Tobacco UseNCT06546618
Little Cigar and Cigarillo Warnings to Reduce Tobacco-Related Cancers and Disease - Eye Tracking
A study testing LCC pack stimuli images in people with Tobacco Use, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The goal of this research is to determine how removal of little cigar and cigarillo (LCC) flavor descriptors on packaging impacts attention and affective responses to LCC warnings. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use
- What is being tested?
- LCC pack stimuli images
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2024to 5 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 21 years old
- Pass quality/bot screening (will answer honestly, captcha, simple math question)
- Speak English
- Current every day or some day users of LCC products
- Able to come to an appointment in NC triangle area
- Do not have any eye conditions that prevent them from being eye tracked (e.g., glaucoma, lazy eye, bifocals)
Who cannot join
- Under 21 years old
- Do not speak English
- Unable to pass quality/bot screening
- Unable to come to an appointment
- Eye conditions that prevent eye tracking (e.g., glaucoma, lazy eye, bifocals)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
The goal of this research is to determine how removal of little cigar and cigarillo (LCC) flavor descriptors on packaging impacts attention and affective responses to LCC warnings. A study will be conducted using eye tracking, electrodermal activity (galvanic skin response), and survey measures of affect to measure participant responses to LCC packages varied by warning type (pictorial vs. text only) and flavor contents ('Sweet' flavor descriptor vs. no flavor descriptor).
Read the detailed description
Over 4 million US adults regularly smoke cigars, which causes multiple cancers, including oral, esophageal, pancreatic, laryngeal, and lung cancer. Even smoking 1-2 cigars per day is associated with elevated cancer risk. Though cigarette consumption decreased 39% from 2000 to 2015, cigar consumption increased 85%. Of the three major types of cigars-large cigars, little cigars, and cigarillos-little cigars and cigarillos (LCC) are the most commonly used in the US. LCC use among adults has increased in part because LCCs are taxed at a lower rate than cigarettes, are subject to fewer regulations and marketing restrictions, can be purchased in small pack sizes, and are exempt from flavor bans that apply to cigarettes.
In May 2016, the Food and Drug Administration (FDA) required text-only warnings on LCC packs, rotating among six statements. Research on cigarettes suggests warnings on packs should have multiple rotating sets, contain images illustrating the negative health effects associated with LCC use, and be large. However, the evidence for cigarette warning labels cannot adequately inform implementation of improved LCC warnings for four reasons: 1) The currently mandated cigar warnings differ from existing cigarette warnings; 2) there is no evidence on the effectiveness of the currently mandated cigar warnings (i.e., behavioral intentions or outcomes) or evidence on efforts that might improve LCC warnings (i.e., images, larger warning size, removal of LCC flavor descriptors on packaging); 3) Courts have ruled that one type of effective tobacco warning (i.e., for cigarettes) cannot be used to justify other types of tobacco warnings, such as those for LCCs and 4) LCC users have different demographic and consumption profiles than cigarette users (i.e., LCC users include a higher proportion of young adults African Americans, and LCCs are used on fewer days per month, which should be taken into account when developing improved warnings.
Gaps exist in understanding how LCC policies, such as the removal of flavor descriptors on packaging, influence the impact of LCC warnings. This eye tracking and psychophysiology project will provide new data to fill these evidence gaps and advance general scientific knowledge about elements of tobacco warnings research.
During the study, Participants will see 12 LCC pack stimuli images presented in random order. 3 packs will feature pictorial LCC warnings and a "Sweet" flavor descriptor, and the same 3 warnings will be presented on packs without a flavor. The remaining 6 LCC packs will have 3 text-only warnings, with 3 images containing the "Sweet" flavor and 3 images without a flavor. We will measure attention to the warnings and attention to the flavor descriptors as well as electrodermal activity and affective responses for each of the 12 stimuli.
