Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography
Phase: NA
Conditions: Tobacco-Related Carcinoma
Sponsor: Roswell Park Cancer Institute

Document Coversheet 
 
 Study Title: 
 Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography 
 
 
Institution/Site:  
Roswell Park Comprehensive Cancer Center 
Document (Approval/Update) Date: 
01/03/2024 
NCT Number: 
NCT05876091 
IRB Number 
I 3234822 
 

Roswell Park Protocol No.: I-3234822
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PROTOCOL TITLE:
Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography
PROTOCOL NUMBER:
I-3234822
PRINCIPAL INVESTIGATOR:
Richard O’Connor, PhD
Roswell Park Comprehensive Cancer Center
Elm and Carlton Street
Buffalo, New York 14263
716-845-4517
Richard.O’Connor@RoswellPark.org
VERSION NUMBER: 2
DATE: 16NOV2023
SPONSOR: Roswell Park Comprehensive Cancer Center
FUNDING: NCI (5U54CA228110)
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
Inclusion and Exclusion Criteria .............................................................................................4
4
Local and Study-Wide Number of Subjects ............................................................................5
5
Local and Study-Wide Recruitment Methods .........................................................................5
6
Multi-Site Research .................................................................................................................5
7
Study Timelines.......................................................................................................................6
8
Study Endpoints.......................................................................................................................6
9
Design......................................................................................................................................7
10
Study Intervention ...................................................................................................................7
11
Procedures Involved ................................................................................................................7
12
Withdrawal of Subjects..........................................................................................................12
13
Risks to Subjects....................................................................................................................13
14
Potential Benefits to Subjects ................................................................................................14
15
Data and Specimen Banking..................................................................................................14
16
Measurement of Effect ..........................................................................................................16
17
Safety Evaluation...................................................................................................................16
18
Data Management and Confidentiality..................................................................................17
19
Statistical Plan .......................................................................................................................18
20
Provisions to Monitor the Data to Ensure the Safety of Subjects..........................................20
21
Vulnerable Populations..........................................................................................................20
22
Community-Based Participatory Research............................................................................20
23
Sharing of Results with Subjects ...........................................................................................20
24
Setting....................................................................................................................................20
25
Provisions to Protect the Privacy Interests of Subjects .........................................................20
26
Resources Available ..............................................................................................................21
27
Prior Approvals......................................................................................................................21
28
Compensation for Research-Related Injury...........................................................................21
29
Economic Burden to Subjects................................................................................................21
30
Consent Process.....................................................................................................................21
31
Process to Document Consent in Writing..............................................................................22
32
Drugs or Devices ...................................................................................................................23
33
References..............................................................................................................................24
34
Appendices/ Supplements......................................................................................................27
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1
OBJECTIVES
The premise of this study is that flavors or synthetic nicotine might be related to the phenomenon 
of ‘indirect’ toxicity. That is, regardless of whether the compounds show evidence of toxicity in a 
biological sense, they may nonetheless increase harm by other means, such as altering vaping 
topography (puffing) patterns, increasing appeal, decreasing risk perceptions, or masking 
harshness or irritation that might lead users to discontinue use.
1.1
Primary Objectives

Examine the influence of tobacco flavoring composition on vaping topography

Examine the influence of synthetic vs. tobacco derived nicotine on vaping topography
1.2
Secondary Objectives

Examine differences in sensory and subjective effects by tobacco flavoring composition

Examine differences in sensory and subjective effects by synthetic vs tobacco derived 
nicotine
1.3
Exploratory Objective

To generate a cell line/tissue from optionally provided oral cell samples to demonstrate the 
feasibility of cell line/tissue generation and later, expose oral cells to the study products or 
product constituents to examine the cellular-level effects of the study products and their 
components.
2
BACKGROUND
To appreciate the potential role of flavor perception in the use of tobacco products, it is instructive 
to look at the broader literature on subjective effects and responses to the sensory properties of 
tobacco products. In general, tobacco products were designed in part with sensory factors in mind, 
in order to maximize appeal to different market segments (1-4). Rees et al. (5) suggest a framework 
of consumer response that groups responses into two broad classes: response to the product, 
including drug effects and sensory perceptions; and perceptions of messaging around that product, 
including advertising and packaging. Much of this literature is focused on cigarettes given their 
greater prevalence but is nonetheless instructive for examining other tobacco products. Sensory 
blockade reduces urge to smoke, providing indirect evidence for the importance of sensory factors 
in maintaining behavior (6, 7), and a body of work has attempted to dissociate the sensory and 
drug components of smoking (8-14). Flavors may also influence expectancies around tobacco 
products. Expectancies of positive sensory effects of smoking (e.g., look, feel, and taste) are 
predictive of smoking behavior and willingness to try different types of cigarettes (15-21).
Understanding how nicotine vaping products (NVP) are used by consumers in the real world is an 
important component of properly assessing their individual and population level health impacts. 
While not as extensively studied as cigarette smoking topography, vaping topography has been 
shown to vary as a function of product design (Hiler et al., 2020 (22); Spindle et al., 2018 (23); 
Kimber et al., 2021(24)) and to be related to aldehyde emissions (Talih et al., 2015 (25); Son et 
al., 2020 (26)). From a regulatory perspective, understanding patterns of puffing (vaping 
topography) is crucial to informing standardized vaping regimens, which can be used to compare 
products across brands and classes. A total of 32 studies published between 2013 and April 2021 
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have directly measured NVP puff topography, and reported mean values for key topography 
parameters (puff duration, volume, flow rate, interval). CORESTA protocols (3s, 55mL, 18.33 
mL/s, 30 s interval) commonly underestimated puff volume and flow rate, for example, for NVP-
experienced users (112.15±18.9 mL, 37.94±7.67 mL/s) and open NVPs (112.98±20.97 mL, 
40.65±8.57 mL/s). Underestimation of puffing parameters such as puff volume may lead to 
underestimation of NVP nicotine and toxicant yields, causing miscommunication of information 
to consumers and regulators. Additional research is necessary to determine whether flavoring 
chemicals or type of nicotine used in the product are further confounds for measuring vaping 
topography.
3
INCLUSION AND EXCLUSION CRITERIA
3.1
Inclusion Criteria
To be included in this study, subjects must meet the following criteria:
1. Age ≥ 21 and ≤ 55 years. 
2. Current daily vapers of products containing nicotine.
3. No daily concurrent use of other tobacco products. 
4. Self-reported general good health.
5. Women of childbearing potential must be willing to provide a urine sample and test 
negative prior to receiving any study-related products/procedures.
6.  Ability to speak, read, and write in English.
7.  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.
3.2
Exclusion Criteria
Subjects will be excluded from this study for the following:
1. Allergies - active untreated seasonal allergies that would interfere with smell or taste 
procedures.
2. Self-reported taste or smell deficits.
3. Pregnant or nursing female participants. 
4. Medications known to interfere with taste/smell (i.e., certain nasal sprays, nasal 
antihistamines, decongestants, antibiotics, medications containing zinc).
5. Unwilling to use open system vaping device in laboratory setting.
6.  Positive diagnosis of COVID-19 within 10 days prior to start of study intervention.
7.  Unwilling or unable to follow protocol requirements.
8.  Any condition which in the Investigator’s opinion deems the participant an unsuitable 
candidate to receive the study intervention.
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3.3
Special Populations
The following special population groups are EXCLUDED from participation:

Cognitively impaired adults/adults with impaired decision-making capacity

Individuals who are not yet adults (infants, children, teenagers)

Pregnant women

Prisoners

Adults aged 18-20 unable to legally purchase tobacco in New York State 
3.4
Inclusion of Women and Minorities
Both men and women and members of all races and ethnic groups are eligible for this study.
4
LOCAL AND STUDY-WIDE NUMBER OF SUBJECTS
A maximum of 72 evaluable participants from the general population in the greater Buffalo area 
and Rochester will be enrolled.
5
LOCAL AND STUDY-WIDE RECRUITMENT METHODS
Adult participants are recruited by offered continuation of another study and local advertising. We 
will recruit via community events, contacts, ad postings in local daily, weekly, and college 
newspapers, websites such as Craigslist, any social media networks (i.e.: Facebook, Instagram, 
Twitter, Snapchat, etc.), local tobacco control networks (methods we have previously used to 
recruit successfully), television, and radio (see Appendix A for example). 
Participants will be recruited from the general population, not from within the RPCI or URMC 
patient populations. 
Participants will be compensated via 1) an Amazon Gift Card Code sent to their provided email 
(all sites), 2) direct deposit (URMC only), or 3) a physical Visa Gift Card (URMC only). A gift 
card code/deposit/card reload notification will be sent within 24-48 hours of the session 
completion. Funds (via Amazon Gift Card Code) are immediately available when added to their 
Amazon account and participants can check their balance as desired. This system will allow 
frequent, immediately available payments. Compensation will be given on an escalating schedule 
upon successful completion of each session. A $50 bonus will be given upon successful 
completion of all seven sessions. The escalating compensation schedule will be as follows:

Session 1: $25

Sessions 2 - 5: $30

Sessions 6 & 7: $50

Completion Bonus: $50
6
MULTI-SITE RESEARCH
University of Rochester Medical Center (URMC) will be an additional study site. The site PI is 
Dr. Deborah Ossip. A reliance agreement will be entered wherein Roswell Park is the IRB of 
record. It is the responsibility of the Principal Investigator to ensure that:
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
All sites have the most current version of the protocol and consent document.

All required approvals (initial, continuing review and modifications) have been obtained 
at each site (including approval by the site’s IRB of record).

All modifications have been communicated to sites, and approved (including approval by 
the site’s IRB of record) before the modification is implemented.

All engaged participating sites will safeguard data, including secure transmission of data, 
as required by local information security policies.

All local site investigators will conduct the study in accordance with applicable federal 
regulations and local laws.

