Oral Nicotine Product Messaging to Communicate Risk of Use for Young Adults
8. července 2026 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
607
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Ohio
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Columbus, Ohio, Spojené státy, 43210
- Ohio State University Comprehensive Cancer Center
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Arm I (absolute risk of ONPs)
Participants receive messaging regarding absolute risk and addiction beliefs.
Participants engage with the content at their discretion.
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Pomocná studia
Receive messaging regarding addiction beliefs
Ostatní jména:
Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes
Ostatní jména:
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
Ostatní jména:
Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs
Ostatní jména:
|
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Experimentální: Arm II (efficacy of ONPs)
Participants receive messaging regarding self and response efficacy of ONPs.
Participants engage with the content at their discretion.
|
Pomocná studia
Receive messaging regarding addiction beliefs
Ostatní jména:
Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes
Ostatní jména:
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
Ostatní jména:
Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs
Ostatní jména:
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Experimentální: 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.
|
Pomocná studia
Receive messaging regarding addiction beliefs
Ostatní jména:
Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes
Ostatní jména:
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
Ostatní jména:
Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs
Ostatní jména:
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Experimentální: Arm IV (Switching to ONPs)
Participants receive messaging regarding switching to ONPs.
Participants engage with the content at their discretion.
|
Pomocná studia
Receive messaging regarding addiction beliefs
Ostatní jména:
Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes
Ostatní jména:
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
Ostatní jména:
Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs
Ostatní jména:
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Aktivní komparátor: Arm V (no messaging)
Participants do not receive messaging.
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Pomocná studia
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Perceived Message Effectiveness
Časové okno: This assessment is administered immediately after participants view study messages.
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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.
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This assessment is administered immediately after participants view study messages.
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Perceived Message Strength
Časové okno: This assessment is administered immediately after participants view study messages.
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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.
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This assessment is administered immediately after participants view study messages.
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Counterarguing
Časové okno: This assessment is administered immediately after participants view study messages.
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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.
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This assessment is administered immediately after participants view study messages.
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Negative Feelings
Časové okno: This assessment is administered immediately after participants view study messages.
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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.
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This assessment is administered immediately after participants view study messages.
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Positive Feelings
Časové okno: This assessment is administered immediately after participants view study messages.
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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.
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This assessment is administered immediately after participants view study messages.
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Oral Nicotine Pouch Use Curiosity
Časové okno: This assessment is administered immediately after participants view study messages.
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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.
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This assessment is administered immediately after participants view study messages.
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Oral Nicotine Pouch use intentions
Časové okno: This assessment is administered immediately after participants view study messages.
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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.
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This assessment is administered immediately after participants view study messages.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Perceived Harm of Oral Nicotine Pouches
Časové okno: This assessment is administered immediately after participants view study messages.
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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.
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This assessment is administered immediately after participants view study messages.
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Perceived Addictiveness of Oral Nicotine Pouches
Časové okno: This assessment is administered immediately after participants view study messages.
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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.
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This assessment is administered immediately after participants view study messages.
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Worry About Harm of Oral Nicotine Pouches
Časové okno: This assessment is administered immediately after participants view study messages.
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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.
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This assessment is administered immediately after participants view study messages.
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Worry About Addictiveness of Oral Nicotine Pouches
Časové okno: This assessment is administered immediately after participants view study messages.
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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.
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This assessment is administered immediately after participants view study messages.
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Motivation to Quit Smoking
Časové okno: This assessment is administered immediately after participants view study messages.
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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.
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This assessment is administered immediately after participants view study messages.
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Motivation to Quit E-Cigarettes
Časové okno: This assessment is administered immediately after participants view study messages.
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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.
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This assessment is administered immediately after participants view study messages.
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Efficacy Beliefs for Switching to Oral Nicotine Pouches from Cigarettes
Časové okno: This assessment is administered immediately after participants view study messages.
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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.
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This assessment is administered immediately after participants view study messages.
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Efficacy Beliefs for Switching to Oral Nicotine Pouches from E-Cigarettes
Časové okno: 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.
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This assessment is administered immediately after participants view study messages.
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Attitudes towards Oral Nicotine Pouches
Časové okno: This assessment is administered immediately after participants view study messages.
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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.
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This assessment is administered immediately after participants view study messages.
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Mahmood Alalwan, PhD, Ohio State University Comprehensive Cancer Center
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. srpna 2025
Primární dokončení (Aktuální)
29. prosince 2025
Dokončení studie (Aktuální)
29. prosince 2025
Termíny zápisu do studia
První předloženo
8. července 2026
První předloženo, které splnilo kritéria kontroly kvality
8. července 2026
První zveřejněno (Aktuální)
14. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
14. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
8. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- OSU-24396
- U54CA287392 (Grant/smlouva NIH USA)
- NCI-2026-02089 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))
- STUDY20250013
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .