Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use
Phase: NA
Conditions: Tobacco Use Disorder
Sponsor: University of Minnesota

Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use 
 
 
NCT03402243 
 
01/16/2020 
 

Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use 
Version date: 01/16/20 
 
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PROTOCOL TITLE: 
Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use 
 
 
PRINCIPAL INVESTIGATOR: 
Michael Kotlyar, PharmD 
Associate Professor 
Department of Experimental and Clinical Pharmacology 
612-625-1160 
kotly001@umn.edu  
 
Co-Investigators 
Dorothy Hatsukami, PhD 
Professor 
Department of Psychiatry 
612-626-2121 
hatsu001@umn.edu  
 
 
 
 
 
 
VERSION NUMBER/DATE: 
Version 5.0 
Version Date: 01/16/20 
 
 

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REVISION HISTORY 
 
Revision # 
Version Date Summary of Changes 
Consent 
Change? 
1 
1/22/2018 
 Daily tobacco diaries to be 
completed via RedCap with 
subjects receiving email or 
text messages daily with 
survey links. This is instead 
of the EMA Life Data 
Application. 
 Subjects will start 
completing tobacco diaries 
after eligibility is confirmed 
rather than after the baseline 
visit.  
 Adding a $15 bonus at the 
baseline visit if over 85% of 
daily tobacco diaries are 
completed prior to the visit. 
This additional bonus raises 
the total amount subjects 
will receive to $190. 
 The addition of inclusion 
criteria specifying that 
subjects must be able to 
receive daily text and email 
reminders and respond to 
the surveys as prompted by 
the reminders.  
 Clarifying that the tank-like 
e-cigarette and liquid use 
are the Joyetech eGo AIO 
device rather than the 
Joyeteich eGo-T 
 Section 5.2.2 has been 
clarified to indicate that in 
determining the number of 
credits needed for each 
product, the retail cost will 
be discounted 
approximately 66% 
Yes 
2 
8/14/18 
 Added additional 
information to section 18.0 
“Provisions to Monitor the 
 

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Revision # 
Version Date Summary of Changes 
Consent 
Change? 
Data to Ensure the Safety of 
Participants” 
3 
10/02/19 
 Added information to 
section 5.2.1 regarding how 
participants who complete 
the online screening survey 
will be notified regarding 
their eligibility to schedule 
a screening visit  
 Updated section 14.1 with 
additional information 
about the potential risk of 
using e-cigarettes / vaping 
devices 
Yes 
4 
01/16/20 
 Changes to inclusion 
criteria that 1) increases the 
minimum age for 
enrollment from 18 to 21; 
2) decreases the minimum 
average number of 
cigarettes smoked per day 
from 10 to 5  
No 
 
 
 

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Table of Contents 
After completing your protocol, right click on the Table of Contents below and select 
“Update Field.” If prompted, select “Update entire table.” This will automatically 
update the protocol sections and page numbers for you. Do this also each time you 
modify your protocol after initial approval. 
 
1.0 
Objectives ................................................................................................................ 7 
2.0 
Background .............................................................................................................. 7 
3.0 
Study Endpoints/Events/Outcomes ........................................................................ 10 
4.0 
Study Intervention(s)/Investigational Agent(s) ...................................................... 10 
5.0 
Procedures Involved ............................................................................................... 11 
6.0 
Data and Specimen Banking .................................................................................. 13 
7.0 
Sharing of Results with Participants ...................................................................... 14 
8.0 
Study Duration ....................................................................................................... 14 
9.0 
Study Population .................................................................................................... 14 
10.0  Vulnerable Populations .......................................................................................... 15 
11.0  Local Number of Participants ................................................................................ 16 
12.0  Local Recruitment Methods ................................................................................... 16 
13.0  Withdrawal of Participants .................................................................................... 16 
14.0  Risks to Participants ............................................................................................... 17 
15.0  Potential Benefits to Participants ........................................................................... 18 
16.0  Data Management .................................................................................................. 18 
17.0  Confidentiality ....................................................................................................... 18 
18.0  Provisions to Monitor the Data to Ensure the Safety of Participants .................... 19 
19.0  Provisions to Protect the Privacy Interests of Participants .................................... 19 
20.0  Compensation for Research-Related Injury ........................................................... 19 
21.0  Consent Process ..................................................................................................... 19 
22.0  Setting .................................................................................................................... 20 
23.0  Multi-Site Research: N/A ...................................................................................... 20 
24.0  Resources Available ............................................................................................... 20 
25.0  References .............................................................................................................. 20 
 

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ABBREVIATIONS/DEFINITIONS 
 
CO – carbon monoxide 
 
FDA – Food and Drug Administration 
 
FSPTCA - Family Smoking Prevention and Tobacco Control 
 
E-Cig – E-Cigarette 
 
 

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STUDY SUMMARY 
 
Study Title 
Effect of Banning Menthol Flavorant on Cigarette 
and E-Cigarette Use 
Study Design 
Randomized Study 
Primary Objective 
To obtain preliminary information regarding how a 
menthol ban that either exempts or includes e-
cigarettes is likely to affect overall tobacco use 
Research 
Intervention(s)/Investigational 
Agents 
Smokers of menthol cigarettes will be randomized 
to one of three experimental marketplace conditions: 
1) a simulated ban on menthol cigarettes but not e-
cigarettes; 2) a simulated ban on both menthol 
cigarettes and e-cigarettes and 3) no menthol ban for 
either product 
IND/IDE # (if applicable) 
n/a 
Investigational Drug Services 
# (if applicable) 
n/a 
Study Population 
Medically stable smokers 
Sample Size (number of 
participants) 
60 
Study Duration for Individual 
Participants 
Approximately 8 weeks 
 
 
 