All non-compliance with the study protocol or applicable requirements will be reported in 
accordance with local policy.
7
STUDY TIMELINES
Participants will complete up to 7 laboratory visits (approximately 1½ hour/visit) over about a 3 
month period. Each visit will be scheduled a minimum of 24 hours and a maximum of 1 week 
apart. The time between visits may be extended up to 14 days (2 weeks) due to participant illness 
(e.g., COVID, influenza).
The total duration of the recruitment is 18 months with an approximate study completion date of 
8-31-2024. 
8
STUDY ENDPOINTS
8.1
Primary Endpoints
The primary endpoints are measures of vaping topography [(per-puff volume, inter-puff interval, 
peak flow rate, puff count, total volume (sum of volumes across all puffs)], which are treated as 
quantitative outcomes and will be summarized by:

Condition (flavor or nicotine composition) and,

Bout (directed or ad-lib) using the appropriate descriptive statistics.
8.2
Secondary Endpoints
The same type of modeling employed for the primary endpoints will be used to evaluate the effect 
of flavoring and nicotine formulation on sensory and subjective measures, such as:

Sensory measures – irritation, harshness

Drug effects – liking.
8.3
Exploratory Endpoint

Oral cell samples will be used for cell line/tissue generation to examine the cellular-level 
effects of the study products and their components.
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9
DESIGN
This is an open-label, factorial multi-center study of e-liquid composition and effects on vaping 
topography.
10 STUDY INTERVENTION
Participants will vape twice per session – once directed and once ad lib. In the directed bout, 
participants are instructed to take a 4 second puff on the device every 60 seconds until a total of 8 
puffs are completed. In the ad lib bout, participants are free to puff as they like for a defined 15 
minute period. 
10.1 Duration of Treatment
Participants may remain on study and continue to receive study product in the absence of 
unacceptable toxicity or withdrawal from study, intercurrent illness that prevents further 
participation, participant demonstrates an inability/refusal to comply with study procedures or, 
participant withdraws from study.
10.2 Compliance
Compliance is assessed in the laboratory by trained research assistants. As participants only use 
the study products on site in the laboratory, participant noncompliance with product use is expected 
to be negligible. 
11 PROCEDURES INVOLVED
11.1 Participant Registration
Eligibility of each participant will be established prior to registration.
Informed consent MUST be completed prior to receiving any study related procedures.
11.2 Screening
Participants will be screened for eligibility and scheduled via telephone by the study coordinator. 
Screening will take approximately 15 minutes. Please see Appendix B1 and Appendix B2 for 
specific screening questions. 
There are up to 7 laboratory sessions of up to approximately 90 minutes each. Participants will 
be scheduled at their convenience with a minimum of 24 hours and maximum of 1 week (2 
weeks if participant illness occurs) between sessions. See Table 1 for an overview of study 
measures/samples.
11.3 Session Procedures
Once a participant is identified as eligible, a visit date and time will be scheduled. 
Participants will complete all experimental conditions, and are to abstain from vaping for a 
minimum of 30 minutes prior to the study session. 
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The order of completion of Sessions 2-5 and 6-7 will be determined using Latin Square and A/B 
designs, respectively. Order of ad lib and directed bouts within a session will be determined by 
A/B designs. 
Each laboratory session is expected to take approximately 90 minutes. 
Directed vs. ad lib bouts. In the directed bout, participants are instructed to take a 4 second puff 
on the device every 60 seconds until a total of 8 puffs is reached. In the ad lib bout, participants 
are free to puff as they like for a defined 15 minute period. 
Priming / Habituation Puff: At the beginning of each session, participants will take 1 priming 
puff and 1 habituation puff at a setting of 10 watts. If 10 watts is too harsh for the participant, 
wattage may be reduced by 2 until comfort level is obtained. Final wattage will be recorded and 
used throughout the session.
Session 1: Vaping topography using own-brand liquid 
In this condition, we will use an A/B design to compare directed vs ad lib vaping of the 
participant’s preferred product. After each bout, participants will complete a battery of sensory 
outcome measures. All questionnaires will be administered by the experimenter. Vape assembly 
and puffing regimen will also be directed by the experimenter. The device used will be a 
SmokTech® NORD2 or equivalent device. This session will be approximately 90 minutes long. 
Sessions 2-5: Relationship of tobacco flavor formulation to vaping topography and sensory 
evaluation. 
In this condition, we will use a 4 (flavor) x 2 (ad lib vs directed) within-subjects design. All 
liquids will have a 60/40 carrier concentration and 5% nicotine. Three commercial tobacco flavor 
variants versus one unflavored liquid (EC Blend) will be tested.
Over 4 laboratory sessions (sequence determined by Latin square), participants will complete ad 
lib and directed bouts (sequence determined by A/B design) using each flavor. After each vape, 
participants will complete a battery of sensory outcome measures. All questionnaires will be 
administered by the experimenter. 
Vape assembly and puffing regimen will also be directed by the experimenter. The device used 
will be a SmokTech® NORD2 or equivalent device. These sessions will be approximately 90 
minutes long. 
Sessions 6-7: Relationship of nicotine formulation to vaping topography and sensory evaluation. 
In this condition, we will use a 2 (nicotine form) x 2 (ad lib vs directed) within-subjects design. 
All liquids will have a 60/40 carrier concentration and 5% nicotine. The primary comparison is 
between 5% synthetic nicotine and 5% tobacco-derived nicotine.
Over 2 laboratory sessions (sequence determined by A/B design), participants will complete ad 
lib and directed bouts (sequence determined by A/B design) using each liquid form. After each 
vape, participants will complete a battery of sensory outcome measures. All questionnaires will 
be administered by the experimenter. 
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Vape assembly and puffing regimen will also be directed by the experimenter. The device used 
will be a SmokTech® NORD2 or equivalent device. These sessions will be approximately 90 
minutes long. 
11.4 Study Measures
Table 1 provides a summary of the study assessments and procedures.
Table 1
Study Measures
Reason
Measure
Visit
1
2-7
Phenylthiocarbamine (PTC)
1x / screening
 
6-n-Propylthiouracil (PROP)
1x / screening
 
Indicators of individual 
differences
Sodium benzoate tasting
1x / screening
 
Pregnant or nursing 
females excluded from 
study participation 
Urine pregnancy test for women of child 
bearing potential 
1x / screening 
 
