Strengthening Little Cigar and Cigarillo Warnings to Prevent Adolescent Use
Phase: NA
Conditions: Little Cigars and Cigarillos (LCC) Use
Sponsor: UNC Lineberger Comprehensive Cancer Center

 
1 
 
 
Strengthening Little Cigar and Cigarillo Warnings 
to Prevent Adolescent Use: Randomized 
Controlled Trial among US Youth  
 
Principal Investigators: Leah Ranney and Jennifer Ross 
08/28/2024 
Registered at ClinicalTrials.gov, ID NCT06413797, https://clinicaltrials.gov/study/NCT06413797 
 
 

 
2 
 
Contents 
Administrative Information .................................................................................................................................................... 4 
Trial Registration ................................................................................................................................................................. 4 
Roles and Responsibilities ................................................................................................................................................... 4 
Funding Statement and Sponsors ....................................................................................................................................... 4 
Abbreviations and Definitions of Terms ............................................................................................................................. 5 
Introduction ............................................................................................................................................................................ 6 
Background and Rationale .................................................................................................................................................. 6 
Hypotheses...................................................................................................................................................................... 6 
Trial Design .......................................................................................................................................................................... 7 
Methods: Participants, Interventions, and Outcomes ............................................................................................................ 7 
Methods Overview .............................................................................................................................................................. 7 
Participant timeline ............................................................................................................................................................. 7 
Study Setting ....................................................................................................................................................................... 8 
Participants ......................................................................................................................................................................... 8 
Eligibility criteria for participation in this study: ............................................................................................................. 8 
Interventions ....................................................................................................................................................................... 8 
Experimental Conditions ................................................................................................................................................. 8 
Warning Stimuli ............................................................................................................................................................... 8 
Stimuli Order ................................................................................................................................................................... 9 
Additional intervention details ....................................................................................................................................... 9 
Outcomes ............................................................................................................................................................................ 9 
Primary ............................................................................................................................................................................ 9 
Secondary ...................................................................................................................................................................... 10 
Other ............................................................................................................................................................................. 10 
Sample Size ....................................................................................................................................................................... 11 
Recruitment ...................................................................................................................................................................... 11 
Compensation Plan ........................................................................................................................................................... 11 
Methods: Assignment of interventions ................................................................................................................................ 11 
Allocation and Blinding ..................................................................................................................................................... 11 
Methods: Data collection management, and analysis .......................................................................................................... 11 
Data collection methods ................................................................................................................................................... 11 
Screener ........................................................................................................................................................................ 11 
Baseline Survey: Day 1 .................................................................................................................................................. 11 
Daily Surveys: Days 2-7 ................................................................................................................................................. 12 

 
3 
 
Post Survey: Day 8 ......................................................................................................................................................... 12 
Data Management ............................................................................................................................................................ 12 
Statistical Methods ........................................................................................................................................................... 12 
Methods: Monitoring ............................................................................................................................................................ 12 
Ethics and dissemination ...................................................................................................................................................... 13 
Consent ............................................................................................................................................................................. 13 
Confidentiality ................................................................................................................................................................... 13 
Declaration of Interests .................................................................................................................................................... 13 
Access to data ................................................................................................................................................................... 13 
Ancillary and post-trial care .............................................................................................................................................. 14 
Dissemination Plan ............................................................................................................................................................ 14 
References ............................................................................................................................................................................ 15 
Protocol Amendment History ............................................................................................................................................... 16 
 
 
 

 
4 
 
Administrative Information 
 
Trial Registration 
Title: Strengthening Little Cigar and Cigarillo Warnings to Prevent Adolescent Use: Randomized Controlled Trial among 
US Youth 
Short Title: Little Cigar and Cigarillo Warnings for Youth 
Registered at ClinicalTrials.gov, ID NCT06413797, https://clinicaltrials.gov/study/NCT06413797 
 
