Oral Nicotine Product Messaging to Communicate Risk of Use for Young Adults
2026년 7월 8일 업데이트: 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.
연구 개요
상태
완전한
정황
상세 설명
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.
연구 유형
중재적
등록 (실제)
607
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ohio
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Columbus, Ohio, 미국, 43210
- Ohio State University Comprehensive Cancer Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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보조 연구
Receive messaging regarding addiction beliefs
다른 이름들:
Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes
다른 이름들:
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
다른 이름들:
Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs
다른 이름들:
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실험적: 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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보조 연구
Receive messaging regarding addiction beliefs
다른 이름들:
Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes
다른 이름들:
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
다른 이름들:
Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs
다른 이름들:
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실험적: 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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보조 연구
Receive messaging regarding addiction beliefs
다른 이름들:
Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes
다른 이름들:
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
다른 이름들:
Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs
다른 이름들:
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실험적: Arm IV (Switching to ONPs)
Participants receive messaging regarding switching to ONPs.
Participants engage with the content at their discretion.
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보조 연구
Receive messaging regarding addiction beliefs
다른 이름들:
Receive messaging regarding relative risk beliefs about the risks of ONPs relative to cigarettes and e-cigarettes
다른 이름들:
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
다른 이름들:
Receive messaging regarding switching beliefs about the potential benefits of switching to ONPs
다른 이름들:
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활성 비교기: Arm V (no messaging)
Participants do not receive messaging.
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보조 연구
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Perceived Message Effectiveness
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Perceived Harm of Oral Nicotine Pouches
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Efficacy Beliefs for Switching to Oral Nicotine Pouches from Cigarettes
기간: 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
기간: 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 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Mahmood Alalwan, PhD, Ohio State University Comprehensive Cancer Center
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
유용한 링크
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 8월 1일
기본 완료 (실제)
2025년 12월 29일
연구 완료 (실제)
2025년 12월 29일
연구 등록 날짜
최초 제출
2026년 7월 8일
QC 기준을 충족하는 최초 제출
2026년 7월 8일
처음 게시됨 (실제)
2026년 7월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 8일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- OSU-24396
- U54CA287392 (미국 NIH 보조금/계약)
- NCI-2026-02089 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- STUDY20250013
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .