Smoking, CigarNCT05838378
Cigarillo Warnings Image Sorting Study
A study testing Package image sorting with pictorial warnings, Package image sorting with Surgeon General text-only warnings and Package image sorting with FDA text-only warnings in people with Smoking, Cigar, run by Boston University at 1 site in United States.
Trial summary
The goal of this study is to examine the impact of repeated exposure to cigarillo warnings on cigarillo users' intentions and behaviors for cigarillo smoking. Eligible participants will be randomized to one of three experimental conditions that will vary based on cigarillo warning format. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Cigar
- What is being tested?
- Package image sorting with pictorial warnings, Package image sorting with Surgeon General text-only warnings and Package image sorting with FDA text-only warnings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 764 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2025to 25 Mar 2025
- 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 user-used cigarillos at least one time per week in the past month
- Recruited through Qualtrics Research Services
Who cannot join
- Not recruited through Qualtrics Research Services
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University School of Public Health, study online
Boston, Massachusetts, 02118
About this study
Official title: The Impact of Cigarillo Warnings on Purchasing and Smoking Behaviors Among Young Adult Cigarillo Users, Aim 2 Survey
The goal of this study is to examine the impact of repeated exposure to cigarillo warnings on cigarillo users' intentions and behaviors for cigarillo smoking. Eligible participants will be randomized to one of three experimental conditions that will vary based on cigarillo warning format.
For 4 weeks, participants will participate in an image-sorting task where they will be asked to sort a set of ~18 cigarillo packages into flavor categories determined a priori by the research team (e.g., Mint, Fruit, Dessert).
Read more
At the end of the study, participants will be notified of the purpose of the study and provided links to resources with information about the harms of cigarillo smoking and cessation.
The study will be conducted in an online survey, working with Qualtrics research company, who will program the survey, recruit and screen participants, and administer the survey.
- Conditions
- Smoking, Cigar
- Being tested
- Package image sorting with pictorial warnings, Package image sorting with Surgeon General text-only warnings, Package image sorting with FDA text-only warnings
- Keywords
- Current cigarillo user, Cigar/cigarillo quit intentions, Pictorial warning format, Surgeon General text warning format, FDA text warning format
- Medical subject headings
- Cigar Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Package image sorting with pictorial warningsOther
Weekly for four weeks participants will complete an image-sorting task based on sorting cigarillos by flavor categories [fruit (e.g., Grape), alcohol (e.g., Wine) desserts/candy (e.g., Sticky Sweets), mint (e.g., Menthol), color (e.g., Blue Crush), and other]. Participants will sort 18 images of cigarillo packages from various brands with pictorial warnings on each pack.
Package image sorting with Surgeon General text-only warningsOther
Weekly for four weeks participants will complete an image-sorting task based on sorting cigarillos by flavor categories [fruit (e.g., Grape), alcohol (e.g., Wine) desserts/candy (e.g., Sticky Sweets), mint (e.g., Menthol), color (e.g., Blue Crush), and other]. Participants will sort 18 images of cigarillo packages from various brands with Surgeon General text-only warnings on each pack.
Package image sorting with FDA text-only warningsOther
Weekly for four weeks participants will complete an image-sorting task based on sorting cigarillos by flavor categories [fruit (e.g., Grape), alcohol (e.g., Wine) desserts/candy (e.g., Sticky Sweets), mint (e.g., Menthol), color (e.g., Blue Crush), and other]. Participants will sort 18 images of cigarillo packages from various brands with FDA text-only warnings on each pack.
| Study group | Role | What they receive |
|---|---|---|
| Pictorial warnings | Experimental | Participants randomized to this group will view pictorial cigarillo warnings. Receives: Other: Package image sorting with pictorial warnings |
| FDA text-only warnings | Active comparator | Participants randomized to this group will view FDA text-only warnings. Receives: Other: Package image sorting with FDA text-only warnings |
| Surgeon General text-only warnings | Active comparator | Participants randomized to this group will view Surgeon General text-only warnings. Receives: Other: Package image sorting with Surgeon General text-only warnings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intention to Quit Smoking Cigarillos in the Next 30 Days at Weeks 2-4
Assessed by the score for 3 survey items: 1) how interested participants are in quitting cigarillo smoking in the next 30 days; 2) how likely they are to quit smoking cigarillos in the next 30 days; and 3) how much they plan to quit smoking cigarillos in the next 30 days. Each survey item has a 5-pt response scale (1=Not at all to 5= Extremely). All items are averaged to create a composite quit intentions score which can range from 1 to 5. Higher scores are associated with a greater intention to quit.
Measured: Weeks 2-4
Secondary outcomes (4)
Interest Cutting Smoking
Assessed by a single survey item asking how interested participants are in cutting back or reducing the number of cigarillos they smoke in the next 30 days. The survey item has a 5-pt response scale (1=Not at all to 5= Extremely). Higher numbers are associated with greater interest in cutting back or reducing the number of cigarillos smoked in the next 30 days
Measured: Weeks 2-4
Number of Participants in Week 2 Who Reported Specific Behaviors to Reduce Cigarillo Smoking for the Past Week
Assessed by 4 survey items with response options of yes/no: in the past week, have you: 1) butted out a cigarillo before you finished because you wanted to smoke less? 2) stopped yourself from smoking a cigarillo because you wanted to smoke less? 3) tried to quit cigarillos completely; 4) tried cutting back on your cigarillo smoking?
Measured: Week 2
Number of Participants in Week 3 Who Reported Specific Behaviors to Reduce Cigarillo Smoking for the Past Week
Assessed by 4 survey items with response options of yes/no: in the past week, have you: 1) butted out a cigarillo before you finished because you wanted to smoke less? 2) stopped yourself from smoking a cigarillo because you wanted to smoke less? 3) tried to quit cigarillos completely; 4) tried cutting back on your cigarillo smoking?
Measured: Week 3
Number of Participants in Week 4 Who Reported Specific Behaviors to Reduce Cigarillo Smoking for the Past Week
Assessed by 4 survey items with response options of yes/no: in the past week, have you: 1) butted out a cigarillo before you finished because you wanted to smoke less? 2) stopped yourself from smoking a cigarillo because you wanted to smoke less? 3) tried to quit cigarillos completely; 4) tried cutting back on your cigarillo smoking?
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start14 Jan 2025
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
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 Smoking, CigarStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 764 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Wake Forest University Health Sciences, Brown University
- Responsible party
- Sponsor
- Investigators
- Jennifer Ross, PhD, Principal investigator, School of Public Health - Health Law Policy & Management Dept
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838378
- Sponsor's protocol ID
- H-43316
- Other IDs
- R01CA260460
- Status last verified
- Mar 2026
- First submitted
- 18 Apr 2023
- Last updated
- 8 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Cigarillo Warnings on Purchasing and Smoking Behaviors Among Young Adult Cigarillo Users, Aim 2 Survey
- ClinicalTrials.gov ID
- NCT05838378
- Acronym / sponsor ID
- H-43316
- Conditions
- Smoking, Cigar
- Keywords
- Current cigarillo user, Cigar/cigarillo quit intentions, Pictorial warning format, Surgeon General text warning format, FDA text warning format
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 764 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Wake Forest University Health Sciences, Brown University
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Posted 8 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to examine the impact of repeated exposure to cigarillo warnings on cigarillo users' intentions and behaviors for cigarillo smoking. Eligible participants will be randomized to one of three experimental conditions that will vary based on cigarillo warning format.
For 4 weeks, participants will participate in an image-sorting task where they will be asked to sort a set of ~18 cigarillo packages into flavor categories determined a priori by the research team (e.g., Mint, Fruit, Dessert).