Registration Date: 5/9/2024 
Roles and Responsibilities 
The research team below is responsible for the study design, management, analysis and interpretation of data; writing 
any reports or publications; and decision to submit any reports or publications. Participant recruitment and data 
collection will be completed through Qualtrics and their panel provider, under the supervision of the study team. 
Name 
Role 
Affiliation 
Leah M. Ranney 
Co-Principal 
Investigator 
Department of Family Medicine, University of North Carolina at 
Chapel Hill 
Lineberger Comprehensive Cancer Center, University of North 
Carolina at Chapel Hill 
Jennifer Cornacchione 
Ross 
Co-Principal 
Investigator 
Department of Health Law, Policy, and Management, Boston 
University, School of Public Health 
Sarah D. Kowitt 
Co-Investigator 
Department of Family Medicine, University of North Carolina at 
Chapel Hill 
Lineberger Comprehensive Cancer Center, University of North 
Carolina at Chapel Hill 
Kristen L. Jarman 
Project Manager 
Department of Family Medicine, University of North Carolina at 
Chapel Hill  
Sonia Clark 
Research Staff 
Department of Family Medicine, University of North Carolina at 
Chapel Hill 
Adam O. Goldstein 
Co-Investigator 
Department of Family Medicine, University of North Carolina at 
Chapel Hill 
Lineberger Comprehensive Cancer Center, University of North 
Carolina at Chapel Hill 
James Thrasher 
Co-Investigator 
Department of Health Promotion, Education, and Behavior, 
Arnold School of Public Health, University of South Carolina 
Michael Jetsupphasuk 
Graduate Research 
Assistant 
Department of Biostatistics, University of North Carolina at 
Chapel Hill 
Rime Jebai 
Postdoctoral Associate 
Department of Health Law, Policy, and Management, Boston 
University, School of Public Health 
 
Funding Statement and Sponsors 
Research reported in this publication was supported by grant number R01CA260822 from the National Cancer Institute 
(NCI) and the Food and Drug Administration (FDA) Center for Tobacco Products (CTP). The content is solely the 
responsibility of the authors and does not necessarily represent the official views of the NIH or the Food and Drug 
Administration. 

 
5 
 
 
National Cancer Institute, 
National Institutes of Health 
9609 Medical Center Drive 
Rockville, MD 20850 
 
Center for Tobacco Products 
Food and Drug Administration 
Document Control Center 
10903 New Hampshire Avenue 
Building 71, Room G335 
Silver Spring, MD 20993-0002 
 
Abbreviations and Definitions of Terms 
Abbreviation 
Definition 
LCC 
Little cigars and cigarillos 
NIH 
National Institutes of Health 
NCI 
National Cancer Institute 
FDA 
Food and Drug Administration  
CTP 
Center for Tobacco Products 
UNC 
University of North Carolina at Chapel Hill 
HWL 
Health warning labels 
OTP 
Other tobacco product (products other than little cigars and cigarillos) 
 
 
 
 

 
6 
 
Introduction 
Background and Rationale 
     Cigar use exposes youth to addictive effects of nicotine during a critical developmental period and increases the risk 
of multiple cancers and premature death (National Cancer Institute, 1998; Chang et al., 2015). Recent data indicate that 
cigars are the second most commonly used combustible tobacco product by youth and that past 30-day cigar use is 
1.8%, which translates into 280,000 high school students (Birdsey et al., 2023). 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 (Wang, 2019). LCC use also contributes to tobacco health disparities, as Black or African 
American youth use cigars more frequently than other youth (Wang, 2019). 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 (Food and Drug Administration, 2016). Little 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 (Noar et al., 
2016; Hammond, 2011). Among youth, health warnings on cigarette packs that contain both text statements and images 
(i.e., pictorial warnings) are more effective (Noar et al., 2016; Hammond, 2011; Hammond et al., 2012; White et al., 
2008; Vardavas et al., 2009; White et al., 2015; Peterson et al., 2010; Andrews et al., 2016) and engaging (Hammond, 
2011; White et al., 2008; White et al., 2015; Peterson et al., 2010) 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 (Richardson et al., 2013; Sterling et al., 2013; Glasser et al., 2017), 2) courts have ruled that 
effective tobacco warnings on one type of tobacco product (i.e., for cigarettes) cannot be used to justify warnings on 
other types of tobacco (i.e., for LCCs) (R.J. Reynolds Tobacco Co. et Al. v. U.S. Food and Drug Administration, 2012), and 
3) LCC users have different demographic and consumption profiles than cigarette users (i.e., LCC users are younger 
(Substance Abuse and Mental Health Services Administration, 2017), include more Black/African Americans (Substance 
Abuse and Mental Health Services Administration, 2017), and use LCCs on fewer days per month (Nyman et al., 2016; 
Jamal et al., 2018)). Furthermore, on July 7, 2020, the US Court of Appeals for the DC Circuit ruled that the FDA cannot 
require their new warning labels for cigars, claiming that the FDA did not provide evidence on the impact of cigar 
warnings on smoking rates, including initiation and cessation (Cigar Association of America v. United States Food and 
Drug Administration, 2020).  
 
