Effects of FDA Authorized Smokeless Tobacco Claims Among US Adults Who Smoke Cigarettes

Rutgers The State University of New Jersey

Status: Not yet enrolling

Conditions: Tobacco Product Beliefs and Use

Treatments: Behavioral: Modified Risk Claim Presence and Type; Behavioral: Product Brand

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06927700

R21CA289541 (U.S. NIH Grant/Contract)

Pro2024000097

Details and patient eligibility

About

This study will be an online survey experiment conducted with adults who smoke cigarettes (ages 21+) to examine their reactions to modified risk advertising claims authorized by the Food & Drug Administration (FDA) for two smokeless tobacco brands (General Snus and Copenhagen), which describe the lower risks of these products compared to cigarette smoking. The study will compare effects of ads with different two different claim types (i.e. claims about reduced lung cancer risk and claims about reduced risks for multiple disease) versus ads with no reduced-risk claims, and examine effects on message and product perceptions, and interest in using the smokeless tobacco products. We will also examine how smokers' reactions/interest may vary based on the product brand, and asses prior awareness/exposure to the authorized claims.

Enrollment: 1,250 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults (age 21 and over) who are current established cigarettes smokers (i.e., smoked 100 cigarettes in their lifetime and now smoke every day or somedays), based in the US, members of Ipsos' KnowledgePanel, and have chosen to complete their research panel surveys in English

Exclusion criteria

• Panel participants who do not meet the criteria outlined above will be excluded.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,250 participants in 6 patient groups

Group 1 (General Snus-Control Ads)

Other group

Description:

Participants in this group will view 4 ads for the brand General Snus that do not include a modified risk claim.

Treatment:

Behavioral: Product Brand

Behavioral: Modified Risk Claim Presence and Type

Group 2 (General Snus-Multiple Disease Ads)

Experimental group

Description:

Participants in this group will view 4 ads for the brand General Snus that include a modified risk claim about the lower risk of multiple diseases.

Treatment:

Behavioral: Product Brand

Behavioral: Modified Risk Claim Presence and Type

Group 3 (General Snus- Lung Ads)

Experimental group

Description:

Participants in this group will view 4 ads for the brand General Snus that include a modified risk claim about the lower risk of lung cancer only.

Treatment:

Behavioral: Product Brand

Behavioral: Modified Risk Claim Presence and Type

Group 4 (Copenhagen-Control Ads)

Experimental group

Description:

Participants in this group will view 4 ads for the brand Copenhagen that do not include a modified risk claim.

Treatment:

Behavioral: Product Brand

Behavioral: Modified Risk Claim Presence and Type

Group 5 (Copenhagen-Multiple Disease Ads)

Experimental group

Description:

Participants in this group will view 4 ads for the brand Copenhagen that include a modified risk claim about the lower risk of multiple diseases.

Treatment:

Behavioral: Product Brand

Behavioral: Modified Risk Claim Presence and Type

Group 6 (Copenhagen- Lung Ads)

Experimental group

Description:

Participants in this group will view 4 ads for the brand Copenhagen that include a modified risk claim about the lower risk of lung cancer only.

Treatment:

Behavioral: Product Brand

Behavioral: Modified Risk Claim Presence and Type