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1.0 
Objectives 
1.1 
Objective: The objective of this study is to obtain preliminary information 
regarding how a menthol ban that either exempts or includes e-cigarettes is likely 
to affect overall tobacco use 
1.2 
Specific Aims: The following specific aims will be pursued: 
Aim 1: Determine the impact of the availability of menthol flavor in e-cigarettes 
on overall tobacco product use patterns  
We hypothesize that menthol cigarette smokers will smoke fewer cigarettes, vape 
more e-cigarettes, have higher motivation to quit smoking and be more supportive 
of a ban on menthol cigarettes when given the option of using menthol flavored e-
cigarettes than when no such option is present.  
Aim 2: Determine if the impact of the availability of menthol flavor in e-
cigarettes on tobacco use behavior is moderated by a ban on menthol flavor in 
cigarettes  
We hypothesize that the impact of menthol flavored e-cigarette availability on the 
above measures will be greater during a simulated ban on menthol cigarettes than 
if smokers can continue smoking menthol cigarettes. 
2.0 
Background 
2.1 
Significance of Research Question/Purpose: With the passage of 
the Family Smoking Prevention and Tobacco Control Act (FSPTCA), the 
United States Food and Drug Administration (FDA) acquired broad ability 
to regulate tobacco products, which included the use of flavorants in 
cigarettes. In 2009, the FDA banned cigarettes flavored with fruit or candy 
in response to evidence that such flavoring encourages experimentation by 
young people and leads to regular use and ultimately addiction.1 Menthol 
was specifically excluded from this ban as the FDA examines the role of 
menthol in initiation, maintenance, and health risks associated with the use 
of such products.1  The Tobacco Products Scientific Advisory Committee 
in a report reviewing the impact of the use of menthol cigarettes to public 
health, provided the overall recommendation that “Removal of menthol 
cigarettes from the marketplace would benefit public health in the United 
States.”2, 3  A report produced by the FDA evaluating the public health 
effects of menthol in cigarettes similarly concluded that menthol use is 
likely associated with increased smoking initiation by youth and young 
adults, that menthol in cigarettes is likely associated with greater 
addiction, and that menthol smokers are less likely to successfully quit 
smoking.  Overall, this report concluded that it is “likely that menthol 
cigarettes pose a public health risk above that seen with non-menthol 
cigarettes.”4  The role of menthol flavoring in other tobacco products was 
not addressed in either of these reports. 
The use of electronic nicotine delivery devices (e-cigarettes) has increased 
dramatically since their introduction in the United States in 2007. Recent surveys 

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have found that over 12% of adults have tried e-cigarettes and that 5.5% of all 
adults and 8.9% of young adults use e-cigarettes either every day or on some 
days.5, 6  Sales of e-cigarettes for 2016 are estimated at approximately $1.6 billion 
and some estimates project that e-cigarette sales may overtake cigarette sales 
within 10 years.7 8 Almost every commonly used brand of e-cigarette is currently 
available in menthol flavor9 and data from surveys suggest that as many as 30% 
of e-cigarette users prefer menthol flavored products with over 12% of e-cigarette 
users stating that they use e-cigarettes “because they come in menthol flavor.”10-13  
However, there is little information assessing if the availability of menthol 
flavorant in e-cigarettes affects smoking behavior in the context of a ban on 
menthol flavorant in cigarettes.  
With the recent extension of FDA authority to additional categories of tobacco 
products including e-cigarettes,14 the ability to enact regulations regarding the 
availability of flavorants (including menthol) will extend to these other categories 
of tobacco products as well.  Although surveys of menthol smokers suggest that a 
substantial number would attempt to quit smoking if menthol cigarettes were 
unavailable,3, 15, 16 our preliminary data found that relatively few in fact made a 
cessation attempt (only 3 out of 31 subjects). However, it is not known if access 
to menthol flavored e-cigarettes would increase the likelihood of menthol smokers 
quitting smoking entirely in the event of a ban since they have an alternate 
menthol product available or conversely if likelihood of quitting would decrease 
with smokers opting  to use a combination of non-menthol cigarettes and menthol 
flavored e-cigarettes. The former would support exempting menthol e-cigarettes 
from a menthol ban whereas the latter would support enacting a menthol ban that 
would include all tobacco products.  Among the numerous research needs 
regarding e-cigarettes identified in an NIH sponsored workshop are the needs to 
evaluate the effects of flavorants, biomarkers of exposure, and patterns of use.14 
The purpose of the current study is to obtain initial data regarding how menthol 
flavoring in e-cigarettes affects tobacco use patterns in menthol cigarette smokers 
in order to plan future studies that more definitely assess if regulatory policy 
regarding menthol flavoring should be uniform across products. 
2.2 
Preliminary Data: Our research team has considerable experience with the 
methods proposed in this study and with the study population being recruited.  
The most relevant projects include: 
2.2.1   Data demonstrating that in the event of a menthol ban in cigarettes, 
smokers of menthol cigarettes switch to smoking non-menthol cigarettes:  In a 
pilot study led by Dr. Kotlyar, we asked African American menthol cigarette 
smokers to not smoke menthol cigarettes for a 4 week period in order to obtain 
information regarding how they would adjust their smoking behavior were 
menthol cigarettes not available (as in the event of a ban).17 No specific 
instructions were provided regarding how to cope with abstaining from menthol 
cigarettes. Of the 32 subjects who completed the study, three reported making a 
quit attempt with all continuing smokers switching to non-menthol cigarettes. 
Modest decreases occurred in cigarettes smoked per day (11.9 vs. 9.8 cigs/day; p 
< .001) and exhaled CO (13.4 vs. 11.1 ppm; p = .03) between the start and the end 