Preference Probes
Personal Food Taste Preferences
1x / session 
start
 
Vaping Dependence 
Penn State Dependence Scale
1x / session 
start
 
Positive and Negative 
Affect 
PANAS
1x / session 
start
1x / session 
start
Preference of large vs 
small reward
Delay Discounting
1x / session 
start
1x / session 
start
Self-Rated Sensory Ability
1x / session 
start
1x / session 
start
Sensory e-cig Experiences Scale
1x / session 
start
1x / session 
start
PROMIS-E
1x / session 
start
1x / session 
start
Base Sensory Measures
SHRI-E
1x / session 
start
1x / session 
start
Sensory Impact
Generalized Magnitude Scale
2x / after each 
use
2x/ after each 
use
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Reason
Measure
Visit
1
2-7
Duke Sensory Scale
2x / after each 
use
2x / after each 
use
Hedonic Attribute Profile
2x / after each 
use
2x / after each 
use
Drug Liking Effects
2x / after each 
use
2x / after each 
use
Upper airway sensation 
and subjective effects
Product Evaluation Scale
2xs / after each 
use
2xs / after each 
use
Nicotine and Cotinine 
Saliva
1x beginning 
of session & 
2x / after each 
use
1x beginning 
of session & 
2x / after each 
use
Oral microbiome 
assessment
Optional Oral Rinse Sample (Roswell Park Site 
only)
1x
Sensory Acuity Screening
Prospective participants will complete phenylthiocarbamine (PTC), 6-n-propylthiouracil (PROP), 
and sodium benzoate tasting, commonly used indicators linked to individual differences (27), 
using manufactured, pre calibrated strips.
Urine
Female participants will be asked to urinate in a sterile 90-mL urine specimen container which will 
be tested for pregnancy.
Saliva Samples
Saliva samples will be collected before and after product use in both session using a Salimetrics 
SalivaBio Passive Drool method (https://salimetrics.com/collection-method/passive-drool-
salivacollection- device/). This method involves unstimulated collection of whole saliva which 
will be passively drooled into a cryovial until ~1.8mL of saliva is collected. Samples will be 
divided into aliquots and frozen at -20 C. Saliva will be tested for nicotine using a GC-qTOF-MS 
method. Saliva will be further tested for stress markers of cortisol ( https://salimetrics.com/assay-
kit/salivary-cortisol-elisa-kit/) and DHEA ( https://salimetrics.com/assay-kit/salivary-dhea-elisa-
kit/) and proinflammatory cytokines of IL-6 (https://salimetrics.com/assay-kit/salivary-il-6-elisa-
kit) and IL-1b (https://salimetrics.com/assaykit/salivary-interleukin-1-beta-elisa-kit/). Color 
intensity will be read at 450nm using a plate reader (BioTek). The integrated values of known 
standards will be used to generate a standard curve. Density values for unknown samples will be 
determined by interpolation from the standard curve for each analyte to calculate concentrations 
in pg/mL saliva. Saliva samples may also be used to test for nicotine and cotinine levels using 
similar methods to blood analyses. Additional details about the processing of saliva samples are 
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provided in Section 15. A full description of the sample collection procedure can be found in 
Appendix D.
Optional Oral Rinse Sample (Roswell Park site only)
Oral rinse samples will be collected using a rinse & gargle method with Scope mouthwash, which 
will be stored in a -80⁰C freezer and kept at Roswell Park for analysis. We will characterize the 
microbiota by analyzing 16S rRNA (bacteria) and ITS1 gene (fungi) and the virome (including 
human papillomaviruses) using NGS. We will also complement analyses with functional 
information obtained through Bioinformatic algorithms (PICRUSt) and shotgun metagenomics. 
This approach will quantify differences in secreted and other microbial gene products; connect 
them to annotated pathways and make them available for downstream analyses. Thus, we will 
analyze inferred biochemical functions that are related to inflammation and subsequent oral and 
respiratory outcomes. Additional details about the processing of oral cell samples are provided in 
Section 15. A full description for oral rinse sample collection is provided in Appendix D.
eTop Vaping Topography
The eTop (American University of Beirut) is a mouthpiece-based desktop device designed to 
measure e-cigarette puff topography. eTop mouthpieces can be adapted for various e-cigarette 
designs. The eTop continuously monitors, digitizes, and records airflow through the mouthpiece 
that is connected to an e-cigarette. A puff is detected by a pressure transducer whenever changes 
in pressure occur across an orifice that is incorporated into the mouthpiece (e.g., when user begins 
to inhale). Orifice dimensions and transducer sensitivity provide valid measurements at puff flow 
rates as low as 3ml/sec. The signal from the transducer is digitized using a National Instruments 
data acquisition device (NI DAQ USB-6008) and communicated to the computer via USB. Data 
are stored offline by an associated computer application that communicates with the eTop device. 
Based on the start and end time of every puff, the total number of puffs detected, and the volume 
of each puff detected, the average puff duration (sec), interpuff interval (sec), puff volume (mL), 
and puff flow rate (mL/s) are computed. The eTop has been shown to capture topography data 
with high validity and reliability and does not interfere with natural e-cigarette puffing behavior 
(Felicione et al., 2020 (28)).
Sensory Measures
The product evaluation scale, Duke Sensory Scale, and Hedonic Attribute Profile will be used to 
examine different aspects of upper airway sensation and subjective effects. A labeled generalized 
magnitude scale will be used to score sensory impact. The sensory e-cig experiences scale; 
PROMIS-E; SHRI-E are also assessments that will be used. Refer to Appendix C. 
Purchase Decision Making 
We will administer a 5-trial adaptive delay discounting task, implemented in REDCap, to assess 
user preference for smaller immediate rewards over larger delayed rewards (i.e., delay 
discounting). This interactive instrument automatically adjusts to respondents’ choices to produce 
a k-parameter after five trials. Participants are asked on the first trial whether they would prefer to 
receive $500 now or $1,000 in 3 weeks. If the immediate choice is selected ($500 now), then the 
second trial shortened the delay (i.e., choice: $500 now or $1,000 in 1 day). If the delayed option 
was chosen on the first trial ($1000 in 3 weeks), then the second trial lengthens the delay (i.e., 
$500 now or $1000 in 2 years). All subsequent trials are adjusted based on responses from the 
preceding trial. The k-parameter is expressed as the natural logarithm of k in a hyperbolic model, 
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with k increasing as the preference for smaller sooner rewards increases.(29) Additional items 
probe participants’ reliance of various sources of information that may influence purchases. 
Other Questionnaires
The PANAS is administered to probe current balance of positive and negative affect. Additional 
items probe personal food taste preferences. All of these will be explored as potential covariates 
for sensory ratings. The Penn State Dependence Scale will evaluate vaping dependence. Refer to 
Appendix C.
12 WITHDRAWAL OF SUBJECTS
Participants will be given phone numbers for research associates and supervising physicians to call 
if there are adverse effects or other study-related problems. Participants will be advised that if they 
have any adverse effects and/or wish to stop participating in the study for any reason, they are free 
to do so. 
Participants who are injured as a result of being in the study will have treatment available. The 
costs of such treatment may be covered by Roswell, depending on a number of factors. 
Any participant who discontinues due to an adverse event or adverse experience (AE) must be 
followed until the event resolves or stabilizes. Appropriate medical care should be provided until 
signs and symptoms have abated, stabilized, or until abnormal laboratory findings have returned 
to acceptable or pre-study limits. The final status of AE will be reported in the participant’s study 
records.
Reasons for study product(s) discontinuation/withdrawal from the study should be classified as 
follows:

Death.

Adverse side effects; related or unrelated to study product(s).

The Investigator may discontinue a participant if, in his/her judgement, it is in the best 
interest of the participant to do so.

Noncompliance: defined as missing a scheduled visit by more than 2 weeks without contact.

Participant voluntary withdrawal. A participant may withdrawal from the study at any time, 
for any reason.
13 RISKS TO SUBJECTS
The potential risks to participants in the clinical studies, and their likelihood and seriousness, aredescribed below

Nicotine overdose: Some people who use nicotine products may experience symptoms of 
nicotine overdose such as nausea, sleep disturbance, headache, and vomiting; however, 
these symptoms are usually mild and temporary. Before nicotine products are used in 
human participants, they have undergone laboratory testing to assess the yields of nicotine 
present in the products; this will also provide quality control information to select the safest 
product.
o
The studies using nicotine products in participants will be performed in a clinical 
setting accustomed to monitoring for adverse events. The Principal Investigator and 
Co-Investigators have considerable experience with conducting outpatient studies 
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on novel nicotine delivery devices and their effects on participants and will be able 
to provide appropriate safety monitoring.
o
Participants will be instructed that the investigational products are not to be 
ingested. If a product is ingested by mistake, the participants will be instructed to 
call the study physician (716-845-5412). If they are experiencing serious symptoms 
of nicotine overdose, the participant should contact Poison Control or Emergency 
Medical Services.

Nicotine withdrawal: Many individuals who quit smoking exhibit a pattern of symptoms 
related to withdrawal from tobacco use. These symptoms include: sadness and anxiety, 
irritability, anger, difficulty concentrating, appetite change and weight gain, insomnia, and 
decreased heart rate. Because participants in the studies will be asked to refrain from 
smoking overnight, it is likely that they will experience some of these symptoms. Consent 
forms will include sections describing the possibility of this occurrence. Study personnel 
will be trained to recognize these symptoms and educate the participants about them.

Respiratory irritation: Some people who use ENDS (Electronic Nicotine Delivery Systems) 
may experience irritation of the mucosal membranes of the upper respiratory tract, but this 
may not be likely as they are already cigarette smokers. We will exclude participants or 
postpone procedures if they demonstrate chronic or acute respiratory problems. 

Inconvenience: It is possible that participants will experience inconvenience due to 
multiple study visits required.

Emotional distress: Participants may experience psychological discomfort during 
assessments when discussing feelings and attitudes about smoking and using nicotine 
products, or from learning about the risks of smoking. However, all participants will be 
current smokers and we do not expect this type of reaction to be likely. Study personnel 
will be alerted to expect this from a small number of participants and will be trained to 
make referrals for mental health services as needed. Personnel will be trained to query for 
adverse emotional reactions during assessments and will be trained to deal with such 
reactions and to provide additional referrals if needed. In addition, if assessments indicate 
psychiatric concerns, referrals to appropriate psychological services will be provided.

Reproductive Risks: Women will be advised to notify the study staff if they become or 
intend to become pregnant during the study period. Because nicotine and ENDS vapor 
safety for an unborn baby is unknown, participants will be told that they should not become 
pregnant while on this study nor should they nurse a baby. If a woman is pregnant or 
breastfeeding, she may not participate in this study, and if she becomes pregnant during 
the study, she will be removed from the study.
As general measures to minimize the likelihood of participants experiencing these side effects, 
staff will have the study physician’s cell phone number and will contact the study physician with 
all questions and concerns. We will also:

Enroll participants in self-reported good general health

Administer products of high quality.

Monitor self-reported side effects at each study session. Participants will be informed about 
the potential for adverse events or side effects, including respiratory/oral irritation, cough, 
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phlegm, headache, nausea, and emotional distress from learning about the adverse health 
consequences of smoking. Participants will be told that they should proceed with caution 
until they are certain that the study products do not affect their performance.

The study physician will be alerted to any severe side effects or any reported adverse 
events. The study physician will review the information provided by the research staff and 
if applicable, will contact the study participant within 24 hours of being notified to gather 
more information and determine the appropriate course of action for the participant. 
Ultimately, the study physician will decide if the adverse event is related to study treatment 
and whether the participant should discontinue its use.
Participants will be told that they should proceed with caution when using study products and to 
report any adverse symptoms or side effects to study personnel immediately.
14 POTENTIAL BENEFITS TO SUBJECTS
There is no direct benefit for those who decide to participate and enroll in this study.
15 DATA AND SPECIMEN BANKING
Samples Collected at Roswell Park:
All samples will be immediately transported to the Health Behavior Department Laboratory 
(Roswell Park Comprehensive Cancer Center). Saliva samples will be centrifuged for 2 minutes 
prior to storage. All samples will immediately be frozen at -20⁰C or below in Dr. Goniewicz’s 
Laboratory until analyzed (unless otherwise noted above). Female urine samples will be tested for 
pregnancy. All sample results are recorded in logs and kept in:
Dr. Goniewicz’s Laboratory
Gratwick Basic Science Building (GBSB)
Health Behavior Department Laboratory
Laboratory location: 4th Floor, Room 4942
Laboratory phone: 716-845-8603
Dr. Goniewicz’s office number: 716-845-8541
If there are remaining samples after all analysis has been done and the participant checks “YES” 
on the consent document to having any extra samples stored for future studies, then the samples 
will be kept in a -20⁰C or below freezer in Dr. Maciej Goniewicz’s Laboratory listed above. If 
there are remaining samples and the participant checks “NO” on the consent document to having 
any extra samples stored, then the extra samples of that participant will be immediately destroyed 
once they are taken off study or analyses are completed. Any future research on the remaining 
samples will only be done under IRB approved protocols. 
EXTERNAL SITES: Follow directions above for sample collection and processing. The 
cryogenic tubes will be labeled with the participant identification number (Participant ID, PID) 
(unique to external-site participants), initials, the participant’s study number, clinical study 
number, protocol time point, and protocol day. The saliva samples will immediately be 
refrigerated or frozen at -20ºC or below (samples are to be stored until requested for batch 
mailing). 
Frozen samples will be shipped via Fed Express Overnight on dry ice with delivery on Mon-Fri. 
NO SATURDAY DELIVERY. Do not ship on a Friday or the day before a holiday.
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Address 
shipments 
and 
any 
questions 
regarding 
specimen 
processing 
to: 
Maciej.Goniewicz@RoswellPark.org, telephone number: 716-845-8541. 
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 both observational and interventional clinical studies collecting clinical 
samples.
Data Banking
For the purposes of this research, we will collect the following identifiable information: Participant 
name (to verify identification), date of birth (to verify age), telephone number and email address 
(to facilitate contact for scheduling). 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 or URMC. All data files will be 
electronic, including only the unique subject ID. At study completion, datafiles from RPCI and 
URMC will be combined and will be stored on the Cancer Prevention server 
(\\CancerPrev\CancerPrev$\HealthBehavior). Access to the folder is restricted to authorized users. 
Standard protocols for data encryption when using laptops and USB drives will be followed.
Any clinical data that is associated with the samples, will be stored on a secure server in the 
Department of Health Behavior, will be accessible only by the PI, Co-Investigators and PI 
designated data manager and, will be password protected. All computer entry and networking 
programs will be done using PIDs only. Any clinical data and/or specimens for future research 
will require verification of an IRB-approved protocol and will be de-identified before being 
released.
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 both observational and interventional clinical studies collecting clinical 
samples.
16 MEASUREMENT OF EFFECT
Nicotine boost will be measured as the post-bout saliva nicotine concentration minus the pre-bout 
saliva nicotine concentration. 
Subjective questionnaires are scored on a 0-100 visual analog scale (some exceptions, such as -
100 to 100) or a Likert scale (varying amount of points). Subjective responses will be evaluated 
based on their change from pre- to post-bout and for differences between products.
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17 SAFETY EVALUATION
17.1 Safety Monitoring
Subjects will be monitored for safety during product use sessions by trained laboratory staff. 
Participants are able to use the study products ad lib and can stop product use at any time without 
being withdrawn from the study completely. Subjects will be given phone numbers for research 
associates and supervising physicians to call if there are adverse effects or other study-related 
problems. Subjects will be advised that if they have any adverse effects and/ or wish to stop 
participating in the study for any reason, they are free to do so. 
The data collected from this study will be organized by a unique identification number assigned to 
the participant so that their identity will be available only to project staff and will remain 
completely confidential. The clinical study coordinator and staff and PI of the study will have 
access to the data records. All study records will be kept electronically in Roswell Park 
Comprehensive Cancer Center maintained and secured equipment. Any data, specimens, forms, 
reports, and other records that leave the site will be identified only by a participant identification 
number (Participant ID, PID) to maintain confidentiality. All records will be kept in a limited 
access environment. All computer entry and networking programs will be done using PIDs only. 
Information will not be released without written authorization of the participant.
17.2 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 or if in relation to an AE is deemed Serious.
17.3 Reporting Unanticipated Problems
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, 
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 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.
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18 DATA MANAGEMENT AND CONFIDENTIALITY
To ensure data security and confidentiality, all assessments will be administered by trained 
research study staff. Data management activities will be performed using REDCap (Research 
Electronic Data Capture). REDCap is a secure web-based application that supports data capture 
and management for research studies. In the event of REDCap being inaccessible for a study visit, 
paper copies of the questionnaires will be administered to the participant at that point in time and 
data entry will be performed by the assigned Senior Research Associate after the study session is 
completed. Data can be entered and changed only by those with the rights to do so. All participant 
records and data will be held in the Health Behavior Department at Roswell Park Comprehensive 
Cancer Center. All personnel involved in the conduct of this study are Roswell Park staff.

Access to the data by all necessary research personnel will be through a password protected 
network computer. At no time will data be downloaded on a thumb drive or other portable 
media or laptop.

Participant identity will not be disclosed in the event of publication or sharing of data.

Any paper files containing identifiers (if applicable to the research) will not be taken off 
Roswell Park premises; they will be kept in a locked filing cabinet in a secure building on 
the Roswell Park campus.

PHI will not be re-used or disclosed for purposes other than research use.

PHI (limited data set) may be shared with the partner site (URMC) to facilitate study 
recruitment and data analysis.

