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Effects of FDA Authorized Smokeless Tobacco Claims Among US Adults Who Smoke Cigarettes

Effects of FDA Authorized Smokeless Tobacco Claims Among US Adults Who Smoke Cigarettes

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06927700
Enrollment
1257
Registered
2025-04-15
Start date
2025-04-24
Completion date
2025-05-04
Last updated
2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Product Beliefs and Use

Keywords

smokeless tobacco, tobacco advertising, modified risk claims, snus, moist snuff

Brief summary

This study will be an online survey experiment conducted with adults who smoke cigarettes (ages 21+) to examine their reactions to modified risk advertising claims authorized by the Food & Drug Administration (FDA) for two smokeless tobacco brands (General Snus and Copenhagen), which describe the lower risks of these products compared to cigarette smoking. The study will compare effects of ads with different two different claim types (i.e. claims about reduced lung cancer risk and claims about reduced risks for multiple disease) versus ads with no reduced-risk claims, and examine effects on message and product perceptions, and interest in using the smokeless tobacco products. This study will also examine how smokers' reactions/interest may vary based on the product brand, and asses prior awareness/exposure to the authorized claims.

Interventions

BEHAVIORALModified Risk Claim Type - None

Participants will view smokeless tobacco ads with no modified risk claim (control)

BEHAVIORALProduct Brand - General Snus

Participants will views ads for the smokeless tobacco brand General Snus

BEHAVIORALProduct Brand - Copenhagen

Participants will views ads for the smokeless tobacco brand Copenhagen

BEHAVIORALModified Risk Claim Type - Multiple Diseases

Participants will view smokeless tobacco ads with a claim about lower risks for multiple diseases

BEHAVIORALModified Risk Claim Type - Lung Cancer

Participants will either view smokeless tobacco ads with a modified risk claim about lower risks for lung cancer only

Sponsors

Rutgers, The State University of New Jersey
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Adults (age 21 and over) who are current established cigarettes smokers (i.e., smoked 100 cigarettes in their lifetime and now smoke every day or somedays), based in the US, members of Ipsos' KnowledgePanel, and have chosen to complete their research panel surveys in English

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
General Relative Harm PerceptionAssessed in survey measures completed immediately after viewing the study stimuliSingle item measure asking participants how harmful they think daily use of the viewed smokeless tobacco product would be to their health compared to daily cigarette smoking, (1=a lot less harmful, 2=somewhat less harmful, 3=about the same, 4=somewhat more harmful, 5=a lot more harmful). Higher scores mean thinking the viewed smokeless tobacco product is more harmful than cigarettes.
Perceptions of Perceived Relative Risks of DiseasesAssessed in survey measures completed immediately after viewing the study stimuliAssessment of perceived risks of getting various smoking related diseases from using the viewed smokeless tobacco product versus from smoking cigarettes. Responses to 6 parallel questions (each asking about a different disease) were averaged together in this composite item. The question stated: "If you used only \[General Snus/Copenhagen - inserted based on brand condition\] or only cigarettes every day, which product would make it more likely that you would get": 1) lung cancer; 2) heart disease; 3) mouth cancer; 4) stroke; 5) chronic bronchitis; 6) emphysema. Response options to each were on a 5 point scale from (1=much more likely with General Snus/Copenhagen to 5=much more likely with cigarettes). Results presented here are based on the averages responses to the six items. Higher scores mean thinking risks are greater from smoking cigarettes than from using the viewed smokeless tobacco product.
Absolute Harm PerceptionAssessed in survey measures completed immediately after viewing the study stimuliSingle item measure asking participants how likely or unlikely they think the viewed smokeless tobacco product would be to cause serious health problems during their lifetime, if they used it every day (from 1=not at all likely to 5=extremely likely). Higher scores mean greater likelihood of thinking the product is harmful to health.
Product Use IntentionsAssessed in survey measures completed immediately after viewing the study stimuliAssessment of intentions to use the viewed smokeless tobacco products based on averaging responses to three parallel questions: "Thinking about the ads you saw for \[General Snus or Copenhagen\] products, how interested, in the next 6 months, would you be in: 1) Using or trying these products? 2) Using these products as a way to quit or cut down on your cigarette smoking? 3) Completely switching from cigarettes to these products? Response options to each were on a 5 point scale from (1=not at all interested to 5=extremely interested). Results presented here are based on the averaged responses to these three items. Higher scores mean greater interest in using the products.

