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OpenTrials
Completed

NCT Number: NCT05434013

The Impact of Cigarillo Warnings on Purchasing

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.

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Key information

Age range

21 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cigarillo warnings-Surgeon General Text-Only

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

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. Intensity Index for Cigarillos

    Time frame: Within the 20 minute survey.

    Number of cigarillos purchased at lowest price, averaged across the six shopping trips

  4. 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.

  5. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Brown University
  • Food and Drug Administration (FDA)
  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)
  • Wake Forest University Health Sciences

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 27, 2022
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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