 
Objectives 
     Our goal is to conduct research that advances the science on LCC warnings that are effective for youth who currently 
use, have ever used, or are susceptible to using LCCs. This study will inform FDA implementation of LCC warnings, which 
can reduce LCC use and lessen tobacco health disparities among youth. 
 
Hypotheses 
• 
We hypothesize that LCC warnings at 30% size that include an image (i.e., pictorial warnings) will decrease 
willingness to use LCCs, compared with FDA-proposed text-only LCC warnings at 30% size and Surgeon General 
text-only warnings at 10% size.  
• 
We hypothesize that LCC warnings at 30% size that include an image (i.e., pictorial warnings) will increase 
cognitive elaboration, knowledge of LCC harms, beliefs about LCC harms, and negative affect compared with 
FDA-proposed text-only LCC warnings at 30% size and Surgeon General text-only warnings at 10% size.  
• 
We hypothesize that LCC warnings at 30% size that include an image (i.e., pictorial warnings) will decrease LCC 
susceptibility, past 7 day little cigar use, and past 7 day cigarillo use compared with FDA-proposed text-only LCC 
warnings at 30% size and Surgeon General text-only warnings at 10% size.  

 
7 
 
Trial Design 
The study is designed to be a parallel group trial, with participants evenly allocated to each study condition, using a 
superiority framework. 
Methods: Participants, Interventions, and Outcomes 
Methods Overview 
We will conduct a one-week web-based RCT among U.S. youth who are susceptible to, have ever used, or currently use 
LCCs. In this study, LCC warnings on packs will be electronically presented to participants daily to determine if pictorial 
LCC warnings at 30% size decrease willingness to use LCCs compared to FDA proposed text-only warnings at 30% size 
and a control condition (Surgeon General text-only warnings at 10% size). We will apply a daily diary methodology to 
present LCC warnings on packs to participants over time. Qualtrics will contact, screen, consent and administer the 
survey. To enroll participants, Qualtrics will screen participants using our inclusion criteria and measures and invite 
eligible participants to enroll in the study. To collect at least 700 quality completes, we anticipate enrolling up to 2,100 
people. 
 
At the beginning of the baseline survey (day 1), participants will first consent to participate in the study and then 
complete a questionnaire about their LCC use and susceptibility, exposure to cigar advertising and warnings, and 
demographic characteristics, in addition to other measures. At the end of the baseline questionnaire, survey software 
will randomly assign participants to one of the 3 study conditions. The three study conditions are 1) Pictorial (text + 
image) 30% size warnings , 2) FDA-proposed text-only LCC warnings at 30% size, and 3) Control condition (current status 
Surgeon General text-only warnings at 10% size). Participants will be contacted each day and invited to complete the 
survey for that day of the study protocol.  
 
For six subsequent days (days 2-7), participants will be contacted and asked to complete a daily survey. During these 
daily surveys, participants will view an image of a cigarillo package with a warning according to the participant’s 
condition. Participants will view a total of 6 different warnings over the course of 6 days. Before seeing the warning, 
participants will be asked about how often they have thought about the health risks of smoking cigars. After seeing the 
warning, participants will be asked about the appeal of the cigars in the package, how relevant they feel the warning is 
to their lives, and how worried the warning makes them feel. Participants will also be asked whether they saw any 
warnings outside the study about the harms of cigar use in the past day. 
 
For the post-test on day 8, participants will be asked to complete a questionnaire about their willingness to use LCCs, 
LCC use, and susceptibility among other measures.  
 
Participant timeline 
Potential participants will be invited to complete the screener (Day 0) and those who are eligible will be invited to 
participate in the study. On Day 1, eligible participants will be asked to complete a baseline survey. The baseline survey 
will be open to enrollment for 2 days. After the baseline closes, participants will receive a survey every morning for Days 
2-7 that includes an LCC warning and questions about their cognitive elaboration over the previous day, reactions to the 
warning, and warning exposure over the previous day. Participants will also be asked to complete a final post-test survey 
on Day 8.   
 
