Smartphone Based Smoking Cessation Intervention
Phase: PHASE2
Conditions: Smoking Cessation
Sponsor: University of Oklahoma

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The University of Oklahoma Health Sciences Center
Study Protocol 
Institutional Review Board
Title of Project: Smartphone Based Smoking Cessation Intervention
Principal Investigator: Michael S. Businelle, Ph.D.; Department of Family and Preventive
Co-Investigators: Darla E. Kendzor, Ph.D.; Department of Family and Preventive Medicine     
Damon J. Vidrine, Dr.PH; Department of Family and Preventive Medicine 
Summer Frank, Ph.D.; TSET Health Promotion Research Center, OUHSC
Sara Vesely, Ph.D.; OUHSC College of Public Health
Emily Hebert, Dr.PH; TSET Health Promotion Research Center, OUHSC
Abstract
Smoking is becoming increasingly concentrated among individuals with the lowest levels of 
income, education, and occupational status. In fact, smoking rates in the United States among 
people living below the poverty line is nearly twice as high as those above the poverty threshold. 
Highly flexible and low burden technology-based treatment approaches may overcome many of 
the barriers that have limited the use and effectiveness of traditional smoking cessation 
treatments among low SES adults. Ecological momentary assessment (EMA), in which mobile 
devices are used to capture moment-to-moment experiences, allows for the measurement of 
phenomena in real-time within natural settings. Smartphone-based smoking cessation apps 
could offer easily accessible, highly tailored, and intensive interventions at a fraction of the cost 
of traditional smoking cessation counseling. The Smart-T app uses a lapse risk estimator to 
identify moments of heightened risk for lapse, and the algorithm tailors treatment messages in 
real-time based upon level of imminent smoking lapse risk and currently present lapse triggers.
A. Specific Aims
The primary long-term objective of this research is to reduce smoking rates among low SES 
adults. The next step towards this goal is to use a fully powered randomized clinical trial to 
compare the efficacy of the Smart-T app with the free and widely available National Cancer 
Institute (NCI) QuitGuide app for smoking cessation in the 26 weeks following a scheduled quit 
attempt. A total of 450 socioeconomically disadvantaged, treatment-seeking males and females 
will be randomly assigned to receive either the Smart-T intervention app or the QuitGuide 
intervention app. All participants will receive nicotine replacement therapy and complete EMAs, 
but only the Smart-T group will receive intervention messages that are tailored to the current 
level of lapse risk and current lapse triggers. The study aims are to:
1.
Determine the impact of treatment condition (i.e., Smart-T vs. QuitGuide app; n=225 
per group) on biochemically verified smoking abstinence.
Hypothesis 1: Participants randomly assigned to Smart-T will have significantly higher rates 
of biochemically-verified abstinence than those assigned to QuitGuide at 26 weeks post- 
quit.
2.
Determine the effect of Smart-T treatment messages on key lapse risk factors. 
Hypothesis 2: Smoking urge, stress, and cigarette availability will decline more and 
cessation motivation will increase more following tailored messages that target these lapse
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triggers in real-time (Smart-T condition) compared with similar situations wherein no 
messages are provided (QuitGuide condition).
B. Background and Significance
Smoking is the leading cause of preventable death in the U.S.1,2 and is implicated in an 
estimated 30% of all cancer deaths in this country.3 Recent studies indicate that smokers have 
average life expectancies that are 11-12 years shorter than those who have never smoked.4 
Importantly, depending on the age that one quits, ex-smokers live up to a decade longer than 
those who do not quit.4 Although smoking prevalence has declined to 13.9% among U.S. adults 
who are not living in poverty, 26.1% of those living in poverty are current smokers.5 The 
prevalence of both poverty (16.6%)6 and smoking (21.1%)7 are greater in Oklahoma than in the 
US overall. More than a third of Oklahomans live in rural areas,8 and rural residence is 
associated with elevated smoking prevalence.9,10 Finally, Oklahoma is home to a large 
population of American Indians (12.9% of all residents),11 who have higher smoking prevalence 
(29.2% smoke) than other racial/ethnic groups.12
Lower SES individuals are the fastest growing group of smartphone owners in the U.S. In 
fact, smartphone ownership has nearly tripled since 201113 to 67% in households earning less 
than $30,000 per year.14,15 Furthermore, our recent work (August 2016; N=610) indicated that 
smartphone ownership is high even among homeless adults (56.1% have active 
smartphones).16 Smartphone-based smoking cessation apps could play a significant role in 
improving cessation rates for current and future generations of lower SES smokers. Smartphone 
apps could offer secure (e.g., data can be encrypted), easily accessible (i.e., smartphone 
owners report that their phones are within arm’s reach for 90% of waking hours17), highly 
tailored, and intensive interventions at a fraction of the cost of traditional smoking cessation 
counseling; thereby, overcoming many of the barriers that have hampered use of other 
empirically supported smoking cessation treatments among lower SES individuals.18,19 
Furthermore, after being downloaded, smartphone apps can deliver tailored content (e.g., video, 
text) even when cellular reception and/or minutes/data are not available, overcoming some of 
the limitations of quit lines and texting based smoking cessation interventions (see20,21).
Although there are hundreds of publicly available smoking cessation apps, few have been 
empirically evaluated using a randomized controlled trial design. In a content analysis of 252 
available iPhone and Android apps for smoking cessation, Abroms and colleagues22 found that 
very few apps adhered to proven strategies for smoking cessation (e.g., suggesting use of 
effective medications, connecting to quit lines or clinics).22 QuitGuide is a free smartphone app 
developed by the Tobacco Control Research Branch at the National Cancer Institute (NCI) and 
based on content from Smokefree.gov.23 Unlike most available apps, QuitGuide’s content 
adheres to established clinical practice guidelines,24 and includes features such as using 
motivational messages to encourage users to make a quit attempt, and detailed information 
about medications (e.g., nicotine replacement therapy; NRT). QuitGuide also enables and 
encourages users to track their mood, cravings, triggers, and lapses, and users can tag 
locations to receive support messages when they are in places they have deemed high risk for 
lapse. To date, only one study has examined the efficacy of the QuitGuide app. Bricker et al. 
compared QuitGuide to a smartphone delivered Acceptance and Commitment Therapy-based 
app (SmartQuit) in a randomized controlled trial.25 The overall quit rate for participants who were 
randomized to QuitGuide was 8%, compared with 13% for SmartQuit. Thus, there appears to be 
much room for improvement in phone-based treatments.
Ecological momentary assessment (EMA), in which handheld devices (e.g., smartphones)
are used to capture moment to moment experience, allows for the measurement of phenomena
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in real-time within natural settings.26,27 EMA data may facilitate a better understanding of the 
mechanisms involved in successful cessation attempts, those affecting smoking lapses, and 
those implicated in the transition from lapse to relapse. Our research team and others have 
identified momentary predictors of smoking cessation and smoking relapse (e.g., smoking 
urge,28-31 stress,29,31-34 easy cigarette availability,31,32,35,36 interacting with people who are 
smoking,30,31,36 alcohol use,30-32,36 cessation motivation29,31). These findings suggest that 
momentary changes in key variables may be tracked and potentially used to initiate 
interventions as they are needed. Using smartphones to detect high relapse risk situations 
and automatically deliver tailored smoking cessation interventions may help socioeconomically 
disadvantaged smokers to avoid lapse and successfully quit smoking.
In summary, socioeconomically disadvantaged adults are less likely to quit smoking and are 
disproportionately affected by smoking-related morbidity and mortality.37-40 EMA studies have 
identified social, psychological, and environmental triggers that contribute to smoking 
lapse.31,32,36,41 To date, no interventions besides our recent pilot work (see Preliminary Studies 
section), have used EMAs to repeatedly assess current smoking lapse risk and automatically 
deliver tailored treatment content. Our preliminary work indicates that smartphones may be used 
to deliver automated, tailored, low burden, and easily accessible interventions to 
socioeconomically disadvantaged smokers, a population with substantial barriers that have 
hampered the use of traditional smoking cessation treatments. The proposed study would 
extend our previous work and determine if automated treatment content (e.g., messages 
focused on coping with lapse triggers, smoking cessation medication reminders) that is tailored 
to current situations can attenuate lapse risk.
