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.
調査の概要
状態
完了
条件
詳細な説明
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.
研究の種類
介入
入学 (実際)
607
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Ohio
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Columbus、Ohio、アメリカ、43210
- Ohio State University Comprehensive Cancer Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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補助研究
Receive messaging regarding addiction beliefs
他の名前：
Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes
他の名前：
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
他の名前：
Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs
他の名前：
|
|
実験的：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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補助研究
Receive messaging regarding addiction beliefs
他の名前：
Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes
他の名前：
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
他の名前：
Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs
他の名前：
|
|
実験的：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.
|
補助研究
Receive messaging regarding addiction beliefs
他の名前：
Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes
他の名前：
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
他の名前：
Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs
他の名前：
|
|
実験的：Arm IV (Switching to ONPs)
Participants receive messaging regarding switching to ONPs.
Participants engage with the content at their discretion.
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補助研究
Receive messaging regarding addiction beliefs
他の名前：
Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes
他の名前：
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
他の名前：
Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs
他の名前：
|
|
アクティブコンパレータ：Arm V (no messaging)
Participants do not receive messaging.
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補助研究
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Perceived Message Effectiveness
時間枠：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
時間枠：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.
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This assessment is administered immediately after participants view study messages.
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Counterarguing
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
This assessment is administered immediately after participants view study messages.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Perceived Harm of Oral Nicotine Pouches
時間枠：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.
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This assessment is administered immediately after participants view study messages.
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Perceived Addictiveness of Oral Nicotine Pouches
時間枠：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.
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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
時間枠：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
時間枠：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
時間枠：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.
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This assessment is administered immediately after participants view study messages.
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Motivation to Quit E-Cigarettes
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Efficacy Beliefs for Switching to Oral Nicotine Pouches from Cigarettes
時間枠：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.
|
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Efficacy Beliefs for Switching to Oral Nicotine Pouches from E-Cigarettes
時間枠：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
時間枠：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.
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This assessment is administered immediately after participants view study messages.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Mahmood Alalwan, PhD、Ohio State University Comprehensive Cancer Center
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年8月1日
一次修了 (実際)
2025年12月29日
研究の完了 (実際)
2025年12月29日
試験登録日
最初に提出
2026年7月8日
QC基準を満たした最初の提出物
2026年7月8日
最初の投稿 (実際)
2026年7月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月14日
QC基準を満たした最後の更新が送信されました
2026年7月8日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。