Influence of Authorized Smokeless Tobacco Product Modified Risk Claims I: Consumer Product Demand
Ifluence of Authorized Smokeless Tobacco Product Modified Risk Claims II: Laboratory Assessment of Sensory and Subjective Effect
2 other identifiers
interventional
160
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2025
CompletedFirst Posted
Study publicly available on registry
August 3, 2025
CompletedStudy Start
First participant enrolled
September 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2026
December 4, 2025
November 1, 2025
1.2 years
July 28, 2025
November 26, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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.
After one session - 1 hour
Increase in knowlege of tobacco-associated diseases
multi item assessment questionnaires of perceived harm/risks from products
After one session - I hour
Study Arms (2)
Group A - no claim
SHAM COMPARATORParticipants view smokeless tobacco ads with no claims
Group B - Modified Risk Tobacco Product Claim
ACTIVE COMPARATORParticipants view ads with a modified risk claim
Interventions
Participants view ads with a modified risk claim
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Roswell Park Cancer Institutelead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Roswell Park
Buffalo, New York, 14206, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard O'Connor
Roswell Park
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2025
First Posted
August 3, 2025
Study Start
September 25, 2025
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
November 30, 2026
Last Updated
December 4, 2025
Record last verified: 2025-11