C. Preliminary Studies/Progress Report
Drs. Businelle and Kendzor have used smartphones in 9 studies to collect EMA data for 
up to 6 months and influence health behavior in high-risk samples, including homeless (e.g., 
1R01MD010733-01A1; PI Businelle)29,42 and other socioeconomically disadvantaged adults 
(e.g., R01CA197314-01; PI Kendzor).31,34,43-45 In Project Prevail, EMA data were collected from 
smokers seeking treatment at a safety-net hospital tobacco cessation clinic (N=146).34,44,45 
Participants completed 83% of all EMAs. Using just 6 EMA variables (i.e., urge, stress, cigarette 
availability, alcohol use, motivation to quit, proximity to others smoking), we created a smoking 
lapse risk estimator that identified 80% of all smoking lapses within 4 hours of the lapse (false 
positive rate = 17%; see a detailed description of the development of the risk estimator here 31). 
In another study, we developed the Smart-T app that includes on-demand features (e.g., tips on 
coping with stress) and incorporates the Prevail lapse risk estimator to deliver tailored 
messages based on a person’s momentary risk for smoking lapse. We examined the feasibility 
of the Smart-T app among smokers recruited from an urban safety-net hospital tobacco 
cessation clinic (n=59). In that study, socioeconomically disadvantaged participants completed 
87% of all EMAs and received an intensive level of tailored smoking-cessation treatment 
messages (102 messages on average) over a 3-week intervention period. We found that the on 
demand app functions were used regularly and the app was well-liked (e.g., 97% would like to 
use the app in the future if they were to relapse, and 85% would refer their friends who smoke to 
use the app).31 Analyses of EMA data revealed that urges to smoke were significantly reduced 
when tailored urge messages were delivered by the app, as compared to instances where other 
types of messages were delivered (p<.001).46 We also found reductions in stress (p=.021) and 
cigarette availability (p<.001) following tailored stress and cigarette availability messages, 
compared to other types of messages.46 A total of 20% of participants were biochemically 
confirmed abstinent 12 weeks post-quit,47 which is better than many interventions conducted 
with low SES smokers.25,48-52 Finally, Dr. Businelle is completing a 3-armed pilot randomized
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clinical trial (i.e., Project Smart-T2; OUHSC IRB #7195) that compares the Smart-T2 app to 
standard in-person smoking cessation clinic care and the free NCI QuitGuide app. Smokers who 
attend a clinic based tobacco cessation program are randomized to groups and followed for 13 
weeks (1 week pre-quit through 12 weeks post-quit). All participants are asked to complete 
EMAs on study provided smartphones for 5 weeks. To date, 64 participants have reached the 
12-week post-quit follow-up visit. A total of 26% of Smart-T, 14% of QuitGuide, and 21% of in- 
person participants have achieved biochemically confirmed 7-day point prevalence abstinence 
at the 12-week post-quit visit.
D. Research Design and Methods
Eligibility Criteria. Participants (N=450) will be recruited through the TSET Health 
Promotion Research Center (HPRC) Tobacco Treatment Research Program (TTRP) which is 
directed by Dr. Darla Kendzor (Co-I). Participants will also be recruited through advertisements 
(e.g. Facebook and Craigslist ads). Individuals seeking smoking cessation services at the TTRP 
will be given a verbal description of the study during their first visit, and those interested will be 
screened for study eligibility. Those who respond to study advertisements will complete a brief 
REDCap screener online (i.e., OKSmokerstudy.com), and those who qualify for the study will 
contacted by study staff and scheduled for a screening/baseline visit. Consistent with our 
previous research with low SES populations,31,45,47,53-55 we have limited exclusion criteria so that 
the sample is as broad and representative of the population as possible. Interested individuals 
will be included in the study if they: 1) earn a score ≥ 4 on the Rapid Estimate of Adult Literacy 
in Medicine-Short Form (REALM-SF)56 indicating > 6th grade English literacy level (required to 
complete EMAs; at least 88% of all individuals screened for our EMA studies have met this 
inclusion criterion), 2) are willing to quit smoking 7 days after the baseline assessment, 3) are ≥ 
18 years of age, 4) have an expired CO level ≥ 7 ppm suggestive of current smoking for those 
who attend in person baseline visits or substantiate smoking status (e.g., produce a pack of 
cigarettes) during baseline assessments by sending picture of cigarettes to staff 5) are currently 
smoking ≥ 5 cigarettes per day, 6) have no contraindications to using NRT, 7) agree to complete 
EMAs and CO tests on a study provided or personal smartphone, 8) have household income < 
200% of the federal poverty guideline,57 and 9) agree to complete the 26-week post-quit follow-
up assessment over the phone and via EMA. We will ask participants to verify their mailing 
address by showing (e.g., texting) a member of our study team a picture of their photo ID or a 
photo ID with a bill that was mailed to participant to verify their address. Those who are unable 
to provide a valid photo ID or piece of mail with their name and address will not be eligible to 
participate in the study. During the screener, a trained research assistant will confirm the 
participant’s residency status, date of birth, University of Oklahoma employment status, and 
social security number with the participant. To be in compliance with IRS regulations, the 
University of Oklahoma must collect residency status for all participants. This determines how 
the payment is handled. All payments required to be reported as outlined in this policy require 
collection of the participant’s name, tax identification number (SSN or ITIN), address, amount 
paid and source of funding for the payment.
Participant Flow. Individuals who provide informed consent and meet the study inclusion 
criteria will complete the baseline assessment in TTRP clinic space (the TTRP is located in 
Research Parkway in a building that is adjacent to the PI’s office) or via phone calls with study 
staff.
Following the baseline assessment, participants will be given instruction on how to complete 
phone-based EMAs and carbon monoxide assessments. All participants, regardless of
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condition, will be compensated for completing the baseline assessments, phone based follow- 
up, and EMAs. In addition, participants will complete expired breath carbon monoxide tests 
using the portable iCO device 3 days per week (weeks 1-27).
Study Overview. Eligible and interested individuals will be randomized to 1 of 2 groups: 1) 
Smart-T smoking cessation intervention plus NRT, or 2) NCI QuitGuide smoking cessation 
intervention plus NRT. Stratified randomization will be used to assign participants to groups 
based upon race, sex, and cigarettes smoked per day. Participants will be followed for 27 weeks 
and will attend either 1 in-person visit or complete phone-based baseline visits. Participants will 
be prompted to complete daily EMAs and tests of smoking status using a portable, low-cost, 
carbon monoxide monitor (Bedfont iCO Smokerlyzer) on 3 days each week. This data will be 
used to address primary (i.e., biochemically verified 7-day point prevalence abstinence at 26 
weeks post-quit) and secondary outcomes (e.g., 30-day point prevalence abstinence, number of 
days to first lapse, longest period of smoking abstinence). Geographic location data will be 
captured multiple times per day to link characteristics of the present environment (e.g., proximity 
to tobacco outlets) with cessation-related outcomes. We have already created software that 
integrates the iCO sensor into our InsightTM mobile application platform.
Participants who complete the in-person baseline visit will: 1) receive combination NRT (i.e., 
nicotine patch and gum/lozenge), and 2) complete EMAs daily on study provided smartphones. 
Participants who complete the remote baseline process will be mailed NRT, and a phone (if 
necessary) to complete EMAs. NRT has been shown to increase successful smoking 
cessation,58 and is currently offered via Quitline in all but 5 states.59 Combination NRT (patch + 
gum or lozenge) is considered a first line treatment,60 is relatively low-cost, can be kept on-site 
for easy distribution to study participants and is more effective than the patch or gum/lozenge 
alone.58 Consistent with over-the-counter package labeling, participants will be offered up to 10 
weeks of nicotine patches (i.e., label dosage recommendations will be followed) and up to 12 
weeks of nicotine gum or lozenges (i.e., participants will receive a 4 week supply of NRT at the 
completion of the baseline process and will be mailed NRT upon request for post-quit weeks 
512).