 
 
 

 
8 
 
Survey timing: 
 
 
Study Setting 
The study will be conducted with online surveys, so participants can complete the surveys from any location. 
Participants must reside in the United States (US) to meet eligibility criteria. 
Participants 
Eligibility criteria for participation in this study: 
1. Members of the recruitment panel (we are partnering with a panel provider for recruitment of all participants) 
2. Agree to provide their honest answers 
3. Susceptible to using LCCs, or have ever used little cigars and/or cigarillos, or currently use little cigar and/or 
cigarillos in the past 30 days 
4. Age 15 – 20 years old 
5. Currently living in US or a US territory 
6. Inclusion criteria based on the design of the study: 
a. Able to complete 2 surveys that take approximately 10 minutes 
b. Able to complete a 2-minute survey each day for 6 days 
7. Inclusion criteria based on verifying real participants: 
a. Able to verify they are not a bot using CAPTCHA 
b. Able to answer a simple, random math question 
 
Interventions 
Experimental Conditions 
1) FDA-proposed warnings with added images at 30% size (pictorial warnings) 
2) FDA-proposed text-only LCC warnings at 30% size 
3) Control condition – Surgeon General text-only warnings at 10% size  
 
Warning Stimuli  
The stimuli will vary based on the day of the protocol. The packages that the study warning labels will be shown on will 
be standardized across the three conditions (see table below for warning text). Specifically, warning labels will be shown 
on cigarillo packages that are red and branded with the fictitious name “Grey Fox” to minimize the influence of brand 
loyalty and pre-existing brand perceptions.  
 
 
Baseline (Day 1)
10 minute survey
Days 2 - 7
2 minute survey each day
Day 8
10 minute survey

 
9 
 
 
Stimuli Order  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Additional intervention details 
Participants can withdraw from the study at any time if they choose to do so by no longer responding to the survey links 
and may withdraw their data by contacting the UNC study team. 
Multiple strategies have been implemented to maximize adherence to the trial protocol, including reaching out to 
participants with invitations and reminders each day. 
There is no relevant concomitant care or interventions that are permitted or prohibited during the trial. 
Outcomes 
Primary 
- 
Willingness to use LCCs (day 8) 
Day 
Condition 1 
Condition 2 
Condition 3 
Day 2 
WARNING:   
Tobacco use increases the 
risk of infertility, stillbirth 
and low birth weight. 
 
WARNING:   
Tobacco use increases the 
risk of infertility, stillbirth and 
low birth weight. 
SURGEON GENERAL 
WARNING:  
Tobacco Use Increases The 
Risk Of Infertility, Stillbirth 
And Low Birth Weight. 
Day 3 
WARNING:  
This product contains 
nicotine. Nicotine is an 
addictive chemical.  
WARNING:  
This product contains 
nicotine. Nicotine is an 
addictive chemical.  
SURGEON GENERAL 
WARNING:  
This Product Contains 
Nicotine. Nicotine Is An 
Addictive Chemical. 
Day 4 
WARNING:   
Cigar smoking can cause 
cancers of the mouth and 
throat, even if you do 
not inhale.  
WARNING:   
Cigar smoking can cause 
cancers of the mouth and 
throat, even if you do 
not inhale.  
SURGEON GENERAL 
WARNING:  
Cigar Smoking Can Cause 
Cancers Of The Mouth And 
Throat, Even If You Do Not 
Inhale. 
Day 5 
WARNING:   
Cigars are not a safe 
alternative   
to cigarettes.  
WARNING:   
Cigars are not a safe 
alternative   
to cigarettes.  
SURGEON GENERAL 
WARNING:  
Cigars Are Not A Safe 
Alternative To Cigarettes. 
Day 6 
WARNING:  
Cigar smoking can cause 
lung cancer and heart 
disease.  
WARNING:  
Cigar smoking can cause lung 
cancer and heart disease.  
SURGEON GENERAL 
WARNING:  
Cigar Smoking Can Cause Lung 
Cancer And Heart Disease. 
Day 7 
WARNING:   
Tobacco smoke increases 
the risk of lung cancer and 
heart disease, even 
in nonsmokers.  
WARNING:   
Tobacco smoke increases the 
risk of lung cancer and heart 
disease, even 
in nonsmokers.  
SURGEON GENERAL 
WARNING:  
Tobacco Smoke Increases The 
Risk Of Lung Cancer And Heart 
Disease, Even In Nonsmokers. 

 
10 
 
o Average willingness to use score measured by survey, measured with 2 questions. The final willingness 
to use score is a mean of the response to the 2 questions, on a scale of 1 to 5, where 1 indicates low 
willingness to use LCCs and 5 indicates a high willingness to use LCCs. 
 
Secondary 
- 
Past 7 day little cigar use (day 8) 
o Measured by survey with 1 item 
- 
Past 7 day cigarillo use (day 8) 
o Measured by survey with 1 item 
- 
LCC susceptibility (day 8) 
o Measured by survey with 3 items 
- 
Cognitive elaboration about risk of LCC use (day 8) 
o Measured by survey with 1 item 
- 
Warning negative affect/worry (each day) 
o Measured by survey with 1 item 
- 
Knowledge of LCC harms (day 8) 
o Measured by survey with 13 items 
- 
Beliefs about LCC harms (day 8) 
o Measured by survey with 10 items 
 
Other 
- 
LCC quit intentions (day 8) 
o Measured by survey with 3 items 
- 
Past 7 day use of other tobacco products (day 8) 
o Measured by survey with 1 item 
- 
Past 7 day butting out of LCCs (day 8) 
o Measured by survey with 1 item 
- 
Past 7 day forgoing LCCs (day 8) 
o Measured by survey with 1 item 
- 
LCC self efficacy to quit (day 8) 
o Measured by survey with 1 item 
- 
Past 7 day use of blunts (day 8) 
o Measured by survey with 1 item 
- 
Reactance to warnings (day 8) 
o Measured by survey with 3 items 
- 
Conversations about cigar health risks (day 8) 
o Measured by survey with 1 item 
- 
Cigar appeal (each day) 
o Measured by survey with 1 item 
- 
Warning relevance (each day) 
o Measured by survey with 1 item 
- 
Unaided recall of cigar warnings (day 8) 
o Measured by survey with 1 item 
- 
Confirmed recall of cigar warnings (day 8) 
o Measured by survey 
- 
Recognition of cigar warnings (day 8) 
o Measured by survey with 6 items 
- 
Self-reported learning (day 8) 
o Measured by survey with 1 item 

 
11 
 
 
Sample Size 
The sample size is based on a meta-analysis that compared text-only cigarette warnings to warnings with text and 
images and reported a standardized mean difference in willingness of d=0.26 (Noar, 2016). Based on the standardized 
effect size observed in that study and enrolling 700 people in the study (233 per group), we would have 80% power at 
α=0.05 to detect the same standardized effect size change between the FDA pictorial warning and FDA text only warning 
group. Secondary outcomes that are measured daily will have higher power to detect differences between groups. 
Recruitment 
We are working with Qualtrics research services to conduct this study and enroll participants from one of the panel 
providers that they work with. Qualtrics has access to high quality research panels across the US. Qualtrics is able to 
leverage its panels to provide timely and reliable data collection to UNC and other research universities. We have high 
confidence that Qualtrics will be able to meet our recruitment goals. 
Compensation Plan 
Qualtrics will manage participant incentives. Participants in studies conducted by Qualtrics receive an incentive based on 
the length of the survey and their specific profile. The types of rewards vary and may include cash, airline miles, gift 
cards, redeemable points, sweepstakes entrance and vouchers. For this study, participants who complete the baseline, 3 
of the daily message surveys, and the post survey on day 8 will receive an incentive. Participants who complete only a 
few of the surveys but do not satisfy the criteria above will not receive an incentive. 
 
Methods: Assignment of interventions 
Allocation and Blinding 
Participants will not be informed specifically about the possible interventions that they may be assigned to. Researchers 
will not be blinded to the condition that participants have been assigned to. All outcome measures will be assessed via 
online survey. At the end of the baseline survey, survey software will randomly assign participants to one of the three 
study arms. Participants will have an equal chance of being randomized to each study arm. 
 
