NCT06546618

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

August 14, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2025

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2024

Enrollment Period

7 months

First QC Date

August 6, 2024

Last Update Submit

September 15, 2025

Conditions

Keywords

Text-only warning messagesLCC packages with flavor descriptorspictorial warnings messagesLCC packages without flavor descriptors

Outcome Measures

Primary Outcomes (2)

  • Attention to warning areas of interest

    Attention to warning areas of interest will be measured by dwell time to pre-defined areas of interest on the little cigars or cigarillos (LCCs) package. The total amount of time in iseconds that participants spend looking at warnings will be determined.

    Baseline

  • Attention to flavor area of interest

    Attention to flavor area of interest will be measured by dwell time to pre-defined areas of interest on the little cigars or cigarillos (LCCs) package. The total amount of time inseconds that people spend looking at the area where the flavor of the LCC is shown will be determined.

    Baseline

Secondary Outcomes (2)

  • Electrodermal activity

    Baseline

  • Affective response to warnings

    Baseline

Study Arms (4)

LCC Package with pictorial warning and no flavor

EXPERIMENTAL

Participants will see a mock LCC package with pictorial warnings and no flavor descriptor.

Behavioral: pictorial warning and no flavor

LCC Package with pictorial warning and 'sweet' flavor

EXPERIMENTAL

Participants will see a mock LCC package with pictorial warnings and a 'sweet' flavor descriptor.

Behavioral: pictorial warning and 'sweet' flavor

LCC Package with text-only warning and no flavor

EXPERIMENTAL

Participants will see a mock LCC package with text-only warnings and no flavor descriptor.

Behavioral: text-only warning and no flavor

LCC Package with text-only warning and 'sweet' flavor

EXPERIMENTAL

Participants will see a mock LCC package with text-only warnings and a 'sweet' flavor descriptor

Behavioral: text-only warning and 'sweet' flavor

Interventions

LCC Package with pictorial warning and no flavor

LCC Package with pictorial warning and no flavor

LCC Package with pictorial warning and 'sweet' flavor

LCC Package with pictorial warning and 'sweet' flavor

LCC Package with text-only warning and no flavor

LCC Package with text-only warning and no flavor

LCC Package with text-only warning and 'sweet' flavor

LCC Package with text-only warning and 'sweet' flavor

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

MeSH Terms

Conditions

Tobacco Use

Interventions

Candy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Adam O Goldstein

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2024

First Posted

August 9, 2024

Study Start

August 14, 2024

Primary Completion

March 5, 2025

Study Completion

March 5, 2025

Last Updated

September 16, 2025

Record last verified: 2024-09

Locations