At the end of the study, participants will be notified of the purpose of the study and provided links to resources with information about the harms of cigarillo smoking and cessation.
The study will be conducted in an online survey, working with Qualtrics research company, who will program the survey, recruit and screen participants, and administer the survey.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pictorial warnings | Experimental | Other: Package image sorting with pictorial warningsParticipants randomized to this group will view pictorial cigarillo warnings. |
| FDA text-only warnings | Active comparator | Other: Package image sorting with FDA text-only warningsParticipants randomized to this group will view FDA text-only warnings. |
| Surgeon General text-only warnings | Active comparator | Other: Package image sorting with Surgeon General text-only warningsParticipants randomized to this group will view Surgeon General text-only warnings. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Current cigarillo user-used cigarillos at least one time per week in the past month
- Recruited through Qualtrics Research Services
Key exclusion criteria (2 listed)
- Not recruited through Qualtrics Research Services
- Non-English speaking
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 |
|---|---|---|
| Package image sorting with pictorial warningsWeekly for four weeks participants will complete an image-sorting task based on sorting cigarillos by flavor categories [fruit (e.g., Grape), alcohol (e.g., Wine) desserts/candy (e.g., Sticky Sweets), mint (e.g., Menthol), color (e.g., Blue Crush), and other]. Participants will sort 18 images of cigarillo packages from various brands with pictorial warnings on each pack. | Other | Pictorial warnings |
| Package image sorting with Surgeon General text-only warningsWeekly for four weeks participants will complete an image-sorting task based on sorting cigarillos by flavor categories [fruit (e.g., Grape), alcohol (e.g., Wine) desserts/candy (e.g., Sticky Sweets), mint (e.g., Menthol), color (e.g., Blue Crush), and other]. Participants will sort 18 images of cigarillo packages from various brands with Surgeon General text-only warnings on each pack. | Other | Surgeon General text-only warnings |
| Package image sorting with FDA text-only warningsWeekly for four weeks participants will complete an image-sorting task based on sorting cigarillos by flavor categories [fruit (e.g., Grape), alcohol (e.g., Wine) desserts/candy (e.g., Sticky Sweets), mint (e.g., Menthol), color (e.g., Blue Crush), and other]. Participants will sort 18 images of cigarillo packages from various brands with FDA text-only warnings on each pack. | Other | FDA text-only warnings |
Primary outcome
Intention to Quit Smoking Cigarillos in the Next 30 Days at Weeks 2-4
Time frame: Weeks 2-4
Assessed by the score for 3 survey items: 1) how interested participants are in quitting cigarillo smoking in the next 30 days; 2) how likely they are to quit smoking cigarillos in the next 30 days; and 3) how much they plan to quit smoking cigarillos in the next 30 days. Each survey item has a 5-pt response scale (1=Not at all to 5= Extremely). All items are averaged to create a composite quit intentions score which can range from 1 to 5. Higher scores are associated with a greater intention to quit.
4 secondary outcomes
Interest Cutting Smoking
Time frame: Weeks 2-4
Number of Participants in Week 2 Who Reported Specific Behaviors to Reduce Cigarillo Smoking for the Past Week
Time frame: Week 2
Number of Participants in Week 3 Who Reported Specific Behaviors to Reduce Cigarillo Smoking for the Past Week
Time frame: Week 3
Number of Participants in Week 4 Who Reported Specific Behaviors to Reduce Cigarillo Smoking for the Past Week
Time frame: week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 Ross, PhD principal investigator
School of Public Health - Health Law Policy & Management Dept
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Package image sorting with pictorial warnings, Package image sorting with Surgeon General text-only warnings and Package image sorting with FDA text-only warnings in people with Smoking, Cigar, 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 2 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 8 Apr 2026. 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 8 Apr 2026). 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?
Intention to Quit Smoking Cigarillos in the Next 30 Days at Weeks 2-4 (time frame: Weeks 2-4). 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 8 Apr 2026.