Effects of Filter Ventilation and Ventilation Information on Product Use Behaviors in Cigarette Smokers (COMET 2 3 1)
Phase: NA
Conditions: Cigarette Smoking-Related Carcinoma
Sponsor: Roswell Park Cancer Institute

Document Coversheet 
 
 Study Title:    Effects of filter ventilation and ventilation information on product use behaviors in 
cigarette smokers (COMET 2 3.1) 
 
 
 
Institution/Site:  
Roswell Park Comprehensive Cancer Center 
Document (Approval/Update) Date: 
07/07/2021 
NCT Number: 
NCT04744285 
IRB Number 
I 757820 
 

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PROTOCOL TITLE:
Effects of Filter Ventilation and Ventilation Information on Product Use Behaviors 
in Cigarette Smokers (COMET 2 3.1)
PROTOCOL NUMBER:
I 757820
PRINCIPAL INVESTIGATOR:
Dr. Richard O’Connor
Roswell Park Cancer Institute
Elm and Carlton Street
Buffalo, New York 14263
716-845-4517
Richard.O’Connor@roswellpark.org
VERSION NUMBER: 
5
DATE: 
July 7, 2021
Confidentiality Statement
Any and all information presented in this document shall be treated as confidential and shall 
remain the exclusive property of the party (ies) mentioned above (Roswell Park Cancer Institute 
Corporation d/b/a Roswell Park Comprehensive Cancer Center). The use of such confidential 
information must be restricted to the recipient for the agreed purpose and must not be disclosed, 
published, or otherwise communicated to any unauthorized persons, for any reason, in any form 
whatsoever without the prior written consent of the party(ies) above.
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Table of Contents
1
Objectives ................................................................................................................................3
2
Background..............................................................................................................................3
3
Study Endpoints.......................................................................................................................6
4
Local and Study-Wide Number of Subjects ............................................................................7
5
Study Timelines.......................................................................................................................7
6
Setting......................................................................................................................................8
7
Inclusion and Exclusion Criteria .............................................................................................9
8
Local and Study-Wide Recruitment Methods .......................................................................10
9
Consent Process.....................................................................................................................11
10
Process to Document Consent in Writing..............................................................................12
11
Procedures Involved ..............................................................................................................12
12
Withdrawal of Subjects..........................................................................................................17
13
Risks to Subjects....................................................................................................................17
14
Potential Benefits to Subjects ................................................................................................18
15
Sharing of Results with Subjects ...........................................................................................18
16
Economic Burden to Subjects................................................................................................18
17
Provisions to Protect the Privacy Interests of Subjects .........................................................18
18
Vulnerable Populations..........................................................................................................19
19
Data and Specimen Banking..................................................................................................19
20
Safety Reporting ....................................................................................................................20
21
Data Management and Confidentiality..................................................................................21
22
Statistical Plan .......................................................................................................................22
23
Community-Based Participatory Research............................................................................23
24
Multi-Site Research ...............................................................................................................23
25
Resources Available ..............................................................................................................23
26
Prior Approvals......................................................................................................................23
27
References..............................................................................................................................24
28
Appendices/ Supplements......................................................................................................37
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1
OBJECTIVES
1.1
Purpose, Specific Aims, or Objectives
In this project, we will assess whether messaging about ventilation from cigarette filters lowers 
cigarette product appeal among smokers. This study, part of a series (I 50217, I 59617) will help 
determine whether a regulatory requirement to reduce ventilation will lower demand for cigarettes 
without unintended consequences This project will assess the effect of variation in pack messaging 
about filter ventilation on consumers’ rating of product appeal, perceptions of health risks, and 
changes in cigarette consumption in a 2-week field study. Our premise is that messaging about 
risks of filter ventilation will reduce the appeal of cigarette smoking and increase the likelihood 
that smokers would either quit smoking or switch to an alternative product (e.g., electronic 
cigarettes). This project is well-integrated with the other studies in this P01, using the same 
standardized research cigarettes with defined ventilation characteristics and design parameters, as 
well as relying on common biobehavioral measures.
The aim of the proposed study is to assess how adding messaging to cigarette packages about filter 
vents and filters influences respondents awareness of filter ventilation, beliefs about the function 
of filter vents and filters, smoking behavior, ratings of cigarette satisfaction, smoking topography, 
exposure to nicotine and carbon monoxide, perceptions about the risk of smoking, and intention 
to stop smoking.6  The protocol will consist of a randomized experiment via two-week field study.
1.2
Hypothesis
We hypothesize that exposing smokers to messages about filter vents and filters will increase 
awareness and knowledge of the impact of filter ventilation on cigarette smoking behavior and 
increase intention to stop smoking.  Exposure to messages on packs will also lower ratings of 
cigarette satisfaction but have no significant impact on smoking behavior, topography, and 
exposure to nicotine and carbon monoxide.
2
BACKGROUND
2.1
Prior Experience and Gaps in Current Knowledge
The physical design features of cigarette products directly impact their appeal by influencing both 
cognitive and sensory perceptions. The introduction of a now common design feature, filter 
ventilation, has led to greater public harm than benefit because of the potential for greater toxicity 
while enhancing product appeal among smokers.  Ventilated cigarettes dilute smoke, which 
promotes perceptions of “smoothness” and therefore lower health risk, contributing to the overall 
appeal of these products. Tobacco product appeal is driven by factors including abuse liability (i.e. 
the potential for tobacco products to initiate and maintain nicotine dependence), subjective 
responses (e.g., liking, satisfaction, taste perceptions), and perceptions of cigarette pack messaging 
and other marketing strategies (including normative beliefs, risk perceptions, perceived benefits, 
outcome expectancies, use intentions, & product purchase). These perceptions and beliefs are 
further shaped by cigarette manufacturers’ use of descriptive terms and colors on packaging 
designs and advertising.
In this project, we will assess whether messaging about ventilation from cigarette filters lowers 
cigarette product appeal among smokers. This project is significant because it will generate 
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tobacco product regulatory science to support future policy approaches to filter ventilation that 
may reduce demand for cigarettes and the population harm associated with their use.
This project is innovative because it will generate novel science that informs our understanding on 
interactions between product physical design and messaging influence smokers’ perceptions of the 
product appeal and health risk.
2.2
Relevant Preliminary Data
The PI (O’Connor) and the investigative team have extensive experience in examining 
biobehavioral responses to cigarette design. Pilot research relevant to the current proposal (Rees, 
unpublished) assessed responses to “light” cigarettes and packaging. Participants (N=90) were 
current smokers whose brand of choice was Marlboro “Lights”/Gold. Using a factorial design, 
participants were randomized to receive a Marlboro “Lights” cigarette presented in one of three 
pack conditions 1) text descriptors present; 2) text descriptor removed; and 3) plain (brown) pack. 
Participants smoked two cigarettes, in counterbalanced order: 1) blocked and 2) unblocked. A 
significant interaction was observed between pack design and ventilation on measures of smoking 
Effect (p=0.007), with the ventilated cigarette producing greater perceived effect as pack 
descriptors were removed, and Throat Impact (a cue for nicotine delivery) (p=0.039). Pack design 
and ventilation also interacted to influence sensory perceptions of irritation, and taste (p’s< 0.017), 
with higher ratings seen on plain packs with blocked ventilation.
Figure 1.  Interaction of filter ventilation and pack descriptor on drug effect and liking measures.
Figure 1 shows that variation in filter ventilation interacts with pack descriptors to influence drug 
effect and liking. Web-based survey work (conducted in August-September 2016) funded under 
the prior COMET project (under protocol I 218912) included items on awareness of filter 
ventilation among smokers,113 and an administration of the mCEQ.96 Among the 1986 current 
smokers in the sample, 44.7% were aware of filter vents in cigarettes, while 45.7% were unaware, 
and 9.7% replied ‘don’t know.’  Smokers aged 18-34 were more likely than those aged 35+ to be 
aware of vents (49.9% vs. 32.4%, <.001). Men were substantially more likely than women to be 
aware of vents (60.1% vs. 30.0%, p<.0001). Most smokers (among those aware; n=1079) believed 
that covering the vents would make the cigarette taste stronger (58.6%), though 15% reported 
‘don’t know.’ Those aged 18-34 were slightly more likely to believe covering vents would make 
cigarettes stronger (59.9% vs. 52.1%), though older smokers were more likely to say ‘don’t know’ 
(10.9% vs. 27.4%). All in all, these data suggest continued lack of awareness of filter ventilation 
among smokers.  Overall, 30.4% of smokers believed their cigarette was lighter in taste than other 
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cigarettes on the market, and 29.7% believe their cigarettes were smoother on the throat. Nearly 
half (46.9%) reported that they enjoyed the taste of their cigarettes ‘a lot.’ 
2.3
Scientific or Scholarly Background for, Rationale for, and Significance of the 
Research Based on the Existing Literature and How Will It Add to Existing 
Knowledge
An important design feature that separates cigarette brand variants is the degree of filter 
ventilation, achieved by the placement of holes in cigarette filters.1-3 Filter ventilation has 
contributed to population harm by attracting new users and diverting existing smokers from 
quitting.4,11-16 Filter ventilation is deceptive in this regard because most smokers are unaware of 
it,18-21 and it promotes taking larger puffs by reducing resistance to draw.4,5,22 Smokers fingers and 
lips may also block vents during smoking, reducing or even eliminating the smoke dilution 
effect.4,23-29 Smokers of ‘light’ and ‘ultralight’ brands tend to take in similar levels of nicotine 
compared to ‘regular’ cigarette smokers, while often being exposed to higher concentrations of 
tobacco toxicants that reach deeper parts of the lung 22,30-41 and likely contributing to a higher risk 
for lung adenocarcinomas.  Unfortunately, many smokers continue to believe that ‘low tar’ 
cigarettes are less hazardous to their health.18,19,42-49 For all these reasons, scientists have called for 
restrictions on filter ventilation as a fundamentally harmful feature, which can be easily removed 
by cigarette manufacturers.
In order for the FDA to exert regulatory authority in this area, evidence is needed to demonstrate 
that regulations will benefit population health.50 The effects of banning ventilated filters could 
have positive consequences. The unvented products may be rendered harsher to smoke and less 
appealing, which could decrease use and exposures and increase intentions to quit or substitution 
of less hazardous alternatives.  On the other hand, removal could potentially lead to increased or 
similar levels of smoking behaviors and toxicant exposures among consumers because they adapt 
to the harsher smoke or because of higher reinforcing doses of nicotine.
Product
Messaging
(Color,
Descriptor)
Product
Design
(Ven la on)
Consumer
Percep on
(Percep on of messaging;
Response to product use)
Product
Use
(Purchase inten on,
Actual use)
Figure 2. Conceptual Framework
Product appeal and risk perception. Two inter-related domains drive consumer trial and adoption 
of tobacco products 54-67, as illustrated in Figure 2. These include: i) perceptions of product 
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messaging, often communicated via the product packaging; and ii) responses to product use, which 
include both sensory and other subjective response measures. Taken together, these consumer 
responses reflect the combined effects of product design and branding, and the subsequent 
outcome of product use behavior.
Sensory factors in smoking. There is substantial evidence that sensory effects of smoking, such as 
harshness, smoothness, and taste of smoke, are important drivers of continued use.  Initial work 
showed that sensory blockade reduced urge to smoke.87,88 Rose and colleagues examined various 
approaches to disassociate the nicotine and sensory components of smoking reward as approaches 
to cessation.89-95 Measurement approaches were developed to examine the upper airway sensory 
experience and factors associated with reward,92,93,95 which would later be refined into a modified 
Cigarette Evaluation Questionnaire.96 The release of internal tobacco industry research revealed 
the extent to which sensory factors were studied as important components of cigarette 
design.55,68,97,98 Continued misperceptions of cigarettes with misleading descriptors (e.g., “light”, 
“ultralight”, “mild”) are likely due to the sensory characteristics such as strength and harshness/ 
irritation 4,9 and filter ventilation level is related to perceptions of the relative harshness and 
strength of cigarettes.40,41 Expectancies of positive sensory effects of smoking (e.g., look, feel, and 
taste) are predictive of smoking behavior and willingness to try different cigarettes.99-105 This 
suggests that misperceptions about safety may persist as long as there is a perceptible sensory 
difference between products. Despite the critical regulatory science need, there are few published 
methods for testing tobacco products,57,106-108 particularly as applied to a systematic evaluation of 
a potential product standard.
Summary & Scientific Premise. Cigarette product design directly impacts product appeal via 
cognitive and sensory perceptions. Ventilated cigarettes dilute smoke, which is perceived as 
“smoother” and thus having lower health risks, contributing to the overall appeal of these products. 
These perceptions and beliefs are shaped by descriptive terms and colors on used in cigarette 
packaging and advertising. The FDA, through the Family Smoking Prevention and Tobacco 
Control Act (FSPTCA),50 has regulatory authority over tobacco products. This places cigarettes 
and other tobacco products under a public health regulatory framework.109-111 Section 907 of the 
Act relates to the agency’s ability to issue and enforce product standards. While there are 
substantial studies about the impact of filter ventilation on smokers’ perceptions, to date there are 
none about the impact of removing filter ventilation. Our premise is that messaging about filter 
ventilation will reduce the appeal of cigarette smoking and increase the likelihood that smokers 
would either quit smoking or move to alternative nicotine delivery systems (ANDS), e.g., e-
cigarettes or nicotine replacement therapy. 
3
STUDY ENDPOINTS

Primary 1:  Subjective questionnaires of product evaluation (Duke Sensory Scale, Product 
Evaluation Scale, Drug Effects, Hedonic Attribute), withdrawal (MNWS, QSU-B, 
PANAS), and readiness to quit (contemplation ladder).

Primary 2: Number of cigarettes smoked per week during the field period.

Secondary:   Awareness and beliefs about filter ventilation and perceptions of messaging.

Secondary:  Exhaled CO is defined as level of CO measured in exhaled breath after a 15 s 
breathhold. This is typically 10ppm or above in daily smokers and <3 ppm in nonsmokers.

Secondary:  Smoking topography as assessed by particulate matter retained on used filters.
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4
LOCAL AND STUDY-WIDE NUMBER OF SUBJECTS
4.1
Total Number of Subjects to be Accrued Across All Sites.
We will conduct this study with current cigarette smokers (100 in Buffalo, 100 in Boston, 100 in 
Charleston) for a total N of 300.  We hope to achieve N=240 with complete data.  An equal number 
of males and females will be recruited for the study at each site. 
Stratified recruitment scheme for Study 
3.1
Cigarette Smoker
Sex
M
F
Overall N
150
150
Buffalo
50
50
Boston
50
50
Charleston
50
50
4.2
Total Number of Subjects to be Accrued Locally

Buffalo, NY will recruit an n of 100, with a target of 80 complete cases.

Charleston, SC will recruit an n of 100, with a target of 80 complete cases.

Boston, MA will recruit an n of 100, with a target of 80 complete cases.
5
STUDY TIMELINES
5.1
Duration of an Individual Subject’s Participation in the Study
The proposed study consists of multiple videoconferencing sessions (a total of 3) throughout a 2-
week field study. Following informed consent, participants will be randomly assigned to 1 of 4 
message conditions and use the assigned product for 2 weeks. This 2-week field study involves 
participants logging their use of tobacco products, while the weekly videoconferencing sessions 
involve additional questionnaires and guidance about field data collection.
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Data Collection Sessions (Weekly)
Field (Daily 
for 14 days)
Video 1
Video 2
Video 3
Ecological 
Momentary 
Assessment 
Tobacco Use Behavior
Cigarettes per Day
X
X
X
X
Other Tobacco Use
X
X
X
X
Context of Use (e.g., location)
X
Questionnaires
Message Perceptions (response, health risk, 
purchase)
X
All messages
X
Randomly 
Assigned 
Message
X
Randomly 
Assigned 
Message
Vent Awareness
X
X
X
Product Evaluation (Duke Sensory, Product 
Evaluation Scale, Drug Effects, Hedonic 
Attribute) 
X
X
X
X 
Select Items
Readiness to Quit (Contemplation Ladder)
X
X
X
Withdrawal (MNWS, QSU-B, PANAS)
X
Select Items
Attention to Messaging
X
Biomarkers
Exhaled CO
X
Topography via Filter Analysis
X
Estimated date for the investigators to complete this study 
Data collection should be completed by 12/31/2022.
6
SETTING
6.1
Sites or Locations Where Research Will Be Conducted
We will conduct this laboratory study in Buffalo, Charleston, and Boston.
6.1.1
Where Research Team Will Identify and Recruit Potential Subjects
We will recruit for our laboratory study via community contacts, ad postings in local, daily, 
weekly, and college newspapers, websites such as Craigslist and Facebook, and local tobacco 
control networks (methods we have previously used to recruit successfully, cf. 71,152,153). In 
addition, we plan to make arrangements with local shopping centers to allow recruitment of patrons 
on-site.
6.1.2
Where Research Procedures Will Be Performed
Remote visits will involve participants joining videoconferences in their own homes.
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7
INCLUSION AND EXCLUSION CRITERIA
7.1
How Individuals Will Be Screened For Eligibility
We will recruit adult smokers for the study via community contacts, ad postings in local daily, 
weekly, and college newspapers, websites such as Craigslist and Facebook, and local tobacco 
control networks (methods we have previously used to recruit successfully, cf. 71,152,153). 
Screening methods may involve live telephone interviews, automated telephone screeners (via 
IVR), and online screening methods where the recruit will complete an eligibility screener online 
and receive a callback for scheduling pending eligibility. 
7.2
Inclusion Criteria 
1. Aged 21-69 years old.
2. Currently smoking daily, at least 5 cigarettes per day, for the past year:
a.
Primarily using factory-made filtered cigarettes. 
3. Fair and above self-rated physical health (self-rated).
4. Fair and above self-rated mental health (self-rated).
5. Not planning to quit smoking in the next 30 days.
6. Able to converse, read, and write in English.
7. Access to smartphone (e.g., iPhone, Android) for Ecological Momentary Assessment 
(EMA) component.
8. Access to a smartphone/tablet/computer with video capabilities and internet access for 
remote videoconferencing (EMA check-ins).
9. AUDIT-C score <7 (i.e., no problematic alcohol consumption).
10. Cannabis use <5 days in the past month.
11. No other illegal drug use in the past month (allow for prescriptions).
12. Not pregnant or breastfeeding or planning to become pregnant during the study period.
13. Participant must understand the investigational nature of this study and sign an Independent 
Ethics Committee/Institutional Review Board approved written informed consent form 
prior to receiving any study related procedure.
7.3
Exclusion Criteria
1. Age < 21 or > 69.
2. Using roll-your-own cigarettes or usual brand of cigarettes is unfiltered.
3. Planning to quit smoking in the next 30 days.
4. Not able to converse, read, and write in English.
5. Adults unable to consent.
6. Minors (any persons under age 21).
7. Prisoners.
8. Poor physical health by self-report.
9. Poor mental health by self-report:
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o
Exclude Dx psychosis, Dx bipolar, K6 score indicating serious psychological 
distress.
10. AUDIT-C score >7 (i.e. problematic alcohol consumption).
11. Cannabis use >5 days in past month.
12. Other illegal drug use in past month.
13. Pregnant or breastfeeding by self-report.
14. No access to smartphone or videoconferencing.
7.4
Inclusion of Women and Minorities
Both men and women and members of all races and ethnic groups are eligible for this study.
7.5
Special Populations
The following populations will be excluded from study participation:

Cognitively impaired adults/adults with impaired decision-making capacity

Individuals who are not yet adults (infants, children, teenagers) 

Pregnant Women 

Prisoners 
8
LOCAL AND STUDY-WIDE RECRUITMENT METHODS
8.1
When, Where, and How Potential Subjects Will Be Recruited
We will recruit for our laboratory study via community contacts, ad postings in local daily, weekly, 
and college newspapers, websites such as Craigslist and Facebook, and local tobacco control 
networks, and lists of prior study participants (methods we have previously used to recruit 
successfully, cf. 71,152,153).
8.2
Methods That Will Be Used to Identify Potential Subjects
Screening methods may involve live telephone interviews, automated telephone screeners (via 
IVR), and online screening methods where the recruit will complete an eligibility screener online 
and receive a callback for scheduling pending eligibility.
Additionally, we plan to implement a chain referral method. This method has been successfully 
used in other participant-based studies. Here, all participants who complete the study will be given 
a “coupon book” containing 3 “coupons” (Appendix A), each with a unique code per participant. 
The participant may give a coupon to a friend/colleague/relative if they choose. The friend, in turn, 
may voluntarily call in to complete the screener, just as if they saw an ad. Should the friend 
successfully complete the study and return the coupon, the original participant may earn $10 per 
referral (up to a maximum of $30). A gift code (e.g., Amazon, Target) will be e-mailed upon the 
close of the entire study, guaranteeing the maximum amount of time to earn the largest monetary 
reward.  Finally, letters (Appendix A) will be mailed to the home address of participants who have 
previously completed a tobacco-related studies as the one of the three study sites (i.e., Roswell 
Park Comprehensive Cancer Center, Medical University of South Carolina, and Harvard School 
of Public Health) and gave consent to be contacted in the future for other research opportunities.
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8.3
Materials That Will Be Used to Recruit Subjects
Ad and chain referral materials included (Appendix A).
8.4
Amount and Timing of Any Payments to Subjects
Participants receive $50 for each videoconference session (three total).  Payment will be in the 
form of a gift code (e.g., Amazon, Target).  Participants can earn up to $10 for each day of EMA 
compliance (up to 14 days, totaling $140), which will be paid by check at the end of the study.  
Total potential compensation is $290.
9
CONSENT PROCESS
9.1
Indication of Obtaining Consent
An initial videoconferencing session will be used for informed consent. Consent will be obtained 
through the REDCap (Research Electronic Data Capture) system used for data collection. REDCap 
is a secure web-based application that supports data capture and management for research studies. 
The Investigator and Research Associate will design the study specific consent and upload the 
most recent CRS versions to the REDCap system. A secure link will be sent to each participant 
prior to the start time of the study. Research staff will guide the participant form, provide time to 
read the consent, and answer any questions. Participants and staff will be able to electronically 
sign, data, and submit the consent in real-time. Once the consent is submitted, it is automatically 
saved on RPCI protected servers. Access to this folder is restricted to authorized users. Standard 
protocols for data encryption (via Credant) when using laptops and USB drives will be followed. 
In the event of REDCAP being inaccessible for a study visit, .pdf files or paper copes of the consent 
will be provided to the participants and the participants will be able to sign and return or submit a 
photo of the signed copy.
9.2
Where the Consent Process Will Take Place
Consent will take place via video-conference.
9.3
SOP: Informed Consent Process for Research (HRP-090)
Standard SOP and Summary of Current Guidance on Alternative Informed Consent Procedures 
for Research Studies Impacted by COVID-19.
For Multi-Site Study: This study will not be initiated until the protocol and informed consent 
document(s) have been reviewed and approved by a properly constituted Institutional Review 
Board (IRB) or Independent Ethics Committee (IEC). Each participant (or legal guardian) shall 
read, understand, and electronically sign an instrument of informed consent prior to performance 
of any study-specific procedure. It is the responsibility of the investigator to ensure that the 
participant is made aware of the investigational nature of the treatment and that informed consent 
is given.
The Investigator is responsible for the retention of the participant log and participant records; 
although personal information may be reviewed by authorized persons, that information will be 
treated as strictly confidential and will not be made publicly available. The investigator is also 
responsible for obtaining participant authorization to access medical records and other applicable 
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study specific information according to Health Insurance Portability and Accountability Act 
regulations (where applicable).
This study will be conducted in compliance with all applicable laws and regulations of the state 
and/or country and institution where the participant is treated. The clinical trial should be 
conducted in accordance with the ethical principles embodied in the Belmont Report: Ethical 
Principles and Guidelines for the Protection of Human Subjects of Research, consistent with good 
clinical practice and the applicable regulatory requirements and according to the guidelines in this 
protocol, including attached appendices.
10
PROCESS TO DOCUMENT CONSENT IN WRITING
10.1 SOP: Written Documentation of Consent (HRP-091) 
We will obtain documentation of consent.
10.2 If Your Research Presents No More Than Minimal Risk of Harm to Subjects and 
Involves No Procedures for Which Written Documentation of Consent is Normally 
Required Outside of the Research Context, the IRB Will Generally Waive the 
Requirement to Obtain Written Documentation of Consent.
N/A.
10.3 Waiver of Consent Documentation
N/A.
For Multi-Site Study: The Investigator (or IRB specified designee) is responsible for obtaining 
written consent from each participant in accordance with GCP guidelines using the approved 
informed consent form, before any study specific procedures (including screening procedures) are 
performed. The informed consent form acknowledges all information that must be given to the 
participant according to applicable GCP guidelines, including the purpose and nature of the study, 
the expected efficacy and possible side effects of the treatment(s), and specifying that refusal to 
participate will not influence further options for therapy. Any additional information that is 
applicable to the study must also be included. Additional national or institutionally mandated 
requirements for informed consent must also be adhered to. The participant should also be made 
aware that by signing the consent form, processing of sensitive clinical trial data and transfer to 
other countries for further processing is allowed.
The investigator or designee shall provide a copy of the signed consent form to the participant and 
the signed original shall be maintained in the investigator file. A copy of the signed consent form 
must be filed in the participant file. At any stage, the participant may withdraw from the study and 
such a decision will not affect any further treatment options.
11
PROCEDURES INVOLVED
11.1 Study Design
Examine how filter ventilation messaging influences real-world product use, perceptions of 
and responses to products, and awareness of filter ventilation. 
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Cigarettes are not smoked in isolation, but in a broader informational context. Thus, the effects of 
ventilation on responses to product use must be assessed with respect to product communications. 
We will conduct a field protocol in which various product messaging will be assessed under real-
world product use experiences in terms of consumers’ ratings of product appeal, risk perceptions, 
or change cigarette smoking behavior. We hypothesize that messaging will influence filter 
ventilation awareness and perceptions, but not behavior change. 
Filters from these sessions will be used to examine within-cigarette compensatory smoking 
behaviors (e.g., vent blocking; mouth level exposure).114-116
11.2 Treatment
This study will use two types of cigarettes. On set of cigarettes are commercially available 
Marlboro cigarettes (Philip Morris USA, Richmond, VA), all combustible King size (83mm) 
cigarettes consisting of filler, filter paper, tipping paper, cigarette paper, tipping glue and seam 
glue.  Specific varieties are listed in the table.  Products will be sourced at retail from local outlets.  
Alternatively, participants may receive investigational “roll your own” (RYO) cigarettes 
that will be prepared in the laboratory. These cigarettes will be made to match the 
commercially available Marlboro cigarettes. These cigarettes will be prepared with 
conventional tobacco (e.g., Good Stuff) rolled using an automatic rolling machine (e.g., 
Powermatic III+) and packaged into 20 rod packs. The investigational RYO cigarettes 
will use ventilated filter tubes (e.g., ~25-37% filter ventilation). The dose of nicotine in 
these RYO cigarettes will be similar to conventional cigarettes.
Within each pair of products is a nonmenthol and menthol equivalent.  Participants who report 
regularly smoking menthol cigarettes will receive the menthol versions for the study.  
Variety
Vent %
Filter length 
(mm)
Tobacco 
weight
(mg)
Special Blend Smooth Mellow 
30.6
27
625.1
Smooth Fresh Menthol
37.6
27
630.8
Additionally, cigarettes will be paired with messaging about filter ventilation. This message will 
be affixed to the front exterior of each package provided to participants. 

