Trial Outcomes & Findings for Little Cigar and Cigarillo Warnings for Youth (NCT NCT06413797)
NCT ID: NCT06413797
Last Updated: 2025-12-24
Results Overview
The average willingness to use score will be measured by the average of the responses to the 2 survey questions scores. Question Scoring is on a scale of 1 to 5, where 1 indicates low willingness to use LCCs, and 5 indicates a willingness to use LCCs score.
COMPLETED
NA
928 participants
Day 8
2025-12-24
Participant Flow
Participants were recruited and screened for study eligibility online between 7/18/2024- 11/25/2024 and invited to in the study once they were determined to be eligible.
1,039 potential participants began the baseline survey. Of those, 9 did not consent to participate in the study, and 96 did not complete the baseline questionnaire and were not randomized, and 6 did not meet quality control criteria. 928 participants were enrolled and randomized in the study.
Participant milestones
| Measure |
FDA Warnings + Image
Participants will receive FDA-proposed LCC warnings with images
|
FDA Warnings Text-Only Warnings
Participants will receive FDA-proposed text-only LCC warnings.
|
Surgeon General Text-Only Warnings
Participants will receive Surgeon General text-only LCC warnings.
|
|---|---|---|---|
|
Overall Study
STARTED
|
310
|
309
|
309
|
|
Overall Study
COMPLETED
|
310
|
309
|
309
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Little Cigar and Cigarillo Warnings for Youth
Baseline characteristics by cohort
| Measure |
FDA Warnings + Image
n=310 Participants
Participants will receive FDA-proposed LCC warnings with images
|
FDA Warnings Text-Only Warnings
n=309 Participants
Participants will receive FDA-proposed text-only LCC warnings.
|
Surgeon General Text-Only Warnings
n=309 Participants
Participants will receive Surgeon General text-only LCC warnings.
|
Total
n=928 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
18.5 years
STANDARD_DEVIATION 1.4 • n=30 Participants
|
18.4 years
STANDARD_DEVIATION 1.5 • n=30 Participants
|
18.4 years
STANDARD_DEVIATION 1.5 • n=60 Participants
|
18.5 years
STANDARD_DEVIATION 1.5 • n=219 Participants
|
|
Sex/Gender, Customized
Male
|
161 Participants
n=30 Participants
|
138 Participants
n=30 Participants
|
143 Participants
n=60 Participants
|
442 Participants
n=219 Participants
|
|
Sex/Gender, Customized
Female
|
146 Participants
n=30 Participants
|
170 Participants
n=30 Participants
|
165 Participants
n=60 Participants
|
481 Participants
n=219 Participants
|
|
Sex/Gender, Customized
Unknown
|
3 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
5 Participants
n=219 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
73 Participants
n=30 Participants
|
68 Participants
n=30 Participants
|
65 Participants
n=60 Participants
|
206 Participants
n=219 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
236 Participants
n=30 Participants
|
240 Participants
n=30 Participants
|
241 Participants
n=60 Participants
|
717 Participants
n=219 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
5 Participants
n=219 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=30 Participants
|
7 Participants
n=30 Participants
|
6 Participants
n=60 Participants
|
17 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=30 Participants
|
13 Participants
n=30 Participants
|
17 Participants
n=60 Participants
|
45 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
3 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Black or African American
|
49 Participants
n=30 Participants
|
52 Participants
n=30 Participants
|
56 Participants
n=60 Participants
|
157 Participants
n=219 Participants
|
|
Race (NIH/OMB)
White
|
194 Participants
n=30 Participants
|
192 Participants
n=30 Participants
|
183 Participants
n=60 Participants
|
569 Participants
n=219 Participants
|
|
Race (NIH/OMB)
More than one race
|
22 Participants
n=30 Participants
|
12 Participants
n=30 Participants
|
19 Participants
n=60 Participants
|
53 Participants
n=219 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=30 Participants
|
32 Participants
n=30 Participants
|
27 Participants
n=60 Participants
|
84 Participants
n=219 Participants
|
|
Region of Enrollment
United States
|
310 Participants
n=30 Participants
|
309 Participants
n=30 Participants
|
309 Participants
n=60 Participants
|
928 Participants
n=219 Participants
|
PRIMARY outcome
Timeframe: Day 8Population: Participants who responded to the measures at the time point of interest, day 8
The average willingness to use score will be measured by the average of the responses to the 2 survey questions scores. Question Scoring is on a scale of 1 to 5, where 1 indicates low willingness to use LCCs, and 5 indicates a willingness to use LCCs score.
