Effects Among Smokers Who Use and Do Not Use E-Cigarettes
Phase: NA
Conditions: Toxicant Exposure
Sponsor: California State University, San Marcos

 
 
 
 
 
 
Toxicant exposure and harm perceptions in cigarette smokers who use or do not use e-cigarettes 
 
ClinicalTrials.gov Identifier: NCT03511001 
 
04/23/2018 

PROJECT SWITCH Protocol  
NIH PROJECT #5SC3GM122628-02; CLINICALTRIAL.GOV IDENTIFIER: NCT03511001 
 
TOXICANT EXPOSURE AND HARM PERCEPTIONS IN CIGARETTE SMOKERS 
WHO USE OR DO NOT USE E-CIGARETTES 
 
STUDY PROTOCOLS & PROCEDURES 
 
I. 
Introduction 
II. 
Study Sites  
III. 
Study Personnel 
IV. 
Participant Recruitment 
V. 
Participant Screening and Enrollment 
VI. 
Study Design and Timeline 
VII. 
Participant Retention  
VIII. 
Laboratory Procedures and Sampling 
 
IX. 
Laboratory Analysis 
X. 
Study Visits Overview  
XI. 
Study Questionnaires 
XII. 
Data Management 
XIII. 
Recording and Reporting of Adverse Effects 
 
 
 

PROJECT SWITCH Protocol  
NIH PROJECT #5SC3GM122628-02; CLINICALTRIAL.GOV IDENTIFIER: NCT03511001 
I. 
Introduction 
 
This study, Toxicant Exposure and Harm Perceptions in Cigarette Smokers Who 
Use or Do Not Use E- Cigarettes is funded by the National Institutes of Health and 
registered on ClinicalTrials.gov.  
 
Document Purpose 
 
This document is intended to detail all relevant study protocols and procedures. Given 
rapid advancement in the understanding of the effects of smokers switching to 
electronic cigarettes, particularly on toxicant exposure (our primary outcome), we 
considered how to maximize the scientific contribution of the project. The body of work 
on the use of electronic cigarettes for risk reduction has been conducted with the 
general population and is now moving into vulnerable populations who carry a 
substantial disease burden from smoking. The investigative team is uniquely positioned 
to create progress in the field by examining the research questions with ethnically 
diverse populations who face significant barriers to smoking cessation. A commitment 
was made at the San Diego site to enroll Latinx smokers and to offer the study in 
Spanish in order to address the research questions with an under-studied population. 
NIH prior approval and Institutional Review Board (IRB) approval was granted to add 
the University of Kansas Medical Center as a study site to enroll African American 
smokers. This change enhances the ethnic diversity of enrolled participants as well as 
expands the science on risk reduction. The second study site (University of Kansas 
Medical Center) agreed to rely on the IRB of the primary institution (CSUSM).  
Additionally, because this project was funded on the first round, reviewer comments were 
addressed in the implementation of the study protocol post-proposal. These changes 
impacted inclusion/exclusion criteria and the length of the intervention period. There were 
no changes to aims, hypotheses, or sample size. 
 
The following Project Summary reflects our implemented protocol and contains an 
updated premise reflecting the ethnic minority population focus. 
 
 
Project Summary 
This proposal addresses a critical gap in the research regarding the use of electronic 
cigarettes (ECs) for harm reduction by ethnic minority smokers. Smokers cite reducing 
perceived harm from smoking as a leading reason for using ECs, and ECs have been 
suggested by tobacco researchers as a potential harm reduction vehicle for smokers who 
cannot or will not achieve smoking cessation. The National Academies of Science 
concluded that ECs pose significantly less exposure to toxicants and less short-term 
health risks than combustible cigarettes. However, smokers with less education and from 
ethnic minority backgrounds are less likely to switch to exclusive EC use. Socioeconomic 
disparities in switching to ECs will perpetuate a greater burden of tobacco-related death 
and disease among disadvantaged populations. As a human behavioral EC study in 
which toxicant exposure via the tobacco-specific nitrosamine, NNAL, a highly potent 
pulmonary carcinogen will be measured, this project addresses a critical barrier in the 

PROJECT SWITCH Protocol  
NIH PROJECT #5SC3GM122628-02; CLINICALTRIAL.GOV IDENTIFIER: NCT03511001 
field and advances science on the widely used practice of EC use for harm reduction 
among the two largest ethnic minority groups in the US, Latinx and African Americans. 
Furthermore, this will be among the first studies to determine how uptake of ECs affects 
cognitive-perceptual factors involved in sustained tobacco use, such as risk perceptions, 
utility of smoking, self-efficacy to quit, and tobacco dependence among under-
represented minority smokers. This study is directly relevant to the NIH’s mission to 
address cancer risk factors and supports the long-term objective to reduce the disease 
burden of tobacco use. In the current proposal, Latinx (n=90) and African American 
(n=90) cigarette smokers will be randomized in a 2:1 fashion to an EC group (n=60 per 
racial/ethnic group; N=120) or an assessment-only control group (n=30 per racial/ethnic 
group; N=60). Those randomized to EC will receive a 6-week supply of a fourth generation 
EC starter kit with their choice of liquid flavor from a standard list. Those randomized to 
assessment only (n=60) will not be provided with an EC. Tobacco consumption in both 
groups will be assessed at weeks 0 (baseline), 2, and 6. Changes in toxic exposure 
(NNAL, a primary lung carcinogen and the primary outcome) and carbon monoxide (CO) 
will be measured from baseline to week 6. Planned covariates include study site, gender, 
income, tobacco dependence score, and mental health symptoms.  
 
Aim 1.  To characterize the toxic exposure of cigarette smokers randomized to the 
EC group compared to cigarette smokers randomized to assessment-only controls 
Hypothesis 1: It is hypothesized that toxicant exposure from baseline to week 6 
will be significantly lower in the EC group compared to the assessment-only group. 
Hypothesis 2: It is hypothesized that change in cigarette consumption in the EC 
group from baseline to week 6 will be associated with reduction in toxicant 
exposure from baseline to week 6. 
 
Aim 2. To assess the effects of uptake of e-cigarettes on perceptions of harm and 
utility of products 
It is hypothesized that from baseline to week 6, the EC as compared to control arm 
a) will have decreased perceptions of harm to their health from current tobacco 
use, b) will increase positive utility of EC and increase negative utility of cigarette 
products, and c) will have decreased expectations of the difficulty of quitting 
cigarette smoking. 
 
Aim 3. To understand patterns of tobacco product consumption among smokers 
switching to electronic cigarettes  
Changes in tobacco product consumption (cotinine-verified), subjective effects of 
smoking, and levels of tobacco dependence from baseline to week 6 will be 
examined in the EC group and baseline predictors of those patterns, including 
demographic, smoking history, and psychosocial characteristics will be identified. 
 
This project will advance science on the widely used practice of EC use for harm reduction 
by examining change in toxicant exposure via NNAL and change in cognitive-perceptual 
variables among African American and Latinx smokers switching to EC compared to 
smokers who continue to use cigarettes alone. Study findings will have major public 
health implications, particularly for smokers who have experienced difficulty in quitting 
cigarettes and for whom EC use as a harm reduction strategy has been considered. The 
study will enhance the research environment at the PI’s university which is classified as 

PROJECT SWITCH Protocol  
NIH PROJECT #5SC3GM122628-02; CLINICALTRIAL.GOV IDENTIFIER: NCT03511001 
both a Hispanic Serving Institution and an Asian American-Native American-Pacific 
Islander Serving Institution. 
 
 
 
 
 

PROJECT SWITCH Protocol  
NIH PROJECT #5SC3GM122628-02; CLINICALTRIAL.GOV IDENTIFIER: NCT03511001 
Important Terms and Abbreviations 
NNAL  
 
4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol 
REDCap 
 
Research Electronic Data Capture 
CO 
 
 
Carbon Monoxide  
TLFB  
 
Timeline Followback  
 
II. 
Study Sites 
 
1. San Diego  
a. California State University San Marcos – 333 S Twin Oaks Valley Rd, 
San Marcos, CA 92096 
b. San Diego State Research Foundation – 4283 El Cajon Blvd Suite 226, 
San Diego, CA 92105  
c. Neighborhood Healthcare, Behavioral Health – 425 N. Date Street 
Escondido, CA 92025 
2. Kansas City – Swope Medical Center – 3801 Blue Pkwy, Kansas City, MO   
64130 
 
III. 
Study Personnel 
 
Name 
Organization 
Role  
Kim Pulvers, PhD, MPH 
California State University San Marcos 
Principal Investigator  
Jasjit Ahluwalia, MD, MPH, MS 
Brown University  
Co-Investigator  
Nicole Nollen, PhD 
University of Kansas School of Medicine Co-Investigator  
Tricia Snow, MA 
University of Kansas Medical Center 
Project Manager  
Brian Hernandez, BA 
University of Kansas Medical Center 
Lead Researcher  
Michael Arnold, BA 
University of Kansas Medical Center 
Research Assistant 
Myra Rice, BA 
California State University San Marcos 
Project Manager  
Amanda Dean, BA 
California State University San Marcos 
Research Assistant 
Dalia Hipolito, BA 
California State University San Marcos 
Research Assistant 
Jennifer Mosley, BA 
California State University San Marcos 
Research Assistant 
Mirella Orozco, BA 
California State University San Marcos 
Research Assistant  
Ana Leon, BA 
California State University San Marcos 
Research Assistant  
Justin Sanchez 
California State University San Marcos 
Research Assistant  
Crystal Marez, BA  
California State University San Marcos 
Research Assistant  
Juan Alva 
California State University San Marcos 
Research Assistant  
John Le 
California State University San Marcos 
Research Assistant  
Laura Wells, BA 
California State University San Marcos 
Research Assistant  
Jeremy Mills-Shimmel 
California State University San Marcos 
Research Assistant  
Shyla Everett 
California State University San Marcos 
Research Assistant  
Daniell Derry 
California State University San Marcos 
Research Assistant  
Flavia Ponce, BS 
University of California San Diego 
Research Assistant  
Nathan Au-Yeng, BS 
University of California San Diego 
Research Assistant  
Madison Garrett 
University of California San Diego 
Research Assistant  
Alexis Osuna 
 
San Diego State University 
Research Assistant  
Table 1. Study personnel for Project Switch.  
 

PROJECT SWITCH Protocol  
NIH PROJECT #5SC3GM122628-02; CLINICALTRIAL.GOV IDENTIFIER: NCT03511001 
IV. 
Participant Recruitment 
Recruitment will utilize online sources including Craigslist and Facebook, as well as radio 
advertisements, newspaper advertisements, flyers, information cards, clinic referrals, 
participant referrals, and community outreach. Enrolled participants will be encouraged 
to refer other smokers to the study and provided material such as information cards, pens, 
and t-shirts to facilitate referrals.   
 
Sample Size. We estimated our sample requirements using power analyses for primary 
aims to characterize the reduction in toxic exposure of cigarette smokers randomized to 
the e-cigarette group compared to cigarette smokers randomized to assessment-only 
controls (Aim 1:H1) from baseline to week 6 will be significantly lower in the EC group 
compared to the assessment-only group. Empirical power estimates were assessed by 
generating multivariate random samples that were matched to the expected response 
patterns for smokers in control and switching arms with each condition using the same 
correlation structure of assessments over time as observed in a previous study. In the 
switching condition we expect larger effects (d=-0.67) on primary outcomes (NNAL) for 
the ~40% of smokers able to switch more completely relative to smokers partially 
switching (d=-0.16). With no change expected in control, we powered primary outcomes 
for end-of-treatment analyses using an average of effects given 30% of switching 
smokers with large and 70% with small effects. With a median effect of -0.37 (SD=0.11) 
across 1000 data sets, simulations revealed that the planned design would provide 
greater than 0.82 power for detecting the treatment differences with a sample of 180 
subjects, with an allowance for up to 20% attrition. For Aim1: H2 we will have power to 
detect moderate effects of changes in cigarette consumption on change in toxicants. In 
published effects of differences in consumption levels on nitrosamines, 77 differences in 
consumption (20 vs 10 cig/day) reflected mean difference in log NNAL of 2.60-2.35=0.24 
and effect sizes with d=0.48 after 10 weeks 78. We estimate adequate power >0.80 given 
expected cigarette reductions. Changes in cognitive measures (Aim 2) including 
decreased perception of harm, average differences in utility of combustible and EC, and 
increased self-efficacy for quitting are expected to be moderately associated with EC use. 
Empirical power analyses using regression models of change in cognitive measures over 
1000 simulated data sets support the ability to detect moderate effects (d>0.30) using a 
standardized difference in means of cognitive measures with power >0.80. 
 
V. 
Participant Screening and Enrollment 
Prospective participants will be determined eligible or ineligible within 48 hours of initial 
contact. If eligible, the baseline visit will be scheduled, and a postcard reminder sent out. 
Screening will occur over the phone, in person, or with an online screening survey 
developed in REDCap.  
 
Final eligibility is not decided until baseline visit, contingent on blood pressure under 160 
(systolic) and 105 (diastolic), carbon monoxide over 5 PPM to validate smoking status, 
and researcher-assessed stability. Participants who do not meet criteria will not be 
included in the study and given a smoking cessation referral. San Diego ineligible 
participants will be referred to the California Smokers’ Helpline and Kansas City ineligible 
participants will be referred to the Kansas Tobacco Quitline. Transportation will be 
provided to and from study visits when needed in San Diego. 
 

PROJECT SWITCH Protocol  
NIH PROJECT #5SC3GM122628-02; CLINICALTRIAL.GOV IDENTIFIER: NCT03511001 
 
A. Inclusion Criteria 
• 
≥ 21 years of age 
• 
Smoked cigarettes on ≥ 25 of past 30 days 
• 
Smoked ≥ 5 cigarettes per day on days that smoked 
• 
Smoked cigarettes for ≥ 6 months  
• 
Carbon monoxide > 5 PPM at baseline 
• 
Blood pressure systolic or diastolic < 160/105 
• 
Hispanic/Latinx at San Diego or Black/African American at Kansas City  
• 
Fluent in English or Spanish 
• 
Willing to switch from smoking cigarettes to e-cigarettes for 6 weeks 
• 
Regular access to a telephone  
• 
Transportation to attend Swope Health Central in next six weeks (Kansas 
City) 
 
B. Exclusion Criteria 
• 
Primary use of other tobacco products or equal use of cigarettes and other 
tobacco products 
• 
E-cigarette use on ≥ 4 of the past 30 days  
• 
Currently in a smoking cessation program or other clinical trial 
• 
Use of nicotine replacement therapy or medicine which aids smoking 
cessation in the past 30 days 
• 
Hospitalizations for a psychiatric issue in the past 30 days  
• 
Heart-related event in the past 30 days. Examples include heart attack, 
stroke, severe angina (i.e. chest pain), ischemic heart disease, and vascular 
disease 
• 
Planning to move out of San Diego or Kansas City in the next 6 weeks  
• 
Another person in the household enrolled in the study  
• 
Women: pregnant, breastfeeding, or planning to become pregnant in the next 
six months 
• 
Screener judgment about unstable mental status or health status 
 
VI. 
Study Design and Timeline 
 
This study is a randomized controlled trial using a 2:1 study randomization ratio. The 
treatment group will receive an e-cigarette and nicotine pods for six weeks and are 
encouraged to make a complete switch from combustible cigarettes to e-cigarettes. 
The study will consist of three in-person visits (baseline, week 2, and week 6) in which 
measurements are conducted and behavioral support is provided to the e-cigarette group. 
Phone calls will be scheduled between the visits (week 1 and week 4) to confirm 
appointments, collect data on tobacco use, and to support switching to e-cigarettes (e-
cigarette group only).  
 
 
 
 

PROJECT SWITCH Protocol  
NIH PROJECT #5SC3GM122628-02; CLINICALTRIAL.GOV IDENTIFIER: NCT03511001 
 
Figure 1. Study Timeline.  
 
Informed Consent. The informed consent will be reviewed by having the researcher read 
the consent form out loud. The participant will be given time to read the informed consent 
form and ask questions. It will be made clear in the consent form that the participant has 
the option to take more time to consider their desire to participate in the study and 
reschedule at a later date, or to decline to participate at any point. The study begins once 
the participant signs the consent form, indicating understanding of the procedures, 
requirements, and consent.  
 
Incentives. Participants will be compensated for their time during the lab visits at 
escalating increments of $20 at baseline, $40 at week 2, and $60 at week 6, totaling up 
to $120. Participants in the e-cigarette group are instructed that full compensation is 
contingent upon bringing back their used and unused pods to their next visit. At week 2 
and week 6, $20 of compensation is contingent upon bringing back pods. Those in the e-
cigarette group have the opportunity to participate in a follow-up phone assessment six 
months after enrollment, entailing an additional $20 compensation.  
 
Study E-cigarettes. Participants in the e-cigarette group will be provided JUUL, a 
nicotine-salt based e-cigarette (see Figure 2). Participants will have the flavor selection 
of Virginia tobacco, cool mint, menthol, or mango pods containing .07 mL nicotine (5% 
nicotine). Pod use will be tracked using the Pod Count Form, requiring participants to 
bring to lab visits all used, unused, and partially used pods. Pods will be distributed based 
on cigarette use, and determined using the Pod Count Calculation Form. Education about 
switching will be verbally provided to the e-cigarette group. Participants will engage in 
motivational enhancement-based action planning and will receive JUUL usage 
instructions. Participants in the e-cigarette group will be provided a compatible wall 
adapter to ensure proper charging, a device carrying case, Q-tips to clean the device as 
needed, and a gallon Ziplock bag to store used pods. 
 
 

PROJECT SWITCH Protocol  
NIH PROJECT #5SC3GM122628-02; CLINICALTRIAL.GOV IDENTIFIER: NCT03511001 
 
Figure 2. JUUL electronic cigarette. Reprinted from JUUL Labs, Inc, Retrieved 
December 9, 2018, from www.juul.com. Copyright 2018.  
VII. 
Participant Retention  
Participant retention will be maintained by using a variety of contact methods including 
call, text, email, physical letter in the mail, and reaching out to emergency contacts. No 
more than six contact attempts, of various forms, will be made. Contacting emergency 
contacts and sending a letter will be the last efforts made to contact an unreachable 
participant. Additionally, participants will be sent postcards reminding them of the day 
and time of their next lab visit, and appointment reminder cards will be given out at the 
baseline and week 2 visit reminding about upcoming phone calls.  
 
Lab visits will have pre-determined time windows. The week 2 visit can be scheduled up 
to one week before or after the originally scheduled date of two weeks after the baseline 
visit. The week 6 visit can be scheduled up to four weeks before or after the originally 
scheduled date of six weeks after the baseline visit. Ripple protocol details the 
scheduling protocol. 
 
VIII. 
Laboratory Procedures and Sampling 
 
Data from biological measurements and samples will be recorded on paper and/or 
in REDCap. 
 
The table below shows the equipment used for the biological measures, and timepoints 
taken.  
 
Measure 
Equipment 
Baseline 
Week 2 Week 6 
Carbon Monoxide 
coVita|Bedfont Micro+ 
Smokerlyzer® 
X 
X 
X 
Systolic Blood Pressure, 
Diastolic Blood Pressure, and 
Pulse 
Omron® BP742N 5 Series 
Upper Arm Blood Pressure 
Monitor 
X 
X 
X 
Height 
Health o meter® 500KL 
X 
 
 

PROJECT SWITCH Protocol  
NIH PROJECT #5SC3GM122628-02; CLINICALTRIAL.GOV IDENTIFIER: NCT03511001 
Professional Digital Scale  
Weight 
Health o meter® 500KL 
Professional Digital Scale  
X 
 
X 
Spirometry: FVC, FEV1, 
FEV1/FVC%, PEF, and FEF25-
75% 
Futuremed® Discovery-2TM  
Desktop Spirometer 
X 
X 
X 
Saliva (10 San Diego 
participants) 
Saliva collection aid (straw): 
SB-WS No.61/524,096 
 
Collection tube: Wheaton 1.8 
mL yellow cap collection tube 
X 
 
X 
Nasal Swab (20 Kansas City 
Participants) 
Leukosorb tubes, Q-tips, 
saline 
X 
 
X 
Urine  
Dynarex Specimen Container 
4oz. 118cc reorder No. 4253 
 
Aliquots: Wheaton 20 ml 
disposable scintillation vials  
X 
X 
X 
 
Table 2. Biological measures, timepoints, and equipment for Project Switch.  
 
CO measurement. Exhaled breath samples will be taken at all visits for carbon monoxide 
(CO), a by-product of smoke, using a Bedfont Micro+ Smokerlyzer. At baseline, CO 
measurement will be taken to confirm eligibility. A carbon monoxide level over 5ppm 
verifies smoking status. A carbon monoxide level 5ppm or lower at baseline makes a 
person ineligible to participate in the study. Participants will be allowed the opportunity to 
re-screen two weeks later. 
 
Blood pressure. Systolic and diastolic blood pressure will be measured for screening 
purposes and throughout the study using a digital blood pressure cuff. If, at the baseline 
or week 2 visit, a participant’s systolic blood pressure is greater than or equal to 160 mm 
Hg or their diastolic blood pressure is greater than or equal to 105 mm Hg, they will not 
be eligible to participate or continue participating in the study. Pulse will also be measured 
but not as an exclusion criteria. Participants who are ineligible at baseline due to 
uncontrolled blood pressure will be allowed the opportunity to re-screen two weeks later. 
 
Height and weight. A medical scale will be used for a one-time measure of height. 
Weight will be measured at baseline and week 6 visit, with shoes removed.  
 
Spirometry. Lung function will be measured at all lab visits using a Discovery-2 
SpiroVision spirometer. At each session, participants will complete a minimum of three 
maneuvers (depending on the quality) consisting of a strong exhale and a strong inhale. 

PROJECT SWITCH Protocol  
NIH PROJECT #5SC3GM122628-02; CLINICALTRIAL.GOV IDENTIFIER: NCT03511001 
Participants will be given a mouthpiece at baseline that will be stored and used at 
subsequent visits. Participants will be given the option to manually hold their nose closed 
or to apply a nose clip.  
 
Spirometer measures include: (1) forced vital capacity, FVC (2) Forced expiratory 
volume in one second, FEV1 (3) The percentage of the FVC expired in one second, 
FEV1/FVC% (4) peak expiratory flow, PEF (5) Forced expiratory flow over the middle 
one half of the FVC, FEF25-75%.  
 
Saliva sampling. Saliva sampling is an exploratory addition to this study and will be taken 
from ten San Diego participants at baseline and week 6. The decision to take saliva 
sampling in San Diego resulted in an increase from the original n=90 to an n=94. Samples 
will be frozen and transported the testing facility on dry ice. 
 
Nasal swab sampling. Nasal swab sampling is an exploratory addition to this study and 
will be taken from twenty Kansas City participants at baseline and week 6. The decision 
to take nasal swab sampling in Kansas City resulted in an increase of two participants for 
a final n=92. Samples will be frozen and transported the testing facility on dry ice. 
 
Urine sampling. Urine will be collected at all lab visits and refrigerated until aliquoting. 
Participants will be instructed to provide at least half of the specimen cup of urine (about 
60mL). Participants will be offered water at the beginning of lab sessions to help facilitate 
sampling. 
 
Urine will be processed by aliquoting the sample into two smaller samples, each 15 mL. 
One sample will test for cotinine and need to be pre-treated with sodium bisulfate to obtain 
a pH between 2 and 3. The second sample will test for NNAL and will receive no additional 
treatment. Both samples will be frozen and stored at -20 °C before shipping with dry ice 
for testing.  
 
A urine log will provide the following information for each urine sample: (1) participant ID 
(2) study time point (3) date: mm/dd/yyyy (4) testing for: NNAL or cotinine. Each lab visit 
will produce two samples stored for further testing.  
 
Although urine will be taken at all three lab visits, only baseline and week 6 urine will be 
sent for testing. In the case of missing week 6 samples, week 2 samples will be sent 
instead as a method of imputation.  
 
Sample shipment. Specimens will be transported in a leak-proof Styrofoam container in 
leak-proof secondary packaging, with absorbent material placed at the bottom and sides 
of the container for absorption. 10-15lbs dry ice will be used to maintain storage 
temperature during transport.  
 
 
 
IX. 
 Laboratory Analysis 
 

PROJECT SWITCH Protocol  
NIH PROJECT #5SC3GM122628-02; CLINICALTRIAL.GOV IDENTIFIER: NCT03511001 
Urine: cotinine ng/mL, creatinine mg/mL, nitrosamine 4-(methylnitrosamino)-1-(3-
pyridyl)-1-butanol (NNAL) pg/mL, and 3-hydroxycotinine ng/mL 
 
Saliva: Cytokine Panel and C-Reactive Protein 
 
Nasal Swab: MMP9 ELISA in pg/mL and TGF-B1 ELISA in pg/mL 
 
 
X. 
Study Visits Overview  
 
 
Baseline 
Week 1 
Week 2 
Week 4 
Week 6 
Participant consent 
Follow-up 
check-in  
Urine test 
Follow-up 
check-in  
Saliva sample (San 
Diego) 
Saliva sample (San Diego) 
Yesterday 
tobacco use 
Blood pressure test 
(must be less than 
160/105) 
Yesterday 
tobacco use 
Urine test 
Complete contact sheet 
 
Carbon monoxide test 
 
Blood pressure test 
Blood pressure test (must 
be less than 160/105) 
 
Eligibility check  
 
Carbon monoxide 
test 
Carbon monoxide test (must 
be greater than 5 ppm) 
 
Follow-up check in 
sheet (EC group) 
 
Nasal swab (Kansas 
City) 
Nasal swab (Kansas City) 
 
Timeline follow back  
 
Weight 
Final eligibility check and 
Study ID assignment 
 
Spirometry test  
 
Follow-up check in 
sheet (EC group) 
Randomization 
 
Week 2 survey  
 
Timeline follow back 
Charge JUUL (EC group) 
 
Collect used JUUL 
pods (EC group) 
 
Spirometry test 
Timeline follow back  
 
Provide more JUUL 
pods (EC group) 
 
Week 6 survey 
Pod count form (EC group) 
 
Schedule visits/phone 
calls  
 
Collect used JUUL 
pods (EC group) 
Height and weight 
 
Compensation  
 
Tobacco cessation 
referral 
Baseline survey part 1 
 
 
 
Exit survey 
Spirometry test 
 
 
 
Compensation 
Baseline survey part 2 
 
 
 
 
Cigarette questions and 
breathing conditions  
 
 
 
 
E-cigarette switching fact 
sheet (EC group) 
 
 
 
 
E-cigarette use instructions 
(EC group) 
 
 
 
 
E-cigarette trial and 
subjective effects 
questionnaire (EC group) 
 
 
 
 

PROJECT SWITCH Protocol  
NIH PROJECT #5SC3GM122628-02; CLINICALTRIAL.GOV IDENTIFIER: NCT03511001 
Baseline action planning 
(EC group) 
 
 
 
 
Schedule visits/phone calls 
 
 
 
 
Reimbursement schedule 
 
 
 
 
Urine test 
 
 
 
 
Compensation 
 
 
 
 
Table 3. Surveys and tests by study timepoint. 
 
At each lab visit, participants will receive compensation and sign a receipt. At the end of 
the study, participants will be given a referral to the California Smokers’ Helpline (1-800-
NO-BUTTS) or Kansas Tobacco Quitline (1-800-QUIT-NOW).  
 
 
XI. 
Study Questionnaires  
Surveys will contain items on demographics, smoking measures, tobacco measures, 
physiological measures, and psychosocial assessments. Given the possibility of low 
literacy among participants, surveys will be verbally administered along with visual cue 
cards.  
 
XII. 
Data Management 
Missing data will be minimized through extensive training of research staff in addition to 
follow-up with participants. Data will be entered into REDcap electronically and paper 
forms (biological measures and pod count forms) will be stored in participant files. Paper 
forms with identifiable information such as consent and contact information will be stored 
in a separate, locked location. TLFB data will be entered into excel, with paper calendars 
and data entry forms stored in participant files. REDcap entry will happen after the lab 
session and will be audited and checked by project managers daily. REDCap is a secure, 
HIPAA-compliant, web-based application designed to support data capture for research 
studies. All protocol-specified data will be linked by unique subject ID, assigned at 
randomization. Paper files will be stored on site in a locked filling cabinet and any forms 
with identifying information (consent form and contact sheet) will be kept in a separate 
location. Data is only accessible to personnel involved with this research. Access is 
limited by the research facility being locked at all times. 
 
 
XIII. 
Recording and Reporting of Adverse Effects 
Development of any adverse effects will be monitored closely by a project manager such 
that fields capturing adverse events will be reviewed daily. At each study visit, participants 
will be asked about the development of any other, new, or worsening symptoms. At each 
visit and each phone call after the initial visit, participants in the e-cigarette condition will 
be asked if they were experiencing any barriers to switching to e-cigarettes or any 
concerns about switching. This open-ended format is intended to capture any unexpected 
adverse events. Unexpected serious adverse events will be reported to the CSUSM IRB 
and assessed by the PI to determine if related to e-cigarette use, and if so, reported to 
the NIH and FDA. Participants will be encouraged to contact staff if they have any 
questions, problems using their e-cigarette, or if any adverse events develop.