No Message (e.g., unaltered cigarette pack).

Neutral Message: “Nothing about this product’s color or name means that it will protect a 
smoker from the health risks of smoking.”

Compensation Message: “This product has a ventilated filter. Filter vents increase how 
deeply a smoker inhales without them knowing, which can increase the health risks of 
smoking.”

Blocking Message: “This product has a ventilated filter. Be sure not to block the vent holes 
with your fingers or lips, which can increase the health risks of smoking.”
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With these conditions, ‘no message’ serves as a true control (smoking as normal), while the neutral 
message serves as a control message to determine if added messaging impacts 
behavior/perceptions, even if that message is not informational. The compensation and blocking 
messages will determine if added messaging about the health risks of filter ventilation affect 
behavior/perceptions, and which type of message has the greater impact.
 11.3 Study Procedures
The proposed study is a between-subjects design in which participants will be randomized to 1 of 
4 conditions for 2 weeks. 

No Message (e.g., unaltered cigarette pack).

Neutral Message: “Nothing about this product’s color or name means that it will protect a 
smoker from the health risks of smoking.”

Compensation Message: “This product has a ventilated filter. Filter vents increase how 
deeply a smoker inhales without them knowing, which can increase the health risks of 
smoking.”

Blocking Message: “This product has a ventilated filter. Be sure not to block the vent holes 
with your fingers or lips, which can increase the health risks of smoking.
Data will be collected in three remote video sessions and via EMA conducted over 2 weeks. Each 
study session is expected to take 0.5 hours. For each condition, active data collection is expected 
to take no more than 15 minutes. Study materials (cigarettes, CO monitor, containers for cigarette 
filter collection, scales) will be mailed to, delivered, or picked up by participants. Session 1 will 
involve confirmation of receipt of study materials, questionnaires, and training on procedures. 
Then, participants will track their product use via EMA app (REDCap) for 2 weeks, with two 
remote sessions via videoconference for additional questionnaires.
Informed Consent. An initial videoconferencing session will be used for informed consent. 
Consent will be obtained through the REDCap (Research Electronic Data Capture) system used 
for data collection. REDCap is a secure web-based application that supports data capture and 
management for research studies. The Investigator and Research Associate will design the study 
specific consent and upload the most recent CRS versions to the REDCap system. A secure link 
will be sent to each participant prior to the start time of the study. Research staff will guide the 
participant form, provide time to read the consent, and answer any questions. Participants and 
staff will be able to electronically sign, data, and submit the consent in real-time. Once the 
consent is submitted, it is automatically saved on RPCI protected servers. Access to this folder is 
restricted to authorized users. Standard protocols for data encryption (via Credant) when using 
laptops and USB drives will be followed.
In the event of REDCap being inaccessible for a study visit, .pdf files or paper copes of the consent 
will be provided to the participants and the participants will be able to sign and return or submit a 
photo of the signed copy. 
The participant will then be randomized to 1 of 4 message conditions (No message, Neutral 
message, Compensation message, Blocking message) and arrangements will be made to mail, 
deliver, or have participants pick up study materials (study cigarettes with pack messages, CO 
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monitor, scales, butt collection materials, shipping materials, etc.). Participants will be provided 
with two weeks of materials. 
Session 1. Session 1 will occur upon receipt of study materials by the participant. Participants will 
complete a baseline intake questionnaire including smoking and tobacco use history, nicotine 
dependence scales, SCQ, TRIRISK, delay discounting, respiratory symptoms, and knowledge, 
attitudes, and beliefs about filter vents. In addition, participants complete questionnaires on 
message perceptions (response to messaging, health risk, purchase intention) for all pack 
messages. Questionnaires also will be used to get baseline assessments of the user’s usual brand 
of cigarettes (Duke Sensory Scale, Product Evaluation Scale, Hedonic Attribute Scale). 
Participants will be instructed to record each smoking event using the EMA app provided 
(described in more detail below) and to retain all spent cigarette butts and unused product. 
Participants will be informed that they are free to use other tobacco products (though they will not 
be provided as part of the study), and that these should be recorded using EMA. Participants will 
be provided for cigarettes for a total of two weeks, with the amount determined by normal self-
reported weekly consumption rounded to nearest whole pack. 
Remote Data Collection. Participants will complete the two-week study remotely using EMA 
methods. At the conclusion of Session 1, participants will be trained to record their assigned 
product use via EMA for data collection. Specifically, participants will respond to 5 scheduled 
questionnaires daily. These questionnaires are designed to assess product consumption, context of 
use (e.g., location, social situation), and subjective responses (e.g., withdrawal, product evaluation, 
message attention - more details on surveys provided below). Participants will be prompted to 
measure their exhaled-air CO level and product weight twice each day using a personal monitor 
provided to them. Participants will also retain all spent cigarette butts and unused products 
throughout the two weeks.
Day 3 Check-in: Research assistants will monitor EMA data to ensure the participant is compliant 
with study procedures. Participants will send a secure text message (via Twilio) or arrange a phone 
call to discuss the participant’s compliance in the initial days of data collection. Participants that 
are not responding to prompts will be retrained to ensure they understand procedures and warned 
that compliance must increase to continue participating in the study.
Session 2 will take place one week later (± 2 days) via remote videoconference using an institution-
approved software with a password protected meeting (e.g., WebEx, Microsoft Teams, Zoom). 
The Session 2 videoconference will include the completion of questionnaires on vent awareness, 
product evaluation, and readiness to quit (similar to Visit 1). Participants will again be asked on 
message perceptions, but only in relation to their randomly assigned condition.
Session 3 will take place one week later (±2 days) via remote videoconference. The same 
questionnaires from Session 2 will be administered again. Laboratory staff will guide participants 
to place all materials (retained filter butts, unused products, unsigned payment receipts) in the 
provided shipping box. Arrangements will be made for the participant to return materials or for 
research staff to pick up materials. Participants will be paid for Visit 3 upon verification of returned 
study materials. 
11.4 Data To Be Collected

Baseline measures and covariates will assess:
o
Demographics (age, sex, race/ethnicity, education, income) 
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o
Tobacco use behaviors (consumption, brand, menthol preference, past quit 
attempts) 

Delay discounting

A series of previously used items will assess knowledge and perceptions of filter 
vents.113,117 

Nicotine dependence will be assessed using: 
o
Fagerström Test for Nicotine Dependence (FTND118) 
o
PROMIS
Behavioral aspects of cigarette dependence will be assessed using:

The Glover-Nilsson scale 120,121 

The different scales are used to capture different dimensions of tobacco dependence.122 

