Smokeless Tobacco Claims for Smoking

Overseen By Olivia A Wackowski, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Non-smokers, Under 21, Non-English speakers, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how adults who smoke cigarettes react to ads for smokeless tobacco products with modified risk claims. The study focuses on two brands, General Snus and Copenhagen, comparing ads that mention reduced risks of lung cancer and multiple diseases to those without reduced-risk claims. The goal is to assess how these ads influence smokers' perceptions and interest in using the products. Ideal participants are U.S.-based adults who smoke regularly and are part of Ipsos' KnowledgePanel. As an unphased trial, this study allows participants to contribute to important research on tobacco advertising and public health.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on reactions to advertising claims rather than medication use.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that using General Snus instead of cigarettes lowered the risk of several serious diseases, such as mouth cancer, heart disease, and lung cancer. People recognize that snus presents less risk than cigarettes, but it is important to remember that snus is not completely safe. Similarly, research has shown that using Copenhagen Classic Snuff instead of smoking can reduce the risk of lung cancer and other diseases. The FDA has allowed these products to be marketed with claims of being less risky than smoking, indicating that they have reviewed safety data suggesting these smokeless tobaccos are less harmful than smoking. However, it is crucial to note that while they are safer than smoking, these products still carry some health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how the presence and type of modified risk claims in ads for smokeless tobacco products like General Snus and Copenhagen may influence perceptions of their health risks compared to smoking. While traditional smokeless tobacco products are marketed with general health warnings, this trial examines whether specific claims about reduced risks of diseases like lung cancer can change consumer behavior. By investigating different advertising strategies, this trial could provide new insights into how risk communication affects public understanding and decision-making regarding tobacco use.

What evidence suggests that this trial's treatments could be effective for reducing smoking-related risks?

This trial will compare different advertising claims for smokeless tobacco products. Research has shown that using General Snus instead of cigarettes might reduce the risk of diseases like mouth cancer, heart disease, and lung cancer. Participants in this trial will view ads for General Snus; some groups will see ads with modified risk claims about lower disease risks, while others will see control ads without such claims. The FDA has approved claims that General Snus is less risky than smoking, but it is not completely safe. For the Copenhagen brand, participants will also view ads with and without modified risk claims. No specific data compares Copenhagen's risks to cigarettes. Both products are marketed as possibly less harmful than smoking, but the actual health benefits can vary. ^{4 6 7 8 9}

Who Is on the Research Team?

Olivia A Wackowski, PhD, MPH

Principal Investigator

Rutgers University

Are You a Good Fit for This Trial?

This trial is for adults in the US who are 21 years or older and currently smoke cigarettes. It's an online survey to see how they respond to ads about smokeless tobacco products that claim to be less risky than smoking.

Inclusion Criteria

I am over 21, smoke regularly, live in the US, and complete surveys in English.

Exclusion Criteria

Panel participants who do not meet the criteria outlined above will be excluded.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Survey Experiment

Participants complete an online survey to assess reactions to modified risk advertising claims for smokeless tobacco products.

1 day

1 online session

Follow-up

Participants are monitored for their responses and perceptions immediately after viewing the study stimuli.

Immediate

What Are the Treatments Tested in This Trial?

Interventions

• Modified Risk Claim Presence and Type
• Product Brand

Trial Overview The study tests reactions to FDA-authorized advertising claims for two brands of smokeless tobacco, comparing different types of reduced-risk claims against no claims at all. It looks at how these ads affect perceptions and interest in using the products.

How Is the Trial Designed?

Group I: Group 6 (Copenhagen- Lung Ads) Experimental Treatment 2 Interventions

Participants in this group will view 4 ads for the brand Copenhagen that include a modified risk claim about the lower risk of lung cancer only.

Group II: Group 5 (Copenhagen-Multiple Disease Ads) Experimental Treatment 2 Interventions

Participants in this group will view 4 ads for the brand Copenhagen that include a modified risk claim about the lower risk of multiple diseases.

Group III: Group 4 (Copenhagen-Control Ads) Experimental Treatment 2 Interventions

Participants in this group will view 4 ads for the brand Copenhagen that do not include a modified risk claim.

Group IV: Group 3 (General Snus- Lung Ads) Experimental Treatment 2 Interventions

Participants in this group will view 4 ads for the brand General Snus that include a modified risk claim about the lower risk of lung cancer only.

Group V: Group 2 (General Snus-Multiple Disease Ads) Experimental Treatment 2 Interventions

Participants in this group will view 4 ads for the brand General Snus that include a modified risk claim about the lower risk of multiple diseases.

Group VI: Group 1 (General Snus-Control Ads) Experimental Treatment 2 Interventions

Participants in this group will view 4 ads for the brand General Snus that do not include a modified risk claim.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. tobacco.ucsf.edu tobacco.ucsf.edu/fda-should-not-renew-modified-risk-granted-order-eight-swedish-match-general-snus-products-because-actually-used-consumers-these-products-will-not-benefit-health-population-whole

FDA should not renew the Modified Risk Granted Order for ... The data submitted in this MRTP renewal application suggest that use of General Snus does not contribute to reductions in cigarette smoking ...

2. 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, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11246795/

Perceived Relative Harm and Addictiveness Compared with ... The General Snus brand is authorized to state the claim: “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer ...

4. 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.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06927700

Effects of FDA Authorized Smokeless Tobacco Claims ... Participants in this group will view 4 ads for the brand General Snus that include a modified risk claim about the lower risk of multiple diseases. Intervention ...

6. fda.gov fda.gov/media/122019/download

RE: Modified Risk Tobacco Product Applications We support this application because Copenhagen Snuff Fine Cut has been shown to be a less harmful alternative to combustible products and ...

7. fda.gov fda.gov/news-events/press-announcements/fda-authorizes-copenhagen-classic-snuff-be-marketed-modified-risk-tobacco-product

FDA Authorizes Copenhagen Classic Snuff to be Marketed ... Today's action now allows the product to be marketed as a modified risk product with the claim: “IF YOU SMOKE, CONSIDER THIS: Switching ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10527275/

Effects of a Reduced Risk Claim on Adolescents' Smokeless ... Participants who viewed the claim were less likely to perceive smokeless tobacco to cause “a lot” of harm (56% vs. 64%; P=0.03), including after statistical ...

9. sciences.altria.com sciences.altria.com/en/harm-reduction/smoke-free-product-platforms/smokeless-tobacco

Smokeless Tobacco - Altria Science ... modified risk claim for Copenhagen Classic Snuff. The claim is "IF YOU SMOKE, CONSIDER THIS: Switching to this product from cigarettes reduces risk of lung ...