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of the 4 week period. Motivation to quit smoking was higher at the week 4 visit 
than at baseline (5.3 vs. 6.3 on a 10 point scale; p = .03). At the end of the study, 
subjects indicated that quitting menthol cigarettes was difficult (average score = 
7.2 on a 10 point scale) but that they were supportive of banning menthol 
(average score = 7.1). Our finding of substantial support for a ban on menthol 
cigarettes is consistent with other surveys16, 18 and is important data since 
broadening support for a menthol cigarette ban among current users of menthol 
cigarettes would likely ease passage of such regulations. The current study would 
expand on these data to determine if these changes in smoking, motivation to quit 
smoking, and other measures assessed are either enhanced or undermined by the 
availability of menthol flavored e-cigarettes.  This study will also provide 
information regarding the level of support among menthol flavored cigarette 
smokers of banning menthol flavoring across tobacco products. 
2.2.2 Experience using an experimental marketplace to evaluate smoker product 
preferences:  Dr. Hatsukami conducted a study utilizing an experimental 
marketplace similar to the one proposed in this project. The goal of the study was 
to determine the pattern of tobacco use and levels of biomarker exposure when 
smokers were switched to very low nicotine content (VLNC) cigarettes and had 
access to alternative nicotine delivery systems.19  Similar to the proposed study, 
smokers were randomized to one of three experimental marketplace conditions 
(i.e., access to combustible and non-combustible products, access to only non-
combustible products, and a control normal nicotine content cigarette condition) 
and were provided a set number of credits which could be used to obtain available 
products. The study found significant differences in tobacco product use among 
the three experimental conditions (with greater number of participants in the 
VLNC condition using alternative products and with higher rate of quit attempts) 
demonstrating that the experimental marketplace approach was feasible and was 
acceptable to smokers. The proposed project will evaluate the feasibility of using 
this approach to study effects of flavorants on tobacco product use. 
2.3 
Existing Literature: Studies have found that when cigarette smokers are 
provided e-cigarettes to use ad libitum, the number of cigarettes smoked decreases 
substantially. For example, two studies in which cigarette smokers not interested 
in quitting were provided e-cigarettes for a 24 week period and asked to use them 
ad libitum found an overall 80% reduction in median cigarettes per day with 23% 
- 36% of smokers quitting cigarettes entirely.20, 21  Similar results were seen in 
another study in which smokers were given e-cigarettes that they could use ad 
libitum over a 2 month period while continuing to smoke.22  All of these studies 
used tobacco flavored (i.e., non-menthol flavored) products and therefore effects 
of menthol were not assessed.  Studies looking at the effects of e-cigarettes on 
craving and withdrawal symptoms have found that these products significantly 
decrease craving and withdrawal symptom severity but most of these studies do 
not specifically assess menthol flavored products.22-27   
Studies that have specifically examined menthol flavoring in e-cigarettes include 
a study in which African American menthol smokers could select using either 
menthol or tobacco flavored e-cigarettes (or nicotine gum) for a two week quit 

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attempt. This study found that 74% selected menthol flavored e-cigarettes.28 A 
study designed specifically to examine the role of flavor on smoking patterns 
asked smokers to abstain from cigarettes and only use an assigned flavor of e-
cigarettes.  This study found that those assigned to menthol flavored e-cigarettes 
had the largest decrease in number of cigarettes smoked relative to those assigned 
to tobacco, cherry, or chocolate flavored e-cigarettes.13 In an additional cross-over 
study, twenty non-treatment seeking smokers used menthol and tobacco flavored 
e-cigarettes, each for 7 – 10 days and completed on their last day of e-cigarettes 
use, a laboratory session at which they used their assigned product for 5 minutes.  
In female smokers who used their non-preferred flavor (i.e., menthol smokers 
using non-menthol e-cigarettes and vice versa), nicotine concentrations were 
lower and the e-cigarette was rated as less likeable than when using their 
preferred flavor with no such differences found in men.29  These studies suggest 
that menthol cigarette smokers prefer menthol flavored e-cigarettes, that menthol 
flavored e-cigarettes have the potential to decrease smoking to a greater extent 
than other e-cigarette flavors and that there may be sex differences in response to 
menthol flavoring in e-cigarettes. The current study will build on this research by 
providing preliminary data into how availability of e-cigarettes affects cigarette 
smoking and if these effects are moderated by the availability of menthol flavored 
cigarettes and / or e-cigarettes.    
 
3.0 
Study Endpoints/Events/Outcomes 
3.1 
Primary Endpoint/Event/Outcome: The primary outcome is the amount of 
each tobacco product used per week as recorded on their tobacco use surveys.      
3.2 
Secondary Endpoint(s)/Event(s)/Outcome(s): Secondary outcomes 
measured at each visit include how much of each product is obtained from the 
experimental marketplace, motivation and self-efficacy to quit smoking cigarettes 
and to quit all tobacco product use, number of quit attempts, severity of craving 
and withdrawal symptoms, and exhaled carbon monoxide concentrations. Support 
for a menthol ban and urinary cotinine concentrations will be assessed at baseline 
and at week 6. 
 
4.0 
Study Intervention(s)/Investigational Agent(s) 
4.1 
Description: Subjects will be randomized to one of three experimental 
marketplaces (20 subjects in each condition): 1) a condition simulating a ban on 
menthol cigarettes but not menthol e-cigarettes (condition A); 2) a condition 
simulating a ban on both menthol cigarettes and menthol e-cigarettes (Condition 
B); and 3) a condition in which menthol is not banned for either product 
(Condition C – the control condition). All conditions would have medicinal 
nicotine available if subjects decide to quit tobacco products entirely.   
The goal of the experimental marketplace is to provide a context in which product 
preferences can be evaluated in a systematic way but with a high degree of 
ecological validity. We have therefore included in the marketplace both a 

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cigarette-like e-cigarette system and a tank-like e-cigarette system (which has the 
potential to deliver higher doses of nicotine), as those are the two most commonly 
used e-cigarette systems currently available. 
Products available to subjects in each experimental marketplace 
Condition A  
(menthol ban for cigs) 
Condition B (menthol ban for cigs 
and e-cigs) 
Condition C 
(no menthol ban) 
-  Non-menthol cigarettes 
-  Menthol & tobacco flavored versions 
of commonly used cigarette-like e-
cigarette (e.g., Vuse) 
-  Menthol & tobacco flavored versions 
of commonly used tank-like e-cigarette 
(e.g., Joyetech eGo AIO) 
-  Nicotine gum and lozenge (various 
flavors)  
-  Non-menthol cigarettes 
-  Tobacco flavored version of 
commonly used cigarette-like e-
cigarette (e.g., Vuse) 
-  Tobacco flavored version of 
commonly used tank-like e-cigarette 
(e.g., Joyetech eGo AIO) 
-  Nicotine gum and lozenge 
(various flavors) 
-  Menthol & non-menthol cigarettes 
-  Menthol & tobacco flavored 
versions of commonly used cigarette-
like e-cigarette (e.g., Vuse) 
-  Menthol & tobacco flavored 
versions of commonly used tank-like 
e-cigarette (e.g., Joyetech eGo AIO)  
-  Nicotine gum and lozenge (various 
flavors) 
We will include the subject’s usual brand of cigarettes in the marketplace (either the non-menthol version 
or both the non-menthol and menthol version depending on the randomization).  Information about their 
usual brand will be collected at the screening visit in order to incorporate it into the marketplace.   
4.2 
Drug/Device Handling:  The tobacco and nicotine replacement products 
that will be provided to subjects are marketed products and are not required to be 
dispensed by a physician or licensed pharmacy.  They will be provided to 
participants by the study coordinator 
4.3 
IND/IDE.  N/A  
4.4 
Biosafety: N/A  
 