Participants who own an Android smartphone (OS version 6.0 or higher) will be encouraged 
to download and use the study app on their own phone. Those who do not own this type of 
smartphone and those who do not have a data plan will be loaned a Samsung smartphone (or 
equivalent) for 27 weeks so that they may complete EMAs. Participants will navigate through the 
EMA program and enter data simply by touching the screen. The study app (i.e., Smart-T app or 
EMA only app) includes a “Call Staff” function/button that automatically calls study staff (e.g., if 
they have problems completing EMAs). The EMA app also includes a “Payment” button which, 
when pressed, indicates the number of EMAs that have been prompted and completed and the 
current level of compensation based upon the up-to-the-moment percentage of EMAs 
completed. Smartphones will automatically collect data when on-demand features are accessed 
for both the QuitGuide and Smart-T groups (e.g., number of times features are used). Use of 
personal vs. study provided phones will be examined as a covariate in all analyses.
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Sub-Study: A sample (n=30) of American Indian/Alaska Native participants who have completed 
the 6 month follow-up assessment will be asked to participate in another qualitative interview 
designed to assess the perceived utility and cultural fit of the Smart-T App and NCI QuitGuide 
app. Information gathered from these qualitative interviews will be used to culturally modify and 
then experimentally test a new, culturally tailored, version of
the apps for AI/AN smokers who want to quit smoking. In 
addition, this will serve as an incredibly valuable training 
opportunity for an emerging Native American scientist to learn 
tobacco cessation, mHealth, and qualitative methods 
research from an interdisciplinary team of leading experts in 
the field.
Description of Treatment Groups.
NCI QuitGuide App + NRT Condition The National 
Cancer Institute’s QuitGuide app is a free smartphone app 
that is available on the Apple and Android app stores and has 
been downloaded by thousands of users. QuitGuide is one of 
the few apps that includes many of the recommendations 
detailed in the Clinical Practice
Guideline.24 Individual level app feature use is accessible by 
request from the Smokefree.gov server (the PI has already 
obtained this type of QuitGuide data for a pilot study). The 
QuitGuide app aims to help smokers understand their 
smoking patterns and develop the skills needed to quit 
smoking. Participants who are randomly assigned to the 
QuitGuide condition will download the QuitGuide app and it
will be set for a quit date 1 week following the baseline visit.
Figure 1. QuitGuide app home screen 
QuitGuide provides content during the pre-quit period to prepare participants for their quit 
attempt. Participants will receive information on how to use QuitGuide app features. During the 
baseline process and will be encouraged to use the app for the duration of the study. QuitGuide 
features are listed in Table 1. Participants will be instructed to click “I Was Smoke Free Today” 
and the “I Slipped” tab to update their status every day (see Figure 1). Participants can use the 
on-demand “Track My Craving” tab to record and get help with managing cravings. They can 
click the “Manage My Mood” tab to track their mood and get tips on managing bad moods.
Participants can also personalize the app home screen with their list of reasons for quitting. 
Clicking the icon on the top right of the home screen will open a summary screen that will help 
participants to monitor their smoking cessation milestones and money saved by not smoking. 
Clicking the icon on the top left of the home screen enables modification of the quit plan; setting 
places and times of day when/where participants would like to receive app messages, and 
create journal entries. Participants can also click “My History” to examine their mood, urge, and 
lapse history. Lastly, participants may click “How to Quit” to learn more about ways they can 
improve their chances of successfully quitting (Figure 1).
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Smart-T + NRT Condition.
Participants who are randomly assigned to the 
Smart-T condition will download the Smart-T app and it 
will be set for a quit date 1 week following the baseline 
process. Smart-T provides content during the pre-quit 
period to prepare participants for their quit attempt.
Participants will receive information on how to use 
Smart-T app features at the baseline visit and will be 
encouraged to use the app for the duration of the study. 
The Smart-T app contains multiple components 
including an EMA delivery and data transfer system, 
automated messages, and on demand content. Each 
feature is described below.
Automated messages. Over 400 unique messages 
have been created for the Smart-T app and message 
content has been evaluated by 5 tobacco treatment 
experts. Similar to our pilot study of the Smart-T app, 4 
levels of automated messages will be used for this study 
(see Table 2). One message will be delivered at the end 
of each EMA (note: the message will include the 
participant’s first name). Level 0 messages will be 
pushed during the one week pre-quit period. These 
messages are not tailored, but rather are delivered in a 
predetermined order. Message topics are primarily 
motivational and/or focused on planning and preparing 
for the quit attempt and benefits of quitting (e.g., “John, 
Now is the time to create a “smoke free” home 
environment! Studies show that people who ban 
smoking in their home increase their chances for 
quitting”; “John, Sometimes people save a pack of 
cigarettes (or even a few cigarettes) “just in case” or to 
prove they have the willpower to not smoke. DON’T! This 
just makes it easier to start smoking again!”;
Table 1. Comparison of treatment conditions.
Components
Smart-T
QuitGuide
Combination NRT
X
X
EMA
X
X (add on for 
this study)
Set a quit date
Quit date is set to 1 week 
after the baseline visit
Smoking cessation 
psychoeducation
X
X
Treatment messages tailored to 
currently present lapse triggers
X
On demand tips and exercises
X
Coping with cravings
X
Coping with mood
Coping with stress
Coping with others smoking
X
Motivational messages
Benefits of quitting
Harms of smoking
Coping with insomnia
Coping with pain
X 
X 
X 
X 
X 
X 
X 
X 
X
Scheduled cessation tips
X
Individualized quit plan
X
Record craving/withdrawal
X
X
Record slip
X
X
Record smoking triggers
X
List reasons for quitting
X
Summary of savings from 
smoking fewer cigarettes
X
Share quit information on social 
media
X
“John, it’s OK to have mixed feelings about
Table 2. Smart-T message types.
quitting. Don’t let that stop you! There will be times that you 
don’t feel like quitting! Stick with it anyway!”). Participants 
will receive level 4 messages during the post-quit period 
when they indicate that they smoked that day. Level 4 
messages attempt to motivate the participant to stop 
smoking.
Type
Conditions for message delivery
Level 0
Pre-quit
Level 1
Post-quit when imminent lapse risk is low.
Level 2
Post-quit when lapse risk is high & 
following lapse when participant is still 
interested in quitting.
Level 3
Post-quit immediately following lapse.
Level 4
Post-quit when already smoked that day.
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Figure 2. Level 2 messages.
At the end of each post-quit EMA, participants will receive individually tailored (i.e., the 
message will include the participant’s first name) automated messages based on their risk for 
imminent smoking lapse (see 31 for a complete description of our EMA based lapse risk 
estimator). Level 1 messages will be delivered when EMA responses indicate a low level of 
imminent smoking lapse risk, and message content will focus on maintaining abstinence 
motivation and general cessation advice (e.g., seeking social support for cessation, coping with 
and avoiding various lapse triggers, and benefits of quitting). Level 2 messages will be delivered 
when EMA responses indicate high imminent risk of smoking lapse OR the participant already 
smoked that day or the day before OR the participant indicates that they have a greater than 0% 
chance of smoking that day. Level 2 messages will also be delivered at the end of participant 
initiated About to Slip EMAs, Already Slipped EMAs, and when the iCO indicates recent 
smoking. Level 2 messages primarily focus on ways to cope with current lapse triggers (i.e., 
reported during the current EMA) and are tailored to the highest rated current lapse trigger (i.e., 
low motivation for cessation, high urge to smoke, high stress, easy access to cigarettes). In 
instances where multiple triggers are equally highly rated, one message will be delivered with 
preference given in the order listed above. The justification for this ordering system is grounded 
in the results from Projects Prevail and Smart-T. Specifically, preference is given to variables 
that were better at distinguishing moments of high risk for imminent lapse from moments of low 
risk for lapse. An innovative
feature of this study is that when risk
for lapse is determined to be
high and a level 2 message is
pushed, a second message 
will suggest that the 
participant use nicotine 
replacement (i.e., nicotine 
gum/lozenge) in that 
moment (see Figure 2).