Essential documents will be retained per Roswell Park’s policy for 6 years from the study 
termination date. These documents could be retained for a longer period, however, If 
required by the applicable local regulatory requirements or by an agreement with Roswell 
Park.
18.1 Data Collection
Data management activities are performed using REDCap.
18.2 Maintenance of Study Documents
Essential documents will be retained per Roswell Park’s policy for 6 years from the study 
termination date. These documents could be retained for a longer period, however, if required by 
the applicable local regulatory requirements or by an agreement with Roswell Park.
18.3 Revisions to the Protocol
Roswell Park may make such changes to the protocol as it deems necessary for safety reasons or 
as may be required by the U.S. FDA or other regulatory agencies. Revisions will be submitted to 
the IRB/ERC for written approval before implementation.
18.4 Termination of the Study
It is agreed that, for reasonable cause, either the Roswell Park Investigators or the Sponsor, may 
terminate this study, provided a written notice is submitted within the time period provided for in 
the Clinical Trial Agreement. In addition, Roswell Park may terminate the study at any time upon 
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immediate notice if it believes termination is necessary for the safety of participants enrolled in 
the study.
19 STATISTICAL PLAN
This is an open-label, factorial-design, multi-center study of e-liquid composition and effects on 
vaping topography. 
19.1 Sample Size Determination
The planned sample size is n=72 evaluable patient, who are expected to complete 7 potential 
sessions, for a total of 504 observations.
However, we anticipate an attrition rate of 5-10% per session and the table below provides 
expected sample sizes under differing rates of attrition:
Session
1
2
3
4
5
6
7
5% Attrition
72
68
65
62
59
56
53
10% Attrition
72
65
58
52
47
43
38
Subjects 
Completed
5% 1-3
and 10% in 4-7
72
68
65
58
53
47
43
A conservative sample size calculation is based on comparing any two flavors or nicotine 
formulations using a two-sided paired t-test. The minimum expected sample size per combination 
is expected to be between 38 and 53; which provides 80% power (at α=0.05) to detect a difference 
of at least 0.47 and 0.39 standard deviations. Since the actual models used in the analysis will 
account for additional sources of variability and will borrow information across sessions, the actual 
detectable effect sizes may be larger.
19.2 Randomization
Subjects will complete up to 7 sessions. At each session, subjects will complete directed and ad 
lib bouts of vaping. The order of directed and ad lib bouts will be randomized within participant 
using a permutation block design (block sizes of 2 and 4).
Session 1 will use their own-brand liquid. No randomization is required.
Sessions 2-5 will evaluate the relationship of tobacco flavor formulation (no flavor and 3 
commercial flavor variants) on outcomes. The order of nicotine forms (i.e., what flavor is 
experienced at a given session) will be randomized using a permuted Latin Square design.
Sessions 6-7 will evaluate the relationship of nicotine formulation (2 forms) on outcomes. The 
order of nicotine forms will be randomized using a permuted Latin Square design.
19.3 Demographics and Baseline Characteristics
Descriptive statistics (as appropriate: n, percent, mean, median, min and max) will be used to 
summarize demographic and baseline characteristics.
19.4 Primary Analysis
The primary objective is to evaluate the influence of:
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a.
tobacco flavoring composition on vaping topography
b. synthetic vs. tobacco derived nicotine on vaping topography
The primary endpoints are measures of vaping topography, which are treated as quantitative 
outcomes and will be summarized by condition (flavor or nicotine composition) and bout (directed 
or ad-lib) using the appropriate descriptive statistics.
Using data from sessions 1-5, each endpoint will be modeled as a function of flavoring (own, none, 
and 3 commercial flavors), bout (directed or ad-lib), their two-way interaction, and random subject 
and site effects using a linear mixed model. Tests about the appropriate contrasts of model 
estimates will be used to compare: 
i)
mean differences between flavors within a type of bout,
ii) mean differences between bouts within a flavor,
iii) effects of bout (ad lib – directed) between flavors,
iv) effect of flavor between bouts.
Using data from sessions 6 & 7, each endpoint will be modeled as a function of nicotine 
composition (synthetic vs. tobacco derived), bout (directed or ad-lib), their two-way interaction, 
and random subject and site effects using a linear mixed model. Tests about the appropriate 
contrasts of model estimates will be used to compare: 
i)
mean differences between composition within a type of bout,
ii)
mean differences between bouts within a composition,
iii)
effects of bout (ad lib – directed) between compositions,
iv)
effect of composition between bouts.
19.5 Secondary Analysis
The models described above will be used to evaluate the effect of flavoring and nicotine 
formulation on sensory measures.
20 PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF 
SUBJECTS
Subjects will be monitored for safety during product use sessions by trained laboratory staff. 
Participants are able to use the study products ad lib and can stop product use at any time without 
being withdrawn from the study completely. Subjects will be given phone numbers for research 
associates and supervising physicians to call if there are adverse effects or other study-related 
problems. Subjects will be advised that if they have any adverse effects and/ or wish to stop 
participating in the study for any reason, they are free to do so. 
The data collected from this study will be organized by a unique identification number assigned to 
the participant so that their identity will be available only to project staff and will remain 
completely confidential. The clinical study coordinator, study staff, and PI of the study will have 
access to the data records. All study records will be kept electronically in Roswell Park 
Comprehensive Cancer Center maintained and secured equipment. Any data, specimens, forms, 
reports, and other records that leave the site will be identified only by a participant identification 
number (Participant ID, PID) to maintain confidentiality. All records will be kept in a limited 
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access environment. All computer entry and networking programs will be done using PIDs only. 
Information will not be released without written authorization of the participant.
21 VULNERABLE POPULATIONS
N/A
22 COMMUNITY-BASED PARTICIPATORY RESEARCH
N/A
23 SHARING OF RESULTS WITH SUBJECTS
Positive pregnancy test results will be shared with participants where applicable.
24 SETTING
All study sessions will take place in The Health Behavior Human Exposure Lab located at Roswell 
Park Comprehensive Cancer Center or an equivalent laboratory environment at the University of 
Rochester Medical Center (URMC). The research team will identify and recruit potential 
participants from the Western New York region.
25 PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF SUBJECTS
Any data, specimens, forms, reports, video recordings, and other records that leave the site will be 
identified only by a participant identification number (Participant ID, PID) to maintain 
confidentiality. All records will be kept in a limited access environment. All computer entry and 
networking programs will be done using PIDs only. Information will not be released without 
written authorization of the participant.
26 RESOURCES AVAILABLE
Investigators on this protocol have the education and research training and experience to conduct 
this study safely and appropriately. All data and specimen collection will be done by trained 
clinical research coordinators, research associates or certified phlebotomists working on this study.
All study procedures at RPCI will be performed in the:
Health Behavior Human Exposure Lab
Gratwick Basic Science Building (GBSB)
Laboratory location: 3rd Floor, Room 3920
Laboratory phone: 716-845-3312
The laboratory is 10’ x 10.5” x 11’8” space equipped with a sink, multiple infusion chairs, and an 
Axis Communications video camera. In addition, the laboratory also has specialized mechanical 
exhausts and ducts designed to keep the room under negative air pressure at all times.
University of Rochester Medical Center (URMC) will be an additional study site. The site PI is 
Dr. Deborah Ossip. A reliance agreement will be entered wherein Roswell Park is the IRB of 
record.
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Dr. Nicholas Felicione (SUNY Buffalo) will be providing technical assistance on topography 
device use, troubleshooting, and interpretation. Dr. Felicione will be acting primarily in an 
advisory capacity and will not have access to any data containing PHI.
27 PRIOR APPROVALS
Not applicable.
28 COMPENSATION FOR RESEARCH-RELATED INJURY
If the subject believes they have been injured as a direct result of their participation in this research 
study, they will be advised to notify the Roswell Park Patient Advocate at (716) 845-1365 or the 
Study Doctor at (716) 845-4517.
Medical diagnosis and treatment for the injury will be offered, and a determination will be made 
regarding appropriate billing for the diagnosis and treatment of the injury. A financial counselor 
(716-845-3161) will be able to provide an explanation of coverage and to answer questions the 
subject may have regarding study related billing.
The subject is not prevented from seeking to collect compensation for injury related to malpractice, 
fault, or blame on the part of those involved in the research.
29 ECONOMIC BURDEN TO SUBJECTS
Participants will be responsible for transportation to and from the research site and any costs that 
might entail. The remainder of the study will be conducted at no financial cost or obligation to the 
participant.
30 CONSENT PROCESS
The Roswell Park SOP: Informed Consent Process for Research (HRP-090) will be followed.
Consent will be obtained at Session 1 before any tests, procedures, or questionnaires (other than 
eligibility screeners) are administered in the tobacco research laboratory.
Each participant shall read, understand, and 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. Consent will be obtained at the beginning at the first visit prior to any data 
collection. Research staff will guide participants through the consent form, provide the participant 
time to read the consent form, and answer any questions. Participants will verbally consent, sign 
the consent form (physically or electronically), and show the consent form to research staff to 
ensure it is filled out correctly. The research staff will sign their copy of the consent form upon 
verbal consent and demonstration of signing the consent form. The signed consent form (or a 
photograph of signed consent) will then be returned to research staff through secure email or drop 
off/pick up.
Consent may 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 version to the REDCap system. A secure link 
will be sent to each participant prior to the start of the study. Research staff will guide the 
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participant form, provide time to read the consent, and answer any questions. Participants will be 
able to electronically sign, date, and submit the consent in real-time. Once the consent is submitted, 
it is automatically saved on Roswell Park protected servers.
In the event of REDCap being inaccessible for a study visit, pdf files or paper copies of the consent 
will be administered, and the participant will be able to either sign and return or submit a photo of 
the signed copy as stated above. 
All RedCap consent files will be stored on protected servers at Roswell Park. Access to this folder 
is restricted to authorized users. Standard protocols for data encryption when using laptops and 
USB drives will be followed.
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 
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.
31 PROCESS TO DOCUMENT CONSENT IN WRITING
The Roswell Park SOP: Written Documentation of Consent (HRP-091) will be followed.
Consent will be obtained at Session 1 before any tests, procedures, or questionnaires (other than 
eligibility screeners) are administered in the tobacco research laboratory.
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 s(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.
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32 DRUGS OR DEVICES
During each visit, participants will be asked to use E-liquids (unflavored, tobacco flavor). The 
primary psychoactive ingredient in all products is nicotine. All products are currently available for 
commercial purchase and will be purchased by the research team either online or at local stores 
(e.g., tobacco/vape shops, convenience store). These nicotine-containing products will be stored 
in a cool, dark location in laboratories or offices that are locked and only accessible to those with 