5.0 
Procedures Involved 
5.1 
Study Design: This is a pilot study in which over a 6 week period, menthol 
cigarette smokers will receive all of their tobacco products from a simulated 
experimental marketplace. Smokers will be assigned to one of three marketplace 
conditions: 1) a condition simulating a ban on menthol cigarettes but not menthol 
e-cigarettes; 2) a condition simulating a ban on both menthol cigarettes and 
menthol e-cigarettes; and 3) a condition in which menthol is not banned for either 
product (i.e., the control condition). All conditions would have medicinal nicotine 
available if subjects decide to quit tobacco products entirely.  Subjects would 
receive “credits” that they can exchange, at visits occurring every two weeks, for 
any product available in their randomized marketplace condition.  At the end of 
the experimental period any unused credits can be exchanged for monetary 
payment.  
5.2 
Study Procedures: The following procedures will occur during the study. 
5.2.1 Screening Visit: Initial eligibility will be assessed via a phone interview or 
online screening form housed on REDCap. All screened participants will be 
notified by phone or email regarding their eligibility to be scheduled for a 
screening visit at which written informed consent will be obtained and eligibility 

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confirmed.  At the screening visit, medical and psychiatric history will be 
obtained via subject report. Women will have a urine pregnancy test to confirm 
that they are not pregnant.  A medical professional (e.g., Nurse Practitioner) will 
review medical histories to ensure eligibility.  Baseline questionnaires assessing 
smoking history will be administered and an exhaled carbon monoxide (CO) will 
be measured to confirm smoking (CO > 8 ppm). A NicCheck using a urine 
sample will be performed (with a cut-off = 6 for those who otherwise qualify but 
for whom CO is < 8 ppm (e.g., they didn’t smoke that morning, they came 
straight from work, etc.).  Subjects who qualify and are interested in continuing 
will be invited to return to the baseline visit.   
After eligibility is confirmed, subjects will begin receiving links daily via either 
text message or email (whichever they prefer) to a tobacco use survey that is to be 
completed on RedCap.  On this survey subjects will report use of all tobacco and 
nicotine containing products used during the past day. These survey will continue 
until the end of the subject’s participation in the study.  
5.2.2 Baseline Visit (i.e., week 0):  At the baseline visit, urine will be collected 
from which baseline urinary cotinine concentrations will be measured.  Exhaled 
CO will be measured from a breath sample.  Tobacco use behavior subsequent to 
the screening visit will be determined as will subjects’ level of craving, 
withdrawal, motivation and self-efficacy to quit smoking and support for a ban on 
a variety of menthol containing tobacco products.  Degree of nicotine dependence 
will be assessed using the Fagerstrom Test for Nicotine Dependence.30  Subjects 
will be informed which products are available in the marketplace that they have 
been randomized to and will be allowed to handle each of the products and 
examine the packaging that each normally comes in.  
Subject will be given credits at each visit that can be exchanged for products in 
their marketplace.  All products will be discounted to approximately 66% of the 
retail market value (similar to the study summarized in preliminary data) in order 
to discourage subjects from purchasing products outside the marketplace and also 
prevent hoarding credits for payment at the end of the study.  The credit amount 
will be calculated in order to allow on average a 1 pack/day smoker to replace all 
of their tobacco products based on normal usage patterns (e.g., for example, one 
cartridge of Vuse lasts about as long as one pack of cigarette).  In order to 
discourage subjects obtaining more products than they need, any credits not used 
at each visit can be banked and used at later visits or converted to monetary 
payment at the end of the study.  Subjects will be informed that they can obtain 
any amount or type of product up to the value of current and banked credits and 
will be provided with the packaging that normally accompanies these products.   
Instructions for product use will be primarily limited to what is on the packaging 
so as to more accurately simulate natural marketplace conditions; however 
subjects can ask questions about the products to which accurate answers will be 
provided.  While subjects will be encouraged to obtain all tobacco products they 
use from the experimental marketplace, no penalties will be levied for outside 
purchases in order to encourage truthful reports of noncompliance.   

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5.2.3 Evaluation Visits (3 visits occurring at 2 week intervals).  Subsequent to 
the baseline visit, subjects will be evaluated at 3 visits occurring at two week 
intervals (i.e., at approximately 2, 4 and 6 weeks after the baseline visit). To each 
visit, subjects will be asked to bring back any unused product as well as all used 
and unused e-cigarette cartridges or e-fluid vials.  The cartridges and vials will be 
weighed prior to distribution and after use to determine the extent to which they 
were used.  Participants will be allowed to keep any of the unused products so as 
to not discourage them from bringing back unused product.   
At each visit, exhaled carbon monoxide concentrations will be measured and 
subjects will complete questionnaires assessing various aspects of smoking 
behavior including craving, withdrawal symptoms and motivation to quit 
smoking.  Questionnaires assessing how they rate the effects of the products they 
are using and their perceived health risks of using these products will also be 
assessed.  A food diary asking primarily about dietary menthol will be completed 
to determine if dietary intake changes occur if menthol in tobacco products is no 
longer available.  Level of support for a ban on a variety of menthol containing 
tobacco products will be evaluated at the baseline and week 6 visits.  
Additionally, at the week 6 visit urine will be collected in order to measure 
cotinine concentrations.  At each visit (except for the week 6 visit), subjects will 
again have the opportunity to obtain additional products for the subsequent 2 
weeks using their available credits.  They may choose to obtain any of the 
available products in their marketplace and are not limited to products that they 
had previously chosen. 
5.3 
Individually Identifiable Health Information: All information is collected 
directly from subjects (i.e., medical records will not be requested) and this is not a 
treatment study.  The data being collected therefore does not meet the definition 
of PHI.   
 