Exhaled air CO will be collected by the participants twice each day using a personal CO 
monitor provided by the researchers. The CO monitors provided are coVita iCo™ 
Smokerlyzers®, which are intended for research and consumer use and are compatible with 
a Smartphone or tablet (iOS or Android).
Perceptions of product messaging: In this study, we are interested in risk perceptions, smoking-
related expectancies, and behavioral intentions. We will assess risk perceptions for specific 
products using a risk ladder.129 More generalized perceptions of risk for cancer are captured using 
the tripartite risk (TRIRISK) measure, which captures deliberative, affective, and experiential 
components of risk perception.130 The adult smoking consequences questionnaire (SCQ) will 
assess smoking-related expectancies.103,131 Behavioral intention is assessed using Juster’s 
consumer purchase probability scale, a widely used marketing metric.132-134 Additional questions 
will include responses to messaging (e.g., message was powerful, memorable).
Responses to product use will be assed in a number of ways:  Response to nicotine dose will be 
assessed using the Minnesota Nicotine Withdrawal Scale (symptoms of nicotine withdrawal).135 
Cigarette craving in field will be assessed using the Brief QSU commonly used in cue reactivity 
research. Behavioral economic measures will assess product demand. A delay discounting task 
will assess preference for immediate reward,148 while purchase tasks will be used to estimate level 
and elasticity of demand.149-151 Sensory measures will be collected using the Duke Sensory Scale 
and Hedonic Attribute Scale. Drug effect measures include the Product Evaluation Scale and Drug 
Effects/Liking Scale.
Cigarette tracking via EMA: For the field study, the key outcome is the total number of cigarettes 
smoked. Participants will be asked to complete REDCap questionnaires on their personal phone 
(iOS or Android). Participants can use the MyCap application to respond to questionnaires. 
Additionally, REDCap can interface with Twilio, a secure text-messaging platform, to send study 
related messages and surveys via SMS (text messaging). Proposed EMA methods are based on 
established best practices. Participants will complete 5 questionnaires every day. These 
questionnaires will occur at the same time each day: 11am, 1:30pm, 4pm, 6:30pm, and 9pm. These 
daily reports will be used to assess cigarette and e-cigarette consumption, and 10 items relating to 
subjective ratings of nicotine withdrawal (e.g., craving, irritability) and mood (e.g., calm/relax, 
happy). At 11am only, participants will complete selected items from the Hedonic Attribute Profile 
and Product Evaluation Scale. At 9pm only, participants will be asked to rate the taste, satisfaction, 
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enjoyment, and craving relief from the cigarettes they smoked that day. Participants will also be 
asked to take a CO measurement at this time. At the 1:30 and 6:30 prompts, participants will be 
asked about situational factors related to use (Location, smoking permitted, with others, activity, 
craving) and complete the Duke Sensory Evaluation scale. Participants also will be asked to take 
a picture of their research cigarette pack to ensure compliance. Surveys will be open for 1 hour 
after the scheduled time for completion. Appendix C demonstrates the EMA schedule and the 
questions asked at each daily report and pseudo-random prompt. Participants can earn up to $10 
for each day of EMA compliance, with compliance being defined as responding to > 4 of 5 daily 
prompts (up to 14 days, totaling $140). Studies that used similar methods had >90% compliance. 
[189, 190].
12
WITHDRAWAL OF SUBJECTS
12.1 Anticipated Circumstances Under Which Subjects Will be Withdrawn From the 
Research Without Their Consent
Participants will be withdrawn from the study if they do not follow the study schedule or 
requirements. Participants are expected to reach 80% EMA compliance daily (>4 of 5 prompts). 
If a participant fails to reach 80% compliance for 3 consecutive days, that participant will be 
warned and retrained. If the participant continues to be noncompliant for 3 additional days, they 
will be withdrawn from the study. Failure to respond to any study prompts (0% compliance) for 
three consecutive days will result in withdrawal.
12.2 Procedures That Will be Followed When Subjects Withdraw From the Research, 
Including Partial Withdrawal From Procedures With Continued Data Collection
The participants will only be paid for the completed study sessions and then will be dismissed 
from the study. 
13
RISKS TO SUBJECTS
13.1 Foreseeable Risks
Answering questionnaires pose none to minimal risk. In the event a question causes any type of 
distress, information will be provided to identify psychological resources available to the 
participant.  There is no to minimal risk for providing breath samples for measurement of carbon 
monoxide (CO).  When providing materials to participants by mail, delivery confirmation with 
signature will be used to confirm the correct person receives the materials.
Cigarette smoking.
Since we are using commercially available cigarettes, the side effects of the cigarettes used in this 
study would be similar to the use of other commercial cigarette products, including those the 
participants smoke themselves. Participants could experience an increased risk for mouth sores, 
gum disease and tooth loss, nausea or stomach aches, vomiting, or high blood pressure. Some 
people who use cigarettes may experience irritation of the mucosal membranes of the upper 
respiratory tract (i.e., the membranes that line the mouth and throat), but as the participants in this 
study are already regular users, we do not think that this is likely to occur.
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
Rare but Serious Side Effects: Those that occur in less than 5% of persons who use nicotine 
products.
o
Mouth irritation
o
Severe sore throat
o
Irregular heartbeat or rapid heartbeat

More common but less Serious Side Effects: Those that occur in less than 10-30% of 
persons who use nicotine products.
o
Indigestion or heartburn
o
Nausea, vomiting, dizziness, diarrhea, or weakness
14
POTENTIAL BENEFITS TO SUBJECTS
14.1 Potential Benefits
There are no direct benefits to taking part in this study.
14.2 Indication of No Direct Benefits
There are no direct benefits to taking part in this study.  This research has potential to inform FDA 
regulation of tobacco products.
15
SHARING OF RESULTS WITH SUBJECTS
All analyses will be completed as a group. Though the goal is to publish the overall results in a 
scientific journal made available to the public, no individual’s results or information will be shared 
either with the subject or public. Participants may receive overall final results of the study by mail 
if desired.
16
ECONOMIC BURDEN TO SUBJECTS
16.1 Costs that Subjects May be Responsible for Because of Participation in the Research
There are no costs to the participant associated with study participation.
17
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF SUBJECTS
17.1 Protection of the Subjects’ Privacy Interests 
Participants will only interact with the research coordinator conducting the interview. 
17.2 Steps Taken to Make the Subjects Feel at Ease with the Research Situation in Terms 
of the Questions Being Asked and the Procedures Being Performed. “At Ease” Does 
Not Refer to Physical Discomfort, but the Sense of Intrusiveness a Subject Might 
Experience in Response to Questions, Examinations, and Procedures.
The research coordinators will administer and review an informed consent document, explaining 
all components of the research study. Participants are only encouraged to verbally agree to the 
conditions in the consent only if they are completely comfortable with the study design and 
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procedures. Participants will have the opportunity to ask questions at any point during the study 
and may withdraw at any time.
17.3 How the Research Team is Permitted to Access Any Sources of Information 
About the Subjects
The research team is only permitted to access sources of information provided by the participant.
18
VULNERABLE POPULATIONS
N/A.
19
DATA AND SPECIMEN BANKING
19.1 Data Banking
For purposes of this research, we will collect the following identifiable information:

Participant Name – to verify identification

Date of birth - to verify age 

Telephone number - to facilitate contact for scheduling 

Mailing address - to send study materials 

Email address - to facilitate contact for scheduling and videoconference access

Identifiable information will be retained in a separate Excel file from the analytic dataset. 
The only link to identifiable information will be via a unique ID number.
All questionnaires are administered via REDCap, housed at RPCI.  All data files will be electronic, 
including only the unique subject ID. All datafiles will be stored on the Cancer Prevention server 
(\\CancerPrev\CancerPrev$\HealthBehavior\TobaccoLab). Access to this folder is restricted to 
authorized users. Standard protocols for data encryption (via Credant) when using laptops and 
USB drives will be followed. Twilio is a third-party web service that has been integrated into 
REDCap to send survey invites and SMS messages to participants via text. All participant data is 
stored in REDCap, and Twilio is only used to send the text and survey link. When the respondent 
presses the link, their browser on their smart phone will open to complete the survey in the secure 
website or reed any sent messages. When a participant provides permission for study staff to send 
the daily survey invite by SMS (text), the Twilio program within REDCap will provide that 
functionality. When a participant responds, Twilio will relay the information back to REDCap.  
Once a participant completes a daily survey, the data are sent through Twilio servers to REDCap. 
Data are stored in the REDCap database, not in Twilio, so that the data are encrypted and secured.  
Twilio does not maintain a log of outgoing/incoming messages or calls.
19.2 Data Procedures
All data files will be electronic, including only the unique subject ID. All datafiles will be stored 
on the Cancer Prevention server (\\CancerPrev\CancerPrev$\HealthBehavior\TobaccoLab). 
Access to this folder is restricted to authorized users. Standard protocols for data encryption (via 
Credant) when using laptops and USB drives will be followed.
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19.3 Data Protocol for Multi-Site Study
All sites will input data from surveys and interviews directly into the RedCap database housed at 
RPCI.  RPCI will conduct all data analysis.
Note: All investigator or analyzing research laboratories housing research samples need to 
maintain current Temperature Logs and study-specific Sample Tracking and Shipping Logs. The 
Principal Investigator/Laboratory Manager must ensure that the stated lab(s) have a process in 
place to document the receipt/processing/storage/shipping of study-related samples/specimens. 
This is required for all studies collecting clinical samples.
20
SAFETY REPORTING
Unanticipated Problems
An Unanticipated Problem (UP) is any incident, experience, or outcome that meets all of the 
following criteria:

Unexpected (in terms of nature, severity, or frequency) given:
o
The research procedures that are described in the study-related documents, 
including study deviations, as well as issues related to compromise of participant 
privacy or confidentiality of data.
o
The characteristics of the participant population being studied.

Related or possibly related to participation in the research (possibly related means there is 
a reasonable possibility that the incident, experience, or outcome may have been caused by 
the procedures involved in the research).
Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized 
and if in relation to an AE is also deemed Serious as deemed below: 
Serious Adverse Events
A serious adverse event (SAE) is any adverse event (experience) that in the opinion of either the 
investigator or sponsor results in ANY of the following:

Death

A life-threatening adverse event (experience). Any AE that places a participant or 
participants, in the view of the Investigator or sponsor, at immediate risk of death from 
the reaction as it occurred. It does NOT include an AE that, had it occurred in a more 
severe form, might have caused death.

Inpatient hospitalization or prolongation of existing hospitalization (for > 24 hours).

A persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions.

A congenital anomaly or birth defect.

Important Medical Event (IME) that, based upon medical judgment, may jeopardize 
the participant and may require medical or surgical intervention to prevent one of the 
outcomes listed above.
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Reporting Unanticipated Problems
Unanticipated problem reporting will begin at the time of participant consent. The Reportable New 
Information (RNI) Form will be submitted to the CRS Quality Assurance (QA) Office within 1 
business day of becoming aware of the Unanticipated Problem. After review, the CRS QA Office 
will submit the RNI to the IRB.
When becoming aware of new information about an Unanticipated Problem, submit the updated 
information to the CRS QA Office with an updated Reportable New Information Form.  The site 
Investigator or designated research personnel will report all unanticipated problems to the IRB in 
accordance with their local institutional guidelines.
21
DATA MANAGEMENT AND CONFIDENTIALITY
21.1 Identifiable Information Necessary for Research
For purposes of this research, we will collect the following PHI:

Participant Name – to verify identity

Date of birth - to verify age 

Telephone number - to facilitate contact for scheduling 

Mailing address - to send study appointment materials 

Email address (optional) - to facilitate contact

Identifiable Information protocol
Identifiable information will be retained in a separate Excel file from the analytic dataset. The only 
link to identifiable information will be via a unique ID number in order of participation. 
All data files will be electronic, including only the unique subject ID. All data files will be stored 
on the Cancer Prevention server (\\CancerPrev\CancerPrev$\HealthBehavior\TobaccoLab). 
Access to this folder is restricted to authorized users. Standard protocols for data encryption (via 
Credant) when using laptops and USB drives will be followed.
Remote participation will be facilitated using videoconferencing software approved by the 
institution site, such as Webex, Zoom, or Microsoft Teams. All videoconferencing will be 
conducted using institution-affiliated logins and password protected meetings. Cisco WebEx, for 
which Roswell Park has a license, will be used by Roswell Park staff.  This software allows for 
secure videoconferencing.  For this study, participants will receive information to access a specific 
videoconference as a predetermined time with a study research assistant.  Videoconferences will 
be recorded to confirm compliance with study procedures.
21.2 Plan to Protect Research Data
All data files will be electronic, including only the unique subject ID. All data files will be stored 
on the Cancer Prevention server (\\CancerPrev\CancerPrev$\HealthBehavior\TobaccoLab). 
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21.3 Data File Security
Standard protocols for data encryption (via Credant) when using laptops and USB drives will be 
followed.
21.4 Data File Access
Access to this folder is restricted to authorized users.
21.5 Protocol for Data Accessed by Multiple Personnel
Standard protocols for data encryption (via Credant) when using laptops and USB drives will be 
followed.
21.6 Plan to Destroy Identifiers
Identifiers will be deleted at the earliest possible opportunity.
21.7 Identifiable Information to be Reused or Disclosed to any Other Person or Entity
Access to this folder is restricted to authorized users.
21.8 Data Security Plan
Identifiable information will be retained in a separate Excel file from the analytic dataset. The only 
link to PHI will be via a unique ID number in order of participation. 
All data files will be electronic, including only the unique subject ID. All datafiles will be stored 
on the Cancer Prevention server (\\CancerPrev\CancerPrev$\HealthBehavior\TobaccoLab). 
Access to this folder is restricted to authorized users. Standard protocols for data encryption (via 
Credant) when using laptops and USB drives will be followed.
22
STATISTICAL PLAN
22.1 Data Analysis Plan
The analysis of EMA data will be analyzed using a linear mixed model with fixed effects for vent 
message (product design, color/name), as well as sex and other tobacco product strata (cigarettes 
only or dual use). The effect of packaging will be tested using a Bonferroni-corrected type-I error 
rate of 0.008 (0.05/6) to account for all possible pairwise comparisons of packaging types. Data 
from the field-study (e.g., change in product responses, risk, TNE, aldehyde-DNA adducts) will 
be analyzed using linear regression with terms in the model for vent message (no message, neutral, 
compensation, blocking), sex, and other tobacco product use.. Categorical outcomes for the field-
study will be analyzed using logistic regression.  As exploratory approaches, we will use time-
varying effects models (TVEMs) to explore the effect of message condition on smoking behavior 
(product compliance), craving, risk perception, and quit intention in the EMA data.[191, 192] 
TVEMs have been used previously to examine treatment effects on craving [193] and relapse.[194] 
TVEMs will provide daily effect sizes, thereby allowing us to examine whether treatment effects 
(and relationships with other predictors) change over time (i.e., early vs. later in product 
switching). Responses at Visit 1  can be treated as time invariant predictors and mCEQ from EMA 
can be treated as time-varying predictor (and/or outcome) of product use.
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We will enroll a total sample size of 300 subjects and assume a 20% drop-out rate with uniform 
drop-out from Visit 1 to Visit 3. This will result in a sample size of 300 subjects for Visit 1, 270 
subjects for the first week of the field study, and 240 subjects for the end of field study. Our sample 
size was determined to have adequate power for the field study, For the field study, we hypothesize 
a 25% difference between conditions, corresponding to a 3.9 CPD difference. Assuming a standard 
deviation of 7.6,[195] a sample size of 240 subjects will provide 95% power to detect a significant 
difference between ventilation conditions at the 0.05 level and 80% power to detect a significant 
difference between packaging conditions with a Bonferroni-corrected type-I error rate of 0.008.
mCEQ is scored using an established algorithm.96  This results in 3 subscales (Psychological 
Reward, Relief, Reward) and 2 single items (Aversion, Respiratory sensation).  Scores range from 
1-7.
CO boost is defined as the difference between pre-smoking exhaled CO and post-smoking exhaled 
O.  This is typically a positive value.
23
COMMUNITY-BASED PARTICIPATORY RESEARCH
N/A.
24
MULTI-SITE RESEARCH
24.1 Communication and Protocol Approval at Multi-Site Centers
Roswell Park will be the IRB of record for this study.  Accruals will occur at Roswell Park, Harvard 
School of Public Health (Site PI: Vaughan Rees), and Medical University of South Carolina (Site 
PI: K Michael Cummings).  Each participating site will enter into a reliance agreement with the 
Roswell Park IRB, with appropriate inclusion of local information.
25
RESOURCES AVAILABLE
The PI has over a decade of experience in behavioral research.  We are recruiting from the general 
population of Erie/Niagara.  The total population over 21 is approximately 1 million, of which 
15% smoke, we anticipate no issues in accruing 100 smokers.
26
PRIOR APPROVALS
This study is funded by National Cancer Institute.  P01 CA217806 (PI: Dorothy Hatsukami, 
University of Minnesota).
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27
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Kozlowski LT, Mehta NY, Sweeney CT, et al. Filter ventilation and nicotine 
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O'Connor RJ, Hammond D, McNeill A, et al. How do different cigarette design 
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Gray N, Kozlowski LT. More on the regulation of tobacco smoke: how we got 
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Jarvis MJ. Trends in sales weighted tar, nicotine, and carbon monoxide yields of 
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Jarvis MJ, Russell MA. Tar and nicotine yields of U.K. cigarettes 1972-1983: 
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King B, Borland R. The "low-tar" strategy and the changing construction of 
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Burns DM, Anderson CM, Gray N. Do changes in cigarette design influence the 
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Harris JE, Thun MJ, Mondul AM, Calle EE. Cigarette tar yields in relation to 
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Proctor R. Golden holocaust : origins of the cigarette catastrophe and the case 
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Thun MJ, Burns DM. Health impact of "reduced yield" cigarettes: a critical 
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Tindle HA, Shiffman S, Hartman AM, Bost JE. Switching to "lighter" cigarettes 
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Tindle HA, Rigotti NA, Davis RB, Barbeau EM, Kawachi I, Shiffman S. 
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Health OoSa. Nicotine Addiction: A Report of the Surgeon General. Atlanta: US 
Department of Health and Human Services, Public Health Service, Centers for 
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Disease Control, National Center for Chronic Disease Prevention and Health 
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application of (case 1) best–worst scaling in marketing research. International 
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health care research and how to do it. Journal of Health Economics. 
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Hatsukami DK. Validation of a Measure of Normative Beliefs About Smokeless 
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smokers. Tobacco induced diseases. 2015;13(1):7.
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waking and time of day as predictors of puffing behaviour in UK adult smokers. 
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191. 
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dependence item banks. Nicotine & Toabcco Research. 2014;16(Suppl 3):S190-
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assessing dependence on electronic cigarettes among a large sample of ex-
smoking e-cigarette users. Nicotine & Tobacco Research. 2015;17(2):186-192.
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28 APPENDICES/ SUPPLEMENTS
Appendix A: Recruitment Materials
Print ad copy.  
 
[insert site logo]
RESEARCH PARTICIPANTS NEEDED
Researchers at [insert study site] are searching for smokers to participate in a two-week field 
study for an important research project.
Participation involves two weeks of remote data collection and three videoconferencing sessions. 
Remote data collection involves 5 daily questionnaires on product use.
Must be 21-69 years old daily cigarette smokers to participate. 
Participants will be compensated for their time.
If interested, please contact
[insert site contact number here]
And ask for the VENT study
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Referral Coupon Example
VENT Study Coupon 
Code: 
Return of this coupon ensures the referrer to $10 
after the referral successfully completes the VENT Study
Date Distributed:
Date Returned:
Signed (Research Coordinator):
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Prior Participant Recruitment Letter 
[to be printed on [insert site]letterhead]
Dear [insert name],
We are contacting you because you previously completed study with us, and asked to be 
contacted in the future if another research opportunity became available.   
We are looking for regular cigarette smokers to participate in an important research project. The 
purpose of the study is to examine the impact of messaging about filter ventilation, a common 
design feature of cigarettes.  
To do this, we are asking people to participate in a study involving two weeks of remote data 
collection and three videoconferencing sessions in which you will be asked to use specific 
cigarettes. During the first videoconference session, we would ask you to answer questionnaires 
on your smoking behavior and train you on remote data collection procedures. During remote 
data collection, we will ask you to respond to 5 questionnaires about product use, situational 
factors (location, social situation) and how you’re feeling. We hope findings from this study can 
inform the regulation of cigarette products by the federal or state government.
This research has received ethics clearance from the Roswell Park Institutional Review Board 
and all the information you provide will be kept strictly confidential.  Only the investigators 
directly associated with the study will have access to this information. This study is funded by 
the National Cancer Institute, National Institutes of Health, and the investigators have no 
affiliations with any tobacco or pharmaceutical company.   
If you are interested, please contact insert site contact number], and ask for the VENT Study.  
You may also email  [insert site email] with a good time to call you.  
Sincerely,  
[insert name]
 [insert title] [insert location] [insert study site]
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Appendix B: Eligibility Screener
Core Eligibility Screener
1. Please enter your name.
__________________________________
2. Please enter your phone number, starting with the area code. 
___ ___ ___ - ___ ___ ___ - ___ ___ ___ ___ 
3. Do you currently use tobacco products? By currently, we mean any use at all in the last month 
(30 days)
___ Yes 
___ No 
4a. Which products have you used in the past 30 days? Please check all that apply. 
___ Cigarettes (proceed to 4b)
___ Cigars
___ Cigarillos
___ Clove Cigarettes
___ Herbal Cigarettes
___ Bidis
___ Pipe Tobacco
___ Roll Your Own 
___ Chewing Tobacco
___ Moist Snuff
___ Snus
___ E-Cigarettes
___ Vapes
___ No products. I am not a smoker. (Ineligible)
4b. Are your current cigarettes made by a company or roll your own?
___ Manufactured
___ Roll Your Own 
5. Which brand of cigarettes do you currently smoke?  Please be as specific as possible (e.g. 
Marlboro gold 100s box).  
_____________________________________ (needs to smoke factory-made filtered cigarettes)
Note to interviewer:  check brand variety against lab database.  Eligible if 
ventilation >10%.  Common ineligible brands:  Newport menthol; Newport red; 
Marlboro Black.  If data unavailable, ask participant to bring a pack of their own 
cigarettes to Session 1 for confirmation. 
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6. Have you used any Nicotine Replacement medication such as the patch, gum, lozenge, spray, 
or inhaler in the past 30 days?
___ Yes
___ No
7. Do you smoke cigarettes some days or every day?
___ Every Day
___ Some Days
___ Not at all
8. How many cigarettes do you smoke per day? Please enter a number. 
___ 5 or more 
___ Less than 5
9. How long have you been smoking? 
___ More than 1 year
___ Less than 1 year
10. Have you tried to quit smoking in the past 30 days? 
(More than a 24-hour time period without smoking)
___ Yes
___ No
11. Are you seriously thinking of quitting smoking?
___ Yes, within the next 30 days
___ Yes, within the next 6 months
___ No, not thinking of quitting
12. What sex do you identify with?
___ Male
___ Female
___ Undetermined
___ Refused
13. What is your age? Please enter a number (years). 
______________________ (Eligible = 18-69 years old)
14. Please describe your overall health.
___ Excellent
___ Very Good
___ Good
___ Fair
___ Poor 
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15. Please describe your overall mental health. 
___ Excellent
___ Very Good
___ Good
___ Fair
___ Poor 
16a. How often did you have a drink containing alcohol in the past year?
Never (0)
Monthly or less (1)
Two to four times a month (2)
Two to three times a week (3)
Four or more times a week (4)
16b. How many drinks did you have on a typical day when you were drinking in the past year?
None, I do not drink (0)
1 or 2 (0)
3 or 4 (1)
5 or 6 (2)
7 to 9 (3)
10 or more (4)
16c. How often did you have six or more drinks on one occasion in the past year?
Never (0)
Less than monthly (1)
Monthly (2)
Weekly (3)
Daily or almost daily (4)
16total. Sum responses to 16a-c (score must be <7 for inclusion)
17. How many times in the past month have you consumed cannabis/marijuana/THC? 
_____________ (>5 = Ineligible)
18. How many times in the past month have you used an illegal drug or used a prescription 
medication for non-medical reasons? Please enter the number below. 
________________ (>1 = Ineligible)
19. Are you currently involved in any other Roswell Park research studies?
___ Yes (place on wait list if otherwise eligible; can begin after involvement in other study ends)
___ No 
These next few questions ask about rules of using tobacco inside your home. Please think about 
everyone who might be in your home including children, adults, visitors, guests, or workers.  For 
tobacco products that are burned, such as cigarettes, cigars, pipes or hookah, which statement best 
describes the rules about smoking a tobacco product inside your home?
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1 It is not allowed anywhere or at any time inside my home
2 It is allowed in some places or at sometimes inside my home
3 It is allowed anywhere and at any time inside my home
For electronic cigarette products, such as e-cigarettes, vape pens, tanks, mods, JUUL, which 
statement best describes the rules about vaping inside your home?
1 It is not allowed anywhere or at any time inside my home
2 It is allowed in some places or at sometimes inside my home
3 It is allowed anywhere and at any time inside my home
If Ineligible:
Unfortunately, you are ineligible for the study.  However, we thank you for your interest and hope you 
have a great day.
If Eligible: 
You are eligible for the study! I’d like to give you some more information before asking whether you’d 
like to participate. The purpose of the study is to examine the relationship of certain cigarette design 
features, such as pack messages, to exposure and consumer perceptions. You will be asked to take part in 
a two-week field experiment where you will be assigned to smoke specific cigarettes and track your use. 
The study is done remotely, so we will send you all study materials and text/email questionnaires to you. 
Three times during the field experiment, you will be asked to videoconference with a research assistant for 
approximately 30 minutes. In addition, you will be asked to respond to 5 brief questionnaires daily to track 
your cigarette use and report on study cigarettes. 
This project has received ethics clearance from the Roswell Park Comprehensive Cancer Center 
Institutional Review Board and all the information you provide will be kept strictly confidential. Only the 
investigators directly associated with the study will have access to this information and it will be 
destroyed once the study is completed.   
I realize I’ve given you a lot of information- do you have any questions about the study? 
Would you like to participate in the study? 
If no: Thank you and goodbye. 
If yes: Great. 
We’d like to get your mailing address and email address so we can send you additional information about 
the study.  Are you willing to provide one or both?
Mailing Address: 
________________________________________________________________________________
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Email:  
_____________________________________________________________________________________
___
What day(s) would be the best to reach you? Please check all that apply. 
___ Monday
___ Tuesday
___ Wednesday
___ Thursday
___ Friday
___ Saturday
___ Sunday
What time of day would be best to reach you? Please check all that apply.
___ Morning (8am – 12pm)
___ Afternoon (12pm – 4pm) 
___ Evening (4pm – 8pm)
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Appendix C: Study Questionnaires 
DEMOGRAPHICS AND SMOKING HISTORY QUESTIONNAIRE
1.  Age 
2.  Are you of Hispanic, Latino, or Spanish origin? (check all that apply)
 Yes, Hispanic or Latino
 NOT Hispanic or Latino
 Unknown / Not Reported
3.  What is your race? (check all that apply)
 American Indian, Alaskan Native
 Asian 
 Native Hawaiian / Pacific Islander
 Black/African American
 White
 More Than One Race
 Unknown / Not Reported
4. Gender 
 Female  
 Male
5. What is your current marital status?
 Never Married
 Married for the First Time
 Remarried
 Separated
 Divorced
 Widowed
6. What is the highest level of education you completed?
 8th grade or less
 Some High School
 High School Graduate/Equivalent
 Some College/2-year Degree
 College Graduate/4-year Degree
 Graduate or Professional Degree
7. Are you currently a student? 
 Yes, studying full-time
 Yes, studying part-time
 No, I am not currently undertaking formal study
8. What is your annual household income (from all sources)?
 Less than $10,000
 $10,000 to $14,999
 $15,000 to $19,999
 $20,000 to $24,999
 $25,000 to $29,999
 $30,000 to $34,999
 $35,000 to $39,999
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 $40,000 to $49,999
 $50,000 to $74,999
 $75,000 to $99,999
 $100,000 to $149,999
 $150,000 to $199,999
 $200,000 or more
 Prefer not to say
9. What is your current employment status?
 Regular full-time work (daytime shift: 6 AM to 6 PM)
 Regular full-time work (evening or night shift)
 Part-time work (typically consistent shift)
 Casual work (irregular or informal work)
 Looking for paid work
 A homemaker or caregiver not looking for paid work
 Retired
 Unable to work due to health reasons
 Unable to work due to other reasons
 