Level 3 messages will be 
delivered immediately after 
lapse occurs and these 
motivational messages will 
encourage a return to 
abstinence (e.g., “John, A 
slip is a sign that you need
to improve your smoking cessation plan. Think about what went wrong and develop a stronger 
plan to stay quit. Keep trying and YOU WILL SUCCEED!”). On-demand content. Several Smart- 
T components are available through the smartphone app 24 hours a day, 7 days a week (see 
Smart-T pre-quit home screen in Figure 3). First, the “Call Counselor” function/button is 
programmed to automatically call the free Oklahoma Tobacco Help Line (1-800-Quit-Now) so 
that participants can reach a live counselor at any time (the Smart-T app automatically saves 
the duration of each Help Line call for future analysis).
Second, the “Quit Tips” function/button links to a menu of treatment related messages (see 
Figure 4). Third, the “Medications” function/button offers information (e.g., common side effects, 
quit statistics, use instructions) about NRT medications that will be provided to participants (i.e., 
nicotine patch and gum/lozenge; see Figure 5).
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In the 
Smart-T 
feasibility study, 
most 
participants 
(83%) used the 
on-demand 
Quit Tips and 
Medication Tips 
features
and 
participants 
viewed
an 
average of 31 
(median=18) 
Quit Tips and 
15
(median=10)
Figure 3. Smart-T pre-quit home screen. Figure 4. Quit Tips function.
Figure 5. Medication function.
Medication tips per viewing session.47 Participants may have viewed such a high number of tips 
because they found the information useful and engaging. High participant ratings for 
helpfulness/ usefulness of the on-demand Tip features adds weight to this explanation.28
Other Smart-T app features. During the pre-quit period, Smart-T participants will receive 
a daily message that reminds them of the number of days until their scheduled quit date (e.g., 
“John, You are scheduled to quit smoking in 5 DAYS at 10:00 pm next Sunday night.
Developing a plan to quit and taking your medications will GREATLY increase your chances for 
staying quit.”). Periodically, participants also receive messages to remind them that the on 
demand features are available when/if needed.
Description of Study Measures.
Baseline and Follow-Up Assessments. Measures will assess demographic and smoking 
characteristics, multiple constructs that are known to be related to lapse (e.g., depression, 
stress, affect, social support), and document intervention effects (See Table 3 and Appendix). 
We will also access participant perceptions of each app feature. The Baseline process will take 
approximately 60-90 minutes to complete and data will be collected either on laptop/tablet 
computers using Questionnaire Development System (QDS) software or remotely via REDCap 
surveys. QDS uses a computer-administered self-interview format (i.e., ACASI), which reduces 
data entry errors and the need to retain paper copies of raw data. Each item appears on the 
computer screen while the program simultaneously reads the item (participants touch the screen 
to select answers only after QDS reads each item). Participants wear headphones so that 
others do not hear the survey items. Participants from our previous studies in similar 
populations, including those with no computer experience, have reported few problems using 
the QDS program. Staff will be available to help participants who may have difficulty. The 
REDCap surveys have been designed to replicate the QDS version as closely as possible. Up 
to 30 participants will complete a 16-week qualitative interview with a staff member over the 
phone regarding their experiences in the study so far. The 26 week post-quit follow-up 
assessment, which includes a longer EMA (i.e., 20-30 minutes) will be completed by participants 
in the smartphone application or through REDCap survey. Additionally, up to 100 intervention 
group participants and up to 100 control group participants will complete a 15-30 minute 
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qualitative interview with a staff member over the phone (or via REDCap if a medical condition
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prevents them from being able to speak for long periods of time) as part of their 26 week post- 
quit follow-up assessment. Recordings will be transcribed by internal staff, Microsoft Transcribe, 
or by approved contractors with whom a Business Associates Agreement has been made. 
When using Microsoft Transcribe, all transcriptions will be reviewed by study staff. Participants 
will be notified that they will earn a $5 bonus if they complete the final EMA within the first 24 
hours that it is available.
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Ecological Momentary Assessment (EMA) enables measurement of phenomena in real- 
time, natural settings.26,27 EMA items will identify fluctuations in key variables that predict study 
outcomes with less bias than traditional in-person assessments. EMA data will be used to 
identify moments of high smoking lapse risk, tailor Smart-T messages, and examine treatment 
mechanisms.
EMA types. The EMA methodology used in this study will be similar to what has been used 
in our previous studies, and by other researchers.29,31,36,43,47,63,76-80 EMA items will assess multiple                       
Table 3. Measures.
FULL BATTERY 
ASSESSMENTS
EMA31,36,47,61-63
MEASURE
ITEMS
Screen
Base
26- 
W
Morning Daily 
Diary‡
Screening Questionnaire
22
X
Cigarettes 
Smoked
Rapid Estimate of Adult 
Literacy in Medicine-Short 
Form64
9
X
Social 
Interactions 
and support
Weight/Height/CO
5
X
NRT Use
Smoking Status 
Questionnaire65
2-4
2
4
Side Effect 
Items
Tobacco History 
Questionnaire
40
X
20
Alcohol 
Consumption
Heaviness of Smoking 
Index66
2
X
X
Self-Efficacy Scale67
10
X
X
Sleep Items
Demographic/Background 
Questionnaire
23
X
End of Day 
Daily Diary‡
Scale of Subjective Social 
Status
2
X
X
Cigarettes 
Smoked
Urban Life Stressors 
Scale68
21
X
Alcohol + 
Marijuana Use
Center for 
Epidemiological Studies 
Depression69
10
X
X
iCO Breath 
Test (3 times 
per week)
Perceived Stress Scale70
4
X
X
Weekly App 
Questions
Pandemic Stress Index 
(PSI) 95
3
X
X
Random/Event 
EMAs
Interpersonal Support 
Eval. List71
12
X
Self-Rated Health72
31
X
10
Recency of 
Smoking
BRFSS Inadequate Sleep
5
X
Urge to Smoke
BRFSS Adverse 
Childhood Experience
11
X
Stress
Health Related Quality of 
Life
3
X
X
Availability of 
Cigarettes
Patient Health 
Questionnaire + GAD7
15
X
X
Recent Alcohol 
Use
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constructs that are hypothesized 
to be related to smoking lapse 
(see Table 3). Three types of 
EMAs will be used: daily diary, 
random sampling, and event 
sampling. Random and
daily diary EMAs will be prompted 
and initiated by the phone. The 
phone will ring and vibrate to cue 
these EMAs for 30-60 seconds. If 
the participant has not responded 
after 5 prompts, the EMA will be 
recorded as missed. Event 
sampling is initiated by 
participants. Participants are 
instructed to self-initiate “Record 
Cigarette” EMAs during the pre- 
quit period, and “Lapse” EMAs 
during the post-quit period. We 
expect random and event 
sampling EMAs to take 
approximately 30 seconds to 
complete and daily diary EMAs to 
take approximately 1-2 minutes to 
complete. All EMAs will be date 
and time stamped for future 
analyses.
Daily diary. Daily diary 
EMAs will be completed twice 
each day for the first 14 weeks of 
the study and once per day for the 
last 13 weeks of the study. The 
phone will initiate the morning 
daily diary 30 minutes after the
participant’s pre-set wake time 
(weeks 1-14) and questions ask 
about the previous day (e.g., 
“How many cigarettes did you 
smoke yesterday?” “Did you use 
marijuana yesterday?,” and “Did 
you drink any alcohol yesterday?” 