Outcome measures
| Measure |
FDA Warnings Text-Only Warnings
n=255 Participants
Participants will receive FDA-proposed text-only LCC warnings.
|
Surgeon General Text-Only Warnings
n=236 Participants
Participants will receive Surgeon General text-only LCC warnings.
|
FDA Warnings + Image
n=250 Participants
Participants will receive FDA-proposed LCC warnings with images.
|
|---|---|---|---|
|
Willingness to Use Little Cigars Cigarillos (LCCs)
|
3.08 score on a scale
Standard Deviation 1.39
|
2.99 score on a scale
Standard Deviation 1.40
|
2.86 score on a scale
Standard Deviation 1.47
|
SECONDARY outcome
Timeframe: Day 8Population: Participants who responded to the measures at the time point of interest, day 8
The number of days in the past 7 days that a participant reported using little cigars, range 0-7. Measured by survey, 1 item.
Outcome measures
| Measure |
FDA Warnings Text-Only Warnings
n=256 Participants
Participants will receive FDA-proposed text-only LCC warnings.
|
Surgeon General Text-Only Warnings
n=236 Participants
Participants will receive Surgeon General text-only LCC warnings.
|
FDA Warnings + Image
n=250 Participants
Participants will receive FDA-proposed LCC warnings with images.
|
|---|---|---|---|
|
Past 7 Days Little Cigar Use
|
1.86 number of days
Standard Deviation 2.60
|
1.88 number of days
Standard Deviation 2.59
|
1.92 number of days
Standard Deviation 2.62
|
SECONDARY outcome
Timeframe: Day 8The number of days in the past 7 days that a participant reported using cigarillos, range 0-7. Measured by survey, 1 item.
Outcome measures
| Measure |
FDA Warnings Text-Only Warnings
n=256 Participants
Participants will receive FDA-proposed text-only LCC warnings.
|
Surgeon General Text-Only Warnings
n=236 Participants
Participants will receive Surgeon General text-only LCC warnings.
|
FDA Warnings + Image
n=249 Participants
Participants will receive FDA-proposed LCC warnings with images.
|
|---|---|---|---|
|
Past 7 Days Cigarillo Use
|
1.86 number of days
Standard Deviation 2.41
|
1.82 number of days
Standard Deviation 2.33
|
1.93 number of days
Standard Deviation 2.57
|
SECONDARY outcome
Timeframe: Day 8Population: Participants who responded to the measures at the time point of interest, day 8
The average susceptibility to little cigar and cigarillo (LCC) use measured with the average of 3 survey item scores. Question scoring is on a scale of 1 to 4, where 1 indicates high susceptibility and 4 indicates low susceptibility to LCCs.
Outcome measures
| Measure |
FDA Warnings Text-Only Warnings
n=256 Participants
Participants will receive FDA-proposed text-only LCC warnings.
|
Surgeon General Text-Only Warnings
n=236 Participants
Participants will receive Surgeon General text-only LCC warnings.
|
FDA Warnings + Image
n=250 Participants
Participants will receive FDA-proposed LCC warnings with images.
|
|---|---|---|---|
|
Little Cigar and Cigarillos (LCCs) Susceptibility
|
2.49 score on a scale
Standard Deviation 0.91
|
2.46 score on a scale
Standard Deviation 0.95
|
2.33 score on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Day 2Population: Participants who responded to the scale at the time point of interest, day 2
The cognitive elaboration score is measured by survey with 1 item. Question scoring is on a scale of 1 to 6, where 1 indicates that the participant has low cognitive elaboration about the health risks of LCCs and 6 indicates that a participant has high cognitive elaboration about smoking LCCs.
Outcome measures
| Measure |
FDA Warnings Text-Only Warnings
n=229 Participants
Participants will receive FDA-proposed text-only LCC warnings.
|
Surgeon General Text-Only Warnings
n=205 Participants
Participants will receive Surgeon General text-only LCC warnings.
|
FDA Warnings + Image
n=218 Participants
Participants will receive FDA-proposed LCC warnings with images.
|
|---|---|---|---|
|
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use
|
3.90 units on a scale
Standard Deviation 1.64
|
3.91 units on a scale
Standard Deviation 1.60
|
3.78 units on a scale
Standard Deviation 1.60
|
SECONDARY outcome
Timeframe: Day 2Population: Participants who responded to the scale at the time point of interest, day 2
Warning negative affect/worry is measured by survey with 1 item. Question scoring is on a scale of 1 to 5, where 1 indicates low worry due to the warning and 5 indicates high worry due to the warning.
Outcome measures
| Measure |
FDA Warnings Text-Only Warnings
n=229 Participants
Participants will receive FDA-proposed text-only LCC warnings.
|
Surgeon General Text-Only Warnings
n=205 Participants
Participants will receive Surgeon General text-only LCC warnings.
|
FDA Warnings + Image
n=218 Participants
Participants will receive FDA-proposed LCC warnings with images.
|
|---|---|---|---|
|
Warning Negative Affect/Worry
|
3.85 units on a scale
Standard Deviation 1.23
|
3.61 units on a scale
Standard Deviation 1.26
|
3.79 units on a scale
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Day 8Population: Participants who responded to the measures at the time point of interest, day 8
Knowledge of LCC harms will be measured by 12 items the survey. Scores can range from 0 to 12 and indicate the number of questions out of 12 about LCC harms that participants answered correctly.
Outcome measures
| Measure |
FDA Warnings Text-Only Warnings
n=256 Participants
Participants will receive FDA-proposed text-only LCC warnings.
|
Surgeon General Text-Only Warnings
n=236 Participants
Participants will receive Surgeon General text-only LCC warnings.
|
FDA Warnings + Image
n=250 Participants
Participants will receive FDA-proposed LCC warnings with images.
|
|---|---|---|---|
|
Knowledge of Little Cigar and Cigarillo (LCC) Harms
|
10.12 score on a scale
Standard Deviation 2.46
|
9.71 score on a scale
Standard Deviation 2.82
|
10.06 score on a scale
Standard Deviation 2.63
|
SECONDARY outcome
Timeframe: Day 8Population: Participants who responded to the measures at the time point of interest, day 8
The average score on beliefs about LCC harms measured with 10 items by survey, are an average of the responses to the 10 questions. Belief scoring is on a scale of 1 to 5, where 1 indicates strong disagreement with statements about the health harms of LCCs and 5 indicates strong agreement with the statements about the health harms of LCCs.
Outcome measures
| Measure |
FDA Warnings Text-Only Warnings
n=256 Participants
Participants will receive FDA-proposed text-only LCC warnings.
|
Surgeon General Text-Only Warnings
n=236 Participants
Participants will receive Surgeon General text-only LCC warnings.
|
FDA Warnings + Image
n=249 Participants
Participants will receive FDA-proposed LCC warnings with images.
|
|---|---|---|---|
|
Beliefs About Little Cigar and Cigarillo (LCC) Harms
|
4.31 score on a scale
Standard Deviation 0.54
|
4.24 score on a scale
Standard Deviation 0.59
|
4.30 score on a scale
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Day 3Population: Participants who responded to the scale at the time point of interest, day 3
The cognitive elaboration score is measured by survey with 1 item. Question scoring is on a scale of 1 to 6, where 1 indicates that the participant has low cognitive elaboration about the health risks of LCCs and 6 indicates that a participant has high cognitive elaboration about smoking LCCs.
Outcome measures
| Measure |
FDA Warnings Text-Only Warnings
n=240 Participants
Participants will receive FDA-proposed text-only LCC warnings.
|
Surgeon General Text-Only Warnings
n=227 Participants
Participants will receive Surgeon General text-only LCC warnings.
|
FDA Warnings + Image
n=231 Participants
Participants will receive FDA-proposed LCC warnings with images.
|
|---|---|---|---|
|
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use
|
4.08 units on a scale
Standard Deviation 1.50
|
3.74 units on a scale
Standard Deviation 1.64
|
3.97 units on a scale
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: Day 4Population: Participants who responded to the scale at the time point of interest, day 4
The cognitive elaboration score is measured by survey with 1 item. Question scoring is on a scale of 1 to 6, where 1 indicates that the participant has low cognitive elaboration about the health risks of LCCs and 6 indicates that a participant has high cognitive elaboration about smoking LCCs.
Outcome measures
| Measure |
FDA Warnings Text-Only Warnings
n=233 Participants
Participants will receive FDA-proposed text-only LCC warnings.
|
Surgeon General Text-Only Warnings
n=216 Participants
Participants will receive Surgeon General text-only LCC warnings.
|
FDA Warnings + Image
n=238 Participants
Participants will receive FDA-proposed LCC warnings with images.
|
|---|---|---|---|
|
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use
|
3.94 units on a scale
Standard Deviation 1.52
|
3.74 units on a scale
Standard Deviation 1.65
|
3.88 units on a scale
Standard Deviation 1.59
|
SECONDARY outcome
Timeframe: Day 5Population: Participants who responded to the scale at the time point of interest, day 5
The cognitive elaboration score is measured by survey with 1 item. Question scoring is on a scale of 1 to 6, where 1 indicates that the participant has low cognitive elaboration about the health risks of LCCs and 6 indicates that a participant has high cognitive elaboration about smoking LCCs.
Outcome measures
| Measure |
FDA Warnings Text-Only Warnings
n=238 Participants
Participants will receive FDA-proposed text-only LCC warnings.
|
Surgeon General Text-Only Warnings
n=217 Participants
Participants will receive Surgeon General text-only LCC warnings.
|
FDA Warnings + Image
n=225 Participants
Participants will receive FDA-proposed LCC warnings with images.
|
|---|---|---|---|
|
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use
|
4.08 units on a scale
Standard Deviation 1.54
|
3.88 units on a scale
Standard Deviation 1.64
|
4.00 units on a scale
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: Day 6Population: Participants who responded to the scale at the time point of interest, day 6
The cognitive elaboration score is measured by survey with 1 item. Question scoring is on a scale of 1 to 6, where 1 indicates that the participant has low cognitive elaboration about the health risks of LCCs and 6 indicates that a participant has high cognitive elaboration about smoking LCCs.
Outcome measures
| Measure |
FDA Warnings Text-Only Warnings
n=222 Participants
Participants will receive FDA-proposed text-only LCC warnings.
|
Surgeon General Text-Only Warnings
n=217 Participants
Participants will receive Surgeon General text-only LCC warnings.
|
FDA Warnings + Image
n=230 Participants
Participants will receive FDA-proposed LCC warnings with images.
|
|---|---|---|---|
|
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use
|
4.05 units on a scale
Standard Deviation 1.59
|
3.78 units on a scale
Standard Deviation 1.67
|
4.01 units on a scale
Standard Deviation 1.58
|
SECONDARY outcome
Timeframe: Day 7Population: Participants who responded to the scale at the time point of interest, day 7
The cognitive elaboration score is measured by survey with 1 item. Question scoring is on a scale of 1 to 6, where 1 indicates that the participant has low cognitive elaboration about the health risks of LCCs and 6 indicates that a participant has high cognitive elaboration about smoking LCCs.
Outcome measures
| Measure |
FDA Warnings Text-Only Warnings
n=208 Participants
Participants will receive FDA-proposed text-only LCC warnings.
|
Surgeon General Text-Only Warnings
n=209 Participants
Participants will receive Surgeon General text-only LCC warnings.
|
FDA Warnings + Image
n=218 Participants
Participants will receive FDA-proposed LCC warnings with images.
|
|---|---|---|---|
|
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use
|
4.11 units on a scale
Standard Deviation 1.50
|
3.83 units on a scale
Standard Deviation 1.70
|
3.98 units on a scale
Standard Deviation 1.54
|
SECONDARY outcome
Timeframe: Day 8Population: Participants who responded to the scale at the time point of interest, day 8
The cognitive elaboration score is measured by survey with 1 item. Question scoring is on a scale of 1 to 6, where 1 indicates that the participant has low cognitive elaboration about the health risks of LCCs and 6 indicates that a participant has high cognitive elaboration about smoking LCCs.
Outcome measures
| Measure |
FDA Warnings Text-Only Warnings
n=256 Participants
Participants will receive FDA-proposed text-only LCC warnings.
|
Surgeon General Text-Only Warnings
n=236 Participants
Participants will receive Surgeon General text-only LCC warnings.
|
FDA Warnings + Image
n=250 Participants
Participants will receive FDA-proposed LCC warnings with images.
|
|---|---|---|---|
|
Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use
|
3.99 units on a scale
Standard Deviation 1.52
|
4.00 units on a scale
Standard Deviation 1.60
|
4.12 units on a scale
Standard Deviation 1.55
|
SECONDARY outcome
Timeframe: Day 3Population: Participants who responded to the scale at the time point of interest, day 3
Warning negative affect/worry is measured by survey with 1 item. Question scoring is on a scale of 1 to 5, where 1 indicates low worry due to the warning and 5 indicates high worry due to the warning.
