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OpenTrials
Completed

NCT Number: NCT06546618

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

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).

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Key information

Conditions

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

LCC pack stimuli images

Behavioral

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).

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Positive Affect

    Time frame: During one time study appointment

    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.

  2. Negative Affect

    Time frame: During one time study appointment

    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.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • Food and Drug Administration (FDA)
  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Jul 2, 2026

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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