Methods: Data collection management, and analysis 
Data collection methods 
Data collection will be conducted using Qualtrics web survey platform. Where possible, the measures used are 
previously developed and validated measures. Multiple strategies have been implemented to maximize adherence to 
the trial protocol, including reaching out to participants with invitations and reminders each day, and compensating 
them based on completion of the most important questionnaires (i.e., baseline, at least 3 daily surveys, and the post 
survey). 
Screener 
Qualtrics will invite potential participants to complete the screening survey and people who are eligible will be invited to 
complete the baseline survey. The screener is used to assess participant eligibility and collect demographic data. 
 
Baseline Survey: Day 1 
• 
Eligible participants will be invited to participate in the study and complete the baseline survey to enroll. The 
baseline survey will be open to enrollment for 2 days. 
• 
The first part of the baseline survey will be an assent/consent form with an agreement to participate in the 
study. 

 
12 
 
• 
The baseline survey contains baseline tobacco use and susceptibility questions and additional demographic 
questions. 
• 
At the end of the baseline questionnaire, survey software will randomly assign participants to one of the 3 study 
conditions. 
Daily Surveys: Days 2-7 
• 
There are 6 daily surveys, which align with each participant’s condition. Participants will stay in their condition 
throughout the study. Depending on the day, participants will see a different message and be asked questions 
about their perceptions of the warning and the previous day. 
Post Survey: Day 8 
• 
For the post-test on day 8, participants will be asked to complete a questionnaire that is approximately 15 
minutes in length about their willingness to use LCCs, susceptibility to LCCs, cigar knowledge, and other relevant 
survey questions. 
• 
Participants will also be asked about their study experience. 
Data Management 
Data management will be conducted by the study team. Multiple processes will be implemented to ensure high data 
quality, including internal pilots to test the protocol and ensure that data collection instruments are working properly, 
and ongoing data monitoring will be conducted during data collection to ensure that any issues with data quality are 
caught early and fixed. A pilot of the protocol with actual participants will be conducted before the full study is launched 
and participants will be asked about their experience in the study at the end of the pilot to further ensure that the 
protocol is working as intended and ensure high quality data collection. 
Statistical Methods 
We will analyze the data using intention-to-treat analyses. Our primary outcome is willingness to use LCCs at post-test. 
We will model willingness to use LCCs with randomly assigned experimental condition as the between-participant 
predictor. 
Analysis methods will depend on the time point that the outcome was measured. Post-test measures will be analyzed 
differently than repeated measures from the daily surveys, as outlined below. 
Analysis methods for post-test measures will use linear models for continuous outcomes, including the primary outcome 
of willingness to use, and logistic models for dichotomous outcomes. Participants who were randomized to an 
intervention will be included in the analysis. Missingness will be accounted for by including covariates in regression 
models where the covariates are assumed to satisfy a missing at random (MAR) assumption for the outcomes. 
Estimation will proceed using maximum likelihood. 
Mixed models will examine differences between treatment groups for items measured multiple times in the daily 
surveys (e.g., negative affect). For these models, we will use linear mixed modeling to account for the repeated measure 
design.  
Methods: Monitoring 
To ensure maximum protection of human subjects, we submitted our research project information to the School of 
Medicine Data Safety and Monitoring Board at the University of North Carolina at Chapel Hill and asked them to make 
the final decision regarding risk to participants and whether our study should receive their supervision. A representative 
of the board agreed that given that the study involves a low risk behavioral intervention in a healthy population, 
oversight by the board was not necessary. 

 
13 
 
Adverse events are not expected in this trial due to the minimal risks to participants, and no threat to participant health. 
Accordingly, plans for collecting, assessing and reporting adverse events are not necessary. 
We have no plans for auditing trial conduct. 
Ethics and dissemination  
This trial was approved by UNC’s IRB under IRB # 23-2455.  
All protocol changes will be communicated to the study team, and any change in participant interaction will be approved 
by UNC’s IRB. Protocol changes will be tracked in an appendix table with new versions after initial approval including the 
date, version number, and a summary of changes. 
 
Consent 
Consent will be collected electronically as part of the baseline survey at the beginning of the study. At the beginning of 
the baseline survey, potential participants who are 18 years old or older will view the consent form with an agreement 
to participate in the study. For participants who are younger than 18, we will collect consent from their parent or 
guardian and then collect assent from the potential participants themselves. Participants will only be able to proceed 
with the study with appropriate consent/assent agreements.  
Confidentiality 
We will take the following steps to minimize the risk to a breach of confidentiality via unauthorized access, use, 
disclosure, modification, loss or theft of participants’ information:  
• 
We will use and enforce appropriate security measures including physical, technical and administrative 
safeguards.  
• 
Data will be stored on a university secure server that is password accessed and is only accessible to key research 
personnel.  
• 
All study personnel are required to have valid training on ethics of research on human subjects and to complete 
confidentiality certification procedures upon employment.  
• 
The research team will not collect nor have access to personal identifying information. 
This study proposes research that has been determined to include Security Level 2 data security requirements. The MPIs 
have agreed to accept responsibility for managing these risks appropriately in consultation with departmental and/or 
campus security personnel. The Data Security Requirements addendum can be reviewed here: 
https://guides.lib.unc.edu/datasecurity/irbis 
 
Declaration of Interests  
The study team declares that they have no competing interests.  
 
Access to data 
On reasonable request, we will make deidentified data sets available, stripped of individual identifiers, following 
publication of the relevant study’s main findings. We may submit deidentified data collected in this study to a data 
repository, such as UNC Odum Institute's Dataverse (https://dataverse.unc.edu/dataverse/unc) to make our deidentified 
data publicly available. As part of submitting the data to a repository, we will provide basic information about how the 
data was collected and upload a deidentified dataset to the repository. 
 

 
14 
 
Ancillary and post-trial care 
This trial presents no more than minimal risk to participants, does not collect data on harms to participants or assess 
interim data during the trial. There is no need for ancillary or post-trial care. 
 
Dissemination Plan  
The study team plans to disseminate study findings via conference presentation and peer reviewed manuscripts in 
scientific journals. The study team will also share findings via ClinicalTrials.gov registration. We will follow authorship 
guidelines depending on the journal to which manuscripts are submitted. 
 
 
 

 
15 
 
References 
Andrews JC, Netemeyer RG, Burton S, Kees J. Effects of plain package branding and graphic health warnings on 
adolescent smokers in the USA, Spain and France. Tob Control. 2016;25(e2):e120-e126. 
doi:10.1136/tobaccocontrol-2015-052583 
Birdsey J, Cornelius M, Jamal A, et al. Tobacco Product Use Among U.S. Middle and High School Students — National 
Youth Tobacco Survey, 2023. MMWR Morb Mortal Wkly Rep 2023;72:1173–1182. 
DOI: http://dx.doi.org/10.15585/mmwr.mm7244a1. 
Chang CM, Corey CG, Rostron BL, Apelberg BJ. Systematic review of cigar smoking and all cause and smoking related 
mortality. BMC Public Health. 2015;15(1):390. doi:10.1186/s12889-015-1617-5 
Cigar Association of America v. United States Food and Drug Administration., U.S. Circuit Court, District of Columbia, No. 
18-5195.(2020). 
Corey CG, Holder-Hayes E, Nguyen AB, et al. US Adult Cigar Smoking Patterns, Purchasing Behaviors, and Reasons for 
Use According to Cigar Type: Findings From the Population Assessment of Tobacco and Health (PATH) Study, 
2013–2014. Nicotine Tob Res. September 2017. doi:10.1093/ntr/ntx209 
Delnevo CD, Giovenco DP, Miller Lo EJ. Changes in the Mass-merchandise Cigar Market since the Tobacco Control Act. 
Tob Regul Sci. 2017;3(2 Suppl 1):S8-S16. 
Delnevo CD, Hrywna M, Giovenco DP, Miller Lo EJ, O’Connor RJ. Close, but no cigar: certain cigars are pseudo-cigarettes 
designed to evade regulation. Tob Control. 2017;26(3):349-354. doi:10.1136/tobaccocontrol-2016-052935 
Food and Drug Administration Department of Health and Human Services. Deeming Tobacco Products To Be Subject to 
the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control 
Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Toba. 
Fed Regist. 2016;811:28973-29106. 
Glasser AM, Johnson AL, Rose SW, et al. Correlates of Cigar Use by Type and Flavor among US Young Adults: 2011-2015. 
Tob Regul Sci. 2017;3(2):59-71. doi:10.18001/TRS.3.2(Suppl1).7 
Hammond D. Health warning messages on tobacco products: a review. Tob Control. 2011;20(5):327-337. 
doi:10.1136/tc.2010.037630 
Hammond D, Thrasher J, Reid JL, Driezen P, Boudreau C, Santillán EA. Perceived effectiveness of pictorial health 
warnings among Mexican youth and adults: a population-level intervention with potential to reduce tobacco-
related inequities. Cancer Causes Control. 2012;23 Suppl 1(0 1):57-67. doi:10.1007/s10552-012-9902-4 
Jamal A, Phillips E, Gentzke AS, et al. Current Cigarette Smoking Among Adults — United States, 2016. MMWR Morb 
Mortal Wkly Rep. 2018;67(2):53-59. doi:10.15585/mmwr.mm6702a1 
National Cancer Institute. Cigars, Health Effects and Trends, Smoking and Tobacco Control Monograph No. 9. Bethesda, 
MD; 1998. 
Noar SM, Hall MG, Francis DB, Ribisl KM, Pepper JK, Brewer NT. Pictorial cigarette pack warnings: a meta-analysis of 
experimental studies. Tob Control. 2016;25(3):341-354. doi:10.1136/tobaccocontrol-2014-051978 
Nyman AL, Sterling KL, Weaver SR, Majeed BA, Eriksen MP. Little cigars and cigarillos: users, perceptions, and reasons for 
use. Tob Regul Sci. 2016;2(3):239-251. 
Peterson EB, Thomsen S, Lindsay G, John K. Adolescents’ Attention to Traditional and Graphic Tobacco Warning Labels: 
An Eye-Tracking Approach. J DRUG Educ. 2010;40(3):227-244. doi:10.2190/DE.40.3.b 
Richardson A, Rath J, Ganz O, Xiao H, Vallone D. Primary and Dual Users of Little Cigars/Cigarillos and Large Cigars: 