Secondary

MeasureTime frameDescription
Risk Message RecallAssessed in survey measures completed immediately after viewing the study stimuliParticipants are asked to recall (yes/no) if the ads they viewed include any statement saying that using the product can lower risks of certain diseases.
Switching ComprehensionAssessed in survey measures completed immediately after viewing the study stimuliAn item assessing participants' understanding of the need to completely switch to the smokeless tobacco product viewed in order to reduce risks. It said: Please answer the next question based on your understanding of the ads you viewed earlier. Based on the ads, \[General Snus OR Copenhagen, inserted based on condition\] can reduce a smoker's health risks if you: (Select all that apply) 1. Use only \[General Snus/Copenhagen\] and not smoke any cigarettes anymore 2. Use \[General Snus/Copenhagen\] and smoke fewer cigarettes than before 3. Use both products (\[General Snus/Copenhagen\] and cigarettes) about equally 4. None of the above 5. I don't know/not sure
Ad PersuasivenessAssessed in survey measures completed immediately after viewing the study stimuliA composite measure based on the average of 6 advertisement perceptions, asking participants to rate whether they agreed or disagreed that they ads they viewed: 1) included important information; 2) were understandable; 3) included believable information; 4) included credible information; 5) included information new to me; 6) make me want to learn more about those products. Response options were on a 6 point agreement scale from 1=strongly disagree to 6=strongly agree. Higher scores mean greater agreement that the ads were effective and persuasive.
Claim Believability & CredibilityAssessed in survey measures completed immediately after viewing the study stimuliA composite measure based on the average of 2 claim perception items, asking participants to rate whether they agreed or disagreed that the modified-risk claim in the ads they viewed was : 1) believable 2) credible. Participants responded to this while seeing the claim again on the survey screen. Response options were on a 7 point agreement scale from 1=strongly disagree to 7=strongly agree. Higher scores mean greater agreement that the claims were believable and credible.
Overall Perceived Claim PersuasivenessAssessed in survey measures completed immediately after viewing the study stimuliA composite measure based on the average of 7 claim perception items, asking participants to rate whether they agreed or disagreed that the modified-risk claim in the ads they viewed was : 1) believable; 2) credible; 3) important; 4) new to me; 5) makes me think using this product could be less harmful to my health than smoking; 6) makes me more interested in trying this product; 7) would make me think seriously about completely switching to this product. Participants responded to this while seeing the claim again on the survey screen. Response options were on a 7 point agreement scale from 1=strongly disagree to 7=strongly agree. Higher scores mean greater agreement that participants thought the claim was persuasive/effective.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATOROlivia A Wackowski, PhD, MPH

Rutgers University

Baseline characteristics

Characteristic
Age, Continuous54.1 years
Race/Ethnicity, Customized
2+ Races, Non-Hispanic
17 Participants
Race/Ethnicity, Customized
Black, Non-Hispanic
25 Participants
Race/Ethnicity, Customized
Hispanic
19 Participants
Race/Ethnicity, Customized
Other, Non-Hispanic
38 Participants
Race/Ethnicity, Customized
White, Non-Hispanic
156 Participants
Region of Enrollment
United States
203 participants
Sex/Gender, Customized
Female
107 Participants
Sex/Gender, Customized
Male
106 Participants
Smoking frequency
Smoke every day
998 Participants
Smoking frequency
Smoke some days
259 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
0 / 2130 / 2090 / 2030 / 2090 / 2090 / 214
other
Total, other adverse events
0 / 2130 / 2090 / 2030 / 2030 / 2090 / 214
serious
Total, serious adverse events
0 / 2130 / 2090 / 2030 / 2090 / 2090 / 214

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026