Influence of Authorized Smokeless Tobacco Product Modified Risk Claims II: Laboratory Assessment of Sensory and Subjective Effects
NCT ID: NCT07107139
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-12-30
2027-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
BASIC_SCIENCE
NONE
Study Groups
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Copenhagen group
Participants will place .66 grams of Copenhagen between cheek and gums for up to 30 minutes.
Copenhagen group
Participants use product for up to 30 minutes
Snus Group
Participants will place one pouch of snus beween cheek and gums for up to 30 minutes.
Snus group
Participants use product for up to 30 minutes
Interventions
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Copenhagen group
Participants use product for up to 30 minutes
Snus group
Participants use product for up to 30 minutes
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Roswell Park Cancer Institute
OTHER
Responsible Party
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Locations
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Roswell Park
Buffalo, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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I-4008824-1
Identifier Type: -
Identifier Source: org_study_id
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