Oral Nicotine Product Messaging to Communicate Risk of Use for Young Adults
8. juli 2026 opdateret af: Mahmood Alalwan, Ohio State University Comprehensive Cancer Center
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.
Studieoversigt
Status
Status
Afsluttet
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
607
Fase
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Ohio
-
Columbus, Ohio, Forenede Stater, 43210
- Ohio State University Comprehensive Cancer Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
5
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Arm I (absolute risk of ONPs)
Participants receive messaging regarding absolute risk and addiction beliefs.
Participants engage with the content at their discretion.
|
Hjælpestudier
Receive messaging regarding addiction beliefs
Andre navne:
Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes
Andre navne:
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
Andre navne:
Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs
Andre navne:
|
|
Eksperimentel: Arm II (efficacy of ONPs)
Participants receive messaging regarding self and response efficacy of ONPs.
Participants engage with the content at their discretion.
|
Hjælpestudier
Receive messaging regarding addiction beliefs
Andre navne:
Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes
Andre navne:
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
Andre navne:
Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs
Andre navne:
|
|
Eksperimentel: 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.
|
Hjælpestudier
Receive messaging regarding addiction beliefs
Andre navne:
Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes
Andre navne:
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
Andre navne:
Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs
Andre navne:
|
|
Eksperimentel: Arm IV (Switching to ONPs)
Participants receive messaging regarding switching to ONPs.
Participants engage with the content at their discretion.
|
Hjælpestudier
Receive messaging regarding addiction beliefs
Andre navne:
Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes
Andre navne:
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
Andre navne:
Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs
Andre navne:
|
|
Aktiv komparator: Arm V (no messaging)
Participants do not receive messaging.
|
Hjælpestudier
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Perceived Message Effectiveness
Tidsramme: This assessment is administered immediately after participants view study messages.
|
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
Tidsramme: This assessment is administered immediately after participants view study messages.
|
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
Tidsramme: This assessment is administered immediately after participants view study messages.
|
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
Tidsramme: This assessment is administered immediately after participants view study messages.
|
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
Tidsramme: This assessment is administered immediately after participants view study messages.
|
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
Tidsramme: This assessment is administered immediately after participants view study messages.
|
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
Tidsramme: This assessment is administered immediately after participants view study messages.
|
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.
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Perceived Harm of Oral Nicotine Pouches
Tidsramme: This assessment is administered immediately after participants view study messages.
|
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
Tidsramme: This assessment is administered immediately after participants view study messages.
|
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
Tidsramme: This assessment is administered immediately after participants view study messages.
|
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
Tidsramme: This assessment is administered immediately after participants view study messages.
|
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
Tidsramme: This assessment is administered immediately after participants view study messages.
|
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
Tidsramme: This assessment is administered immediately after participants view study messages.
|
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.
|
Andre resultatmål
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Efficacy Beliefs for Switching to Oral Nicotine Pouches from Cigarettes
Tidsramme: This assessment is administered immediately after participants view study messages.
|
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
Tidsramme: This assessment is administered immediately after participants view study messages.
|
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
Tidsramme: This assessment is administered immediately after participants view study messages.
|
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.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Ledende efterforsker: Mahmood Alalwan, PhD, Ohio State University Comprehensive Cancer Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
1. august 2025
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
29. december 2025
Studieafslutning (Faktiske)
Studieafslutning
29. december 2025
Datoer for studieregistrering
Først indsendt
Først indsendt
8. juli 2026
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
8. juli 2026
Først opslået (Faktiske)
Først opslået
14. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
14. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juli 2026
Sidst verificeret
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- OSU-24396
- U54CA287392 (U.S. NIH-bevilling/kontrakt)
- NCI-2026-02089 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- STUDY20250013
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .