CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,029 enrolled
Drug / intervention
Newly developed warnings with images at 30% size +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05849051
NCT05849051N/ACompleted

Little Cigar and Cigarillo Warnings to Reduce Tobacco-Related Cancers and Disease: Randomized Controlled Trial Among US Adults Who Use LCCs

UNC Lineberger Comprehensive Cancer Center·interventional·Posted May 8, 2023·Updated Jan 8, 2025

In Brief

A clinical study evaluating Newly developed warnings with images at 30% size and FDA proposed text-only warnings at 30% size for Tobacco Use. Completed, enrolled 1,029 participants across 1 site.

Detailed Summary

The goal of this research is to assess whether little Cigars and cigarillos (LCC) warnings developed by the study team are more effective than the current warnings proposed by FDA for LCC products. A 3-week web-based randomized controlled trial will be conducted in the United States. Participants are adult persons who currently use LCCs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTobacco Use
CountriesUnited States

Timeline

N/ACompletedFinished
202420252026
First PostedMay 8, 2023
Enrollment StartMay 22, 2023
Primary CompletionAug 27, 2023
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 3.1 years ago

Interventions

Newly developed warnings with images at 30% sizebehavioral

On study days 1-6, 8-13 and 15-20, participants in this condition will view an image of a little cigar and cigarillo package with a warning developed by the study team that includes an image. The warnings will take up 30% of the package. Participants will view a total of 6 different warnings over the course of 6 days each week, this will be repeated 3 times during the study, resulting in a total of 18 exposures. Participants will be required to view the warning for at least 5 seconds.

FDA proposed text-only warnings at 30% sizebehavioral

On study days 1-6, 8-13 and 15-20, participants in this condition will view an image of a little cigar and cigarillo package with a warning proposed by the FDA which is text only. The warnings will take up 30% of the package. Participants will view a total of 6 different warnings over the course of 6 days each week, this will be repeated 3 times during the study, resulting in a total of 18 exposures. Participants will be required to view the warning for at least 5 seconds.