Modified Risk Claims for Smoking

Overseen By ASK RPCI

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Plan to quit smoking, Use smokeless tobacco, Lifetime use of Copenhagen or General Snus, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 session - 1 hour

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study reactions to new risk claims about smokeless tobacco products. Participants will view advertisements with or without these modified risk claims to assess their impact. It suits individuals in Western New York who smoke at least five cigarettes daily and are open to trying smokeless tobacco. Participants must have internet access and be comfortable with online surveys. As an unphased study, this trial allows participants to contribute to important research on public health messaging.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on smoking habits and smokeless tobacco use.

What prior data suggests that this modified risk claim is safe?

Research has shown that claims about smokeless tobacco products, such as Copenhagen and General Snus, suggest they might be less harmful than regular cigarettes. The FDA evaluated claims that using snus instead of cigarettes could reduce the risk of diseases like mouth cancer and heart disease.

However, these products are not completely safe. Studies indicate that such claims can lead people to perceive a lower risk, increasing their willingness to try these products. This perception may cause people to believe these products are safer than they actually are.

In summary, while these claims suggest less harm compared to smoking, smokeless tobacco still carries health risks. Always consider both the potential benefits and risks before making a decision. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how modified risk claims in tobacco advertising can impact consumer behavior. Unlike existing ads that typically highlight health risks, these modified claims suggest reduced harm, potentially influencing smokers' perceptions and choices. This approach could lead to a better understanding of how communication strategies might encourage smokers to opt for products with lower health risks, ultimately contributing to public health efforts.

What evidence suggests that this trial's treatments could be effective for modified risk claims in smokeless tobacco products?

This trial will compare the effects of viewing ads with modified risk claims to ads without claims. Research has shown that claims about modified risk tobacco products can alter perceptions of tobacco's dangers. For instance, these claims often lead people to believe these products are less harmful, increasing their willingness to try them. One study found that general claims about reduced risk had a greater impact than specific claims. However, some claims approved by the FDA did not clearly convey to most people that these products are less harmful or addictive than regular cigarettes. Overall, the effect of these claims can vary, but they typically lead people to perceive lower risks and can influence their decision to use these products. ^{1 3 6 7 8}

Who Is on the Research Team?

Richard O'Connor

Principal Investigator

Roswell Park

Are You a Good Fit for This Trial?

This trial is for daily cigarette smokers who are open to trying non-combusted oral tobacco products and live in Western New York. They must smoke at least 5 cigarettes per day, have internet access, and be able to read and communicate in English. Pregnant individuals or those planning to quit smoking soon cannot participate.

Inclusion Criteria

Open to trying a non-combusted oral tobacco product

Have access to a device (ie: computer/tablet/smartphone) with internet capabilities to participate in an online survey study

I have been smoking daily for at least a year.

Exclusion Criteria

Pregnant or planning to become pregnant (by self report)

Plan to quit smoking in the next 30 days

Use of smokeless tobacco at least weekly in the last 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants view advertisements with or without modified risk claims and participate in experimental auctions and questionnaires

1 session - 1 hour

Follow-up

Participants are monitored for changes in product demand and perceived risk after exposure to advertisements

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Modified Risk Claim

Trial Overview The study examines how consumers react to new modified risk claims for Copenhagen and General Snus smokeless tobacco products through online surveys and other research methods.

How Is the Trial Designed?

Group I: Group B - Modified Risk Tobacco Product Claim Active Control 1 Intervention

Participants view ads with a modified risk claim

Group II: Group A - no claim Placebo Group 1 Intervention

Participants view smokeless tobacco ads with no claims

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10959159/

Effects of Modified Risk Tobacco Product Claims ... MRTP claims led to lower perceived risk and exposure, and higher willingness to try IQOS. General claims elicited larger effects than specific claims.

2. fda.gov fda.gov/files/tobacco%20products/published/Modified-Risk-Tobacco-Product-Applications--Draft-Guidance-for-Industry-PDF.pdf

Modified Risk Tobacco Product Applications This draft guidance provides information about submitting applications for modified risk tobacco products under section 911 of the Federal Food, Drug, and ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871624002126

Perceived relative harm and addictiveness compared with ... Two current FDA-authorized MRTP claims were not effective in conveying that MRTPs were less harmful or addictive than cigarettes to most participants.

4. tandfonline.com tandfonline.com/doi/full/10.1080/10410236.2025.2543575?src=

The Influence of the US FDA Authorized Modified Exposure ... Our findings support scholarly concerns about the negative impact of FDA-authorized marketing claims for newer tobacco products on young people.

5. tobaccocontrol.bmj.com tobaccocontrol.bmj.com/content/27/Suppl_1/s62

Impact of modified risk tobacco product claims on beliefs ... Claims that an MRTP exposed users to less chemicals lowered adults' perceived risk of health harm (p<0.001). Perceived risk differed among the products (p<0.001); ...

6. fda.gov fda.gov/media/131923/download

Scientific Review of Modified Risk Tobacco Product ... The FDA reviewed a claim that using general snus instead of cigarettes lowers the risk of mouth cancer, heart disease, lung cancer, stroke, ...

7. escardio.org escardio.org/Journals/E-Journal-of-Cardiology-Practice/Volume-19/new-tobacco-product-regulations-in-the-era-of-reduced-harm-should-europe-follow

New tobacco product regulations in the era of reduced ... “The Modified Risk Tobacco Product (MRTP) provisions may be valuable tools in the effort to promote public health by reducing the morbidity and ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2352853219301993

Assessing comprehension and perceptions of modified-risk ... The modified-risk information, conveying that snus presents less risk than cigarettes but is not completely safe, was understood by majorities of respondents.