Behavioral: Behavioral Intervention; Receive messaging regarding self and response efficacy beliefs about ability to use ONPs instead of cigarettes/e-cigarettes and the potential benefits of doing so; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioural; Behavioral: Behavioral Intervention; Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioural
Experimental: Arm II (efficacy of ONPs); Participants receive messaging regarding self and response efficacy of ONPs. Participants engage with the content at their discretion.	Other: Survey Administration; Ancillary studies; Behavioral: Behavioral Intervention; Receive messaging regarding addiction beliefs; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioural; Behavioral: Behavioral Intervention; Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioural; Behavioral: Behavioral Intervention; Receive messaging regarding self and response efficacy beliefs about ability to use ONPs instead of cigarettes/e-cigarettes and the potential benefits of doing so; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioural; Behavioral: Behavioral Intervention; Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioural
Experimental: Arm III (relative risk of ONPs); Participants receive messaging regarding risk of ONPs relative to cigarettes and e-cigarettes. Participants engage with the content at their discretion.	Other: Survey Administration; Ancillary studies; Behavioral: Behavioral Intervention; Receive messaging regarding addiction beliefs; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioural; Behavioral: Behavioral Intervention; Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioural; Behavioral: Behavioral Intervention; Receive messaging regarding self and response efficacy beliefs about ability to use ONPs instead of cigarettes/e-cigarettes and the potential benefits of doing so; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioural; Behavioral: Behavioral Intervention; Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioural
Experimental: Arm IV (Switching to ONPs); Participants receive messaging regarding switching to ONPs. Participants engage with the content at their discretion.	Other: Survey Administration; Ancillary studies; Behavioral: Behavioral Intervention; Receive messaging regarding addiction beliefs; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioural; Behavioral: Behavioral Intervention; Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioural; Behavioral: Behavioral Intervention; Receive messaging regarding self and response efficacy beliefs about ability to use ONPs instead of cigarettes/e-cigarettes and the potential benefits of doing so; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioural; Behavioral: Behavioral Intervention; Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioural
Active Comparator: Arm V (no messaging); Participants do not receive messaging.	Other: Survey Administration; Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Message Effectiveness	Perceived message effectiveness will be assessed as the mean of three items asking how much the messages made participants concerned about the health effects of ONP use compared to cigarettes/e-cigarettes, made ONP use seem unpleasant compared to cigarettes/e-cigarettes, and discouraged them from wanting to use ONPs compared to cigarettes/e-cigarettes. Responses range from 1 "a great deal" to 5 "not at all," and will be reverse coded and averaged to create a score where higher values indicate greater perceived effectiveness. Higher perceived effectiveness is considered a better outcome.	This assessment is administered immediately after participants view study messages.
Perceived Message Strength	Perceived message strength will be assessed as the mean of seven items assessing responses such as the messages grasped attention, were believable, and interesting. Responses range from 1 "strongly agree" to 7 "strongly disagree," and will be reverse-coded and averaged to create a score where higher values indicate greater perceived strength. Higher perceived strength is considered a better outcome.	This assessment is administered immediately after participants view study messages.
Counterarguing	Counterarguing will be assessed as the mean of three items asking whether participants criticized the messages while viewing them, thought of points that went against what was being said while viewing the messages, and were skeptical of what was being said while viewing the messages. Responses range from 1 "very much" to 7 "not at all" and will be reverse-coded and averaged to create a score where higher values indicate greater counterarguing. Lower counterarguing is considered a better outcome.	This assessment is administered immediately after participants view study messages.
Negative Feelings	Negative feelings will be assessed as the mean of seven items asking whether participants felt frightened, anxious, nervous, worried, irritated, angry, and annoyed. Responses range from 1 "extremely" to 4 "not at all." Responses will be reverse-coded and averaged to create a score where higher values indicate greater negative feelings. Lower negative feelings are considered a better outcome.	This assessment is administered immediately after participants view study messages.
Positive Feelings	Positive feelings will be assessed as the mean of three items asking whether participants felt interested, excited, and happy. Responses range from 1, "extremely," to 4, "not at all." Responses will be reverse-coded and averaged to create a score where higher values indicate greater positive feelings. Higher positive feelings are considered a better outcome.	This assessment is administered immediately after participants view study messages.
Oral Nicotine Pouch Use Curiosity	Oral nicotine pouch use curiosity will be assessed with the item, "Overall, how curious are you about trying nicotine pouches?" Response options range from 1 "not at all curious" to 7 "very curious." Lower curiosity is considered a better outcome.	This assessment is administered immediately after participants view study messages.