Outcome measures
| Measure |
FDA Warnings Text-Only Warnings
n=240 Participants
Participants will receive FDA-proposed text-only LCC warnings.
|
Surgeon General Text-Only Warnings
n=227 Participants
Participants will receive Surgeon General text-only LCC warnings.
|
FDA Warnings + Image
n=231 Participants
Participants will receive FDA-proposed LCC warnings with images.
|
|---|---|---|---|
|
Warning Negative Affect/Worry
|
3.42 units on a scale
Standard Deviation 1.24
|
3.48 units on a scale
Standard Deviation 1.26
|
4.02 units on a scale
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: Day 4Population: Participants who responded to the scale at the time point of interest, day 4
Warning negative affect/worry is measured by survey with 1 item. Question scoring is on a scale of 1 to 5, where 1 indicates low worry due to the warning and 5 indicates high worry due to the warning.
Outcome measures
| Measure |
FDA Warnings Text-Only Warnings
n=233 Participants
Participants will receive FDA-proposed text-only LCC warnings.
|
Surgeon General Text-Only Warnings
n=216 Participants
Participants will receive Surgeon General text-only LCC warnings.
|
FDA Warnings + Image
n=238 Participants
Participants will receive FDA-proposed LCC warnings with images.
|
|---|---|---|---|
|
Warning Negative Affect/Worry
|
3.55 units on a scale
Standard Deviation 1.25
|
3.65 units on a scale
Standard Deviation 1.20
|
4.03 units on a scale
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Day 5Population: Participants who responded to the scale at the time point of interest, day 5
Warning negative affect/worry is measured by survey with 1 item. Question scoring is on a scale of 1 to 5, where 1 indicates low worry due to the warning and 5 indicates high worry due to the warning.
Outcome measures
| Measure |
FDA Warnings Text-Only Warnings
n=238 Participants
Participants will receive FDA-proposed text-only LCC warnings.
|
Surgeon General Text-Only Warnings
n=217 Participants
Participants will receive Surgeon General text-only LCC warnings.
|
FDA Warnings + Image
n=225 Participants
Participants will receive FDA-proposed LCC warnings with images.
|
|---|---|---|---|
|
Warning Negative Affect/Worry
|
3.52 units on a scale
Standard Deviation 1.38
|
3.36 units on a scale
Standard Deviation 1.29
|
4.00 units on a scale
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: Day 6Population: Participants who responded to the scale at the time point of interest, day 6
Warning negative affect/worry is measured by survey with 1 item. Question scoring is on a scale of 1 to 5, where 1 indicates low worry due to the warning and 5 indicates high worry due to the warning.
Outcome measures
| Measure |
FDA Warnings Text-Only Warnings
n=222 Participants
Participants will receive FDA-proposed text-only LCC warnings.
|
Surgeon General Text-Only Warnings
n=217 Participants
Participants will receive Surgeon General text-only LCC warnings.
|
FDA Warnings + Image
n=230 Participants
Participants will receive FDA-proposed LCC warnings with images.
|
|---|---|---|---|
|
Warning Negative Affect/Worry
|
3.72 units on a scale
Standard Deviation 1.23
|
3.71 units on a scale
Standard Deviation 1.23
|
4.02 units on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: Day 7Population: Participants who responded to the scale at the time point of interest, day 7
Warning negative affect/worry is measured by survey with 1 item. Question scoring is on a scale of 1 to 5, where 1 indicates low worry due to the warning and 5 indicates high worry due to the warning.
Outcome measures
| Measure |
FDA Warnings Text-Only Warnings
n=208 Participants
Participants will receive FDA-proposed text-only LCC warnings.
|
Surgeon General Text-Only Warnings
n=209 Participants
Participants will receive Surgeon General text-only LCC warnings.
|
FDA Warnings + Image
n=218 Participants
Participants will receive FDA-proposed LCC warnings with images.
|
|---|---|---|---|
|
Warning Negative Affect/Worry
|
3.79 units on a scale
Standard Deviation 1.15
|
3.79 units on a scale
Standard Deviation 1.16
|
3.90 units on a scale
Standard Deviation 1.13
|
Adverse Events
Surgeon General Text-Only Warnings
FDA Warnings + Image
FDA Warnings Text-Only Warnings
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Leah Ranney, PhD, MA, Research Professor and Director of the Tobacco Prevention and Evaluation Progr
University of North Carolina at Chapel Hill, School of Medicine, Department of Family Medicine, and Lineberger Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place