a key. When participants are randomized to a condition, the laboratory staff session will retrieve 
only the product needed for the individual session and will bring it directly to the participant in the 
lab.
Under no circumstances will the Investigator allow the study product to be used in a manner other 
than as directed by this protocol.
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33 REFERENCES
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PubMed PMID: 17030447.
16.
Hanson K, O'Connor R, Hatsukami D. Measures for assessing subjective effects of 
potential reduced-exposure products. Cancer Epidemiol Biomarkers Prev. 2009;18(12):3209-24. 
doi: 10.1158/1055-9965.EPI-09-0971. PubMed PMID: 19959674; PMCID: PMC2821025.
17.
Harrell PT, Juliano LM. A direct test of the influence of nicotine response expectancies 
on the subjective and cognitive effects of smoking. Experimental and clinical 
psychopharmacology. 2012;20(4):278-86. Epub 2012/06/20. doi: 10.1037/a0028652. PubMed 
PMID: 22708609.
18.
Hendricks PS, Brandon TH. Smoking expectancy associates among college smokers. 
Addictive behaviors. 2005;30(2):235-45. doi: 10.1016/j.addbeh.2004.05.006. PubMed PMID: 
15621395.
19.
Hendricks PS, Brandon TH. Smokers' expectancies for smoking versus nicotine. Psychol 
Addict Behav. 2008;22(1):135-40. doi: 10.1037/0893-164X.22.1.135. PubMed PMID: 
18298240.
20.
O'Connor RJ, Ashare RL, Fix BV, Hawk LW, Cummings KM, Schmidt WC. College 
students' expectancies for light cigarettes and potential reduced exposure products. American 
journal of health behavior. 2007;31(4):402-10. doi: 10.5555/ajhb.2007.31.4.402. PubMed PMID: 
17511575.
21.
Wetter DW, Smith SS, Kenford SL, Jorenby DE, Fiore MC, Hurt RD, Offord KP, Baker 
TB. Smoking outcome expectancies: factor structure, predictive validity, and discriminant 
validity. J Abnorm Psychol. 1994;103(4):801-11. PubMed PMID: 7822583.
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22.
Hiler M, Karaoghlanian N, Talih S, Maloney S, Breland A, Shihadeh A, Eissenberg T. 
Effects of electronic cigarette heating coil resistance and liquid nicotine concentration on user 
nicotine delivery, heart rate, subjective effects, puff topography, and liquid consumption. 
Experimental and clinical psychopharmacology. 2020;28(5):527-39. Epub 2019/12/20. doi: 
10.1037/pha0000337. PubMed PMID: 31855003; PMCID: PMC9159736.
23.
Spindle TR, Talih S, Hiler MM, Karaoghlanian N, Halquist MS, Breland AB, Shihadeh 
A, Eissenberg T. Effects of electronic cigarette liquid solvents propylene glycol and vegetable 
glycerin on user nicotine delivery, heart rate, subjective effects, and puff topography. Drug 
Alcohol Depend. 2018;188:193-9. Epub 2018/05/21. doi: 10.1016/j.drugalcdep.2018.03.042. 
PubMed PMID: 29778773; PMCID: PMC7193252.
24.
Kimber CF, Soar K, Dawkins LE. Changes in puffing topography and subjective effects 
over a 2-week period in e-cigarette naïve smokers: Effects of device type and nicotine 
concentrations. Addictive behaviors. 2021;118:106909. doi: 
https://doi.org/10.1016/j.addbeh.2021.106909.
25.
Talih S, Salman R, Karaoghlanian N, El-Hellani A, Saliba N, Eissenberg T, Shihadeh A. 
“Juice Monsters”: Sub-Ohm Vaping and Toxic Volatile Aldehyde Emissions. Chemical 
Research in Toxicology. 2017;30(10):1791-3. doi: 10.1021/acs.chemrestox.7b00212.
26.
Son Y, Weisel C, Wackowski O, Schwander S, Delnevo C, Meng Q. The Impact of 
Device Settings, Use Patterns, and Flavorings on Carbonyl Emissions from Electronic Cigarettes. 
Int J Environ Res Public Health. 2020;17(16). Epub 2020/08/09. doi: 10.3390/ijerph17165650. 
PubMed PMID: 32764435; PMCID: PMC7460324.
27.
Bartoshuk LM. Comparing sensory experiences across individuals: recent psychophysical 
advances illuminate genetic variation in taste perception. Chem Senses. 2000;25(4):447-60. 
PubMed PMID: 10944509.
28.
Felicione NJ, Karaoghlanian N, Shihadeh A, Eissenberg T, Blank MD. Comparison of 
Measurement Methods for Electronic Cigarette Puff Topography. Tob Regul Sci. 2020;6(5):318-
30. Epub 2021/05/08. doi: 10.18001/trs.6.5.2. PubMed PMID: 33959673; PMCID: 
PMC8096180.
29.
Mazur JE. An adjusting procedure for studying delayed reinforcement. In: M.L. 
Commons JEM, J.A. Nevin, H. Rachlin, editor. Qantitative Analysis of Behavior. Hillsdale, NJ: 
Erlbaum; 1987. p. 55-73.
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34 APPENDICES/ SUPPLEMENTS
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Appendix A
Recruitment Materials (Print Ad Copy)
RESEARCH PARTICIPANTS 
NEEDED
Researchers at Roswell Park are searching for current daily vapers to participate 
in a laboratory  research study.
Participation involves up to 7 sessions that last about 1 hour each.
Must be 21+ years old daily vaper to participate.
Participants will be compensated 
for their time.
If interested, please contact [716-845-3456 or CROFT@roswellpark.org and ask 
for the TOPOG study
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Appendix B
Study Screeners
Appendix B1: Core Eligibility Screener
Core Eligibility Screener
Name: ____________________________________________________
Preferred Phone Number______________________________________________
Type of phone:  _____ Land Line ____ Mobile
If Mobile Phone, may we text you? ___ yes
___no ___ only if necessary
1. Do you currently use tobacco products? By currently, we mean any use at all in the last month 
(30 days)
___ Yes (please proceed to question 2) 
___ No (please proceed to question 3)
2. Which tobacco products have you used in the past 30 days? Please check all that apply. 
___ Cigarettes
___ Cigars
___ Cigarillos
___ Clove Cigarettes
___ Herbal Cigarettes
___ Bidis
___ Pipe Tobacco
___ Roll Your Own 
___ Chewing Tobacco
___ Moist Snuff
___ Snus
___ E-Cigarettes
___ Vapes
___JUUL
___Nicotine pouches (i.e.: Zyn, On!, Velo)
___Nicotine gummies
___Nicotine gum 
___Nicotine lozenges
___ No products. I do not use tobacco or nicotine products. 
(Please proceed to question 6)
3. Have you used tobacco or nicotine products in the past?
___ Yes (please proceed to question 4) 
___ No (please proceed to question 6) 
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4. What products did you use? Please check all that apply.
___ Cigarettes
___ Cigars
___ Cigarillos
___ Clove Cigarettes
___ Herbal Cigarettes
___ Bidis
___ Pipe Tobacco
___ Roll Your Own 
___ Chewing Tobacco
___ Moist Snuff
___ Snus
___ E-Cigarettes
___ Vapes
___JUUL
___Nicotine pouches (i.e.: Zyn, On!, Velo)
___Nicotine gummies
___Nicotine gum 
___Nicotine lozenges
5. How long ago did you quit smoking?
___ More than a year ago
___ Less than a year ago
___ Less than 6 months ago
___ Less than a month ago
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?
___ Some Days
___ Every Day
___ Not at all
8. How many cigarettes do you smoke per day? Please enter a number. 
______________
9. How long have you been smoking? 
___ More than 1 year
___ Less than 1 year
___ Not at all
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10. Have you tried to quit smoking in the past 30 days? 
(more than a 24 hour time period without smoking)
___ Yes
___ No
___ Not a smoker
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
___ Not a smoker
12. How would you describe your gender identity? (for demographics purposes, only) 
__Male 
__Female
__Trans-male
__Trans-female
__A different gender identity not listed above
13. What is your age? Please enter a number (years). 
______________________
14. Please describe your overall health.
___ Excellent
___ Very Good
___ Good
___ Fair
___ Poor 
15. Please describe your overall mental health. 
___ Excellent
___Very Good
___Good
___ Fair
___ Poor 
16 MEN. How many times in the past year have you had 5 or more alcoholic drinks in a day? 
Please enter the number below. 
________________
16 WOMEN. How many times in the past year have you had 4 or more alcoholic drinks in a 
day? Please enter the number below. 
________________
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17. Are you currently involved in any other Roswell Park research studies?
___ Yes
___ No
End Script: Thank you for completing the Roswell Park Cancer Institute, Health Behavior Core 
Screener. Congratulations on your preliminary eligibility! We currently have several ongoing 
studies and want to place you with the best one based on your eligibility. 
1. Would you like to be called for study-specific eligibility?
___ Yes (please proceed to question 2) 
___No, I do not wish to leave a phone number (please proceed to question 6) 
2. Please enter your name.
__________________________________
3. Please enter your phone number, starting with the area code. 
___ ___ ___ - ___ ___ ___ - ___ ___ ___ ___ 
4. What day(s) would be the best to reach you? Please check all that apply. 
___ Monday
___ Tuesday
___ Wednesday
___ Thursday
___ Friday
___ Saturday
___ Sunday
5. What time of day would be best to reach you? Please check all that apply.
___ Morning  (8am – 12pm)
___ Afternoon (12pm – 4pm) 
___ Evening (4pm – 8pm)
6. Would you like to be emailed for study-specific eligibility? 
___ Yes (please proceed to question 7)
___ No, I do not wish to leave an email address (please proceed to question 9)
7. Please enter your name. 
__________________________
8. Please enter your email address.
_________________________________________________________________
9. For more information on study-specific eligibility, please call the Roswell Park Cancer 
Institute, CRoFT Study Line at 716-845-___ ___ ___ ___ or email CROFT@roswellpark.org.
Thank you for your time and have a great day. 
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Appendix B2: Study Specific Eligibility Screener
Additional Study-Specific Eligibility Questions
1. Are you between 21 and 55 years old?
a. ____Yes
b. ____ No
2. What is your birthdate?
__mm__/__dd___/_yyyy__
3. Do you use vapes? This includes e-cigarettes, vaporizers, and JUUL.
a.
____Yes
b. ____ No
4. If yes, what type?
a.
List choices
5. Do you now vape every day, some days, or not at all?
a. ____Everyday 
b. ____Some Days 
c.
____Not at all 
6. Do your vapes/e-cigarettes/JUUL contain nicotine? 
a. ____Yes
b. ____ No
7. Are your vapes/e-cigarettes/JUUL flavored? 
a. ____Yes
b. ____ No
8. If yes, which of the following best describes the flavor you are using now. Check all that 
apply.
a.
Fruit - Berry
b. Fruit - Citrus
c.
Fruit - Tropical 
d. Fruit – Other
e.
Desserts
f.
Candy
g. Other sweets
h. Tobacco
i.
Menthol or mint
j.
Nuts
k. Spices
l.
Coffee/Tea
m. Alcoholic beverage
n. Other beverage
o. Something else: __________________________
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9. Which of these products do you NOT like / be willing to use? Check all that apply
a.
Fruit - Berry
b. Fruit - Citrus
c.
Fruit - Tropical 
d. Fruit – Other
e.
Desserts
f.
Candy
g. Other sweets
h. Tobacco
i.
Menthol or mint
j.
Nuts
k. Spices
l.
Coffee/Tea
m. Alcoholic beverage
n. Other beverage
10. Do you use any other tobacco products daily?
    a. ____Yes
    b. ____ No
11. Do you have any intentions to quit vaping?
a.
Yes – In the next 2 weeks
b. Yes – In the next month
c.
Yes – In the next 6 months
d. Yes – in the next year
e.
 No intention to quit
12.  Please describe your overall health.
___ a. Excellent
___ b. Very Good
___ c. Good
___ d. Fair
___ e. Poor 
13. Please describe your overall mental health. 
___a. Excellent
___b. Very Good
___c. Good
___d. Fair
___ e. Poor 
14. Are you able to speak, read, and write in English?
a. ____Yes
b. ____No
15. Are you male or female?
a.
____Male
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b. ____Female
c.
____Undetermined 
d. ____Refused 
16. If female, are currently pregnant?
a.
Yes
b. No 
17. Do you plan to become pregnant within the next 12 months? 
a.
Yes
b. No 
18. Are you currently breastfeeding? 
a.
Yes
b. No
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19. Do you have any known allergies? 
a. Yes
b. No
20. Please list your allergies 
a. __________
b. __________
c. __________
d. __________
e. __________
21. Do you have the ability to both smell and taste?
a. Yes
b. No
22. Are you on any medications that might interfere with your ability to smell and taste?
a. Yes
b. No
23. Are you able to participate in several 1 hour sessions over the span of 3 months? 
a. Yes
b. No
24. Do you have reliable transportation to travel to and from Roswell Park for a total of 7 
sessions over the course of 3 months? 
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Appendix C
Questionnaires
Demographics 
Please answer each question directly on this questionnaire packet by writing, checking, or circling 
the correct answer or, where spaces are provided, writing in your answer. 
1. What is your date of birth?
______ (month)   ______(date)   ______(year)
2a. What sex were you assigned at birth?
Male
Female
2b. What gender do you currently identify as?
_Male 
_Female
_Trans-male
_Trans-female
_A different gender identity not listed above
3. Are you Spanish, Hispanic, or Latino?
No
Yes
4.  How would you describe your race?
White, Caucasian 
Black, African American
American Indian or Alaska Native
Asian 
Native Hawaiian or other Pacific Islander
Other _____________________________
5.  What is the highest level of school you completed or the highest degree you received?

