Smoking BehaviorsNCT07102082
Influence of Authorized Smokeless Tobacco Product Modified Risk Claims I: Consumer Product Demand
A study testing Modified Risk - None and Modified Risk Claim in people with Smoking Behaviors, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
To explore consumer responses to the announcement and implementation of new modified risk claims for Copenhagen and General Snus (brands of smokeless tobacco (ST) products) using a series of complementary and innovative research activities and methods. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Behaviors
- What is being tested?
- Modified Risk - None and Modified Risk Claim
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2025to 30 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Residing in one of the 8 counties of Western New York (Erie, Niagara, Cattaraugus, Chautauqua, Allegheny, Livingston, Genesee, Orleans, Wyoming).
- Smoke cigarettes every day, at least 5 cigarettes per day, for at least 1 year.
- 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.
- Have the ability to read, write, and communicate in English.
- Participant must understand the investigational nature of this study and an Independent Ethics Committee/Institutional Review Board approved information sheet prior to receiving any study related procedure
Who cannot join
- Plan to quit smoking in the next 30 days.
- Use of smokeless tobacco at least weekly in the last 6 months.
- Lifetime use (that is, ever used at any time prior to the study) of Copenhagen or General Snus.
- Unwilling or unable to follow protocol requirements.
- Pregnant or planning to become pregnant (by self report)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Roswell Park
Buffalo, New York, 14206
About this study
Official title: Ifluence of Authorized Smokeless Tobacco Product Modified Risk Claims II: Laboratory Assessment of Sensory and Subjective Effect
To explore consumer responses to the announcement and implementation of new modified risk claims for Copenhagen and General Snus (brands of smokeless tobacco (ST) products) using a series of complementary and innovative research activities and methods.
Read the detailed description
Primary Objectives:
To assess the influence of smokeless tobacco products' modified risk claims on:
- Product demand (measured as willingness to pay in USD) using an experimental auction approach; and
- Perceived risk of tobacco-associated diseases as assessed using questionnaire-based measures.
- Conditions
- Smoking Behaviors
- Being tested
- Modified Risk - None, Modified Risk Claim
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Risk - NoneBehavioural
Participants view ads with no modified risk claim
Modified Risk ClaimBehavioural
Participants view ads with a modified risk claim
| Study group | Role | What they receive |
|---|---|---|
| Group A - no claim | Sham comparator | Participants view smokeless tobacco ads with no claims Receives: Behavioral: Modified Risk - None |
| Group B - Modified Risk Tobacco Product Claim | Active comparator | Participants view ads with a modified risk claim Receives: Behavioral: Modified Risk Claim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demand for cigarettes
After watching a series of advertisements for oral smokeless tobacco products, participants will provide opinions of them, including likelihood of buying product.
Measured: After one session - 1 hour
Increase in knowlege of tobacco-associated diseases
multi item assessment questionnaires of perceived harm/risks from products
Measured: After one session - I hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start25 Sep 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Richard O'Connor, Principal investigator, Roswell Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102082
- Sponsor's protocol ID
- I-4008824
- Other IDs
- R21CA289541
- Status last verified
- May 2026
- First submitted
- 28 Jul 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No