- Conditions
- Tobacco Use
- Being tested
- LCC pack stimuli images
- Keywords
- Text-only warning messages, LCC packages with flavor descriptors, pictorial warnings messages, LCC packages without flavor descriptors
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCC pack stimuli imagesBehavioural
All participants saw LCC pack stimuli images presented in random order, 4 package conditions were repeated with 3 warnings applied to each (12 stimuli total).
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Other | All participants saw LCC pack stimuli images presented in random order, 4 package conditions were repeated with 3 warnings applied to each (12 stimuli total). Receives: Behavioral: LCC pack stimuli images |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention to Warning Areas of Interest
Mean attention to warning areas of interest in seconds will be measured by dwell time to pre-defined areas of interest on the LCC packages. The mean amount of time in seconds that participants spend looking at the flavor area of interest for the 3 packages in each condition will be determined.
Measured: During one time study appointment
Attention to Flavor Areas of Interest
Mean attention to flavor areas of interest in seconds will be measured by dwell time to pre-defined areas of interest on the LCC packages. The mean amount of time in seconds that participants spend looking at the flavor area of interest for the 3 packages in each condition will be determined.
Measured: During one time study appointment
Secondary outcomes (2)
Positive Affect
Mean positive affect response to warnings will be measured using an adaptation of the Discrete Emotions Questionnaire. The positive affect questionnaire will include 6 different emotions to measure participant's emotional responses to the cigarillo packages. Participants will rate to what extent they experienced each emotion while viewing the LCC package on a scale of 1 to 7, where 1=not at all and 7=an extreme amount. Higher affective responses indicate stronger positive emotional reactions to the LCC package. The mean positive affect will reflect the mean positive affect rating for the 3 packages in each condition.
Measured: During one time study appointment
Negative Affect
Mean negative affect response to warnings will be measured using an adaptation of the Discrete Emotions Questionnaire. The negative affect questionnaire will include 6 different emotions to measure participant's emotional responses to the cigarillo packages. Participants will rate to what extent they experienced each emotion while viewing the LCC package on a scale of 1 to 7, where 1=not at all and 7=an extreme amount. Higher affective responses indicate stronger negative emotional reactions to the LCC package. The mean negative affect will reflect the mean negative affect rating for the 3 packages in each condition.
Measured: During one time study appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start14 Aug 2024
- Primary completion5 Mar 2025
- Study completion5 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 Tobacco UseStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants saw LCC pack stimuli images presented in random order, 4 package conditions were repeated with 3 warnings applied to each (12 stimuli total).
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Adam O Goldstein, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546618
- Sponsor's protocol ID
- 24-0841
- Other IDs
- R01CA240732
- Status last verified
- Jun 2026
- First submitted
- 6 Aug 2024
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Little Cigar and Cigarillo Warnings to Reduce Tobacco-Related Cancers and Disease - Eye Tracking
- ClinicalTrials.gov ID
- NCT06546618
- Acronym / sponsor ID
- 24-0841
- Conditions
- Tobacco Use
- Keywords
- Text-only warning messages, LCC packages with flavor descriptors, pictorial warnings messages, LCC packages without flavor descriptors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Food and Drug Administration (FDA)
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Posted 2 Jul 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 research is to determine how removal of little cigar and cigarillo (LCC) flavor descriptors on packaging impacts attention and affective responses to LCC warnings. A study will be conducted using eye tracking, electrodermal activity (galvanic skin response), and survey measures of affect to measure participant responses to LCC packages varied by warning type (pictorial vs. text only) and flavor contents ('Sweet' flavor descriptor vs. no flavor descriptor).
Detailed description
Over 4 million US adults regularly smoke cigars, which causes multiple cancers, including oral, esophageal, pancreatic, laryngeal, and lung cancer. Even smoking 1-2 cigars per day is associated with elevated cancer risk. Though cigarette consumption decreased 39% from 2000 to 2015, cigar consumption increased 85%. Of the three major types of cigars-large cigars, little cigars, and cigarillos-little cigars and cigarillos (LCC) are the most commonly used in the US. LCC use among adults has increased in part because LCCs are taxed at a lower rate than cigarettes, are subject to fewer regulations and marketing restrictions, can be purchased in small pack sizes, and are exempt from flavor bans that apply to cigarettes.
In May 2016, the Food and Drug Administration (FDA) required text-only warnings on LCC packs, rotating among six statements. Research on cigarettes suggests warnings on packs should have multiple rotating sets, contain images illustrating the negative health effects associated with LCC use, and be large. However, the evidence for cigarette warning labels cannot adequately inform implementation of improved LCC warnings for four reasons: 1) The currently mandated cigar warnings differ from existing cigarette warnings; 2) there is no evidence on the effectiveness of the currently mandated cigar warnings (i.e., behavioral intentions or outcomes) or evidence on efforts that might improve LCC warnings (i.e., images, larger warning size, removal of LCC flavor descriptors on packaging); 3) Courts have ruled that one type of effective tobacco warning (i.e., for cigarettes) cannot be used to justify other types of tobacco warnings, such as those for LCCs and 4) LCC users have different demographic and consumption profiles than cigarette users (i.e., LCC users include a higher proportion of young adults African Americans, and LCCs are used on fewer days per month, which should be taken into account when developing improved warnings.
Gaps exist in understanding how LCC policies, such as the removal of flavor descriptors on packaging, influence the impact of LCC warnings. This eye tracking and psychophysiology project will provide new data to fill these evidence gaps and advance general scientific knowledge about elements of tobacco warnings research.
During the study, Participants will see 12 LCC pack stimuli images presented in random order. 3 packs will feature pictorial LCC warnings and a "Sweet" flavor descriptor, and the same 3 warnings will be presented on packs without a flavor. The remaining 6 LCC packs will have 3 text-only warnings, with 3 images containing the "Sweet" flavor and 3 images without a flavor. We will measure attention to the warnings and attention to the flavor descriptors as well as electrodermal activity and affective responses for each of the 12 stimuli.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants saw LCC pack stimuli images presented in random order, 4 package conditions were repeated with 3 warnings applied to each (12 stimuli total).
| Arm | Type | Receives |
|---|---|---|
| All Participants | Other | Behavioral: LCC pack stimuli imagesAll participants saw LCC pack stimuli images presented in random order, 4 package conditions were repeated with 3 warnings applied to each (12 stimuli total). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over 21 years old
- Pass quality/bot screening (will answer honestly, captcha, simple math question)
- Speak English
- Current every day or some day users of LCC products
- Able to come to an appointment in NC triangle area
Key exclusion criteria (5 listed)
- Under 21 years old
- Do not speak English
- Unable to pass quality/bot screening
- Unable to come to an appointment
- Eye conditions that prevent eye tracking (e.g., glaucoma, lazy eye, bifocals)
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 |
|---|---|---|
| LCC pack stimuli imagesAll participants saw LCC pack stimuli images presented in random order, 4 package conditions were repeated with 3 warnings applied to each (12 stimuli total). | Behavioural | All Participants |
Primary outcome
Attention to Warning Areas of Interest
Time frame: During one time study appointment
Mean attention to warning areas of interest in seconds will be measured by dwell time to pre-defined areas of interest on the LCC packages. The mean amount of time in seconds that participants spend looking at the flavor area of interest for the 3 packages in each condition will be determined.
Attention to Flavor Areas of Interest
Time frame: During one time study appointment
Mean attention to flavor areas of interest in seconds will be measured by dwell time to pre-defined areas of interest on the LCC packages. The mean amount of time in seconds that participants spend looking at the flavor area of interest for the 3 packages in each condition will be determined.
2 secondary outcomes
Positive Affect
Time frame: During one time study appointment
Negative Affect
Time frame: During one time study appointment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
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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.
Adam O Goldstein principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LCC pack stimuli images in people with Tobacco Use, run by UNC Lineberger Comprehensive Cancer Center 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 6 inclusion and 5 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 Jul 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 2 Jul 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?
Attention to Warning Areas of Interest (time frame: During one time study appointment). The study lists 2 primary outcomes in all. 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 Jul 2026.