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

Click on a node to explore related trials.

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
1.3 years until next milestone

Results Posted

Study results publicly available

July 2, 2026

Completed
Last Updated

July 2, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

August 6, 2024

Results QC Date

March 9, 2026

Last Update Submit

June 5, 2026

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

    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.

    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.

    During one time study appointment

Secondary Outcomes (2)

  • Positive Affect

    During one time study appointment

  • Negative Affect

    During one time study appointment

Study Arms (1)

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).

Behavioral: LCC pack stimuli images

Interventions

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).

All Participants

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

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Adam O Goldstein
Organization
UNC Lineberger Comprehensive Cancer Center

Study Officials

  • Adam O Goldstein

    UNC Lineberger Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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).
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

July 2, 2026

Results First Posted

July 2, 2026

Record last verified: 2026-06

Locations