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Little Cigar and Cigarillo Warnings to Reduce Tobacco-Related Cancers and Disease - Eye Tracking

Little Cigar and Cigarillo Warnings to Reduce Tobacco-Related Cancers and Disease - Eye Tracking

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06546618
Enrollment
90
Registered
2024-08-09
Start date
2024-08-14
Completion date
2025-03-05
Last updated
2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use

Keywords

Text-only warning messages, LCC packages with flavor descriptors, pictorial warnings messages, LCC packages without flavor descriptors

Brief 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. 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.

Interventions

BEHAVIORALLCC pack stimuli images

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).

Sponsors

UNC Lineberger Comprehensive Cancer Center
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH
Food and Drug Administration (FDA)
CollaboratorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention 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).

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Participants will be recruited through flyers, emails, and recruitment websites to identify potentially eligible participants local to our study location (Chapel Hill/Carrboro, NC) Inclusion Criteria: * 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)

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Attention to Warning Areas of InterestDuring one time study appointmentMean 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 InterestDuring one time study appointmentMean 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.

Secondary

MeasureTime frameDescription
Positive AffectDuring one time study appointmentMean 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.
Negative AffectDuring one time study appointmentMean 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAdam O Goldstein

UNC Lineberger Comprehensive Cancer Center

Participant flow

Recruitment details

Participants were recruited and screened for study eligibility online between July 2024 and March 2025, and invited to in the study once they were determined to be eligible.

Pre-assignment details

90 participants arrived for their study appointment, began the study, and completed the study, which was a one-time appointment. 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).

Baseline characteristics

Characteristic
Age, Continuous37.3 years
STANDARD_DEVIATION 12.8
Ethnicity (NIH/OMB)
Hispanic or Latino
9 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
80 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
3 Participants
Race (NIH/OMB)
Black or African American
48 Participants
Race (NIH/OMB)
More than one race
7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants
Race (NIH/OMB)
White
25 Participants
Sex/Gender, Customized
Man
53 Participants
Sex/Gender, Customized
Other
2 Participants
Sex/Gender, Customized
Woman
35 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 90
other
Total, other adverse events
0 / 90
serious
Total, serious adverse events
0 / 90

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026