Never attended school 

Less than high school

High school graduate

G.E.D.

Some technical or vocational school

Some college, no degree

AA; technical or vocational school

BA, BS college graduate

At least some graduate or professional school

Graduate or professional degree

Don’t know
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6. What is your yearly average household income? 

$30,000 or less

$30,001-$60,000

$60,001 or more

Prefer not to answer
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Taste Preferences: Meier et al JPSP 2012
For each of the foods shown below, please check the box that corresponds to how much you like 
or dislike that food. If you have never tried a food, please check that box. 
Sweet items: 
Candy
___  Never tried
Caramel
___  Never tried
Chocolate Cake
___  Never tried
Honey
___  Never tried
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Ice cream
___  Never tried
Maple Syrup
___  Never tried
Pears
___  Never tried
Raisins
___  Never tried
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Strawberries
___  Never tried
Sugar
___  Never tried
Sour items:  
Granny Smith Apples
___  Never tried
Lemons
___  Never tried
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Lemon drops
___  Never tried
Limes
___  Never tried
Lime Sherbet
___  Never tried
Plain yogurt
___  Never tried
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Sauerkraut
___  Never tried
Sour Cream
___  Never tried
Vinegar
___  Never tried
Bitter items: 
Beer
___  Never tried
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Celery
___  Never tried
Coffee
___  Never tried
Cottage cheese
___  Never tried
Ginger Ale
___  Never tried
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Grapefruit
___  Never tried
Radishes
___  Never tried
Rye Bread
___  Never tried
Tea
___  Never tried
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Tonic Water
___  Never tried
Salty items: 
Bacon
___  Never tried
Beef Jerky
___  Never tried
Caviar
___  Never tried
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Dill Pickles
___  Never tried
Green Olives
___  Never tried
Pretzels
___  Never tried
Salt
___  Never tried
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Saltine Crackers
___  Never tried
Salty peanuts
___  Never tried
Soy Sauce
___  Never tried
Spicy items: 
Cajun foods
___  Never tried
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Cayenne pepper
___  Never tried
Chilies
___  Never tried
Curry
___  Never tried
Horseradish
___  Never tried
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Hot Salsa
___  Never tried
Jalapeno Peppers
___  Never tried
Spicy Sausage
___  Never tried
Peppers
___  Never tried
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Tabasco sauce
___  Never tried
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Penn State Dependence on Electronic Cigarettes
Please check the answer that best applies to you.
1. How many times per day do you usually use your electronic cigarette (assume that one 
“time” consists of around 15 puffs or lasts around 10 minutes)?
0-4 times/day
5-9 times/day
10-14 times/day
15-19 times/day
20-29 times/day
30+ times/day
2. On the days that you can use your electronic cigarette freely, how soon after you wake up 
do you use your electronic cigarette?
0-5 min
6-15 min
16-30 min
31-60 min
61-120 min
121+ min
3. Do you sometimes awaken at night to use your electronic cigarette?
Yes
No
4. If yes, how many nights per week do you typically awaken to use your electronic 
cigarette?
0–1 night
2–3 nights
4+ nights 
5. Do you use an electronic cigarette now because it is really hard to quit?
Yes
No
6. Do you ever have strong cravings to use an electronic cigarette?
Yes
No
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7. Over the past week, how strong have the urges to use an electronic cigarette been?
None/Slight
Moderate/Strong
Very Strong/Extremely Strong
8. Is it hard to keep using an electronic cigarette in places where you are not supposed to?
Yes
No
9. Did you feel more irritable because you couldn’t use an electronic cigarette?
Yes
No
10. Did you feel nervous, restless, or anxious because you couldn’t use an electronic 
cigarette?
Yes
No
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PANAS 
This measure consists of a number of words that describe different feelings and emotions. Read 
each item and then mark the appropriate response on the line next to the word. Indicate to what 
extent you have felt this way during the past week.
Use the following scale to record your answers.
1
2
3
4
5
very slightly or 
not at all
a little
moderately
quite a bit
extremely
___interested
___irritable
___distressed
___alert
___excited
___ashamed
___upset
___inspired
___strong
___nervous
___guilty
___determined
___scared
___attentive
___hostile
___jittery
___enthusiastic
___active
___proud
___afraid
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PURCHASE DECISION MAKING
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]
We are going to present you with a series of choices between amounts of money. For EACH 
pair, please select the ONE you would prefer…
Would you 
prefer…
Yes?
OR
Yes?
$54  today?
 
$55 in 117 days? 
$55  today?
 
$75 in 61 days? 
$19  today?
 
$25 in 53 days? 
$31  today?
 
$85 in 7 days? 
$14  today?
 
$25 in 19 days? 
$47  today?
 
$50 in 160 days? 
$15  today?
 
$35 in 13 days? 
$25  today?
 
$60 in 14 days? 
$78  today?
 
$80 in 162 days? 
$40  today?
 
$55 in 62 days? 
$11  today?
 
$30 in 7 days? 
$67  today?
 
$75 in 119 days? 
$34  today?
 
$35 in 186 days? 
$27  today?
$50 in 21 days? 
$69  today?
 
$85 in 91 days? 
$49  today?
$60 in 89 days? 
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Factors Influencing Purchases
When making purchase decisions around foods, beverages, and cosmetics, how much would you 
say each of these factors influence your decision to purchase a NEW product?
Not at all
A little
Somewhat
A lot
1. Advertising
2. Celebrity endorsement
3. Packaging
4. Price discount
5. Recommendation from friends/family
6. Smell
7. Taste
$80  today?
 
$85 in 157 days? 
$24  today?
 
$35 in 29 days? 
$33  today?
 
$80 in 14 days? 
$28  today?
 
$30 in 179 days? 
$34  today?
 
$50 in 30 days? 
$25  today?
 
$30 in 80 days? 
$41  today?
 
$75 in 20 days? 
$54  today?
 
$60 in 111 days? 
$54  today?
 
$80 in 30 days? 
$22  today?
 
$25 in 136 days? 
$20  today?
 
$55 in 7 days? 
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Self-Rated Sensory Ability 
Excellent
Very Good 
Good
Fair
Poor
1. Overall, 
how would 
you rate your 
ability to 
smell? 
2. Overall, 
how would 
you rate your 
ability to 
taste? 
Sensory E-Cig Experiences Scale
1 
Strongly 
Agree
2
3
4
5
6
7 
Strongly 
Disagree
1. I like the smell 
of the vapor.
2. I like the taste 
of vaping.
3. I like the feeling 
of creating vapor 
clouds.
4. I like how 
creating vapor 
clouds looks 
visually appealing 
/ cool. 
5. I like the flavor 
of vapor.
6. I like how 
vaping makes me 
feel good 
physically. 
7. I like the feeling 
of satisfaction that 
I get from vaping.
8. I like the feeling 
of pleasure that I 
get from vaping. 
9. I like doing 
vape tricks (e.g. 
Blowing vapor 
clouds or shapes 
like rings). 
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PROMIS-E
0
Never
1
2
3
4
Almost Always
1. I find myself 
reaching for my e-
cigarette without 
thinking about it. 
2. I drop everything 
to go out and buy e-
cigarettes or e-juice.
3. I vape more before 
going into a situation 
where vaping is not 
allowed.
4. When I haven’t 
been able to vape for 
a few hours, the 
craving gets 
intolerable. 
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SHRI-E
Vaping / using an e-cigarette/JUULing is something…
1
Agree
2
3
4
5
6
7
Disagree
1. I do 
automatically.
2. I do 
without 
having to 
consciously 
remember.
3. I do 
without 
thinking.
4. I start 
doing before I 
realize I’m 
doing it. 
5. I would 
find hard not 
to do. 
6. That is 
typically 
“me”. 
APPROVED RPCI IRB
1/3/2024

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Wattage: Research coordinator records wattage
Generalized Magnitude Scale 
For each item, please indicate how you would describe the E-CIG you just used by placing a mark 
on the verticle numbered line. 
1. How would you describe the overall flavor sensation of the e-cig you just used? 
2.  How would you describe the overall harshness/irritancy of the ECIG you just used?
3. How would you describe the throat hit (sensation in the throat) of the ECIG you just used?
APPROVED RPCI IRB
1/3/2024

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You will be presented with vials of liquid, each of which has a characteristic flavor. Please rate 
the taste on the following characteristics, where -100 is the least intense ever experience, 0 is 
neutral, and +100 is the most intense ever experience:
Pleasantness
  
    
   
Irritation
                     
        
Relaxing
Satisfying
-100
-80
-60
-40
-20
0
20
40
60
80
100
Least intense 
ever intense 
experience 
most intense 
ever experience 
neutral 
-100
-80
-60
-40
-20
0
20
40
60
80
100
Least intense ever 
intense experience 
most intense ever 
experience 
neutral 
-100
-80
-60
-40
-20
0
20
40
60
80
100
Least intense ever 
intense experience 
most intense ever 
experience 
neutral 
-100
-80
-60
-40
-20
0
20
40
60
80
100
Least intense ever 
intense experience 
most intense ever 
experience 
neutral 
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1/3/2024

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Sweet
Sour
Bitter
Cool/cooling
-100
-80
-60
-40
-20
0
20
40
60
80
100
Least intense ever 
intense experience 
most intense ever 
experience 
neutral 
-100
-80
-60
-40
-20
0
20
40
60
80
100
Least intense ever 
intense experience 
most intense ever 
experience 
neutral 
-100
-80
-60
-40
-20
0
20
40
60
80
100
Least intense ever 
intense experience 
most intense ever 
experience 
neutral 
-100
-80
-60
-40
-20
0
20
40
60
80
100
Least intense ever 
intense experience 
most intense ever 
experience 
neutral 
APPROVED RPCI IRB
1/3/2024

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Sharp/biting/astringent/pungent
 
-100
-80
-60
-40
-20
0
20
40
60
80
100
Least intense ever 
intense experience 
most intense ever 
experience 
neutral 
APPROVED RPCI IRB
1/3/2024

Roswell Park Protocol No.: I-3234822
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Duke Sensory Evaluation
Please rate the puffs you just took.
1
Not at 
all 
2
3
4
5
6
7
Extremely
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?
5. 
Strength 
of puffs 
on 
tongue?
6. 
Strength 
of puffs in 
nose?
7. 
Strength 
of puffs in 
back of 
throat?
APPROVED RPCI IRB
1/3/2024

