Automated Mobile Contingency Management for Smoking Cessation: A Pilot RCT
Phase: NA
Conditions: Smoking Cessation
Sponsor: University of Oklahoma

IRB NUMBER: 9717
IRB APPROVAL DATE: 11/06/2020
PI Version
1
Title of Project:
Automated Mobile Contingency Management for Smoking Cessation: A 
pilot RCT (SCC PrevailGo)
Principle Investigator: Darla E. Kendzor, Ph.D., Stephenson Cancer Center,
Department of Family and Preventive Medicine, OUHSC
Co-Investigators:
Michael Businelle, Ph.D., Department of Family and Preventive 
Medicine Stephenson Cancer Center, OUHSC
Summer Frank-Pearce, Ph.D., Department of Biostatistics and 
Epidemiology Stephenson Cancer Center, OUHSC
A. Specific Aims
Although smoking prevalence has declined to 15.5% among U.S. adults, 25.3% of those 
living below the poverty threshold continue to smoke.1 Further, socioeconomic disadvantage is 
associated with a reduced likelihood of smoking cessation.2-7 Although socioeconomically 
disadvantaged individuals are just as likely to initiate quit attempts, they are less likely to 
succeed.8 There is mounting evidence that contingency management (CM), or the tangible 
reinforcement of abstinence and other related outcomes, is an effective approach to promoting 
smoking cessation in a variety of populations.9-25 CM interventions are based on behavioral 
principles and operant conditioning, which originated with the work of Thorndike26 and 
Skinner.27 Specifically, outcomes associated with desirable consequences (i.e., positive 
reinforcement) are more likely to recur. Recent research suggests that financial incentives for 
smoking cessation may be particularly appealing among individuals of low socioeconomic 
status.28,29 The findings of two recent meta-analyses have indicated that financial incentives are 
associated with greater odds of behavior change for a variety of behaviors particularly among 
socioeconomically disadvantaged individuals.30,31 The preliminary work of the investigators has 
indicated that offering small escalating financial incentives for smoking abstinence (i.e., CM) 
dramatically increases short-term cessation rates among socioeconomically disadvantaged 
smokers when incentives are included as an adjunct to clinic-based smoking cessation 
treatment.32,33 Preliminary findings from the investigators’ full-scale randomized trial indicate 
that the effect of CM remains at 26 Weeks after the initial cessation attempt and continues 
months after incentives have been discontinued (R01CA197314; PI: Kendzor). However, 
approaches to smoking cessation are needed for those who are unable to attend office visits due 
to transportation difficulties, distance, or incompatible schedules. 
To date, financial incentives interventions for smoking cessation have primarily relied on in-
person visits to verify smoking abstinence. Internet34-37 and mobile phone-based38-40 CM 
approaches have been developed to reduce or eliminate the need for in-person visits. Several 
studies have evaluated an internet-based approach,34-37 where participants access the study 
website and record themselves via webcam as they provide breath samples using a loaned carbon 
monoxide (CO) monitor. Participants upload the recordings for staff review and a credit is 
applied to their study accounts when abstinence and their identity are verified. This process 
requires the provision of expensive carbon monoxide monitoring equipment to participants (e.g., 
Vitalograph ≈ $1200 per device), and staff evaluation of CO values, verification of participant 
identity, and delivery of incentives. Studies have also employed a similar approach using mobile 

IRB NUMBER: 9717
IRB APPROVAL DATE: 11/06/2020
PI Version
2
phones.38-40 Over the past two years, the investigators have automated the mobile CM approach, 
thereby simplifying financial incentives interventions for smoking cessation and making them 
more accessible to individuals who are unable or unwilling to attend in-person abstinence 
confirmation visits. Mobile, automated, CM may offer a scalable approach to cessation that 
could be combined with telephone counseling and pharmacological interventions.
The purpose of the proposed project is to pilot test this automated mobile phone-based CM 
approach. With the assistance of the Mobile Health (mHealth) shared resource41 at the University 
of Oklahoma Health Sciences Center (OUHSC) and Stephenson Cancer Center (SCC), the 
investigators have combined technologies including 1) low-cost carbon monoxide monitors that 
connect with mobile phones42 to remotely verify smoking abstinence, 2) facial recognition 
software43 to confirm the identity of participants while they provide a breath sample, and 3) 
remote delivery of incentives44 automatically triggered by biochemical confirmation of self-
reported smoking abstinence. This automated, mobile CM approach will be evaluated in a 
randomized controlled pilot trial of 40 socioeconomically disadvantaged males and females 
seeking smoking cessation treatment. Participants will be randomly assigned to telephone 
counseling plus nicotine replacement therapy (standard care [SC]) or SC plus a 12 Week mobile 
financial incentives intervention (CM) for biochemically-confirmed abstinence. Participants will 
be followed for 12 Weeks after a scheduled quit attempt to assess smoking status. 
   Primary Aim. To evaluate the preliminary efficacy of an automated, mobile phone-based CM 
approach relative to SC on smoking cessation among socioeconomically disadvantaged adults. 
Hypothesis: Individuals randomly assigned to the CM intervention will have significantly higher 
rates of biochemically-verified abstinence at the 12 Week post-quit follow-up visit than those 
assigned to SC.
The proposed project responds to the Stephenson Cancer Center (SCC) pilot grant funding 
opportunity which encourages collaborative research among SCC members and the translation of 
a novel idea into clinical or community practice. Findings will extend an ongoing, collaborative 
program of research focused on using CM to increase cessation rates among socioeconomically 
disadvantaged adults, and will provide preliminary data supporting an application to the National 
Institutes of Health for a full-scale randomized controlled trial. This fully automated CM 
approach to smoking cessation is highly scalable and will facilitate intervention delivery to 
socioeconomically disadvantaged individuals in Oklahoma and beyond.
B. Research Strategy
I. Significance. The current proposal is significant because the project will evaluate the 
preliminary efficacy of an automated process of identity verification, biochemical verification of 
self-reported abstinence, and delivery of abstinence-contingent incentives. This is different than 
past mobile CM approaches because this approach does not require intensive staff attention and 
oversight. The automated mobile CM approach described in this application was developed by 
the investigators (Kendzor, Businelle) through the SCC mHealth Shared Resource and an NCI 
R01 supplement awarded to Dr. Kendzor (R01CA197314). The proposed project will contribute 
evidence of the efficacy of an automated and scalable approach to CM for smoking cessation, 
which will provide preliminary data for a full-scale randomized controlled trial. 
II. Innovation. The investigators have built upon existing internet34-37 and mobile phone-
based38-40 CM approaches by automating the process, which eliminates the need for staff to 
review recordings, verify identity, and award financial incentives, thus reducing staff burden. 

