Cigar SmokingNCT05434013
The Impact of Cigarillo Warnings on Purchasing
A study testing Cigarillo warnings-Surgeon General Text-Only, Cigarillo warnings-FDA proposed text-only and Cigarillo warnings-Pictorial in people with Cigar Smoking, run by Boston University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigar Smoking
- What is being tested?
- Cigarillo warnings-Surgeon General Text-Only, Cigarillo warnings-FDA proposed text-only and Cigarillo warnings-Pictorial
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,578 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2022to 21 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current cigarillo users: used cigarillos at least one time per week in the past month
- Members of the Kantar Media panel
Who cannot join
- Non-English speakers
- Non-current cigarillo users
- Not members of Kantar Media
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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.
- Conditions
- Cigar Smoking
- Being tested
- Cigarillo warnings-Surgeon General Text-Only, Cigarillo warnings-FDA proposed text-only, Cigarillo warnings-Pictorial
- Keywords
- Cigarillo smoking, Cigarillo packaging warnings
- Medical subject headings
- Cigar Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cigarillo warnings-Surgeon General Text-OnlyBehavioural
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-onlyBehavioural
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-PictorialBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cigarillo warnings-Surgeon General Text-Only | Experimental | 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. Receives: Behavioral: Cigarillo warnings-Surgeon General Text-Only |
| Cigarillo warnings-FDA proposed text-only | Experimental | 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. Receives: Behavioral: Cigarillo warnings-FDA proposed text-only |
| Cigarillo warnings-Pictorial | Experimental | 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. Receives: Behavioral: Cigarillo warnings-Pictorial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Total Number of Cigarillos Purchased
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.
Measured: Within the 20-minute survey
Secondary outcomes (5)
Average Total Amount of mg Combusted Tobacco Purchased
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
Measured: Within the 20-minute survey
Average Total Amount of mg Non-combusted Tobacco Purchased
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.
Measured: Within the 20-minute survey
Intensity Index for Cigarillos
Number of cigarillos purchased at lowest price, averaged across the six shopping trips
Measured: Within the 20 minute survey.
Cost Related Indices for Cigarillos
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.
Measured: Within the 20-minute survey
Rate of Change for Cigarillo Demand
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.
Measured: Within the 20-minute survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start24 Jun 2022
- Primary completion21 Jul 2022
- Study completion21 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cigar SmokingStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,578 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, National Institutes of Health (NIH), Food and Drug Administration (FDA), National Cancer Institute (NCI), Wake Forest University Health Sciences
- Responsible party
- Sponsor
- Investigators
- Jennifer C Ross, PhD, Principal investigator, BU School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434013
- Sponsor's protocol ID
- NE-1
- Other IDs
- R01CA260460
- Status last verified
- Aug 2023
- First submitted
- 22 Jun 2022
- Last updated
- 2 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Cigarillo Warnings on Purchasing Behaviors Among Young Adult Cigarillo Users
- ClinicalTrials.gov ID
- NCT05434013
- Acronym / sponsor ID
- NE-1
- Conditions
- Cigar Smoking
- Keywords
- Cigarillo smoking, Cigarillo packaging warnings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,578 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Brown University, National Institutes of Health (NIH), Food and Drug Administration (FDA), National Cancer Institute (NCI), Wake Forest University Health Sciences
- Study start
- 24 Jun 2022 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 21 Jul 2022 (actual)
- First posted
- 27 Jun 2022 (actual)
- Results
- Posted 2 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cigarillo warnings-Surgeon General Text-Only | Experimental | Behavioral: Cigarillo warnings-Surgeon General Text-OnlyParticipants 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 | Experimental | Behavioral: Cigarillo warnings-FDA proposed text-onlyParticipants 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 | Experimental | Behavioral: Cigarillo warnings-PictorialParticipants 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. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Current cigarillo users: used cigarillos at least one time per week in the past month
- Members of the Kantar Media panel
Key exclusion criteria (3 listed)
- Non-English speakers
- Non-current cigarillo users
- Not members of Kantar Media
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cigarillo warnings-Surgeon General Text-OnlyParticipants 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. | Behavioural | Cigarillo warnings-Surgeon General Text-Only |
| Cigarillo warnings-FDA proposed text-onlyParticipants 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. | Behavioural | Cigarillo warnings-FDA proposed text-only |
| Cigarillo warnings-PictorialParticipants 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. | Behavioural | Cigarillo warnings-Pictorial |
Primary outcome
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.
5 secondary outcomes
Average Total Amount of mg Combusted Tobacco Purchased
Time frame: Within the 20-minute survey
Average Total Amount of mg Non-combusted Tobacco Purchased
Time frame: Within the 20-minute survey
Intensity Index for Cigarillos
Time frame: Within the 20 minute survey.
Cost Related Indices for Cigarillos
Time frame: Within the 20-minute survey
Rate of Change for Cigarillo Demand
Time frame: Within the 20-minute survey
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer C Ross, PhD principal investigator
BU School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cigarillo warnings-Surgeon General Text-Only, Cigarillo warnings-FDA proposed text-only and Cigarillo warnings-Pictorial in people with Cigar Smoking, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Total Number of Cigarillos Purchased (time frame: Within the 20-minute survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.