Tobacco-Related Carcinoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALBehavioral Intervention
Receive messaging regarding addiction beliefs
OTHERSurvey Administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Message Effectiveness | 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. |
| Perceived Message Strength | 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. |
| Counterarguing | 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. |
| Negative Feelings | 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. |
| Positive Feelings | 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. |
| Oral Nicotine Pouch Use Curiosity | 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. |
| Oral Nicotine Pouch use intentions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Harm of Oral Nicotine Pouches | 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. |
| Perceived Addictiveness of Oral Nicotine Pouches | 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. |
| Worry About Harm of Oral Nicotine Pouches | 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. |
| Worry About Addictiveness of Oral Nicotine Pouches | 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. |
| Motivation to Quit Smoking | 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. |
| Motivation to Quit E-Cigarettes | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMahmood Alalwan, PhD
Ohio State University Comprehensive Cancer Center
Outcome results
None listed