If the participant answers “yes,” 
he/she will be prompted to
indicate the type and quantity of the alcohol/cigarettes that were consumed). In addition, 
participants will be asked each day if they experienced severe NRT side effects (the app will 
instruct participants to call 911 if they experience severe NRT side effects, and it will 
automatically send research staff an encrypted email to contact participants). For the entire 27 
weeks of the study, the end of day daily diary will be completed 60 minutes before the
Alcohol Quantity and 
Frequency 
Questionnaire73
9
X
X
Cessation 
Motivation
Alcohol Quantity and 
Frequency 
Questionnaire73
9
X
X
Interaction with 
Smokers
Treatment Quality and 
Satisfaction Survey
19
X
Social 
setting/Location
Treatment Quality and 
Satisfaction Survey
19
X
Reasons for 
Lapse*
Treatment Improvement 
Interview74
18
X
Cigarette 
Reward Value*
Locator Form75
8
X
Lapse Warning 
Signs*
Financial Strain 
Questionnaire
9
X
Weekly EMA
MacArthur Major 
Discrimination
4
X
Pain
Modified Cigarette 
Evaluation Measure
12
X
Treatment 
Quality
Short Scale Anxiety Index
5
X
X
HRQoL
Religious Questionnaire
2
X
Readiness to 
Change
Perceived Neighborhood 
Disorder and decay
15
X
Sleep
Collective Efficacy
10
X
Smoking Items
Informal Integration with 
Neighbors
3
X
Pandemic 
Stress Index
Fear & Mistrust
7
X
Covid Vaccine
Personal Victimization
3
X
Perceptions of Mobile 
Phone Intervention 
Questionnaire
23
X
Covid Vaccine
5
X
X
Delay Discounting Task 
(TOAD)
10
X
Time needed to complete 
assessment (minutes)
--
8
60
40
‡Note: Daily 
Diary EMAs 
also contain all 
Random
EMA items
Note. *Event EMA’s only. 
Screen = Screening; Base
= Baseline; 26-W =
26Week Post-Quit Follow- 
Up.
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participant’s pre-set bedtime. If the participant does not respond to the daily diary assessments, 
they will be rescheduled (up to 2 times) 15 minutes later. A carbon monoxide test will be 
included as one component of this EMA 3 days each week. Participants will not receive credit 
for completing the end of day EMA if they do not complete the prompted iCO breath tests. Both 
the morning and end of day daily diary EMAs will include all random sampling items. Constructs 
that will be assessed are listed in Table 3 and actual EMA items are presented in the Appendix. 
Note: During one EMA each week, participants will be asked multiple questions about the 
usefulness of their app (see Appendix).
Random sampling. Participants will be prompted to complete random EMAs, scheduled 
to occur during each participant’s normal waking hours, 3 times each day for 5 weeks (1 week 
pre-cessation and 4 weeks post-cessation) and 1 time per day for the next 9 weeks (week 6 
through 14). Random sampling will not be conducted during weeks 15-27. EMA items will 
assess the 6 items used for the lapse risk estimator (i.e., urge to smoke, stress, recent alcohol 
use, interaction with other smokers, cessation motivation, and cigarette availability). Other 
relevant constructs will also be assessed during random sampling (e.g., recency of smoking, 
odds of smoking today; See Table 3 and Appendix).
Event sampling. All participants will be asked to self-initiate Smoking EMAs (pre-quit 
week), and Lapse EMAs (post-quit for 26 weeks), see Smart-T pre-quit home screen in Figure 
3). Smoking EMAs. During the first week of assessment (pre-quit week), participants will be 
instructed to indicate when they smoke (by clicking the “Record Cigarette” button). Because the 
assessment burden would be excessive for heavy smokers if each smoking occasion were 
assessed, the smartphone will randomly sample up to two smoking occasions from each 
participant per day. Lapse EMAs. After the quit date, participants will be instructed to complete 
lapse EMAs (by clicking the “About to Slip” or “Already Slipped” buttons) when relevant. Lapse 
EMA items are nearly identical to those presented in the random EMAs. However, questions are 
worded to separately assess the participant’s responses immediately prior to AND following the 
lapse. “About to Slip” EMAs are followed by a second EMA 15 minutes later to assess whether 
participants actually lapsed. Participants are instructed to complete an “Already Slipped” EMA 
when they lapsed, but did not complete the “About to Slip” EMA prior to the lapse. Post-lapse 
EMAs query about the reinforcing value of the lapse cigarette(s), and causes of the lapse.
Constructs that will be assessed are listed in Table 3 and actual EMA items are presented in the
Appendix.
The mHealth Shared Resource at the OUHSC and Stephenson Cancer Center (SCC) 
has developed the InsightTM mHealth Platform which empowers researchers to build, test, and 
launch technology-based assessment and intervention tools. The mHealth resource employs a 
program manager and 4 senior programmers who develop and maintain web and mobile 
applications and relational databases. Applications are developed using state-of-the-art cross 
platform design tools. The Resource is located within the TSET Health Promotion Research 
Center (HPRC), where Dr. Businelle’s office is located. Dr. Businelle is the Scientific Director of 
the mHealth Shared Resource, which will provide the programming services for the proposed 
project.
Smartphone training. Participants will watch a brief step-by-step video tutorial (created by 
the researchers) at the baseline visit that demonstrates use of the app features (i.e., QuitGuide 
or Smart-T). Additional instructions on how to use the study apps will be loaded into the app 
home screen so that participants may view them at any time. We have achieved high EMA 
compliance rates (i.e., 82%-87% of all EMA's completed) using similar protocols in 5 samples of 
socioeconomically disadvantaged smokers (e.g., homeless smokers, safety-net hospital 
patients).29,31,47,54
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Data loss prevention. In order to overcome potential loss of data if participants lose their 
phone (less than 1% of phones have been lost in most studies), phones will be programmed to 
connect to our secure server each day to upload encrypted data. This will ensure that no 
collected EMA data are lost. This tactic will also allow the researchers to remotely monitor each 
participant’s EMA completion rate and intervene (e.g., call the participant) when this rate is low 
(calls will be noted in the dataset and this variable may be used as a covariate in study 
analyses). Importantly, EMA data are password protected and encrypted on the phone and only 
encrypted data are transmitted to our secure server. Thus, study data are ONLY accessible by 
the research team. If a phone is lost, the app and all study data will be remotely wiped and only 
one replacement phone will be provided to each participant.
EMA alert settings. At the baseline visit, a phone set-up wizard is used to set participant 
sleep and wake times for each day of the week (Note: sleep/wake times can be changed for 
those with variable schedules). This practice reduces the likelihood that the phone will ring when 
participants are sleeping. In addition, participants may delay random EMAs by up to 20 minutes 
(i.e., by clicking the snooze assessment option when an EMA is prompted). Daily diaries will be 
automatically rescheduled 15 minutes later (two times) if a participant does not respond to the 
prompt.
Compensation. All participants will be compensated $30 for completing the Baseline 
assessment and $50 for completing the Week 26 post-quit follow-up assessment (note: 
participants who complete the 26 post-quit follow-up EMA within 24 hours will receive a $5 
bonus) and qualitative interview at either the 16-week mark or the 26-week mark. Participants 
will only be asked to complete 1 qualitative interview and will not be asked to complete both 
interviews. We will ask all participants to complete interviews until we have completed 30 16- 
week interviews and a combined 200 26-week interviews (100 per group). Participants will also 
be compensated monthly via GreenPhire gift cards based upon the percentage of Daily and 
Random EMAs that were completed. During the first 37 days (~5 weeks) of the study 
(participants will be prompted to complete 5 EMAs per day). In the first 7 days those who 
complete 50%-69% of all assessments will receive $12 in gift cards, those who complete 70%- 
79% of assessments will receive $18 in gift cards, and those who complete 90% or more of their 
EMAs will receive a total of $25 in gift cards. During the next 30 days, participants will earn up to
$50 per 15-day period (i.e., >90% of EMAs completed = $50 per 15- day period, 80%-89% =
$36 per 15-day period, 50%-79% = $24 per 15-day period). During the next 60 days (~9 weeks) 
of the study (weeks 6-14), participants will be prompted to complete 3 EMAs per day, and will 
earn up to $36 per 15-day period (i.e., >90% of EMAs completed = $36 per 15-day period, 80%- 
89% = $28 per 15-day period, 50%-79% = $18 per 15-day period). During the final 13 weeks of 
the study (weeks 15-27; participants will be prompted to complete 1 EMA per day), participants 
will earn up to $30 per 15-day period depending on the percentage of EMAs completed (i.e., 
>90% of EMAs completed = $30 per 15-day period, 75%-89% = $22 per 15 day period, 50%-
74% = $14 per 15-day period). PARTICIPANTS WILL NOT BE COMPENSATED FOR 
ACCESSING ON-DEMAND APP FEATURES OR COMPLETING TREATMENT 
COMPONENTS. Participants will not receive payment for phone surveys until they confirm or 
update their contact information (i.e., participants can click a button in the app to confirm/update 
their contact information, or study staff will attempt to contact them every 15 days to 
update/confirm contact information). If an interview eligible participant does not complete the 26- 
week post-quit follow-up assessment (either the phone survey component or the phone call 
interview component), he/she will be contacted to reschedule and request that loaned phones 
be returned in person or by mail.
Supplemental Qualitative Interview: Those who participate in the supplemental qualitative
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interview will receive additional $30 compensation. The supplemental qualitative 
interview will take approximately 20-30 minutes to complete.
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Biochemical 
Assessment of 
Smoking Status. 
Consistent with most 
published smoking 
cessation RCTs (see 
Clinical Practice 
Guidelines24), our
primary study outcome will be biochemically confirmed 7-day point prevalence abstinence 26 
weeks following the scheduled quit date. Secondary outcomes (e.g., 30-day point prevalence, 
time to first lapse, longest time of quit) will also be examined. Smoking abstinence will be 
measured daily via EMA self-reports and the Bedfont iCO smokerlyzer will be used to verify 
smoking status on 3 days per week (during the end of day EMA). Participants will be prompted 
to connect the iCO device to the study smartphone and follow step-by-step directions to 
complete the iCO test (e.g., hold your breath countdown, exhale countdown; See Figure 8).
Results of these tests will be date and time stamped and saved. The Smart-T algorithm will 
utilize the results of the iCO test to inform the feedback that is delivered at the completion of 
EMAs. Please note that we have integrated automated and secure (i.e., encrypted) facial 
recognition software to ensure that only the participant completes prompted iCO tests. Our CO 
criteria for abstinence is consistent with numerous studies using cutoffs of ≤ 6 ppm.81-86 The
half-life of CO is up to 8 hours depending on a variety of factors (e.g., time of day, daily smoking 
rate, recency of smoking, physical activity).87 Studies have shown that expired CO is a valid 
indicator of smoking status and cessation outcomes and compares favorably with cotinine and 
other biochemical measures that have longer detection windows.88-91 We believe that self- 
reports of abstinence combined with CO levels suggestive of recent abstinence provide an 
accurate, immediate, and practical measure of abstinence. Finally, the manufacturer indicates 
that the iCO is valid for approximately 200 CO tests and has a sensor sensitivity of 1 ppm.92 Our 
protocol will require 81 CO testing sessions (3 per week for 27 weeks), allowing for repeated 
tests when/if needed.
Description of Study Visits
The Baseline visit will take approximately 60-90 minutes to complete and data will be 
collected on laptop/tablet computers using Questionnaire Development System (QDS) software. 
Staff will be available to help participants who may have difficulty. The Remote Baseline process 
will occur via phone calls with research staff, and data will be collected via REDCap surveys. Up 
to 30 participants will complete a 16-week qualitative interview with a staff member over the 
phone regarding their experiences in the study so far.
The 26 week post-quit follow-up assessment is a longer than usual phone based EMA that will 
take 20-30 minutes to complete. Up to 100 intervention group participants and up to 100 control 
group participants will complete a 15-30 minute qualitative interview with a staff member over 
the phone (or via REDCap if a medical condition prevents them from being able to speak for 
long periods of time) as part of their 26 week post-quit follow-up assessment. Constructs that 
will be assessed are listed in Table 3 and actual assessment items are presented in Appendix 
A.
E. Statistical Methods
Aim 1. We will compare the proportion of participants that are biochemically verified as 
abstinent (i.e., iCO and self-reports indicate no smoking in the past 7 days) between the 
treatment conditions (i.e., Smart-T vs. QuitGuide), at 26 weeks post-quit using a chi-square or
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Fisher’s exact test. We will perform the analysis under the intention to treat (ITT) assumption 
wherein participants who miss iCO EMAs will be considered not abstinent. We will examine the 
missing rate and missing patterns before analysis. If the combined missing rate is very small, 
say less than 5%, then we may safely perform the data analysis on the available data or the 
data assuming ITT. If the missing rate is high, then we will explore sequential multiple 
imputation (SMI) as described by Raghunathan et al.93 The analysis results from SMI data will 
be compared with those from the available data and ITT analyses. Based upon previous 
studies of mobile phone based interventions for smoking cessation (see Cochrane Review94), 
we expect that 9% of those receiving the QuitGuide + NRT treatment will be abstinent at the 26 
week post- quit follow- up visit, and based upon our pilot work, we expect that 18% of those 
receiving the Smart-T + NRT treatment will be abstinent at the 26 week post-quit follow-up visit 
(see47). With an alpha of 0.05 and 225 participants in each group, we have 80% power to 
detect a 9% difference in biochemically confirmed 7-day point prevalence abstinence at 6 
months (i.e., 18% abstinent in the Smart-T group vs. 9% abstinent in the QuitGuide group). We 
expect that groups will be similar in baseline characteristics (e.g., sex, nicotine dependence) 
due to randomization; however, in addition to the chi-square analysis, we will perform logistic 
regression to determine if the odds of abstinence vary by other baseline characteristics (e.g., 
sex, race/ethnicity). Finally, we will examine the interaction between treatment condition and 
sex (and race) to identify potential differential effects on abstinence. The enrollment/baseline 
type (e.g., in person vs. phone call) will be included as a potential covariate in analyses.
We will examine agreement across the iCO and self-reported abstinence measures. Also, 
we will use the self-report and iCO data to construct secondary outcome measures, including 
30day point prevalence abstinence, time to first lapse, and longest period of abstinence, which 
will be compared between treatment conditions. Assuming an 80% iCO compliance rate for 
each participant, we anticipate 62 iCO measures per participant over the study. Lastly, we will 
examine changes in abstinence rates over time using generalized linear mixed model (GLMM) 
regression analysis employing a random intercept or slope parameter, as appropriate, and 
modeling the covariance structure for the repeated outcome measures, while accounting for 
participant characteristics, such as sex.
Aim 2. To determine the impact of treatment condition (i.e., Smart-T vs. QuitGuide) on key lapse 
risk factors (i.e., smoking urge, stress, cigarette availability, and cessation motivation), we will 
examine the effect of tailored messages on lapse risk factors using consecutive pairs of EMAs in 
which the first EMA in the pair results in a tailored message. These paired EMA scores will be used 
to identify whether the change in the lapse risk factor rating from the first to the second EMA in the 
pair differs depending on whether the participant receives a tailored message or not (i.e., Smart-T 
vs. QuitGuide). Assuming that each participant will receive a message targeting a particular risk 
factor at least once, then we have greater than 80% power to observe an effect size of 0.27 or 
larger in the mean of the change in the score for that risk factor in the Smart-T group compared 
with the QuitGuide group. In the Smart-T feasibility study,47 mean changes in raw scores for key 
lapse factors ranged from 0.19 to 0.56; all effect sizes were 0.27 or larger, therefore we have ample 
power to detect potentially clinically relevant changes. There will be up to four pairs of EMAs per 
day across weeks 2-14 of the study. Assuming an 80% EMA completion rate and 25% of EMA pairs 
being considered high risk (thus resulting in a message tailored to a specific high risk trigger), we 
estimate 73 high risk EMA pairs to examine per participant. Roughly 25% of EMA pairs should 
target each key lapse risk factor, resulting in 18 EMA pairs for each message type per participant. 
With 225 participants per group, that provides 4,050 EMA pairs per message type per group to 
include in the longitudinal analyses, resulting in ample power to identify the minimal effect size 
assumed to be clinically relevant. We will also examine the changes in key lapse risk factor scores 
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using linear mixed model (LMM) regression analyses employing a random intercept or slope 
parameter, as appropriate, and modeling the covariance structure for the repeated outcome 
measures, while accounting for baseline participant characteristics. Another analysis will look 
across all paired EMA scores within an individual and assign each individual a success percentage 
score based on the number of times their paired EMA scores decreased by at least one point on 
the Likert scale. For example in an individual that has 50 paired EMA scores for smoking urge, if 40 
resulted in a decrease in urge, 5 resulted in no change, and 5 resulted in an increase in urge, the 
success percentage score would be 80% (40/50). Then we can compare the mean success 
percentage scores between treatment conditions using independent t-tests followed by regression 
analysis to account for baseline participant characteristics. Additional analyses will compare 
success percentage scores early versus late in the study to examine if the effectiveness of tailored 
messages change through time. Finally, we will examine the interaction between Smart-T message 
type and sex (and race) to identify potential differential effects on lapse risk factors.
F. Gender/Minority/Pediatric Inclusion for Research
Inclusion of Women and Minorities. The study has no inclusion/exclusion criteria based on 
gender or race/ethnicity. However, QDS and EMA data collection software is currently offered in 
English only; therefore, all participants must be able to read English at > 6th grade level. Based 
on historical data from TTRP patrons, study participants are expected to be 59% White, 25% 
Black, 10% American Indian, 6% other race, 3% Hispanic, 61% female, and 45% will report <
$20,000 in yearly household income. No eligible participants will be excluded from this study 
due to gender, race, or ethnicity. We will continuously monitor enrollment in order to ensure that 
we are meeting recruitment goals to avoid under-recruiting minorities. If the enrollment for 
minorities is lower than expected, we will make special efforts to increase participation by 
advertising in community newspapers, local church organizations, and community centers. We 
expect that intervention groups (i.e., Smart-T and QuitGuide) will be similar in baseline 
characteristics (e.g., sex, race/ethnicity) due to randomization; however, in addition to the chi- 
square analysis, we will perform logistic regression to determine if the odds of abstinence vary 
by baseline characteristics (e.g., sex, race/ethnicity). We will examine the interaction between 
treatment condition and sex (and race) to identify potential differential effects on abstinence.
Finally, we will examine the interaction between Smart-T message type and sex (and race) to 
identify potential differential effects on lapse risk factors.
Inclusion of Children. Services provided by the TTRP (the proposed data collection site) are 
available to any person ≥ 18 years of age. Children < 18 years of age do not receive services at 
the TTRP (they are referred to the Oklahoma Tobacco Helpline) and will not be included in this 
study for several reasons. First, in order to include these children, the assessment protocols 
being tested would require significant modification to take into account their differing cognitive 
and psychosocial development. Making these modifications would result in a fundamentally 
different set of tasks and would essentially necessitate the conduct of two different studies. We 
do not consider this feasible, short of submitting two different grant applications. Second, the 
FDA has not approved the use of over the counter nicotine replacement therapy in children 
under the age of 18, so we would not be able to provide the full treatment to those individuals, 
making the use of the protocol less than ideal and no longer state-of-the-art. Third, modal quit 
behavior for smoking occurs in adulthood, making this developmental time period particularly 
well suited to a test of mediating processes during a smoking cessation intervention.
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G. Human Participants
1.
Subject Population. Participants (N=450) will be recruited through the TSET Health 
Promotion Research Center (HPRC) Tobacco Treatment Research Program (TTRP). 
Participants will also be recruited through advertisements (e.g. Facebook and Craigslist ads). 
Those who respond to study advertisements will complete a brief REDCap screener online (i.e., 
OKSmokerstudy.com), and those who qualify for the study will contacted by study staff and 
scheduled for a screening/baseline process. Interested individuals may be included in the study 
if they: 1) demonstrate > 6th grade English literacy level (i.e., phone based EMAs require >6th 
grade literacy; at least 88% of all individuals screened for our previous EMA studies have met 
this inclusion criterion), 2) are willing to quit smoking 7 days from the Baseline process, 3) are
 ≥ 18 years of age, 4) have an expired carbon monoxide (CO) level ≥ 7 ppm suggestive of 
current smoking, or substantiate smoking status (e.g., send picture of their pack of cigarettes) 
during the remote baseline process conducted via phone, 5) are currently smoking ≥ 5 cigarettes
 per day, 6) are willing and able to complete the 27 week follow-up session over the phone and 
via EMA, 7) are willing and able to complete EMAs and CO tests on their personal smartphone 
(those who use their personal smartphone will receive an additional $15 per month to offset 
data plan costs if at least 50% of assessments are completed and contact details are confirmed)
 or a study provided smartphone, 8) have household income < 200% of the federal poverty 
guideline, 9) have no contraindications for over the counter nicotine replacement therapy 
(i.e., individuals with uncontrolled blood pressure, history of myocardial infarction within the 
past two weeks, or current pregnancy or plans to become pregnant during the study period
 will be excluded).
2.
Sources of Research Material. All data collection will follow HIPAA guidelines. There
will be 3 sources of data for the current study: 1) in-person or call based data collected during 
the baseline process. The Remote Baseline process will occur via phone calls with research 
staff, and Baseline data will be primarily collected via REDCap surveys, 2) EMA data collected 
on study-provided or personal smartphones via the encrypted InsightTM smartphone application, 
and 3) expired carbon monoxide data assessed via Vitalograph ecolyzer (Baseline visit only) 
and Bedfont iCO smokerlyzer (Baseline and EMA). Measurements of height and weight will be 
collected at the baseline visit.
3.
Recruitment and Informed Consent. Individuals seeking smoking cessation treatment 
during their first TTRP visit will be approached by study research staff to discuss this study. 
Participants will also be recruited through advertisements (e.g. Facebook and Craigslist ads). All 
study staff have completed training in the ethical conduct of research (including CITI training). 
Prior to screening, potential participants will receive information about this voluntary study and 
will be informed that TTRP services are not contingent upon study enrollment. Those who 
remain interested in participating will be provided detailed information about the study by 
research staff, given the opportunity to have their questions answered in a private room or in 
phone calls, and will complete written informed consent via paper or REDCap. Remote 
participants will review and sign consent forms electronically via a REDCap link, and will be 
provided a copy for their records.
4.
Risks. Participation in this study poses minimal risk to participants. Potential risks 
include loss of confidentiality, coercion related to compensation for completion of study 
assessments, nicotine withdrawal, and side effects from nicotine replacement therapy. Each of 
these risks are discussed below. The consent form will clearly describe the potential risks of this 
study. Thus, participants who feel uncomfortable with such assessments or intervention 
programs are not likely to agree to participate.
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Loss of confidentiality. One potential risk is loss of confidentiality. The severity of harm in 
the case of loss of confidentially may range from mild to severe depending upon the individual 
and the specific circumstances. However, the risks of participation in the study are similar to 
that of participation in usual in person or phone based smoking cessation treatments, as loss of 
confidentially may be experienced in each case. Other possible adverse events might include 
compromised data security and discomfort related to being asked study questions. The 
research team will monitor risk and report adverse events immediately to the IRB. Because 
sensitive data will be collected, a Certificate of Confidentiality will be obtained prior to the onset 
of data collection to ensure that data cannot be subpoenaed and used against participants in 
court, and this information will be explained to all participants during the informed consent 
process (Certificates of Confidentiality are now automatically granted for all NIH grants).
Compensation and Potential for Coercion. Considering the very low-income levels of the 
anticipated study sample, we are aware of the potential for coercion in this study due to the 
provision of subject payments. We have paid particular attention the size of payments, 
considering the effort required to complete study assessments. Participants will receive a $30 
gift-card for completing the baseline assessment and $50 gift-card for completing the 26-week 
post-quit assessment (those who complete the final longer EMA within 24 hours will receive a
$5 bonus payment) and qualitative interview at either the 16-week mark or the 26-week 
mark. Participants will only be asked to complete 1 qualitative interview and will not be 
asked to complete both interviews. We will ask all participants to complete interviews 
until we have completed 30 16-week interviews and a combined 200 26-week interviews 
(100 per group). In addition, participants will receive compensation based upon the 
percentage of EMAs that they complete each month. Participants will be able to earn a 
maximum total of $624 in gift cards over 27 weeks (average of < $20/week).
Nicotine Withdrawal. There is a strong likelihood that most study participants who quit 
smoking will experience some nicotine withdrawal symptoms, including anxiety, restlessness, 
anger, irritability, sadness, problems concentrating, appetite change and weight gain, insomnia, 
and decreased heart rate. Withdrawal symptoms are usually short-lived, with most symptoms 
abating within 1-2 weeks. Importantly, Drs. Businelle and Kendzor are trained and experienced 
in addressing these issues as they emerge and the research team will be trained and 
supervised in the monitoring and addressing of psychological problems.
