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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA260822-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Food and Drug Administration (FDA) | FED |
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This study explores the effect of the little cigars and cigarillos (LCC) warnings on youth who currently use, have ever used, or are susceptible to using LCCs. This study will inform the Food and Drug Administration (FDA) implementation of LCC warnings, which can reduce LCC use and lessen tobacco health disparities among youth.
Cigar use exposes youth to the addictive effects of nicotine during a critical developmental period and increases the risk of multiple cancers and premature death. Recent data indicate that cigars are the second most commonly used tobacco product by youth and that past 30-day cigar use is 7.6%, which translates into 1.1 million high school students. Of the three major types of cigars-large cigars, little cigars, and cigarillos-little cigars and cigarillos (LCCs) are the most commonly used in the US, particularly among younger people. LCC use also contributes to tobacco health disparities, as Black or African American youth use cigars more frequently than other youth. In 2016, the Food and Drug Administration (FDA) deemed LCCs subject to FDA regulation, requiring six rotating text-only warning statements to be on LCC packaging. Previous research has examined the effectiveness of LCC warnings in reducing youth willingness to use LCCs.
Research from studies of cigarette warnings suggests that effective LCC warnings should employ images that illustrate negative health effects associated with use and a larger warning label prominently displayed on the pack. Among youth, health warnings on cigarette packs that contain both text statements and images are more effective and engaging than text-only warnings. However, evidence for cigarette warning labels cannot adequately inform implementation of improved LCC warnings for three reasons: 1) there is no evidence on the effectiveness of the FDA-mandated text-only LCC warnings on behavioral intentions or other outcomes among youth 2)courts have ruled that effective tobacco warnings on one type of tobacco product cannot be used to justify warnings on other types of tobacco, and 3) LCC users have different demographic and consumption profiles than cigarette users include more Black/African Americans and use LCCs on fewer days per month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FDA warnings + Image | Experimental | Participants will receive FDA-proposed LCC warnings with images |
|
| FDA Warnings Text-Only Warnings | Experimental | Participants will receive FDA-proposed text-only LCC warnings. |
|
| Surgeon General Text-Only Warnings | Active Comparator | Participants will receive Surgeon General text-only LCC warnings. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDA warnings + Image | Behavioral | For six days (days 2-7) participants will be contacted and asked to complete a daily survey. As part of the survey, participants will view FDA-proposed LCC warnings with images at 30% size on a cigarillo package. Participants will be contacted each day to be invited to complete the survey for that day of the study protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Willingness to Use Little Cigars Cigarillos (LCCs) | 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. | Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Past 7 Days Little Cigar Use | The number of days in the past 7 days that a participant reported using little cigars, range 0-7. Measured by survey, 1 item. | Day 8 |
| Past 7 Days Cigarillo Use | The number of days in the past 7 days that a participant reported using cigarillos, range 0-7. Measured by survey, 1 item. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leah Ranney, PhD, MA | UNC Lineberger Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lineberger Comprehensive Cancer Center at University of North Carolina | Chapel Hill | North Carolina | 27514 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41506908 | Derived | Kowitt SD, Clark SA, Jetsupphasuk M, Jarman KL, Jebai R, Goldstein AO, Cornacchione Ross J, Ranney LM. Examining the influence of descriptors used to market unflavoured cigarillos: an experiment with a sample of youth and young adults from the USA. Tob Control. 2026 Jan 8:tc-2025-059806. doi: 10.1136/tc-2025-059806. Online ahead of print. |
| Label | URL |
|---|---|
| Clinical trials at UNC Lineberger | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | FDA Warnings + Image | Participants will receive FDA-proposed LCC warnings with images |
| FG001 | FDA Warnings Text-Only Warnings | Participants will receive FDA-proposed text-only LCC warnings. |
| FG002 | Surgeon General Text-Only Warnings | Participants will receive Surgeon General text-only LCC warnings. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Everyone who enrolled in the study, consented to participate, completed the baseline questionnaire, and was randomized to each condition.
