Influence of Authorized Smokeless Tobacco Product Modified Risk Claims II: Laboratory Assessment of Sensory and Subjective Effects
Purpose
This study seeks to measure the effects of smokeless tobacco product risk messages on sensory experiences and future intentions to use.
Condition
- Smokeless Tobacco
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial Assignment
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Copenhagen group |
Participants will place .66 grams of Copenhagen between cheek and gums for up to 30 minutes. |
|
|
Active Comparator Snus Group |
Participants will place one pouch of snus beween cheek and gums for up to 30 minutes. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Roswell Park Cancer Institute