Influence of Authorized Smokeless Tobacco Product Modified Risk Claims I: Consumer Product Demand

Roswell Park Comprehensive Cancer Center

Status: Enrolling

Conditions: Smoking Behaviors

Treatments: Behavioral: Modified Risk Claim; Behavioral: Modified Risk - None

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07102082

R21CA289541 (U.S. NIH Grant/Contract)

I-4008824

Details and patient eligibility

About

To explore consumer responses to the announcement and implementation of new modified risk claims for Copenhagen and General Snus (brands of smokeless tobacco (ST) products) using a series of complementary and innovative research activities and methods.

Full description

Primary Objectives:

To assess the influence of smokeless tobacco products' modified risk claims on:

1. Product demand (measured as willingness to pay in USD) using an experimental auction approach; and
2. Perceived risk of tobacco-associated diseases as assessed using questionnaire-based measures.

Enrollment: 160 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Residing in one of the 8 counties of Western New York (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 access to a device (ie: computer/tablet/smartphone) with internet capabilities to participate in an online survey study.
• Have the ability to read, write, and communicate in English.
• Participant must understand the investigational nature of this study and an Independent Ethics Committee/Institutional Review Board approved information sheet prior to receiving any study related procedure

Exclusion criteria

• Plan to quit smoking in the next 30 days.
• Use of smokeless tobacco at least weekly in the last 6 months.
• Lifetime use (that is, ever used at any time prior to the study) of Copenhagen or General Snus.
• Unwilling or unable to follow protocol requirements.
• Pregnant or planning to become pregnant (by self report)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Group A - no claim

Sham Comparator group

Description:

Participants view smokeless tobacco ads with no claims

Treatment:

Behavioral: Modified Risk - None

Group B - Modified Risk Tobacco Product Claim

Active Comparator group

Description:

Participants view ads with a modified risk claim

Treatment:

Behavioral: Modified Risk Claim