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| ID | Title | Description |
|---|---|---|
| BG000 | FDA Warnings + Image | Participants will receive FDA-proposed LCC warnings with images |
| BG001 | FDA Warnings Text-Only Warnings | Participants will receive FDA-proposed text-only LCC warnings. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Willingness to Use Little Cigars Cigarillos (LCCs) | 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. | Participants who responded to the measures at the time point of interest, day 8 | Posted | Mean | Standard Deviation | score on a scale | Day 8 |
|
Low risk study, no adverse event data collected
Low risk study, no adverse event data collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FDA Warnings + Image | Participants will receive FDA-proposed LCC warnings with images |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| 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 | 984-974-4888 | leah_ranney@unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 28, 2024 | Nov 19, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| FDA Warnings Text-Only | Behavioral | Participants will receive messages including images in 30% size. |
|
| Surgeon General Text-Only Warnings | Behavioral | Participants will receive messages including Surgeon General Text-only Warnings. |
|
| Day 8 |
| Little Cigar and Cigarillos (LCCs) Susceptibility | 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. | Day 8 |
| Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 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. | Day 2 |
| Warning Negative Affect/Worry | 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. | Day 2 |
| Knowledge of Little Cigar and Cigarillo (LCC) Harms | 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. | Day 8 |
| Beliefs About Little Cigar and Cigarillo (LCC) Harms | 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. | Day 8 |
| Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 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. | Day 3 |
| Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 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. | Day 4 |
| Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 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. | Day 5 |
| Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 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. | Day 6 |
| Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 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. | Day 7 |
| Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 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. | Day 8 |
| Warning Negative Affect/Worry | 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. | Day 3 |
| Warning Negative Affect/Worry | 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. | Day 4 |
| Warning Negative Affect/Worry | 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. | Day 5 |
| Warning Negative Affect/Worry | 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. | Day 6 |
| Warning Negative Affect/Worry | 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. | Day 7 |
| BG002 | Surgeon General Text-Only Warnings | Participants will receive Surgeon General text-only LCC warnings. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG002 | Surgeon General Text-Only Warnings | Participants will receive Surgeon General text-only LCC warnings. |
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| Secondary | Past 7 Days Little Cigar Use | The number of days in the past 7 days that a participant reported using little cigars, range 0-7. Measured by survey, 1 item. | Participants who responded to the measures at the time point of interest, day 8 | Posted | Mean | Standard Deviation | number of days | Day 8 |
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| Secondary | Past 7 Days Cigarillo Use | The number of days in the past 7 days that a participant reported using cigarillos, range 0-7. Measured by survey, 1 item. | Posted | Mean | Standard Deviation | number of days | Day 8 |
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| Secondary | Little Cigar and Cigarillos (LCCs) Susceptibility | 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. | Participants who responded to the measures at the time point of interest, day 8 | Posted | Mean | Standard Deviation | score on a scale | Day 8 |
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| Secondary | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 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. | Participants who responded to the scale at the time point of interest, day 2 | Posted | Mean | Standard Deviation | units on a scale | Day 2 |
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| Secondary | Warning Negative Affect/Worry | 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. | Participants who responded to the scale at the time point of interest, day 2 | Posted | Mean | Standard Deviation | units on a scale | Day 2 |
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| Secondary | Knowledge of Little Cigar and Cigarillo (LCC) Harms | 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. | Participants who responded to the measures at the time point of interest, day 8 | Posted | Mean | Standard Deviation | score on a scale | Day 8 |
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| Secondary | Beliefs About Little Cigar and Cigarillo (LCC) Harms | 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. | Participants who responded to the measures at the time point of interest, day 8 | Posted | Mean | Standard Deviation | score on a scale | Day 8 |
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| Secondary | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 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. | Participants who responded to the scale at the time point of interest, day 3 | Posted | Mean | Standard Deviation | units on a scale | Day 3 |
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| Secondary | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 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. | Participants who responded to the scale at the time point of interest, day 4 | Posted | Mean | Standard Deviation | units on a scale | Day 4 |
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| Secondary | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 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. | Participants who responded to the scale at the time point of interest, day 5 | Posted | Mean | Standard Deviation | units on a scale | Day 5 |
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| Secondary | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 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. | Participants who responded to the scale at the time point of interest, day 6 | Posted | Mean | Standard Deviation | units on a scale | Day 6 |
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| Secondary | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 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. | Participants who responded to the scale at the time point of interest, day 7 | Posted | Mean | Standard Deviation | units on a scale | Day 7 |
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| Secondary | Cognitive Elaboration About Risk of Little Cigar and Cigarillo Use | 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. | Participants who responded to the scale at the time point of interest, day 8 | Posted | Mean | Standard Deviation | units on a scale | Day 8 |
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| Secondary | Warning Negative Affect/Worry | 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. | Participants who responded to the scale at the time point of interest, day 3 | Posted | Mean | Standard Deviation | units on a scale | Day 3 |
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| Secondary | Warning Negative Affect/Worry | 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. | Participants who responded to the scale at the time point of interest, day 4 | Posted | Mean | Standard Deviation | units on a scale | Day 4 |
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| Secondary | Warning Negative Affect/Worry | 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. | Participants who responded to the scale at the time point of interest, day 5 | Posted | Mean | Standard Deviation | units on a scale | Day 5 |
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| Secondary | Warning Negative Affect/Worry | 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. | Participants who responded to the scale at the time point of interest, day 6 | Posted | Mean | Standard Deviation | units on a scale | Day 6 |
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| Secondary | Warning Negative Affect/Worry | 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. | Participants who responded to the scale at the time point of interest, day 7 | Posted | Mean | Standard Deviation | units on a scale | Day 7 |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | FDA Warnings Text-Only Warnings | Participants will receive FDA-proposed text-only LCC warnings. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Surgeon General Text-Only Warnings | Participants will receive Surgeon General text-only LCC warnings. | 0 | 0 | 0 | 0 | 0 | 0 |
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