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

NCT ID: NCT06927700

Last Updated: 2025-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1257 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-24

Study Completion Date

2025-05-04

Brief Summary

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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. This study will also examine how smokers' reactions/interest may vary based on the product brand, and asses prior awareness/exposure to the authorized claims.

Detailed Description

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Conditions

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Tobacco Product Beliefs and Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1 (General Snus-Control Ads)

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

Group Type OTHER

Modified Risk Claim Type - None

Intervention Type BEHAVIORAL

Participants will view smokeless tobacco ads with no modified risk claim (control)

Product Brand - General Snus

Intervention Type BEHAVIORAL

Participants will views ads for the smokeless tobacco brand General Snus

Group 2 (General Snus-Multiple Disease Ads)

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.

Group Type EXPERIMENTAL

Product Brand - General Snus

Intervention Type BEHAVIORAL

Participants will views ads for the smokeless tobacco brand General Snus

Modified Risk Claim Type - Multiple Diseases

Intervention Type BEHAVIORAL

Participants will view smokeless tobacco ads with a claim about lower risks for multiple diseases

Group 3 (General Snus- Lung Ads)

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.

Group Type EXPERIMENTAL

Product Brand - General Snus

Intervention Type BEHAVIORAL

Participants will views ads for the smokeless tobacco brand General Snus

Modified Risk Claim Type - Lung Cancer

Intervention Type BEHAVIORAL

Participants will either view smokeless tobacco ads with a modified risk claim about lower risks for lung cancer only

Group 4 (Copenhagen-Control Ads)

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

Group Type EXPERIMENTAL

Modified Risk Claim Type - None

Intervention Type BEHAVIORAL

Participants will view smokeless tobacco ads with no modified risk claim (control)

Product Brand - Copenhagen

Intervention Type BEHAVIORAL

Participants will views ads for the smokeless tobacco brand Copenhagen

Group 5 (Copenhagen-Multiple Disease Ads)

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.

Group Type EXPERIMENTAL

Product Brand - Copenhagen

Intervention Type BEHAVIORAL

Participants will views ads for the smokeless tobacco brand Copenhagen

Modified Risk Claim Type - Multiple Diseases

Intervention Type BEHAVIORAL

Participants will view smokeless tobacco ads with a claim about lower risks for multiple diseases

Group 6 (Copenhagen- Lung Ads)

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.

Group Type EXPERIMENTAL

Product Brand - Copenhagen

Intervention Type BEHAVIORAL

Participants will views ads for the smokeless tobacco brand Copenhagen

Modified Risk Claim Type - Lung Cancer

Intervention Type BEHAVIORAL

Participants will either view smokeless tobacco ads with a modified risk claim about lower risks for lung cancer only

Interventions

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Modified Risk Claim Type - None

Participants will view smokeless tobacco ads with no modified risk claim (control)

Intervention Type BEHAVIORAL

Product Brand - General Snus

Participants will views ads for the smokeless tobacco brand General Snus

Intervention Type BEHAVIORAL

Product Brand - Copenhagen

Participants will views ads for the smokeless tobacco brand Copenhagen

Intervention Type BEHAVIORAL

Modified Risk Claim Type - Multiple Diseases

Participants will view smokeless tobacco ads with a claim about lower risks for multiple diseases

Intervention Type BEHAVIORAL

Modified Risk Claim Type - Lung Cancer

Participants will either view smokeless tobacco ads with a modified risk claim about lower risks for lung cancer only

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Olivia A. Wackowski, PhD, MPH

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olivia A Wackowski, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Rutgers University

Locations

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Rutgers Institute for Nicotine & Tobacco Studies

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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Other Identifiers

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R21CA289541

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro2024000097

Identifier Type: -

Identifier Source: org_study_id

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