5.4 Use of radiation: N/A  
5.5 Use of Center for Magnetic Resonance Research: N/A 
 
6.0 
Data and Specimen Banking 
6.1 
Storage and Access: Urine will be collected from subjects at the baseline 
and week 6. The samples will be stored in freezers located in labs used by faculty 
in the ECP department (currently these freezers are located on the 5th floor of 717 
Delaware Ave). 
 
6.2 Data: Urine samples will be labeled with subject number and date of visit.  
Samples will be assayed for cotinine concentrations.  Cotinine is a metabolite of 
nicotine and frequently used to confirm abstinence or quantify nicotine exposure.  
Urine may also in the future be used to assay other measures related to smoking 
or specifically related to smoking menthol cigarettes or substances related to e-
cigarette use.  Examples of such measures would include assaying nicotine or 
metabolites of nicotine other than cotinine, assaying menthol concentrations or 

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assaying toxicants associated with smoking to determine if exposure to such 
substances changes when smokers use e-cigarettes or if flavor of e-cigarettes 
affects these measures.   
 
6.3 The current planned analyses will be performed by labs within the 
University of Minnesota.  However, if by the time the samples are collected these 
labs are no longer able to provide this service, these samples may be sent 
elsewhere for analysis.  Similarly, if samples are in the future assayed for other 
measures, they may be sent to external laboratories depending on the capabilities 
and cost of such analyses.  If samples for other measures are sent to external 
laboratories for additional assays, they will be labeled with a subject code that has 
no identifiable information on it.  Prior to sending samples to an outside source, 
the IRB will be notified.   
 
7.0 
Sharing of Results with Participants 
7.1 Study results will not be shared with participants.   
 
8.0 
Study Duration 
1.2.2 The anticipated duration for an individual participant’s participation in the 
study is approximately 6 to 8 weeks (depending in part on length of time 
between the screening visit and the baseline visit). 
2.2.2 Data collection is expected to be complete within 2 year of starting the 
study.  
 
9.0 
Study Population 
9.1 Inclusion Criteria: To be eligible subjects must: 
a) Be between the ages of 21 and 64 
b) Smoke (on average) at least 5 cigarettes per day over the past year 
c) Purchase exclusively menthol cigarettes 
d) Not currently motivated to quit smoking 
e) Able to receive daily text or email survey reminders and follow the link 
provided to complete the online RedCap surveys 
9.2 Exclusion Criteria: Subjects will be excluded if they: 
a) Report a serious, unstable medical or psychiatric condition 
b) Have a history of substance abuse (other than nicotine) within 3 months 
of beginning the study 
c) Use any medications that might interfere with measures to be studied 
(for example, medications known to affect smoking) 

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d) Have used any smoking cessation therapy during the past month 
e) Regularly use any form of tobacco other than cigarettes (> 9 times per 
month) 
f) Are pregnant or breast feeding or planning to become pregnant or breast 
feed during the study 
g) Currently participating in other clinical research studies 
9.3 Screening: At the screening visit, subjects will complete a series of 
questionnaires including those that ask about medical history, smoking 
history, and motivation to quit smoking.  All inclusion / exclusion will be 
based on self-report except for smoking status which will be confirmed via 
an exhaled carbon monoxide (CO) concentration of > 8 ppm or a urinary 
nicotine test strip reading of 6.  Non-pregnant status will be confirmed via a 
urine pregnancy test. 
 
10.0 Vulnerable Populations 
10.1 Vulnerable Populations:  
☐ Children 
☐ Pregnant women/Fetuses/Neonates 
☐ Prisoners 
☐ Adults lacking capacity to consent and/or adults with diminished 
capacity to consent, including, but not limited to, those with acute 
medical conditions, psychiatric disorders, neurologic disorders, 
developmental disorders, and behavioral disorders 
☐ Approached for participation in research during a stressful situation such 
as emergency room setting, childbirth (labor), etc. 
☐ Disadvantaged in the distribution of social goods and services such as 
income, housing, or healthcare 
☐ Serious health condition for which there are no satisfactory standard 
treatments 
☐ Fear of negative consequences for not participating in the research (e.g. 
institutionalization, deportation, disclosure of stigmatizing behavior) 
☐ Any other circumstance/dynamic that could increase vulnerability to 
coercion or exploitation that might influence consent to research or 
decision to continue in research 
☐ Undervalued or disenfranchised social group 
☐ Members of the military 
☐ Non-English speakers 
☐ Those unable to read (illiterate) 
☐ Employees of the researcher 
☐ Students of the researcher 
☒ None of the above 

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11.0 Local Number of Participants 
11.1 Local Number of Participants to Be Consented:  We plan on recruiting 
approximately 60 subjects anticipating that approximately 54 will complete 
the study.  We expect that as many as 120 subjects will undergo the consent 
process.  Some of those that attend the screening visit will likely not meet 
inclusion / exclusion criteria whereas others will not be interested in 
participating.   
 
12.0 Local Recruitment Methods 
12.1 Recruitment Process: Advertisements for the study will be placed in various 
print and on-line sources and via flyers.  Interested participants will call the 
phone number listed. Study staff will explain the study to potential study 
subjects.  Individuals that indicate an interest in participating in the study 
will then be screened by telephone to see if they are likely to qualify for the 
study.  Additionally subjects that in previous studies agreed to be contacted 
regarding other research opportunities may be called – in this case, subjects 
will be informed why they are being called with the telephone screening 
process being the same as for subjects who contacted us after seeing the 
study advertised.  
12.2 Recruitment Materials:  Flyers and advertisements placed in local 
publications or on on-line resources (for example, Craigslist) will be used to 
recruit participants.   
12.3 Payment:  Subjects will be paid as follows: $20 for completing the screening 
visit.  In addition to receiving credits for tobacco products, they will receive 
$15 for each of the subsequent 4 visits in this study. They will receive an 
additional $15 at the baseline visit, and week 2, 4, and 6 visits if they have 
completed at least 85% of their scheduled electronic diary assessments and 
have brought in their used e-cigarette cartridges.  A $50 bonus will be given 
to subjects completing the study and all study related assessments.  Up to 
$190 will therefore be paid to subjects for the entire study.  Payment will be 
provided at the end of each visit in the form of a pre-paid debit card.   
13.0 Withdrawal of Participants 
13.1 Withdrawal Circumstances: Subjects may be withdrawn from the study if 
they fail to follow study procedures (e.g., show up to scheduled study visits) 
or if there are changes to their health that are likely to affect smoking 
behavior.  Additionally, subjects will be told that participation is voluntary 
and that they may discontinue participation at any time for any reasons.   
13.2 Withdrawal Procedures: We will attempt to contact subjects by telephone 
who do not show up to scheduled visit to ascertain if they wish to continue 
to participate in the study (and if not, why not) and to determine smoking 
status at the time of their withdrawal.   