Roswell Park Protocol No.: I-3234822
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1
Not at 
all 
2
3
4
5
6
7
Extremely
8. 
Strength 
of puffs in 
windpipe?
9. 
Strength 
of puffs in 
chest? 
APPROVED RPCI IRB
1/3/2024

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Hedonic Attribute Scale
For each item, please indicate how you would describe the ECIG you just used by placing a mark 
on the vertical numbered line. 
1. Draw
2. Mouthful of vapor 
3. Visible vapor
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1/3/2024

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4. Smell
5. Impact
6. Irritation
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1/3/2024

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7. Strength
8. Smoothness 
9. Taste 
APPROVED RPCI IRB
1/3/2024

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10. Aftertaste
11. Throat hit
12. Dryness
APPROVED RPCI IRB
1/3/2024

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13. Tingling
14. Burning 
15. Similarity to usual brand
[leave blanks for 3 additional participant-supplied descriptors with gLMS 
scoring]
APPROVED RPCI IRB
1/3/2024

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Drug Effects / Liking 
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?
APPROVED RPCI IRB
1/3/2024

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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?
APPROVED RPCI IRB
1/3/2024

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Product Evaluation Scale.
Using the number scale below, answer the following questions regarding the product you just 
used.
Product Code: _______________________________________________ 
1 
Not at 
all
2
Very 
little
3
A 
little
4
Moderately
5
A 
lot
6
Quite a 
lot
7
Extremely
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 an e-
cigarette?
12. Did it 
relieve 
withdrawal 
symptoms? 
APPROVED RPCI IRB
1/3/2024

Roswell Park Protocol No.: I-3234822
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1 
Not at 
all
2
Very 
little
3
A 
little
4
Moderately
5
A 
lot
6
Quite a 
lot
7
Extremely
13. Did it 
relieve the urge 
to vape?
14. Was it 
enough 
nicotine?
15. Was it too 
much nicotine?
16. Was it easy 
to use?
17. Were there 
bothersome side 
effects?
18. Would you 
be comfortable 
using the 
product in 
public?
19. Did you still 
have a craving 
for an e-
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?
APPROVED RPCI IRB
1/3/2024

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Minnesota Tobacco Withdrawal Scale
How are you feeling at this very moment?
Please mark an (X) in ONE box for each 
condition
Not at all
Slightly
Somewhat
Very
Extremely
Depressed
☐
☐
☐
☐
☐
Irritable
☐
☐
☐
☐
☐
Anxious
/nervou
s
☐
☐
☐
☐
☐
Restless
☐
☐
☐
☐
☐
Dizziness
☐
☐
☐
☐
☐
Hungry
☐
☐
☐
☐
☐
Nausea
☐
☐
☐
☐
☐
Poor 
concentratio
n
☐
☐
☐
☐
☐
How dangerous to your health did you find the ENDS product and solution comparedto
your regular device and solution? (please mark an (X) on ONE of the boxes)
1
2
3
4
5
6
7
8
9
10
APPROVED RPCI IRB
1/3/2024

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Compared to other smokers your age, what do you believe your risk is for 
developing the following health problems? Would you say that you are…
5-point Likert Scale: 1 = Much Less Likely at Risk; 2 = Less Likely at Risk; 3 = 
About the same risk; 4 = more likely at risk; 5 = much more likely at risk
1. Lung Cancer
2. Emphysema
3. Bronchitis
4. Other cancers
5. Heart disease
6. Addiction
7. Stroke
8. Mouth Cancer
9. Tooth Loss
10. Gum Disease
APPROVED RPCI IRB
1/3/2024

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Screening: Oral Health
1. How often do you brush your teeth?
 [ ] Never 
[ ] 2 times a day
[ ] < once a week 
[ ] 3 times a day
[ ] 1-2 times a week
[ ] > 3 times a day
 [ ] Every other day 
[ ] Once a day
[ ] Don’t know 
[ ] Refused
2. What material do you use with the toothbrush?
 [ ] Nothing
[ ] Toothpaste
[ ] Other_______________(Specify) let participant write in answer if selected
 [ ] Don’t know
[ ] Refused
3. Do your gums bleed when you wash your teeth?
 [ ] No
[ ] Sometimes
[ ] Always or almost always
 [ ] Don’t know
[ ] Refused
4. How often do you use mouthwashes?
 [ ] Never 
[ ] 2 times a day
[ ] < once a week
[ ] 3 times a day
[ ] 1-2 times a week 
[ ]> 3 times a day
[ ] Every other day 
[ ] Once a day 
[ ] Don’t know [ ] Refused
5. How many natural teeth do you have? (The adult mouth normally has 32 teeth, 
16 on top and 16 on bottom).
[ ]
(subtract from 32 the number of missing or artificial teeth)
 [ ] Don’t know
[ ] Refused
APPROVED RPCI IRB
1/3/2024

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6. Do you have any removable dentures? Choose all that apply (can choose more 
than one)
 [ ] a partial denture
[ ] a full upper denture 
[ ] a full lower denture
 [ ] Don’t know
[ ] Refused
7.
About how long has it been since you last visited a dentist? Include all types 
of dentists, such as orthodontists, oral surgeons, and all other dental specialists, as 
well as dental hygienists.
 [ ] Between 1 – 6 months
[ ] Between 6 – 12 months
 [ ] More than 1 year ago
[ ] Never seen a dentist
 [ ] Don’t know
[ ] Refused
8.
Do you have any fillings?
[ ] Yes. If yes, how many fillings?let participant write in answer if selected
 [ ] No
[ ] Don’t know
 [ ] Refused
9.
Have you taken any antibiotic medications in the 
last month?
 [ ] Yes, but not currently
[ ] Yes, currently
 [ ] No
[ ] Don’t know
 [ ] Refused
10.
Do you currently take an inhaled corticosteroid 
(e.g. Beclomethasone dipropionate (Qvar), Budesonide 
(Pulmicort), Budesonide/Formoterol (Symbicort), 
Fluticasone (Flovent), Fluticasone INH powder (Arnuity 
Ellipta)?
[ ] Yes
[ ] No
[ ] Don’t know
APPROVED RPCI IRB
1/3/2024

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The next 5 items have response options of Never, Occasionally, and Often.
1. My mouth feels dry when eating a meal.
2. My mouth feels dry.
3. I have difficulty in eating dry foods.
4. I have difficulties swallowing certain foods.
5. My lips feel dry.
Please rate the product you used today on the following effects (0 – 100 VAS)

Dry Mouth

Excessive Salivation 

Mouth Irritation 

Throat Irritation 

Sharpness/cut 

Cough

Phlegm

Burning Sensation in Mouth 

Burning Sensation in throat 

Burning sensation on lip/gum 

Mouth Tingling

Teeth Sensitivity
How likely are you to purchase [product selected above] 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
APPROVED RPCI IRB
1/3/2024

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Appendix D
Sample Collection Procedures
Saliva Sample
Step 1. Open foil pouch and remove the Saliva Collection Aid 
(SCA) 
Step 2. Place ribbed-end of the SCA securely into a pre-labeled 
collection vial
Step 3. Allow saliva to pool in mouth. Then, with head tilted 
forward, gently force saliva through the SCA into the vial. Fill to 
required volume.
Step 4. Remove and discard SCA. Attach cap to collection vial 
and tighten 
Step 5. After collection, freeze samples at or below -20ºC.
Step 6. For Analysis, follow Salimetrics SOP for corresponding ELISA kit.
OPTIONAL Oral Rinse Sample (collected at Roswell Park only)
Supplies:
SCOPE® mouthwash: Travel size Scope mouthwash bottle is used to rinse mouth.
Saline solution: An alternative to Scope mouthwash, it will be used for participants 
with open oral ulcers or in recovering alcoholics concerned about the alcohol content.
Medicine cup: A 4.5 oz. sterile medicine cup used for pouring in the mouthwash.
Specimen container: A 5 oz. sterile specimen container used for spitting in the 
mouthwash and for storing.
Gloves: The dental examiner will use a new pair of gloves before the exam begins.
Procedure:
1. Put on gloves and ask the participant: “Do you have any sores in your mouth 
that might hurt when you use a mouthwash with some alcohol in it, such as 
Scope?”
2. Pour 10mL of SCOPE® mouthwash, or the alternative saline solution, into a 
medicine cup, making sure not to touch the rim of the cup.
3. Hand the medicine cup with the mouthwash to the participant and explain to the 
participant: “We are going to ask you to swish some Scope mouthwash around your 
mouth, gargle, and then spit the mouthwash into a cup. First, you will rinse your 
mouth with the mouthwash for 5 seconds and then gargle for 5 seconds. You will do 
this three times and then spit the mouthwash into a cup. Do you have any questions 
about this test?”
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1/3/2024

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4. Have the participant put the mouthwash, or saline, into their mouth when 
ready and then instruct them through the swish gargle cycles using a timer.
5. At the end of the 30 seconds, open the specimen container and hand it to the 
participant. Hold the top lid down to avoid contaminating it.
6. Have the participant spit the mouthwash into the specimen container when 
done gargling. Participants are allowed to touch the rim of the container when 
they spit the mouthwash.
7. Take the specimen collection cup from the participant being careful not to touch the rim.
8. Seal the specimen container properly to prevent leakage.
9. Place the participant label on the specimen collection container until processing
APPROVED RPCI IRB
1/3/2024

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Appendix E
Full Study Timeline
-15
min
PROP, PTC, Sodium Benzoate 
(1st session only)
Saliva, Urine, Oral Samples (optional)
-10
min
Pre: Questionnaires 
0 min
Begin bout 1
15 min
End bout 1 / Collect Product
20 min
Post: Saliva
20 min
Post: Questionnaires
45 min
Begin bout 2
60 min
End bout 2 / Collect Product
65 min
Post: Saliva
65 min
Post: Questionnaires
APPROVED RPCI IRB
1/3/2024