Oral Nicotine Pouch use intentions	Oral nicotine pouch use intentions will be assessed with the item "Which of the following best describes your thinking about using nicotine pouches?" Response options range from 1 "I am planning to switch to/try within the next month," to 4 "I am not interested in switching to/trying nicotine pouches." Responses will be reverse-coded, so higher values indicate greater intention to use nicotine pouches. Lower intention to use nicotine pouches is considered a better outcome.	This assessment is administered immediately after participants view study messages.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Harm of Oral Nicotine Pouches	Perceived harm of oral nicotine pouches is measured using valid self-report item assessing perceptions of how likely harms are to occur from oral nicotine pouches (response range 1 no chance to 7 certain to happen). Greater perceived likelihood of harm is considered a better outcome.	This assessment is administered immediately after participants view study messages.
Perceived Addictiveness of Oral Nicotine Pouches	Perceived addictiveness of oral nicotine pouches is measured using valid self-report item assessing perceptions of how likely one is to become addicted to oral nicotine pouches (1 = no chance, 7 = certain to happen). Greater perceived likelihood of addictiveness is considered a better outcome.	This assessment is administered immediately after participants view study messages.
Worry About Harm of Oral Nicotine Pouches	Worry about the harms of oral nicotine pouches is measured using a valid self-report item assessing how much participants worry about the risks of oral nicotine pouches (1 = Not at all, 7 = Very much). Greater worry about harm is considered a better outcome.	This assessment is administered immediately after participants view study messages.
Worry About Addictiveness of Oral Nicotine Pouches	Worry about the addictiveness of oral nicotine pouches is measured using a valid self-report item assessing how much participants worry about becoming addicted to oral nicotine pouches (1 = Not at all, 7 = very much). Greater worry about addictiveness is considered a better outcome.	This assessment is administered immediately after participants view study messages.
Motivation to Quit Smoking	Among cigarette smokers, motivation to quit smoking will be assessed with the item "How motivated are you to quit cigarette smoking right now?" Responses range from 1 (not at all) to 7 (very motivated). Responses will be analyzed so that higher values indicate greater motivation to quit cigarette smoking. Higher motivation to quit is considered a better outcome.	This assessment is administered immediately after participants view study messages.
Motivation to Quit E-Cigarettes	Among e-cigarette users, motivation to quit using e-cigarettes will be assessed with the item "How motivated are you to quit e-cigarette use right now?" Responses range from 1 (not at all) to 7 (very motivated). Responses will be analyzed so that higher values indicate greater motivation to quit cigarette smoking. Higher motivation to quit is considered a better outcome.	This assessment is administered immediately after participants view study messages.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Beliefs for Switching to Oral Nicotine Pouches from Cigarettes	Efficacy beliefs for switching to oral nicotine pouches from smoking are measured using the average of 3 items about the health benefits of switching to oral nicotine pouches or reducing smoking, and how easy and confident to switch to oral nicotine pouches or reduce smoking. Greater efficacy beliefs are considered a better outcome.	This assessment is administered immediately after participants view study messages.
Efficacy Beliefs for Switching to Oral Nicotine Pouches from E-Cigarettes	Efficacy beliefs for switching to oral nicotine pouches from e-cigarettes are measured using the average of 3 items about the health benefits of switching to oral nicotine pouches or reducing vaping, and how easy and confident to switch to oral nicotine pouches or reduce vaping. Greater efficacy beliefs are considered a better outcome.	This assessment is administered immediately after participants view study messages.
Attitudes towards Oral Nicotine Pouches	Attitudes towards oral nicotine pouches are measured using the average of four pairs (Positive-Negative, Good-Bad, Like-Dislike, and Pleasant-Unpleasant) with a 1 to 9 bipolar scale. Responses will be analyzed so higher scores indicate increasingly negative attitudes. Higher negative attitudes are considered a better outcome.	This assessment is administered immediately after participants view study messages.

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Mahmood Alalwan, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Actual): December 29, 2025
• Study Completion (Actual): December 29, 2025

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Psychotherapy; Behavioral Disciplines and Activities; Psychological Tests; Neuropsychological Tests; Behavior Therapy; Memory and Learning Tests
• Other Study ID Numbers: OSU-24396; U54CA287392 (U.S. NIH Grant/Contract); NCI-2026-02089 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); STUDY20250013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No