21 and older, any sex, with Tobacco Use. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
LCC Quit IntentionsPrimary· day 21 (post test)
Average quit intention score measured by survey. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 4, where 1 indicates low intention to quit, and 4 indicates a high intention to quit.
Group
Value
95% CI
Newly Developed Warnings With Images
2.9
± 1.10
FDA Proposed Text-only Warnings
2.49
± 1.12
Control Group, no Intervention
2.54
± 1.09
Number of LCCs Smoked in Past DaySecondary· day 1
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant.
Group
Value
95% CI
Newly Developed Warnings With Images
2.75
± 4.09
FDA Proposed Text-only Warnings
2.47
± 3.14
Control Group, no Intervention
2.28
± 2.85
Number of LCCs Smoked in Past DaySecondary· day 2
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Group
Value
95% CI
Newly Developed Warnings With Images
2.43
± 3.09
FDA Proposed Text-only Warnings
2.62
± 3.30
Control Group, no Intervention
2.21
± 2.79
Number of LCCs Smoked in Past DaySecondary· day 3
The mean number of little cigars and cigarillos (LCCs) smoked in the past day was reported by participants.
Group
Value
95% CI
Newly Developed Warnings With Images
2.56
± 3.17
FDA Proposed Text-only Warnings
2.66
± 3.13
Control Group, no Intervention
2.44
± 2.86
Number of LCCs Smoked in Past DaySecondary· day 4
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant.
Group
Value
95% CI
Newly Developed Warnings With Images
2.66
± 3.51
FDA Proposed Text-only Warnings
3.04
± 4.46
Control Group, no Intervention
2.50
± 2.95
Number of LCCs Smoked in Past DaySecondary· day 5
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Group
Value
95% CI
Newly Developed Warnings With Images
2.77
± 3.67
FDA Proposed Text-only Warnings
3.07
± 4.21
Control Group, no Intervention
2.43
± 2.78
Number of LCCs Smoked in Past DaySecondary· day 6
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Group
Value
95% CI
Newly Developed Warnings With Images
2.66
± 3.72
FDA Proposed Text-only Warnings
3.12
± 4.81
Control Group, no Intervention
2.20
± 2.64
Number of LCCs Smoked in Past DaySecondary· day 7
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Group
Value
95% CI
Newly Developed Warnings With Images
2.30
± 3.18
FDA Proposed Text-only Warnings
2.73
± 4.04
Control Group, no Intervention
2.33
± 3.49
Number of LCCs Smoked in Past DaySecondary· day 8
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Group
Value
95% CI
Newly Developed Warnings With Images
2.37
± 3.61
FDA Proposed Text-only Warnings
2.68
± 4.46
Control Group, no Intervention
2.28
± 3.13
Number of LCCs Smoked in Past DaySecondary· day 9
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Group
Value
95% CI
Newly Developed Warnings With Images
2.64
± 4.28
FDA Proposed Text-only Warnings
2.68
± 4.50
Control Group, no Intervention
2.43
± 3.27
Number of LCCs Smoked in Past DaySecondary· day 10
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Group
Value
95% CI
Newly Developed Warnings With Images
2.62
± 4.50
FDA Proposed Text-only Warnings
2.56
± 4.16
Control Group, no Intervention
2.39
± 3.27
Number of LCCs Smoked in Past DaySecondary· day 11
The mean number of little cigars and cigarillos (LCCs) smoked in the past day reported by participant
Group
Value
95% CI
Newly Developed Warnings With Images
2.69
± 4.11
FDA Proposed Text-only Warnings
2.94
± 4.47
Control Group, no Intervention
2.47
± 3.23
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center
Last refreshed: 8 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05849051.