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

NCT07702435 | Completed

• 4 other identifiers: OSU-24396NCI-2026-02089STUDY20250013U54CA287392
• Study Type: interventional
• Target: 607
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tobacco-Related Carcinoma

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (6)

• Perceived Harm of Oral Nicotine Pouches

  This assessment is administered immediately after participants view study messages.

• Perceived Addictiveness of Oral Nicotine Pouches

  This assessment is administered immediately after participants view study messages.

• Worry About Harm of Oral Nicotine Pouches

  This assessment is administered immediately after participants view study messages.

• Worry About Addictiveness of Oral Nicotine Pouches

  This assessment is administered immediately after participants view study messages.

• Motivation to Quit Smoking

  This assessment is administered immediately after participants view study messages.

Other Outcomes (3)

• Efficacy Beliefs for Switching to Oral Nicotine Pouches from Cigarettes

  This assessment is administered immediately after participants view study messages.

• Efficacy Beliefs for Switching to Oral Nicotine Pouches from E-Cigarettes

  This assessment is administered immediately after participants view study messages.

• Attitudes towards Oral Nicotine Pouches

  This assessment is administered immediately after participants view study messages.

Study Arms (5)

Arm I (absolute risk of ONPs)

EXPERIMENTAL

Participants receive messaging regarding absolute risk and addiction beliefs. Participants engage with the content at their discretion.

Behavioral: Behavioral Intervention; Other: Survey Administration

Arm II (efficacy of ONPs)

EXPERIMENTAL

Participants receive messaging regarding self and response efficacy of ONPs. Participants engage with the content at their discretion.

Behavioral: Behavioral Intervention; Other: Survey Administration

Arm III (relative risk of ONPs)

EXPERIMENTAL

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

Behavioral: Behavioral Intervention; Other: Survey Administration

Arm IV (Switching to ONPs)

EXPERIMENTAL

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

Behavioral: Behavioral Intervention; Other: Survey Administration

Arm V (no messaging)

ACTIVE COMPARATOR

Participants do not receive messaging.

Other: Survey Administration

Interventions

Behavioral Intervention BEHAVIORAL

Receive messaging regarding addiction beliefs

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments, Behavioural

Arm I (absolute risk of ONPs)

Survey Administration OTHER

Ancillary studies

Arm I (absolute risk of ONPs); Arm II (efficacy of ONPs); Arm III (relative risk of ONPs); Arm IV (Switching to ONPs); Arm V (no messaging)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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?"

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Interventions

Behavior Therapy; Memory and Learning Tests

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Neuropsychological Tests; Psychological Tests

Study Officials

• Mahmood Alalwan, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: August 1, 2025
• Primary Completion: December 29, 2025
• Study Completion: December 29, 2025
• Last Updated: July 14, 2026

Record last verified: 2026-07

Locations

US (1)