Nicotine Replacement Therapy (NRT; Patch and Gum/Lozenge). Nicotine patch and 
gum/lozenge are smoking cessation medications that are available over the counter and side 
effects (e.g., nausea, skin irritation) are generally mild. All participants will receive NRT. NRT 
has been shown to increase successful smoking cessation, and is currently offered via Quitline 
via mail in all but 5 states. Consistent with over-the-counter package labeling, participants will 
be offered up to 10 weeks of nicotine patches (i.e., label dosage recommendations will be 
followed) and up to 12 weeks of nicotine gum or lozenges (i.e., participants will receive a 4 
week supply of NRT at the baseline visit and will be mailed NRT upon request for post-quit 
weeks 5-12). After 12 weeks, pharmacotherapy will be discontinued. Participants will be asked 
if they experienced NRT side effects each day via EMA. If/When participants report severe side 
effects, the app will suggest that the participant call 911. In addition, the app will automatically 
send an encrypted email to study staff when severe side effects are reported. Study staff will 
attempt to contact the participant to discuss these side effects.
Alternative Treatments. The consent form will explain that, rather than participating in this 
study, individuals may choose to enroll in the standard Tobacco Treatment Research Program 
(TTRP) which provides free smoking cessation medications and in-person, or phone-based 
smoking cessation counseling.
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5. Protections against Risk.
General Procedures. Each participant will be assigned an identification number that will be 
utilized in place of names in all electronic and print data files. The sheet containing the links 
between participant names and identifiers will be kept in locked filing cabinet when not in use 
and will be destroyed 12 months after data collection has been completed. All print information, 
including informed consent and screening questionnaires, will be stored in a separate locked 
filing cabinet in Dr. Businelle’s research offices. All electronic data (with names omitted) will be 
maintained on the investigators’ computers, and all computers and electronic files will be 
encrypted and password protected. Participant information will not be released to any party 
outside the research team at any time.
In-person data. Participants will complete in-person assessments on a laptop or tablet 
computer using the Questionnaire Development System (QDS) program and REDCap. For 
QDS, participants will wear headphones and the computer will read each question aloud.
Participants will be instructed that they may elect to not answer questions that make them feel 
uncomfortable. Participants must have a password to exit the QDS system. Thus, participants 
will not have access to other programs or files on the computer. In addition, all questionnaire 
data is automatically saved and password protected. At the end of each day, participant data will 
be backed up to a password protected database. Those who complete the in-person baseline 
via REDCap will complete the baseline questionnaires on a tablet or computer pre-loaded to the 
required questionnaires. The baseline surveys require a specific website link and code in order 
to access the questionnaire. Participants will be unable to access any other records in REDCap 
due to the use of this link and code. Participants will need a code to complete the final 
questionnaire in order to complete their baseline as well. Thus, they will not have access to any 
other files or programs on the tablet or computer. Alternatively, remote baseline participants will 
complete assessments on their personal electronic devices via a REDCap link. The REDCap 
surveys have been designed to be as similar to the QDS surveys as possible. Questions will not 
be read aloud in the REDCap version, but participants will still have the opportunity to skip 
questions if they choose.
To ensure that research staff are adequately trained in data collection, confidentiality, and 
the protection of human subjects, all project staff will complete extensive training focused on 
each of the following topics: 1) project rationale and objectives; 2) the informed consent 
process; and 3) general data collection procedures (e.g., computer data collection, privacy).
They will also complete all confidentiality, conflict of interest, and HIPAA training programs as 
required by the University of Oklahoma Health Sciences Center.
EMA, GPS, and CO data. Participant responses to study questions, GPS coordinates, and 
results of carbon monoxide tests (i.e., Vitalograph ecolyzer and Bedfont iCO smokerlyzer) will 
be encrypted and stored on the study smartphone. Encrypted data will be automatically 
uploaded to our secure server each day. The following features are designed to ensure the 
security of this data: 1) the data stored on the smartphone device are in a SQLite database in a 
sandbox environment, where read/write operations are only available through the programming 
application (i.e., no file or output is readable to end users); 2) a >10 character password (only 
known to researchers) is required to authenticate the current user before data can be manually 
accessed; 3) the web browser application linking the investigator’s computer to the database is 
on HTTPS protocol (SSL certificate with encryption) which will guarantee the data transfer from 
web browser to the backend database is well protected; and, 4) the backend database is hosted 
by Microsoft Azure. These steps will ensure the security of EMA, GPS, and iCO data. Software 
will be downloaded onto each phone so that study data can be remotely wiped at the end of the 
study and if a phone is lost or stolen.
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Participants will use a study smartphone or their personal smartphone to complete assessments 
through an encrypted mobile application and all data will be automatically saved and sent to the 
study server. For those who receive study smartphones, the research staff will use a unique 
Google Play Store login to download the study app onto the phone. Passwords will only be 
known to research staff. At the conclusion of the participant’s time in the study, participants will 
return the phone and all data collection through the Insight application will end. Study data will 
then be removed from the study phone. Participants who use their personal mobile device will 
receive an additional $15 per month to offset data plan costs (if at least 50% of assessments 
are completed and contact details are confirmed) and will use their personal Google Play Store 
account to download the Insight app. At the conclusion of the participant’s time in the study, the 
study data will be removed from the participant’s phone and all data collection through the 
Insight application will end. Researchers will give participants instructions on how to delete the 
app from their personal device once they complete the study.
6.  Potential Benefits. Potential benefits to participants include the use of study phones 
during the intervention period (at the current time, this benefit is estimated to be unlimited 
voice and text messages and 2 GB high speed data for the duration of their involvement in 
the study [i.e., 6 months]). Participants may also directly benefit from the FREE NRT and 
QuitGuide or Smart-T interventions (i.e., these interventions may reduce the likelihood of 
smoking lapse and relapse).
It should be noted that we also have given thoughtful consideration to the ways in which the 
design of this research may potentially limit the generalizability and specificity of conclusions 
drawn from it. We opted to use the mobile Bedfont iCO to determine smoking status rather than 
require participants to return to the clinic for in-person follow-up visits. This approach will reduce 
burden for socioeconomically disadvantaged smokers who may not have reliable transportation 
and will ensure we have biochemical verification of quit behavior, which is central to the present 
stage of research development. Overall, it is expected that the potential benefits to participants 
in the proposed study will outweigh potential risks.
7. Risks in relation to Benefits. The current study involves very minimal risk to 
participants, and the risks of study participation are similar to that of participation in standard 
care (e.g., loss of confidentiality). All participants will be already seeking standard care before 
they are provided with any information about the research study. In addition, the knowledge 
gained from this study may be utilized to improve our understanding of the barriers to quitting 
and predictors of relapse.
H. Data and Safety Monitoring Plan
Procedures to minimize the risk, including of loss of confidentiality, are described in the 
Protection against Risks section. The study poses minimal risk to participants, therefore 
continuous monitoring and reporting of events will be undertaken by the principal investigator 
(Dr. Businelle) and co-investigators. Although unlikely given our experience, any unanticipated 
problems will be promptly reported to the IRB. The NIH will be informed of any actions taken by 
the IRB as a result of its continuing review. Breach of confidentiality is highly unlikely because 
all data will be encrypted, identified only by numeric code, and stored in locked file 
cabinets/online secure server. A master list of names and numbers will be kept in a separate 
location and is used to facilitate the collection of follow-up data. All staff will be fully trained in 
relevant ethical principles and procedures, particularly around confidentiality. As with any type of 
medication, there is the risk for unexpected side effects from the patch and gum/lozenges. Side 
effects will be monitored daily during daily EMA. When participants report severe side effects in 
the app, a secure email will be automatically sent to research staff with instructions to contact 
the participant to discuss. Study staff will follow-up with participants. In addition, participants will 
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be given contact information and instructed to call 911 and notify study staff immediately if they 
experience any severe side effects.
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