10. Have you smoked at least 100 cigarettes in your entire life? (100 CIGARETTES = APPROXIMATELY 5 
PACKS)
 Yes (GO TO A2)     
 No
11. How old were you when you smoked your first cigarette? (XX years old)
 years old 
12. Do you now smoke cigarettes every day, some days, or not at all?
 Every Day (GO TO B1)     
 Some Days    
 Not At All
13. On the average, about how many cigarettes do you now smoke each day? 
(ONE PACK USUALLY EQUALS 20 CIGARETTES. IF CONVERTING PACKS TO CIGARETTES, ALWAYS 
VERIFY CALCULATION WITH RESPONDENT.)
 
 Cigarettes Per Day
14.
What is your usual brand of cigarettes? Please be specific. (For example, Marlboro Gold, Menthol 
100s) __________________________________
15. 
How long (in years) have you smoked this brand of cigarette? (If you have smoked this brand of 
cigarette  for less than 1 year, enter 0.)
How important to you are each of the following characteristics of your cigarette brand
1=‘Not at all’ to 10=‘Extremely’.
Brand name
Color
Pack design/looks/visuals
Length (e.g., King, 100, 120)
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Pack type (e.g., soft, hard)
Price
Taste
Behavioral aspects of cigarette/vaping dependence will be assessed using:
Glover-Nilsson Scale 
Please indicate your choice by circling the number that best reflects your choice.
0=Not at all
1=Somewhat
2=Moderately 
3=Very much 
4=Extremely 
16. My 
cigarette[vaping] 
habit is very 
important to me
17. I handle and 
manipulate my 
cigarette[vape] 
as 
part of the ritual 
of smoking
Please indicate your choice by circling the number that best reflects your choice.  
0=never
1=seldom
2=sometimes
3=often
4=Always
18. Do you place 
something in your 
mouth to 
distract you from 
smoking[vaping]?
19. Do you reward 
yourself with a 
cigarette [vape]
after 
accomplishing a 
task?
20. If you find 
yourself without 
cigarettes [vape], 
will you
have difficulties in 
concentrating 
before attempting 
a task?
21. If you are not 
allowed to smoke 
[vape]in certain 
places, do you 
then play with 
your cigarette 
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pack [device] or a 
cigarette [vape]?
22. Do certain 
environmental 
cues trigger your 
Smoking[vaping], 
e.g., favorite 
chair, sofa, room, 
car,  or drinking 
alcohol?
23. Do you find 
yourself lighting 
up a cigarette 
[vaping]
routinely (without 
craving)?
24. Do you find 
yourself placing 
an unlit cigarette 
[vape]
or other objects 
(pen, tooth pick, 
chewing gum, 
etc.) 
in your mouth and 
sucking to get 
relief from stress, 
tension or 
frustration, etc.)?
25. Does part of 
your enjoyment of 
smoking [vaping] 
come 
from the steps 
(ritual) you take 
when lighting up?
26. When you are 
alone in a 
restaurant, bus 
terminal, party, 
etc., do you feel 
safe, secure, 
or more confident 
if you are holding 
a cigarette [vape]?
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VENT AWARENESS
1.  What makes the filters on Light cigarettes different than the filters on Regular cigarettes?
2. Have you ever seen or heard that one or more rings of small holes are on the filters or some cigarettes? 
 Yes (Go to 2b)
 No (Go to 3)
 Don’t Know / Not Sure (Go to 3)
2b. How do you know about these holes? 
 Saw them
 Read about them in the news or magazine
 Saw a television advertisement about them
 Saw or heard a news report about them. 
3. Did you ever try to block the filter holes on cigarettes?
 Yes (Go to 3b)
 No (Go to 4)
4. At the present time, do you block holes when you smoke? 
 Yes 
 No 
 Don’t Know 
5. Do you think that blocking filter holes would make a cigarette taste stronger, milder, or have no effect on taste? 
 A lot stronger
 Moderately stronger
 A little stronger
 No effect
 A little milder
 Moderately milder
 A lot milder
 Don’t know
6. Do you think that blocking filter holes would increase, decrease, or have no effect on the tar a smoker gets from 
these cigarettes?
 Greatly increase
 Moderately increase
 Slightly increase
 No effect
 Slightly decrease
 Moderately decrease
 Greatly decrease
 Don’t know
7. Do you think that blocking filter holes would increase, decrease, or have no effect on the nicotine a smoker gets 
from these cigarettes?
 Greatly increase
 Moderately increase
 Slightly increase
 No effect
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 Slightly decrease
 Moderately decrease
 Greatly decrease
 Don’t know
TRIRISK [cancer-specific] -- presentation order should be randomized
1.  On a scale from 0 to 100 %, how would you rate the probability that you will develop cancer 
in the future?  
2.  How likely is it that you will get cancer at some point in the future? [7-point scale (likely–
unlikely)]
3.  The way I look after my health means that my odds of getting cancer in the future are: [7-
point scale (very low–very high)]
For the following items, indicate whether you agree or disagree with the statement. [7-point 
scale (strongly disagree-strongly agree)]
4.  When I think carefully about my lifestyle, it does seem possible that I could get cancer:
5.  If I look at myself as if I was a doctor, I realize that my behavior puts me at risk of getting 
cancer.
6.  I feel very vulnerable to cancer.
7.  I am confident that I will not get cancer.
8.  I would be lying if I said “There is no chance of me getting cancer.” 
9.  My first reaction when I hear of someone getting cancer is “that could be me someday.”
10.  How do you think your chance of developing cancer in the future compares to the average 
person of your gender and age? [7-point scale (much lower-much higher)]
For the following items, rate on a scale from Not at all to extremely.  [7-point scale (not at all-
extremely)]
11.  How worried are you about developing cancer in the future?
12.  How fearful are you about developing cancer in the future?
13.  How nervous are you about developing cancer in your lifetime?
14.  When you think about cancer for a moment, to what extent do you feel fearful?
15.  When you think about cancer for a moment, to what extent do you feel worried?
16.  When you think about cancer for a moment, to what extent do you feel anxious?
17.  How concerned are you about developing cancer in your lifetime?
18.  How easy is it for you to imagine yourself developing cancer in the future?
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PERCEIVED HEALTH RISK RATING: BASELINE
Based on using your usual brand cigarettes indicate what you believe your risk is for developing 
the following health problems on this scale from 1 to 10.
1
2
3
4
5
6
7
8
9
10
Very Low Risk
                 Very High Risk
    of Disease
    of Disease
1. Lung Cancer _____
2. Emphysema _____
3. Bronchitis _____
4. Other Cancers _____
5. Heart Disease _____
6. Risk of Addiction _____
7. Stroke _____
8. Mouth Cancer _____
9. Tooth Loss _____
Minute Discounting 1000 92dd
Which would you rather have?
$500 now $1000 in 3 weeks
Which would you rather have?
$500 now $1000 in 1 day
Which would you rather have?
$500 now $1000 in 2 years
Which would you rather have?
$500 now $1000 in 4 hours
Which would you rather have?
$500 now $1000 in 4 days
Which would you rather have?
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$500 now $1000 in 4 months
Which would you rather have?
$500 now $1000 in 8 years
Which would you rather have?
$500 now $1000 in 2 hours
Which would you rather have?
$500 now $1000 in 9 hours
Which would you rather have?
$500 now $1000 in 2 days
Which would you rather have?
$500 now $1000 in 1.5 weeks
Which would you rather have?
$500 now $1000 in 2 months
Which would you rather have?
$500 now $1000 in 8 months
Which would you rather have?
$500 now $1000 in 4 years
Which would you rather have?
$500 now $1000 in 18 years
Which would you rather have?
$500 now $1000 in 1 hour
Which would you rather have?
$500 now $1000 in 3 hours
Which would you rather have?
$500 now $1000 in 6 hours
Which would you rather have?
$500 now $1000 in 12 hours
Which would you rather have?
$500 now $1000 in 1.5 days
Which would you rather have?
$500 now $1000 in 3 days
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Which would you rather have?
$500 now $1000 in 1 week
Which would you rather have?
$500 now $1000 in 2 weeks
Which would you rather have?
$500 now $1000 in 1 month
Which would you rather have?
$500 now $1000 in 3 months
Which would you rather have?
$500 now $1000 in 6 months
Which would you rather have?
$500 now $1000 in 1 year
Which would you rather have?
$500 now $1000 in 3 years
Which would you rather have?
$500 now $1000 in 5 years
Which would you rather have?
$500 now $1000 in 12 years
Which would you rather have?
$500 now $1000 in 25 years
BSCQ-A  [0–9 Likert scale Not at all – Extremely likely] 
1. Smoking calms me down when I feel nervous. 
2. When I’m feeling irritable, a smoke will help me relax. 
3. When I’m angry, a cigarette can calm me down. 
4. Smoking a cigarette energizes me. 
5. A cigarette can give me energy when I’m bored and tired.
6. The more I smoke, the more I risk my health. 
7. By smoking I risk heart disease and lung cancer. 
8. I will enjoy the flavor of a cigarette. 
9. When I smoke, the taste is pleasant. 
10. I enjoy the taste sensations while smoking. 
11. I feel more at ease with other people if I have a cigarette.
12. Smoking helps me enjoy people more. 
13. I feel like part of a group when I’m around other smokers. 
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14. Smoking keeps my weight down. 
15. Smoking helps control my weight. 
16. Cigarettes keep me from eating more than I should. 
17. Smoking will satisfy my nicotine cravings. 
18. Nicotine ‘‘fits’’ can be controlled by smoking. 
19. Smoking irritates my mouth and throat 
20. My throat burns after smoking. 
21. When I am alone, a cigarette can help me pass the time.
22. If I have nothing to do, a smoke can help kill time. 
23. I look ridiculous while smoking. 
24. Smoking makes me seem less attractive. 
25. People think less of me if they see me smoke. 
Minnesota Nicotine Withdrawal Scale [0 -4, Not at all – Severe]
Please rate how you have felt over the past 24 hours.  
1. Angry, irritable, frustrated 
2. Anxious, nervous
3. Depressed mood, sad
4. Difficulty concentrating 
5. Increased appetite, hungry, weight gain
6. Insomnia, sleep problems, awakening at night 
7. Restless 
8. Desire or craving to smoke 
9. Constipation
10. Coughing
11. Decreased pleasure from events 
12. Dizziness
13. Drowsy
14. Impatient
15. Impulsive 
Barrett Impulsivity Scale-11 [0-4 Never – Always]
People differ in the ways they act and think in different situations. This is a test to measure some 
of the ways in which you act and think.  Read each statement and put an X on the appropriate 
circle.  Do not spend too much time on any statement.  Answer quickly and honestly.
1. I plan tasks carefully.
2. I do things without thinking.
3. I make-up my mind quickly.
4. I am happy-go-lucky.
5. I don’t “pay attention.”
6. I have “racing” thoughts.
7. I plan trips well ahead of time.
8. I am self-controlled.
9. I concentrate easily.
10.  I save regularly.
11. I “squirm” at plays or lectures.
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12. I am a careful thinker.
13. I plan for job security.
14. I say things without thinking.
15. I like to think about complex problems.
16. I change jobs.
17. I act “on impulse.”
18. I get easily bored when solving thought problems.
19. I act on the spur of the moment.
20. I am a steady thinker.
21. I change residences.
22. I buy things on impulse.
23. I can only think about one thing at a time.
24. I change hobbies.
25. I spend or charge more than I earn.
26. I often have extraneous thoughts when thinking.
27. I am more interested in the present than the future.
28. I am restless at the theater or lectures.
29. I like puzzles.
30. I am future oriented.
CIGARETTE PURCHASE TASK
Think about HOW YOU ARE FEELING RIGHT NOW.  The following questions ask how many 
cigarettes you would smoke if they cost various amounts of money.  Assume that: 
1. The available cigarettes are your usual brand. 
2. You have the same income/savings that you have now and NO ACCESS to any cigarettes 
or nicotine products other than those offered at these prices. 
3. You can smoke without any restrictions and without factoring in what might occur in the 
next 24 hours related to your participation in the study
4. You would smoke the cigarettes that you request at this time, not save or stockpile 
cigarettes for a later date.
5. You may not give any of the products you purchase away.
Be sure to consider each price increment carefully.
1. How many cigarettes would you smoke in 24 hours if they 
were
FREE?
______
2. How many cigarettes would you smoke in 24 hours if they 
were
1¢ each?
______
3. How many cigarettes would you smoke in 24 hours if they 
were
2¢ each?
______
4. How many cigarettes would you smoke in 24 hours if they 
were
3¢ each?
______
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5. How many cigarettes would you smoke in 24 hours if they 
were
4¢ each?
______
6. How many cigarettes would you smoke in 24 hours if they 
were
6¢ each?
______
7. How many cigarettes would you smoke in 24 hours if they 
were
10¢ each?
______
8. How many cigarettes would you smoke in 24 hours if they 
were
15¢ each?
______
9. How many cigarettes would you smoke in 24 hours if they 
were
25¢ each?
______
10. How many cigarettes would you smoke in 24 hours if they 
were
40¢ each?
______
11. How many cigarettes would you smoke in 24 hours if they 
were
60¢ each?
______
12. How many cigarettes would you smoke in 24 hours if they 
were
$1 each?
______
13. How many cigarettes would you smoke in 24 hours if they 
were
$1.50 each?
______
14. How many cigarettes would you smoke in 24 hours if they 
were
$2.50 each?
______
15. How many cigarettes would you smoke in 24 hours if they 
were
$4 each?
______
16. How many cigarettes would you smoke in 24 hours if they 
were
$6 each?
______
17. How many cigarettes would you smoke in 24 hours if they 
were
$10 each?
______
18. How many cigarettes would you smoke in 24 hours if they 
were
$15 each?
______
19. How many cigarettes would you smoke in 24 hours if they 
were
$25 each?
______
20. How many cigarettes would you smoke in 24 hours if they 
were
$40 each?
______
21. How many cigarettes would you smoke in 24 hours if they 
were
$60 each?
______
22. How many cigarettes would you smoke in 24 hours if they 
were
$100 each?
______
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5 TRIAL DELAY DISCOUNTING  
You will now complete a series of decision-making tasks. You will be asked to make choices 
between different amounts of money given to you now or after a delay. These are hypothetical 
choices, but please choose your answer as if the items were to be delivered as described. Each 
task will start with some brief instructions on the screen. Read these instructions and press the 5 
key on the keyboard when you are ready to begin. There are no right or wrong answers in the 
tasks, just choose which option you prefer in each case. Please take your time and answer 
thoughtfully. To select the option on the left side of the screen, press the left arrow, and to select 
the option on the right side of the screen, press the right arrow.
[Task implemented on computer via REDCap]
IN SESSION MEASURES (Administered after each cigarette)
Product Evaluation Scale
Think about your general experience when using the product you just tried. 
Please answer the following questions about the product using the scale below [7-point scale, Not 
at all – Extremely]
Cigarette 
Product Code: _________________________________
1. Was it satisfying?
_____
2. Did it taste good?
_____
3. Did it make you dizzy? 
_____
4. Did it calm you down? 
_____
5. Did it help you concentrate? 
_____
6. Did it make you feel more awake? 
_____
7. Did it reduce your hunger for food? 
_____
8. Did it make you nauseated? 
_____
9. Did it make you feel less irritable? 
_____
10. Did you enjoy the sensations in your mouth? 
_____
11. Did it immediately reduce your craving for a cigarette? 
_____
12. Did it relieve withdrawal symptoms? 
_____
13. Did it relieve the urge to smoke? 
_____
14. Was it enough nicotine? 
_____
15. Was it too much nicotine? 
_____
16. Was it easy to use? 
_____
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17. Were there bothersome side effects? 
_____
18. Would you be comfortable using the product in public? 
_____
19. Did you still have a craving for a cigarette after using the product? 
_____
20. Are you concerned you would become dependent on the product? 
_____
21. Did you enjoy using the product? 
_____
22. Would you be willing to use the product long term? 
_____
JUSTER PURCHASE INTENTION  
How likely are you to purchase the product you just tried in the next month?
       