 
16 
 
Demographic and Tobacco Use Profiles. Nicotine Tob Res. 2013;15(10):1729-1736. doi:10.1093/ntr/ntt053 
R.J. Reynolds Tobacco Co. et Al. v. U.S. Food and Drug Administration., U.S. District Court, District of 
Columbia, No. 11-01482.(2012). 
Sterling K, Berg CJ, Thomas AN, Glantz SA, Ahluwalia JS. Factors associated with small cigar use among college students. 
Am J Health Behav. 2013;37(3):325-333. doi:10.5993/AJHB.37.3.5 
Substance Abuse and Mental Health Services Administration. RESULTS FROM THE 2016 NATIONAL SURVEY ON DRUG 
USE AND HEALTH: DETAILED TABLES.; 2017. https://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-
2016/NSDUH-DetTabs-2016.pdf. Accessed September 19, 2019. 
Vardavas CI, Connolly G, Karamanolis K, Kafatos A. Adolescents perceived effectiveness of the proposed European 
graphic tobacco warning labels. Eur J Public Health. 2009;19(2):212-217. doi:10.1093/eurpub/ckp015 
Wang TW, Gentzke AS, Creamer MLR, et al. Tobacco product use and associated factors among middle and high school 
students-United States, 2019. MMWR Surveill Summ. 2019;68(12). doi:10.15585/mmwr.ss6812a1 
White V, Webster B, Wakefield M. Do graphic health warning labels have an impact on adolescents’ smoking-related 
beliefs and behaviours? Addiction. 2008;103:1562-1571. doi:10.1111/j.1360-0443.2008.02294.x 
White V, Williams T, Wakefield M. Has the introduction of plain packaging with larger graphic health warnings changed 
adolescents’ perceptions of cigarette packs and brands? Tob Control. 2015;24(Suppl 2):ii42-ii49. 
doi:10.1136/tobaccocontrol-2014-052084 
 
Protocol structure and contents based on SPIRIT 2013 Statement: Defining standard protocol items for clinical trials, 
https://www.spirit-statement.org/wp-content/uploads/2013/01/SPIRIT-Checklist-download-8Jan13.pdf 
 
Protocol Amendment History 
Version 
Date 
Description of Change 
Brief Rationale 
1 
6/26/2024 
Original protocol finalized 
 
2 
8/28/2024 
Protocol updated to reflect that baseline 
may be open for 2 days 
Allows eligible potential participants more 
time to enroll in the study