Influence of Authorized Smokeless Tobacco Product Modified Risk Claims II: Laboratory Assessment of Sensory and Subjective Effects

Roswell Park Comprehensive Cancer Center

Status: Enrolling

Conditions: Smokeless Tobacco

Treatments: Other: Copenhagen group; Other: Snus group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07107139

R21CA289541 (U.S. NIH Grant/Contract)

I-4008824-1

Details and patient eligibility

About

This study seeks to measure the effects of smokeless tobacco product risk messages on sensory experiences and future intentions to use.

Enrollment: 50 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Copenhagen group

Active Comparator group

Description:

Participants will place .66 grams of Copenhagen between cheek and gums for up to 30 minutes.

Treatment:

Other: Copenhagen group

Snus Group

Active Comparator group

Description:

Participants will place one pouch of snus beween cheek and gums for up to 30 minutes.

Treatment:

Other: Snus group