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Clinical Trials/NCT07107139
NCT07107139RecruitingNot Applicable

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

Roswell Park Cancer Institute1 site in 1 country50 target enrollmentStarted: May 11, 2026Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
50
Locations
1
Primary Endpoint
Change in sensory response
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
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.

Arms & Interventions

Copenhagen group

Active Comparator

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

Intervention: Copenhagen group (Other)

Snus Group

Active Comparator

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

Intervention: Snus group (Other)

Outcomes

Primary Outcomes

Change in sensory response

Time Frame: Before viewing study ads and immediatley after viewing

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

Secondary Outcomes

  • Change in nicotine boost(Will be collected after 5, 15 and 30 minutes of product use.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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