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14.0 Risks to Participants 
14.1 
Foreseeable Risks: The tobacco products and medicinal nicotine products 
that are used for this study are those that are commercially available. Although 
there are numerous risks associated with smoking cigarettes, we are only enrolling 
those who are already smoking and are at the time of enrollment not motivated to 
quit.  The risks of continuing to smoke cigarettes within the context of the study 
are no greater than if they were to continue smoking cigarettes outside of the 
study.   
E-cigarettes do not currently undergo regulatory evaluation, however they are 
easily available and increasingly being used. The risks of using e-cigarettes are 
generally thought to be lower to an individual than the risks of smoking. Nicotine 
gum and lozenge are available without a prescription, commonly used and 
generally well tolerated.  Side effects that can occur include hiccups, mouth or 
throat irritation and upset stomach.   
All of the products being provided to subjects contain nicotine and it is possible 
that overuse can lead to symptoms of nicotine toxicity which could include 
nausea, vomiting, dizziness, weakness, and rapid heartbeat. Considering that we 
only enrolling experienced smokers, nicotine toxicity is not likely.   
The e-cigarette liquid contains propylene glycol which may be associated with 
throat irritation. There have been occasional reports of e-cigarette devices 
malfunctioning and causing injury to users.   
There have been recent reports of seizures and breathing problems occurring in 
people who use e-cigarettes. These cases are being investigated and at this time it 
is not known how common these problems are or what is causing them.  Since 
many of the cases of breathing problems occurred in individuals using e-cigarettes 
products with liquids that contain cannabinoid products such as THC, it is likely  
that the risk is due to people adding substances to e-liquids that were not intended 
by the manufacturer.  The e-cigarette products available in the study are widely 
available and widely used.  The devices and liquids provided to participants are 
not modified in any way after purchase.    
As with any product, there is a risk that unanticipated effects from using the e-
cigarette or lozenges may occur, however the risk of using the product as directed 
by the manufacturer is no higher than it would be if subjects were to buy and use 
these products outside of the study.  
14.2 
Reproduction Risks: Smoking cigarettes during pregnancy is known to be 
harmful to reproductive health.  We will therefore exclude women who are 
pregnant or are planning to become pregnant during the study.  Women who 
inform us that they have become pregnant during the study will not be provided 
any additional tobacco / nicotine products. 
14.3 Risks to Others: There are no anticipated risks to others.   
 

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15.0 Potential Benefits to Participants 
15.1 Potential Benefits: As this is not a treatment study, there is no direct benefit 
to individual participants.   
 
16.0 Data Management 
16.1 
Data Analysis Plan:  Means (arithmetic or geometric for log-transformed 
variables) and their corresponding confidence intervals will be calculated for each 
study condition. Results will also be tabulated separately for men and women.  A 
linear mixed model will be fit for each outcome variable, with fixed categorical 
effects of group, time, and their interaction, and random subject effects to account 
for correlation among repeated measurements on the same subject.  We expect 
randomization to balance groups with respect to important baseline covariates 
such as cigarettes smoked per day and degree of nicotine dependence; however, 
we will check this assumption using ANOVA and consider adjustment for 
imbalanced factors.  Exploratory modeling of gender and race / ethnicity effects 
will also be performed.  Model contrasts will be used to evaluate the hypotheses 
of the two aims, primarily that cigarettes smoked will be lower and e-cigarette use 
higher when menthol e-cigarettes are available (Aim 1: conditions A and C 
compared to B), and that these effects will be larger when menthol cigarettes are 
unavailable (Aim 2: condition A compared to C) 
16.2 
Power Analysis: The main purpose of this project is to provide initial 
information regarding how banning menthol in either only cigarettes or in both 
cigarette and e-cigarettes will influence tobacco use patterns so as to better design 
a subsequent study that more definitively addresses this issue.  This study will 
also provide feasibility information regarding using an experimental marketplace 
for assessing this question.  For this pilot study, we plan on recruiting 60 subjects 
and anticipate (assuming 10% dropout), that there would be 18 evaluable subjects 
per group.  If there is a large effect, we should be able to detect it as this sample 
size will provide 80% power for a between-groups time-averaged effect size of 
0.8, assuming two-sided alpha=0.05 and within-subject autocorrelation of 0.6.   
16.3 
Data Integrity: In order to ensure that data entry is correct, data collected 
on paper questionnaires will be entered twice with the two entries compared and 
any discrepancies resolved.  
 
17.0 Confidentiality 
17.1 
Data Security: To ensure confidentiality, all subjects will be assigned a 
study identification code to be used on all data collection forms except those for 
which use of personal identifiers is mandatory (e.g., informed consent form).  
Forms that link the name of the participant and the subject identification code will 
be kept in a locked cabinet or office or in an electronic file stored on servers 
maintained by the University of Minnesota Academic Health Center.  Visits will 
be conducted at the CTSI, therefore there will be a record of the subject’s 

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participation in the CTSI records although a copy of the consent form will not be 
placed in the participants’ medical records. 
    
18.0 Provisions to Monitor the Data to Ensure the Safety of 
Participants 
If the IRB determines this subject to involve Minimal Risk then no independent 
monitoring will be needed (per IRB guidelines).  In this study we will be 
providing commercially available tobacco products and commercially available 
over the counter nicotine gum and lozenges to smokers who are not interested in 
quitting smoking.  All products will be provided with the labelling that normally 
accompanies it.  The risks are therefore no greater than if subjects were to 
purchase these products outside of the study.   
If the IRB determines this study to involve more than Minimal Risk, the CTSI 
monitoring group will be asked to monitor this study using their standard 
procedures.  
The PI will meet regularly with research staff (at least bi-weekly) 
throughout the project.  During these meetings, the study team will 
evaluate the progress of the trial, review data quality, recruitment, 
retention, and examine other factors that may affect study outcomes.  They 
will also review adverse events to determine if there are any changes in 
participant risk.  Additional meetings will occur if concerns regarding a 
particular participant or another problem should arise. 
 