  10 = Certain, practically certain
       
  9   = Almost sure
       
  8   = Very probable
       
  7   = Probable
       
  6   = Good possibility
       
  5   = Fairly good possibility
       
  4   = Fair possibility
       
  3   = Some possibility
       
  2   = Slight possibility
       
  1   = Very slight possibility
       
  0   = No chance, almost no chance
Duke Cigarette Sensory Evaluation [ 1-7 Not at all – Extremely]
Please rate the puffs you just took.  Circle the number that best answers each question.
1.  How much did you like the puffs you just took?
2.  How satisfying were the puffs you just took?
3.  How high in nicotine do you think the puffs were?
4.  How similar to your own brand were the puffs?
Using the same scale as above, rate how strong the puffs were in the following places.
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5.  Strength of puffs on tongue?
6.  Strength of puffs in nose?
7.  Strength of puffs in back of mouth & throat?
8.  Strength of puffs in windpipe?
9.  Strength of puffs in chest?
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DRUG EFFECTS / LIKING SCALE
Place a vertical line at the point on the scale that indicates how you feel about each of the 
statements right now.
1. Do you feel any study product effects?
2. Do you feel any good study product effects?
3. Do you feel any bad study product effects?
4. How much do you like the study product?
5. How much do you desire the study product?
6. How much would you like to use this product again?
Not At All
Extremely
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HEDONIC ATTRIBUTE PROFILE
Draw
1
2
3
4
5
6
7
TOO EASY
JUST 
RIGHT
TOO 
HARD
Mouthful of 
Smoke
1
2
3
4
5
6
7
TOO LITTLE
JUST 
RIGHT
TOO 
MUCH
Impact
1
2
3
4
5
6
7
TOO LITTLE
JUST 
RIGHT
TOO 
MUCH
Irritation
1
2
3
4
5
6
7
TOO LITTLE
JUST 
RIGHT
TOO 
MUCH
Strength
1
2
3
4
5
6
7
TOO MILD
JUST 
RIGHT
TOO 
STRONG
Smoothness
1
2
3
4
5
6
7
TOO SMOOTH
JUST 
RIGHT
TOO 
HARSH
Tobacco Taste
1
2
3
4
5
6
7
TOO LITTLE
JUST 
RIGHT
TOO 
MUCH
Tobacco Taste
1
2
3
4
5
6
7
UNPLEASANT
NEUTRAL
PLEASANT
Overall Taste
1
2
3
4
5
6
7
UNPLEASANT
NEUTRAL
PLEASANT
Aftertaste
1
2
3
4
5
6
7
UNPLEASANT
NEUTRAL
PLEASANT
Similarity to 
Usual brand
1
2
3
4
5
6
7
VERY 
DIFFERENT
VERY 
SIMILAR
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PANAS (10 item) [1-5 Not at all – Extremely]
The next part involves a number of words that describe different feelings and emotions.  I’ll say 
each word, and you can indicate to what extent you feel this way RIGHT NOW, on a scale from 
1-5.  1 means you don’t feel this way at all or slightly feel this way right now. 2 means feeling 
this way a little, 3 means moderately, 4 means quite a bit, and 5 means extremely feeling this 
way right now.
1. Inspired
2. Afraid
3. Alert
4. Upset
5. Excited
6. Nervous
7. Enthusiastic
8. Scared
9. Determined
10. Distressed
Questionnaire of Smoking Urges – BRIEF [1-7 Likert scale, Strongly disagree – strongly 
agree]
1. I have a desire for a cigarette right now. 
2. Nothing would be better than smoking a cigarette right now.
3. If it were possible, I probably would smoke right now.
4. I could control things better right now if I could smoke.
5. All I want right now is a cigarette.
6. I have an urge for a cigarette.
7. A cigarette would taste good now. 
8. I would do almost anything for a cigarette now.
9. Smoking would make me less depressed.
10. I am going to smoke as soon as possible.
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CONTEMPLATION LADDER
Each rung on this ladder represents where various smokers are in their thinking 
about quitting.   Place an X on the mark that indicates where you are now.  
Ladder 1 Score
☐☐
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Health Risk Ladder
Ladder 1 Score
☐☐
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ANTICIPATED RESPONSES
Health authorities may, in the future, require manufacturers to change their cigarettes in certain 
ways. These changes could make cigarettes taste differently.  
If the taste of your cigarettes became more harsh or unpleasant, what do you think you would be 
MOST likely to do.
 
