The Impact of Cigarillo Warnings on Purchasing

August 1, 2023 updated by: Boston University

The Impact of Cigarillo Warnings on Purchasing Behaviors Among Young Adult Cigarillo Users

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1578

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: 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.
Experimental: 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.
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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Average Total Number of Cigarillos Purchased
Time Frame: Within the 20-minute survey
Participants in each arm will participate in six mock shopping trips with a specified budget. They will purchase (mock) single cigarillos. The primary outcome is the average number of cigarillos purchased during each of the six mock shopping trips.
Within the 20-minute survey

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Average Total Amount of mg Combusted Tobacco Purchased
Time Frame: Within the 20-minute survey
Participants will participate in six mock shopping trips with a specified budget. They will have the option to purchase (mock) tobacco products in addition to cigarillos: cigarettes, menthol cigarettes, e-cigarettes/vaping devices, oral nicotine. This outcome will be the sum mg of the number of combusted non-cigarillo tobacco products purchased during each of the six mock shopping trips
Within the 20-minute survey
Average Total Amount of mg Non-combusted Tobacco Purchased
Time Frame: Within the 20-minute survey
Participants will participate in six mock shopping trips with a specified budget. They will have the option to purchase (mock) tobacco products in addition to cigarillos: cigarettes, menthol cigarettes, e-cigarettes/vaping devices, oral nicotine. This outcome will be the sum mg of the number of non-combusted tobacco products purchased during each of the six mock shopping trips.
Within the 20-minute survey
Intensity Index for Cigarillos
Time Frame: Within the 20 minute survey.
Number of cigarillos purchased at lowest price, averaged across the six shopping trips
Within the 20 minute survey.
Cost Related Indices for Cigarillos
Time Frame: Within the 20-minute survey
Omax is the maximum amount spent on cigarillos across all shopping trips. Breakpoint is the price where no cigarillos were purchased. Pmax is the price where Omax occurs.
Within the 20-minute survey
Rate of Change for Cigarillo Demand
Time Frame: Within the 20-minute survey
The rate of change for cigarillo demand is called Alpha, which is the rate constant of fitted Exponentiated Demand Equation. It is calculated with the Exponentiated Demand Equation, Q=Q0*10^k(e-αQ0C -1), where Q is the mg of nicotine purchased at a given price, Q0 is peak demand consumption or intensity (typically occurring at the lowest price), k is a constant across all compared conditions, and alpha (α) is the rate of change in demand or elasticity.
Within the 20-minute survey

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Perceived Message Effectiveness
Time Frame: Within the 20-minute survey
The 3-item UNC mean perceived message effectiveness scale assesses a participant's judgement of a warning's impact on their cigarillo beliefs and behavior. Response options are on a 1 to 5 scale. Overall scores are determined by summing the scores of the 3 items and dividing by 3 (range 1-5), with higher scores representing a higher amount of the construct
Within the 20-minute survey
Self-Reported Learning
Time Frame: Within the 20-minute survey
One survey item asking participants to what extent did they learn something new from the warning. Response options are on a 1 to 5 scale, with the higher number indicating more self-reported learning.
Within the 20-minute survey
Negative Affect
Time Frame: Within the 20-minute survey
Three survey items to measure emotional reactions (anxious, scared, disgusted) to the cigarillo warning the participant saw. Response options are on a 1 to 5 scale. Overall scale scores are determined by summing scores of the 4 items and dividing by 4 (range 1-5), with higher scores representing a higher amount of the construct.
Within the 20-minute survey
Cognitive Elaboration
Time Frame: Within the 20-minute survey
The 1 item measure assesses the extent to which a participant reports the warning making them think about the risks of cigarillo smoking. Response options are on a 1 to 5 scale, with higher scores representing a higher amount of the construct.
Within the 20-minute survey
Intentions to Quit Using Cigarillos
Time Frame: Within the 20-minute survey
Three survey items to measure participant's interest in quitting cigarillo smoking in the next month, likelihood of quitting smoking cigarillos in the month week, and plans to quit smoking cigarillos in the next month. Response options are on a 1 to 5 scale. Overall scale scores are determined by summing the scores of the 3 items and dividing by 3 (range 1-5), with higher scores representing a higher amount of the construct/intentions to quit
Within the 20-minute survey
Warning Recall
Time Frame: Within the 20-minute survey
one survey item asking participants if they noticed any health warnings on the cigarillo packages during their shopping tasks, with response options of Yes, No, and I'm not sure. Recall will be determine if participants select Yes.
Within the 20-minute survey
Warning Recognition
Time Frame: Within the 20-minute survey
One survey item asking participants to identify which warning they saw during their mock shopping trips. Participants will be shown their warning, a warning that wasn't in their ETM, and "I don't know" response options. Selecting the correct warning indicates warning recognition.
Within the 20-minute survey
Average Total Amount of Non-tobacco Products Purchased
Time Frame: Within the 20-minute survey
Participants will participate in six mock shopping trips with a specified budget. They will have the option to purchase (mock) tobacco products in addition to cigarillos: cigarettes, menthol cigarettes, e-cigarettes/vaping devices, oral nicotine, and two non-tobacco options: snack food and non-alcoholic beverage. This outcome will be the sum mg of the number of non- tobacco products purchased during each of the six mock shopping trips.
Within the 20-minute survey

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
Brown University
National Institutes of Health (NIH)
Wake Forest University Health Sciences
Food and Drug Administration (FDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer C Ross, PhD, BU School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 24, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 21, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 21, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NE-1
  • R01CA260460 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual data may be provided to qualified investigators starting 9 months and ending 36 months after publication. Investigators proposing to use the data must receive a data use agree with Wake Forest University Health Sciences and seek approval from an Institutional Review Board (IRB), or similar body identified for this purpose.

IPD Sharing Time Frame

9-36 months following publication

IPD Sharing Access Criteria

Qualified researchers engaged in independent scientific research with IRB approval and a data use agreement with Wake Forest University Health Sciences.

IPD Sharing Supporting Information Type

  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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