How modified-risk claims change the sensory experience of smokeless tobacco
Influence of Authorized Smokeless Tobacco Product Modified Risk Claims II: Laboratory Assessment of Sensory and Subjective Effects
This test sees whether modified-risk messages on smokeless tobacco products change sensory experiences and future use intentions for adult daily cigarette smokers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Roswell Park Cancer Institute Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT07107139 on ClinicalTrials.gov |
What this trial studies
The study enrolls adult daily cigarette smokers who are open to trying a non-combusted oral tobacco product and exposes them in the laboratory to modified-risk messages tied to either Copenhagen or Snus products. Participants provide breath carbon monoxide verification of short-term abstinence and, if applicable, a urine pregnancy test before sessions. Researchers then record sensory and other subjective responses along with participants' intentions to use the products in the future. Results will compare responses across product/message conditions to see if and how claims alter perception or willingness to try these products.
Who should consider this trial
Good fit: Adults aged 21 or older who smoke cigarettes daily (at least 5 per day for one year), live in the specified Western New York counties, are willing to try an oral non-combusted tobacco product, and completed the required preliminary auction are ideal candidates.
Not a fit: People under 21, non-smokers, pregnant individuals, those unwilling to try oral tobacco, or those living outside the specified counties are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, results could help regulators and health communicators craft clearer product messages that influence smokers' choices and potentially reduce harm.
How similar studies have performed: Prior lab and survey work shows modified-risk claims can change perceptions and intentions in some cases, but effects are mixed and depend on message wording and product type.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 21 years of age * Residing in 8 counties of Western NY (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 the ability to read, write, and communicate in English * Have successfully completed our preliminary Auction study I-4008824 with a bid for Copenhagen and/or General Snus \> $0 * Willing to abstain smoking 8-10 hours prior to each laboratory session and complete breath CO test for verification (\<8ppm) * Female participants must be amenable to taking a pregnancy test (urine) prior to beginning study procedures. * 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. Exclusion Criteria: * Age ≥ 21 years of age * Residing in 8 counties of Western NY (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 the ability to read, write, and communicate in English * Have successfully completed our preliminary Auction study I-4008824 with a bid for Copenhagen and/or General Snus \> $0 * Willing to abstain smoking 8-10 hours prior to each laboratory session and complete breath CO test for verification (\<8ppm) . * Female participants must be amenable to taking a pregnancy test (urine) prior to beginning study procedures. * 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.
Where this trial is running
Buffalo, New York
- Roswell Park — Buffalo, New York, United States (Recruiting)
Study contacts
- Study coordinator: Ask Rpci
- Email: askrpci@roswellpark.org
- Phone: 1-877-275-7724
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.