Oral Nicotine Product Messaging to Communicate Risk of Use for Young Adults
2026年7月8日 更新者：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.
研究概览
地位
完全的
条件
详细说明
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.
研究类型
介入性
注册 (实际的)
607
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Ohio
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Columbus、Ohio、美国、43210
- Ohio State University Comprehensive Cancer Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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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辅助研究
Receive messaging regarding addiction beliefs
其他名称：
Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes
其他名称：
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
其他名称：
Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs
其他名称：
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实验性的：Arm II (efficacy of ONPs)
Participants receive messaging regarding self and response efficacy of ONPs.
Participants engage with the content at their discretion.
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辅助研究
Receive messaging regarding addiction beliefs
其他名称：
Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes
其他名称：
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
其他名称：
Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs
其他名称：
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实验性的：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.
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辅助研究
Receive messaging regarding addiction beliefs
其他名称：
Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes
其他名称：
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
其他名称：
Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs
其他名称：
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实验性的：Arm IV (Switching to ONPs)
Participants receive messaging regarding switching to ONPs.
Participants engage with the content at their discretion.
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辅助研究
Receive messaging regarding addiction beliefs
其他名称：
Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes
其他名称：
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
其他名称：
Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs
其他名称：
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有源比较器：Arm V (no messaging)
Participants do not receive messaging.
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辅助研究
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Perceived Message Effectiveness
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Perceived Harm of Oral Nicotine Pouches
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Efficacy Beliefs for Switching to Oral Nicotine Pouches from Cigarettes
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mahmood Alalwan, PhD、Ohio State University Comprehensive Cancer Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年8月1日
初级完成 (实际的)
2025年12月29日
研究完成 (实际的)
2025年12月29日
研究注册日期
首次提交
2026年7月8日
首先提交符合 QC 标准的
2026年7月8日
首次发布 (实际的)
2026年7月14日
研究记录更新
最后更新发布 (实际的)
2026年7月14日
上次提交的符合 QC 标准的更新
2026年7月8日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.