The Impact of Cigarillo Warnings on Purchasing

NCT ID: NCT05434013

Last Updated: 2023-08-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1578 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-24

Study Completion Date

2022-07-21

Brief Summary

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The purpose of this study is to determine whether different cigarillo warning formats (pictorial, FDA-proposed text-only, current Surgeon General text-only) reduces demand for cigarillos. A previous study has identified that pictorial cigarillo warnings are perceived as more effective, but more information is needed on their impact. This study will address this issue by randomizing participants to see different cigarillo warning formats on cigarillo products within an online experimental tobacco marketplace. Participants will be cigarillo users who are ages 21-35.

Detailed Description

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Warning labels on tobacco products convey the health risks and discourage use. Warnings are even more effective when they contain images that depict the health consequences. However, little is known about the impact of cigarillo warnings, including pictorial warnings, on consumer behavior. The Experimental Tobacco Marketplace (ETM) task examines the effects of regulations on tobacco purchasing in the context of a complex tobacco marketplace. This project aims to address the gap in the knowledge about cigarillo risk communication by providing information on best practices for cigarillo warnings. Identifying effective cigarillo warnings is important to inform policy and guide research on effectively communicating risk to ultimately decrease use and tobacco-related morbidity and mortality.

Conditions

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Cigar Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will conduct a three-group, between-subjects experiment to compare varying cigarillo warning formats: Surgeon General text-only, FDA-proposed text-only, and study developed pictorial cigarillo warning labels.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Participants will be randomly assigned to one of 3 conditions. In each of these conditions participants will see one of the following warning label formats on the cigarillos when they are shopping for tobacco products: a pictorial warning, a text-based warning, or a surgeon general warning. Participants don't know which condition they're assigned to.

Study Groups

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Cigarillo warnings-Surgeon General Text-Only

Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Surgeon General Text-Only format.

Group Type EXPERIMENTAL

Cigarillo warnings-Surgeon General Text-Only

Intervention Type BEHAVIORAL

Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Surgeon General Text-Only format.

Cigarillo warnings-FDA proposed text-only

Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the FDA Proposed Text-Only format.

Group Type EXPERIMENTAL

Cigarillo warnings-FDA proposed text-only

Intervention Type BEHAVIORAL

Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the FDA Proposed Text-Only format.

Cigarillo warnings-Pictorial

Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Pictorial format.

Group Type EXPERIMENTAL

Cigarillo warnings-Pictorial

Intervention Type BEHAVIORAL

Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Pictorial format.

Interventions

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Cigarillo warnings-Surgeon General Text-Only

Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Surgeon General Text-Only format.

Intervention Type BEHAVIORAL

Cigarillo warnings-FDA proposed text-only

Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the FDA Proposed Text-Only format.

Intervention Type BEHAVIORAL

Cigarillo warnings-Pictorial

Participants will complete 6 mock shopping trips in the Experimental Tobacco Marketplace, and be asked to spend their weekly tobacco budget. Cigarillos in the Marketplace will have one of three cigarillo warnings in the Pictorial format.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Current cigarillo users: used cigarillos at least one time per week in the past month
* Members of the Kantar Media panel

Exclusion Criteria

* Non-English speakers
* Non-current cigarillo users
* Not members of Kantar Media
Minimum Eligible Age

21 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brown University

OTHER

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Food and Drug Administration (FDA)

FED

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer C Ross, PhD

Role: PRINCIPAL_INVESTIGATOR

BU School of Public Health

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R01CA260460

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NE-1

Identifier Type: -

Identifier Source: org_study_id

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