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

NCT07107139 | Recruiting

• 2 other identifiers: I-4008824-1R21CA289541
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Smokeless Tobacco

Outcome Measures

Primary Outcomes (1)

• Change in sensory response

  assessed with a 0-100 visual analog scale - anchored by word descriptors at each end.

  Before viewing study ads and immediatley after viewing

Secondary Outcomes (1)

• Change in nicotine boost

  Will be collected after 5, 15 and 30 minutes of product use.

Study Arms (2)

Copenhagen group

ACTIVE COMPARATOR

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

Other: Copenhagen group

Snus Group

ACTIVE COMPARATOR

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

Other: Snus group

Interventions

Copenhagen group OTHER

Participants use product for up to 30 minutes

Copenhagen group

Snus group OTHER

Participants use product for up to 30 minutes

Snus Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park

Buffalo, New York, 14263, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

ASK RPCI

CONTACT

1-877-275-7724; askrpci@roswellpark.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: March 30, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)