19.0 Provisions to Protect the Privacy Interests of Participants 
19.1 
Protecting Privacy: During the consent process, subjects will be told that 
they can discontinue participation at any time for any reason.  Furthermore, they 
are free to not answer any questions asked on the questionnaires.  However since 
certain information is needed to assess eligibility or to assess measures of interest, 
declining to answer certain questions may lead to a subject not being eligible to 
participate or to continue with the study.   
 
20.0 Compensation for Research-Related Injury 
20.1 Compensation for Research-Related Injury: No compensation is available in 
the event of research related injury. 
 
21.0 Consent Process 
21.1 
Consent Process (when consent will be obtained): Informed consent will 
be obtained at the screening visit.  Subjects will have the opportunity to read the 
consent document and ask any questions that they have.  A member of the study 
staff will then ask the subject questions to make sure that they understand the 

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study procedures. No study procedures will be administered until the subject has 
signed the consent form. 
21.2 Waiver or Alteration of Consent Process (when consent will not be 
obtained): N/A 
21.3 Non-English Speaking Participants: N/A 
21.4 
Participants Who Are Not Yet Adults (infants, children, teenagers under 
18 years of age): Individuals under the age of 18 will be excluded from the study.  
Subjects will be asked to present ID at the screening visit to confirm that they are 
at least 18 years of age.  
21.5 
Cognitively Impaired Adults or Adults with Fluctuating or Diminished 
Capacity to Consent:  We are not planning on enrolling subjects with fluctuating 
or diminished capacity to consent.  Subjects that appear to have impaired capacity 
to consent during the consent process will be excluded from the study.   
21.6 Adults Unable to Consent:  N/A  
 
22.0 Setting 
22.1 
Research Sites: Potential subjects will be recruited via the use of flyers 
and advertisements placed in local publications or on on-line resources (for 
example, Craigslist). Additionally subjects that in previous studies agreed to be 
contacted regarding other research opportunities may be called. Study visits will 
occur in the Clinical and Translational Research Institutes (CTSI) facilities.  
 
23.0 Multi-Site Research: N/A 
 
 
24.0 Resources Available  
This study has been submitted for funding to the National Institutes of Health 
with a funding decision pending.  The personnel assisting with this study (e.g., 
study coordinators) work with the research groups of the investigators. Based on 
previous studies, we believe that that there are adequate smokers in the 
community interested in participating in research studies in order to meet 
recruitment goals.  
 
 
25.0 
References 
 
1. 
Deyton L, Sharfstein J, Hamburg M. Tobacco product regulation--a public 
health approach. The New England journal of medicine. 2010;362(19):1753-6. 
PubMed PMID: 20410498. 

Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use 
Version date: 01/16/20 
 
Page 21 of 23 
Revised: October 2, 2019 
2. 
Levy DT, Pearson JL, Villanti AC, Blackman K, Vallone DM, Niaura RS, 
et al. Modeling the future effects of a menthol ban on smoking prevalence and 
smoking-attributable deaths in the United States. American journal of public health. 
2011;101(7):1236-40. PubMed PMID: 21566034. 
3. 
TPSAC. Tobacco Products Scientific Advisory Tobacco.  Menthol 
Cigarette and Public Health: Review of the Scientific Evidence and 
Recommendations. 2012. Available from: 
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoPr
oductsScientificAdvisoryCommittee/ucm247605.htm. 
4. 
Food and Drug Administration. Preliminary Scientific Evaluation of the 
Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes. 2013. 
5. 
Kasza KA, Ambrose BK, Conway KP, Borek N, Taylor K, Goniewicz 
ML, et al. Tobacco-Product Use by Adults and Youths in the United States in 2013 
and 2014. The New England journal of medicine. 2017;376(4):342-53. doi: 
10.1056/NEJMsa1607538. PubMed PMID: 28121512. 
6. 
Schoenborn CA, Gindi RM. Electronic Cigarette Use Among Adults: 
United States, 2014. NCHS data brief. 2015(217):1-8. PubMed PMID: 26555932. 
7. 
Craver R. E-cig sales continue to rebound with FDA regulations looming. 
Richond Times-Dispatch 2016. Available from: 
http://www.richmond.com/business/local/article_fdc0da1c-d1d5-5816-84f5-
77d2bdc96f40.html. 
8. 
Herzog B. US tobacco trends: Disruptive innovation should drive outsized 
growth.  [July 30, 2015]. Available from: http://www.ecigarette-
politics.com/files/WF-DallasMarch2014.ppt. 
9. 
Zhu SH, Sun JY, Bonnevie E, Cummins SE, Gamst A, Yin L, et al. Four 
hundred and sixty brands of e-cigarettes and counting: implications for product 
regulation. Tobacco control. 2014;23 Suppl 3:iii3-9. doi: 10.1136/tobaccocontrol-
2014-051670. PubMed PMID: 24935895; PubMed Central PMCID: PMC4078673. 
10. 
ClearWay Minnesota and Minnesota Department of Health. Tobacco Use 
in Minnesota: 2014 Update. Minneapolis, MN2015. 
11. 
Farsalinos KE, Romagna G, Tsiapras D, Kyrzopoulos S, Spyrou A, 
Voudris V. Impact of flavour variability on electronic cigarette use experience: an 
internet survey. International journal of environmental research and public health. 
2013;10(12):7272-82. doi: 10.3390/ijerph10127272. PubMed PMID: 24351746; 
PubMed Central PMCID: PMC3881166. 
12. 
Bonhomme MG, Holder-Hayes E, Ambrose BK, Tworek C, Feirman SP, 
King BA, et al. Flavoured non-cigarette tobacco product use among US adults: 
2013-2014. Tobacco control. 2016;25(Suppl 2):ii4-ii13. doi: 
10.1136/tobaccocontrol-2016-053373. PubMed PMID: 27794065. 
13. 
Litt MD, Duffy V, Oncken C. Cigarette smoking and electronic cigarette 
vaping patterns as a function of e-cigarette flavourings. Tobacco control. 
2016;25(Suppl 2):ii67-ii72. doi: 10.1136/tobaccocontrol-2016-053223. PubMed 
PMID: 27633766. 
14. 
Walton KM, Abrams DB, Bailey WC, Clark D, Connolly GN, Djordjevic 
MV, et al. NIH electronic cigarette workshop: developing a research agenda. 

Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use 
Version date: 01/16/20 
 
Page 22 of 23 
Revised: October 2, 2019 
Nicotine Tob Res. 2015;17(2):259-69. doi: 10.1093/ntr/ntu214. PubMed PMID: 
25335949; PubMed Central PMCID: PMC4311173. 
15. 
O'Connor RJ, Bansal-Travers M, Carter LP, Cummings KM. What would 
menthol smokers do if menthol in cigarettes were banned? Behavioral intentions 
and simulated demand. Addiction (Abingdon, England). 2012;107(7):1330-8. 
PubMed PMID: 22471735. 
16. 
Pearson JL, Abrams DB, Niaura RS, Richardson A, Vallone DM. A ban 
on menthol cigarettes: impact on public opinion and smokers' intention to quit. 
American journal of public health. 2012;102(11):e107-14. PubMed PMID: 
22994173. 
17. 
Kotlyar M, Mills AM, Shanley R, Okuyemi KS, Robel K, Hatsukami DK. 
Smoker Response to a Simulated Ban of Menthol Cigarettes: A Pilot Study. 
Tobacco Regulatory Science. 2015;1(3):236-42. doi: 10.18001/TRS.1.3.5. 
18. 
Winickoff JP, McMillen RC, Vallone DM, Pearson JL, Tanski SE, 
Dempsey JH, et al. US attitudes about banning menthol in cigarettes: results from a 
nationally representative survey. American journal of public health. 
2011;101(7):1234-6. PubMed PMID: 21566038. 
19. 
Hatsukami DK, Luo X, Dick L, Kangkum M, Allen SS, Murphy SE, et al. 
Reduced nicotine content cigarettes and use of alternative nicotine products: 
exploratory trial. Addiction (Abingdon, England). 2017;112(1):156-67. doi: 
10.1111/add.13603. PubMed PMID: 27614097; PubMed Central PMCID: 
PMC5249662. 
20. 
Polosa R, Caponnetto P, Maglia M, Morjaria JB, Russo C. Success rates 
with nicotine personal vaporizers: a prospective 6-month pilot study of smokers not 
intending to quit. BMC public health. 2014;14:1159. doi: 10.1186/1471-2458-14-
1159. PubMed PMID: 25380748; PubMed Central PMCID: PMC4247211. 
21. 
Polosa R, Caponnetto P, Morjaria JB, Papale G, Campagna D, Russo C. 
Effect of an electronic nicotine delivery device (e-Cigarette) on smoking reduction 
and cessation: a prospective 6-month pilot study. BMC public health. 2011;11:786. 
doi: 10.1186/1471-2458-11-786. PubMed PMID: 21989407; PubMed Central 
PMCID: PMC3203079. 
22. 
Adriaens K, Van Gucht D, Declerck P, Baeyens F. Effectiveness of the 
electronic cigarette: An eight-week Flemish study with six-month follow-up on 
smoking reduction, craving and experienced benefits and complaints. International 
journal of environmental research and public health. 2014;11(11):11220-48. doi: 
10.3390/ijerph111111220. PubMed PMID: 25358095; PubMed Central PMCID: 
PMC4245610. 
23. 
Dawkins L, Kimber C, Puwanesarasa Y, Soar K. First- versus second-
generation electronic cigarettes: predictors of choice and effects on urge to smoke 
and withdrawal symptoms. Addiction (Abingdon, England). 2015;110(4):669-77. 
doi: 10.1111/add.12807. PubMed PMID: 25407505. 
24. 
Spindle TR, Breland AB, Karaoghlanian NV, Shihadeh AL, Eissenberg T. 
Preliminary results of an examination of electronic cigarette user puff topography: 
the effect of a mouthpiece-based topography measurement device on plasma 
nicotine and subjective effects. Nicotine Tob Res. 2015;17(2):142-9. doi: 
10.1093/ntr/ntu186. PubMed PMID: 25239957. 

Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use 
Version date: 01/16/20 
 
Page 23 of 23 
Revised: October 2, 2019 
25. 
Bullen C, McRobbie H, Thornley S, Glover M, Lin R, Laugesen M. Effect 
of an electronic nicotine delivery device (e cigarette) on desire to smoke and 
withdrawal, user preferences and nicotine delivery: randomised cross-over trial. 
Tobacco control. 2010;19(2):98-103. doi: 10.1136/tc.2009.031567. PubMed PMID: 
20378585. 
26. 
Dawkins L, Corcoran O. Acute electronic cigarette use: nicotine delivery 
and subjective effects in regular users. Psychopharmacology. 2014;231(2):401-7. 
doi: 10.1007/s00213-013-3249-8. PubMed PMID: 23978909. 
27. 
Dawkins L, Turner J, Crowe E. Nicotine derived from the electronic 
cigarette improves time-based prospective memory in abstinent smokers. 
Psychopharmacology. 2013;227(3):377-84. doi: 10.1007/s00213-013-2983-2. 
PubMed PMID: 23344557. 
28. 
Richards C, Eischen S, Joseph A, D'Silva J, Gaillard P, Okuyemi K. A 
Pilot Product Preference Study of Electronic Cigarettes and Nicotine Gum as 
Potentia l Smoking Cessation Aids for African-American Menthol Smokers. 
Tobacco Regulatory Science. 2015;1(3):245-53. doi: 10.18001/TRS.1.3.6. 
29. 
Oncken CA, Litt MD, McLaughlin LD, Burki NA. Nicotine 
concentrations with electronic cigarette use: effects of sex and flavor. Nicotine Tob 
Res. 2015;17(4):473-8. doi: 10.1093/ntr/ntu232. PubMed PMID: 25762758. 
30. 
Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The 
Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance 
Questionnaire. Br J Addict. 1991;86(9):1119-27. PubMed PMID: 1932883.