I would quit smoking entirely
I would switch to vaping/using e-cigarettes
I would switch to smokeless tobacco
I would find a way to get cigarettes that were similar to my old ones
I would continue smoking the new version
Don’t know
If the taste of your cigarettes became more harsh or unpleasant, what do you think you would be 
LEAST likely to do.  
I would quit smoking entirely
I would switch to vaping/using e-cigarettes
I would switch to smokeless tobacco
I would find a way to get cigarettes that were similar to my old ones
I would continue smoking the new version
Don’t know
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Kessler-6 (Serious psychological distress)
The following questions ask about how you have been feeling during the past 30 days. For each 
question, please indicate the answer that best describes how often you had this feeling.
1.
During the past 30 days, about how often did you feel...
1.a. ...nervous?
1 [ ] All of the time
2 [ ] Most of the time
3 [ ] Some of the time
4 [ ] A little of the time
5 [ ] None of the time
1.b. ...hopeless ?
1 [ ] All of the time
2 [ ] Most of the time
3 [ ] Some of the time
4 [ ] A little of the time
5 [ ] None of the time
1.c. ... restless or fidgety?
1 [ ] All of the time
2 [ ] Most of the time
3 [ ] Some of the time
4 [ ] A little of the time
5 [ ] None of the time
1.d. ...so depressed that nothing could cheer you up?
1 [ ] All of the time
2 [ ] Most of the time
3 [ ] Some of the time
4 [ ] A little of the time
5 [ ] None of the time
1.e. ...that everything was an effort?
1 [ ] All of the time
2 [ ] Most of the time
3 [ ] Some of the time
4 [ ] A little of the time
5 [ ] None of the time
1.f. ...worthless?
1 [ ] All of the time
2 [ ] Most of the time
3 [ ] Some of the time
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4 [ ] A little of the time
5 [ ] None of the time
2.
The last six questions asked about feelings that might have occurred during the past 30 
days. Taking them altogether, did these feelings occur More often in the past 30 days than is 
usual for you, about the same as usual, or less often than usual? (If you never have any of these 
feelings, circle response option "4.")
1 [ ] A lot (More often than usual)
2 [ ] Some (More often than usual)
3 [ ] A little (More often than usual)
4 [ ] About the same as usual 
5 [ ] A little (Less often than usual)
6 [ ] Some (Less often than usual)
7 [ ] A lot (Less often than usual)
The next few questions are about how these feelings may have affected you in the past 30 days. 
You need not answer these questions if you answered "None of the time" to all of the six 
questions about your feelings.
3.
During the past 30 days, how many days out of 30 were you totally unable to work or 
carry out your normal activities because of these feelings?
_______ (Number of days)
4.
Not counting the days you reported in response to 3, how many days in the past 30 were 
you able to do only half or less of what you would normally have been able to do, because of 
these feelings?
_______ (Number of days)
5.
During the past 30 days, how many times did you see a doctor or other health 
professional about these feelings?
_______ (Number of times)
6.
During the past 30 days, how often have physical health problems been the main cause of 
these feelings?
1 [ ] All of the time
2 [ ] Most of the time
3 [ ] Some of the time
4 [ ] A little of the time
5 [ ] None of the time
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Home environment
1.  Do you have any children living in your home?  Yes, No
If yes, How many?  Ages?  
Smoke Free home and vehicle policies
These next few questions ask about rules of using tobacco inside your home. Please think about 
everyone who might be in your home including children, adults, visitors, guests, or workers. For 
tobacco products that are burned, such as cigarettes, cigars, pipes, or hookah, which statement best 
describes the rules about smoking a tobacco product inside your home?
1 It is not allowed anywhere or at any time inside my home
2 It is allowed in some places or at some times inside my home
3 It is allowed anywhere and at any time inside my home
-8 DON'T KNOW
-7 REFUSED
Do you have a car (this includes a car, van, suv, or any other enclosed vehicle)?
IF YES:  For tobacco products that are burned, such as cigarettes, cigars, pipes or hookah, which 
statement best describes the rules about smoking a tobacco product inside your car?
1 It is not allowed anywhere or at any time inside my car
2 It is allowed in some places or at sometimes inside my car
3 It is allowed anywhere and at any time inside my car
-8 DON'T KNOW
-7 REFUSED
Vape-free home and vehicle policies
For electronic cigarette products, such as e-cigarettes, vape pens, tanks, mods, JUUL, which 
statement best describes the rules about vaping inside your home?
1 It is not allowed anywhere or at any time inside my home
2 It is allowed in some places or at sometimes inside my home
3 It is allowed anywhere and at any time inside my home
-8 DON'T KNOW
-7 REFUSED
IF CAR=YES:  For electronic cigarette products, such as e-cigarettes, vape pens, tanks, mods, 
JUUL, which statement best describes the rules about vaping inside your car?
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1 It is not allowed anywhere or at any time inside my car
2 It is allowed in some places or at some times inside my car
3 It is allowed anywhere and at any time inside my car
-8 DON'T KNOW
-7 REFUSED
Responses to pack messaging
In your opinion, how would you rate the label you just saw on each of the following 
characteristics
1=‘Not at all’ to 10=‘Extremely’.
Effective in discouraging smoking in youth
Effective in encouraging smokers to quit
Believable information
Truthful information
Exaggerated information
New information
Hard to understand
Applies to me
Message Perceptions
This message is: 
Worth remembering
Grabs attention
Powerful
Informative
Meaningful
Convincing
Effect Perceptions
This message:
Discourages me wanting to smoke
Makes smoking seem unpleasant to me
Makes me concerned about health effects of smoking
Negative Affect
How much did the label make you feel:
Anxious
Sad
Scared
Guilty
Disgusted
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Thinking of Harms
How much did the labels make you think about:
The chemicals in the smoke of the cigarettes
Health problems caused by smoking
The harm your smoking might be doing to you
The harm your smoking might be doing to other people
Would you support or oppose a policy that required this label to appear on cigarette packages?
Strongly oppose – Strongly support
Would you support or oppose a policy that required this label to appear in advertising for 
cigarettes?
Strongly oppose – Strongly support
Remote Data Collection – EMA Schedule and Questionnaires
3 Daily Reports – 11 am, 4pm, 9pm (assessments < 5min)
How many cigarettes have you smoked since the last prompt?
How many of these cigarettes were research cigarettes?
How many of these cigarettes were not research cigarettes?
How you used any other tobacco products since the last prompt?
If yes: What product? How many times did you use it?
Please record your product weight with the provided scale. 
RIGHT NOW: How would you rate your (0 – 100 VAS):

Craving

Irritability

Anxiousness/nervousness

Difficulty Concentrating

Stress

Bored

Calm/Relaxed

Happy

Alert

Enthusiastic
Provide Reminder to collect all cigarette butts in provided materials, store used pods
11 am Only (additional questions)
Hedonic Attribute Profile: In the past day, how would you rate the research cigarettes (1-
7 Likert)
Draw
Irritation
Smoothness
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Strength
Tobacco Taste
Similarity to Usual Brand
Product Evaluation Scale (1 -7 Likert):
Was it satisfying?
Did it taste good?
Did it calm you down?
Did you enjoy the sensations in your mouth?
Did it reduce your craving for a cigarette?
Were there bothersome side effects?
Did you enjoy using the product?
Would you be willing to use the product long term?
Record CO measurement
9pm Only (additional questions):
Record CO measurement 
Reflect on today as a whole: How would you rate your (0 – 100 VAS)

Craving

Irritability

Anxiousness/nervousness

Difficulty Concentrating

Stress

Bored

Calm/Relaxed

Happy

Alert

Enthusiastic
Thinking of the cigarettes you smoked today: How would you rate (0 – 100 VAS)

Tastes like my own brand

Satisfying like my own brand

Enjoyable like my own brand

Relieved my cravings like my own brand
2-3 Pseudo-Random Prompts: Between 11 - 4, 4 – 9
Take picture of research cigarette pack 
How often did you notice your warning label in the past day?
Have you read or looked closely at the warning label in the past day?
Have you made any effort to avoid looking at or thinking about the warning labels 
(such as covering them up, keeping them out of site, using a cigarette case, etc.)
Has seeing the warning label stopped you from having a cigarette when you were 
about to smoke?
Has seeing the warning label affected how you smoke a cigarette?
Has seeing the warning label affected how you hold a cigarette?
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Think back on the most recent cigarette you smoked:
Where were you (home, work, other’s home, vehicle, bar/restaurant outside, 
other)
Was smoking permitted (yes, discouraged, no)
Were you with others (yes, no)

IF YES: Were they: smoking, vaping, both, neither
What activity were you doing (working/chores, inactive/leisure, socializing, 
eating/drinking, other)
How strong was your craving prior to use?
How many puffs did you take?
Duke Sensory Evaluation (1 – 7 Not at all – Extremely)

How much did you like the puffs you took?

How satisfying were the puffs you took?

How high in nicotine do you think the puffs were?

How similar to your own brand were the puffs?
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Appendix D: Experimenter Guide 
1. Welcome and Introductions:
2. Introduction:
I would appreciate if you can minimize distractions until our videoconference is done. If 
something important requires your attention, please let me know and we can take a brief 
pause.
First, I’ll ask you to complete an online questionnaire. Here, we are looking for some 
information about you and your tobacco use. 
We will then move onto training you on study procedures. 
There is no right or wrong answer here. You are the expert and we are really interested in 
your honest responses to questions and to the tasks during the laboratory session.
Do you have any questions?
*Answer any questions.
3. Baseline Questionnaires
“We will now begin the baseline questionnaires.”
o
Baseline measures and covariates will assess: 
- Demographics (age, sex, race/ethnicity, education, income) 
- Tobacco use behaviors (consumption, brand, menthol preference, quit history) 
- Cognitive and affective measures 
o
A series of previously used items will assess knowledge and perceptions of filter 
vents.113,117   
o
Nicotine dependence will be assessed using: 
- Fagerström Test for Nicotine Dependence (FTND;118)
o
Behavioral aspects of cigarette dependence will be assessed using:
- The Glover-Nilsson scale 120,121
o
Questionnaires on vent messages
o
Questionnaires on message perceptions
We will now train you and provide you with supplies for the field study
Field Study Description
For the field study, you are going to use your mobile device to record your cigarette and other 
tobacco use and answer questions about how you’re feeling and the situations in which you use 
your products. You will be prompted 5 times each day via text message to answer 
questionnaires. Three of these prompts will be at the same time every day: 11am, 4pm, and 9pm. 
Two of these prompts will be at a random time each day, one between 11am – 4pm and one 
between 4pm – 9pm. To receive bonus payment for the field study, you will need to respond to 
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all 5 prompts. If you fail to respond to prompts for 3 consecutive days, we will send you a 
warning. If compliance to procedures does not improve, you will be discontinued from the study.
Please keep track of the amount of cigarettes and other tobacco you use. The scheduled prompts 
will ask you to report the number of cigarettes you’ve smoked. The random prompts will ask you 
to report on the situation in which you last used your product, such as the location and if 
smoking was allowed. We also ask that you store all used cigarette butts in the provided 
materials 
Here are examples of the questions you will be asked at each assessment (show questionnaires). 
Do you have any questions? 
We are also providing you with a CO monitor that will connect with your phone to take a CO 
measurement each night (demonstrate use). 
We are also providing you with a scale to weigh other tobacco products that you may use, such 
as an e-cigarette or smokeless tobacco. If you use these other products, we would like you to 
weigh your product (e.g., pod, tank, dip tin) at the beginning and end of each day. If you are 
close to finishing your product and may start a new one, please weigh both the older and newer 
one at the beginning and end of the day. 
Two additional times during the field study, we will ask you to videoconference with us as a 
study check-in and to have you respond to some questionnaires. 
These are the cigarettes we are asking you to use during the field study (provide research 
cigarettes). Please use only these cigarettes and do not tamper with the cigarette pack. At random 
points in the study, we may ask you to take a picture of the cigarette pack. 
Do you understand the procedures for the field study? Please call us if you have any questions. 
Videoconferencing Sessions 2 & 3
Hello, today we are going to have you fill out a questionnaire. I will send it to you now.
Have you been regularly storing your cigarette butts. Can I see how you are storing them?
Compliance: Your compliance has been great. Thank you!
Or: Your compliance has not met the standards. Please respond to more prompts or you 
may be discontinued for the study. Do you have any questions about the study procedures that 
may help you respond to more prompts?
Session 3 only:
Please pack up your supplies to prepare a return shipment. Can I see how you’ve stored your 
supplies in the box?
When we receive your materials, we will send you payment for completing the study. Thank you 
for participating.
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Ads for the website/mobile app:
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