Risk Messaging for Smokeless Tobacco

Overseen By ASK RPCI

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how messages about the risks of smokeless tobacco influence people's experiences and future choices regarding these products. Participants will try either Copenhagen or Snus, both smokeless tobacco products placed between the cheek and gums. The study seeks individuals who smoke at least five cigarettes daily and reside in specific counties in Western New York. Participants must be willing to try smokeless tobacco and able to communicate in English. As an unphased trial, this study provides a unique opportunity to contribute to important research on tobacco use and its effects.

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

The trial information does not specify whether you need to stop taking your current medications. It seems the focus is on tobacco use, so you may not need to change other medications, but it's best to confirm with the study team.

What prior data suggests that these risk messages are safe?

Studies have shown that smokeless tobacco products like snus carry different health risks compared to cigarettes. The FDA examined claims that using snus instead of cigarettes might reduce the risk of certain diseases, such as mouth cancer and heart disease. However, smokeless tobacco products remain addictive and can affect heart health.

Research indicates that many people perceive snus as nearly as harmful as smoking cigarettes. Understanding these risks is crucial when considering the use of smokeless tobacco. This trial examines how people perceive these risks and how it might influence their decision to use smokeless tobacco. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different risk messages surrounding smokeless tobacco products, like Copenhagen and snus, influence user perception and behavior. Unlike traditional methods that typically focus on abstinence or cessation, this study aims to understand how specific messaging can impact decision-making and risk assessment among users. By investigating these psychological and behavioral responses, the study could offer new insights into more effective public health strategies and communication techniques for reducing tobacco-related harm.

What evidence suggests that this trial's treatments could be effective?

This trial will compare different risk messaging for smokeless tobacco products. Participants in the Copenhagen group will use Copenhagen, while those in the Snus group will use snus. Studies have shown that many people believe smokeless tobacco, like snus, is as risky as smoking cigarettes. However, research indicates that smokeless tobacco does not carry the same risk of causing lung cancer as smoking. Although people recognize that snus is less harmful than cigarettes, it is not completely safe. The FDA has approved some smokeless tobacco products to be marketed as lower risk for certain diseases compared to smoking. Despite this, evidence is insufficient to show that these risk messages will encourage smokers to switch to smokeless tobacco. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals who currently use smokeless tobacco products. The specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed inclusion and exclusion criteria.

Inclusion Criteria

Smoke cigarettes every day, at least 5 cigarettes per day, for at least 1 year

Willing to abstain smoking 8-10 hours prior to each laboratory session and complete breath CO test for verification (<8ppm)

I am willing to take a pregnancy test before starting the study.

Exclusion Criteria

Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Have successfully completed our preliminary Auction study I-4008824 with a bid for Copenhagen and/or General Snus > $0

I am 21 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will use smokeless tobacco products (Copenhagen or Snus) and sensory responses will be measured

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in sensory response and nicotine boost after product use

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Smokeless Tobacco Product Risk Messages

Trial Overview The study is examining how different risk messages about smokeless tobacco products like Snus and Copenhagen affect people's sensory experiences and their intentions to continue using these products.

How Is the Trial Designed?

Group I: Copenhagen group Active Control 1 Intervention

Participants will place .66 grams of Copenhagen between cheek and gums for up to 30 minutes.

Group II: Snus Group Active Control 1 Intervention

Participants will place one pouch of snus beween cheek and gums for up to 30 minutes.

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/PMC6358499/

Smokers' perceptions of risks and harm from snus relative ... Almost half (44.9%) of smokers perceived snus to be as or more risky than cigarettes for all three specific health outcomes.

2. 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 ... The data show if current smokers switch completely from cigarettes to this product, they would reduce their risk of getting lung cancer. The ...

3. 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.

4. tobacco.ucsf.edu tobacco.ucsf.edu/fda-should-not-permit-us-smokeless-tobacco-company-market-copenhagen-snuff-modified-risk-claims

FDA should not permit the U.S. Smokeless Tobacco ... The modified risk message proposed by USSTC for Copenhagen does not have enough evidence to show it will motivate smokers to switch to the ...

5. tobaccopreventioncessation.com tobaccopreventioncessation.com/The-effectiveness-of-nicotine-replacement-therapy-on-oral-smokeless-tobacco-cessation,208023,0,2.html

The effectiveness of nicotine replacement therapy on oral ... Introduction: Oral smokeless tobacco (OST) is a major preventable risk factor for oral cancer. Nicotine replacement therapy (NRT), a commonly ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306460318313091

Smokers' perceptions of risks and harm from snus relative ... Almost half (44.9%) of smokers perceived snus to be as or more risky than cigarettes for all three specific health outcomes (group 1), while over one third ( ...

7. 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, ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001293

Impact of Smokeless Oral Nicotine Products on ... Smokeless oral nicotine products are addictive, and their use has potential adverse effects on some but not all biomarkers of cardiovascular risk.

9. mdpi.com mdpi.com/1660-4601/16/5/879

Relative Risk Perceptions between Snus and Cigarettes in ... In other words, daily snus use is perceived to be 79.3% as harmful as daily cigarette smoking. The corresponding relative risk scores for E-cigarettes (3.78, SD ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6128772/

The Impact of Smokeless Tobacco Risk Information on ... Little research exists on the impact of risk information comparing smokeless tobacco (SLT) use, particularly snus, to cigarette smoking.