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

Not Applicable

Recruiting

• Conditions: Smokeless Tobacco

• Registration Number: NCT07107139
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-30
• Study First Submitted QC: 2025-07-30
• Last Update Submitted: 2025-07-30
• Study First Posted: 2025-08-06
• Last Update Posted: 2025-08-06
• Study Start: 2025-09-01
• Primary Completion: 2027-03-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Change in sensory response	Before viewing study ads and immediatley after viewing	assessed with a 0-100 visual analog scale - anchored by word descriptors at each end.

Secondary Outcome Measures

Name	Time	Method
Change in nicotine boost	Will be collected after 5, 15 and 30 minutes of product use.	Will be measured after use of products with gas chromatography-mass spectrometry

Trial Locations

Locations (1)

Roswell Park; 🇺🇸 Buffalo, New York, United States