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

Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT06927700

Acronym / sponsor ID

Pro2024000097

Conditions

Tobacco Product Beliefs and Use

Keywords

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

Study type

Interventional

Recruitment status

Completed

Enrolment

1,257 participants (actual)

Lead sponsor

Rutgers, The State University of New JerseyUniversity, hospital or other

Collaborators

National Cancer Institute (NCI)

Study start

24 Apr 2025 (actual)

Primary completion

4 May 2025 (actual)

Study completion

4 May 2025 (actual)

First posted

15 Apr 2025 (actual)

Results

Posted 4 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Prevention

Allocation

Randomised

Intervention model

Parallel groups

Masking

Single blind (participant)

Number of arms

6

Who may qualify

Ages

21 years and older

Sex

All

Healthy volunteers

Accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. General Relative Harm Perception

   Time frame: Assessed in survey measures completed immediately after viewing the study stimuli

   Single 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.

2. Perceptions of Perceived Relative Risks of Diseases

   Time frame: Assessed in survey measures completed immediately after viewing the study stimuli

   Assessment 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.

3. Absolute Harm Perception

   Time frame: Assessed in survey measures completed immediately after viewing the study stimuli

   Single 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.

4. Product Use Intentions

   Time frame: Assessed in survey measures completed immediately after viewing the study stimuli

   Assessment 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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Information about FDA's authorization of modified risk order for Copenhagen snuffLink provided by the sponsor.
• Information about FDA's authorization of modified risk order for General Snus productsLink provided by the sponsor.
• Individual participant dataSharing planned: Yes. The study ad stimuli, survey instrument, codebook, and de-identified dataset will be deposited to a data repository - we anticipate this will be the National Addiction and HIV Data Archive Program (NAHDAP), currently managed by ICPSR at the University of Michigan.

Related trials for Tobacco Product Beliefs and Use

• Not yet recruiting

  The Impact of Cigar Pack Marketing With "Natural" Themes on Young Adults

  Tobacco Product Beliefs and Use

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

1 site in 1 country: see every site and its status.