IRB NUMBER: 9717
IRB APPROVAL DATE: 11/06/2020
PI Version
3
Specifically, the investigators have combined technologies including 1) portable breath CO 
monitors that connect with mobile phones42 for remote biochemical verification of abstinence, 2) 
mobile phone-based facial recognition software43 to verify the identity of the individual 
providing the breath sample, and 3) automated delivery of incentives to a credit card44 following 
biochemical verification of self-reported abstinence. Thus, the current proposal is highly 
innovative in the following ways: 1) the investigators will be the first to completely automate the 
mobile CM approach by combining existing technologies to offer researchers and clinicians a 
tool to remotely verify and incentivize smoking abstinence that requires little staff involvement, 
2) frequent mobile phone assessments will be used to prompt breath CO samples, which will 
increase the possibility of detecting smoking between assessments, and 3) this automated mobile 
CM approach will increase the reach of an effective smoking cessation treatment (CM) to 
individuals who are unable or unwilling to attend regular office visits to verify smoking 
abstinence. 
Preliminary Studies. PREVAIL Pilot. The PREVAIL pilot study was designed to evaluate the 
feasibility and short-term efficacy (4 and 12 Weeks post-quit) of offering small financial 
incentives (gift cards) for biochemically-verified 
abstinence as an adjunct to the smoking cessation 
program offered at the Dallas County safety net 
hospital (i.e., counseling and pharmacological 
treatment). Findings were published in the 
American Journal of Public Health.32 Interested 
and eligible individuals newly enrolled in the 
Parkland smoking cessation program (N = 146) were 
randomized to either Usual Care (UC; n = 71) or 4 
Weeks of CM (UC + adjunctive financial incentives; 
n = 75). All participants were followed weekly from 
1 Week pre-quit through 4 Weeks post-quit; and a 
sub-sample (N = 128) was additionally asked to 
complete an in-person follow-up visit at 12 Weeks 
post-quit. Individuals randomized to the CM intervention earned gift cards for self-reported and 
biochemically-verified abstinence at each visit, such that participants could earn $20 in gift cards 
for quitting on the specified quit day, and this amount increased by $5 with each successive 
abstinent visit (i.e., up to $40 in gift cards at 4 Weeks post-quit; up to $150 total). Participants 
who were non-abstinent at any visit were able to earn gift cards at the next visit if abstinence 
criteria were met, though the gift card payment was reset to the starting level of $20. This 
incentive schedule was also used with a sample of sheltered homeless adults.33 CM 
participants were significantly more likely to achieve 7-day point prevalence abstinence than UC 
participants at all visits after the quit date (all p’s < .05; see Figure 1). CM participants also had 
higher rates of continuous abstinence than UC participants at 4 Weeks (i.e., 25.3% vs. 12.7%, 
p<.05) and 12 Weeks post-quit (20.3% vs. 7.8%, p<.05). Findings suggest that this CM 
intervention approach continues to have a significant impact on cessation outcomes even after 
the incentives are discontinued. 
PREVAIL II. Based on promising findings from the PREVAIL Pilot study, Dr. Kendzor was 
awarded an NCI R01 (R01CA197314) to evaluate the longer term effectiveness (26 weeks post-
quit) of providing small financial incentives (gift cards) for biochemically verified abstinence as 
an adjunct to the smoking cessation program offered through the Tobacco Treatment Research 
Quit Date Week +1
Week +2
Week +3
Week +4 Week +12
0
10
20
30
40
50
60
70
80
90
CM (n = 75)
UC (n = 71)
Figure 1.  PREVAIL Pilot, % abstinent by treatment group (N = 146)
Last Incentive

IRB NUMBER: 9717
IRB APPROVAL DATE: 11/06/2020
PI Version
4
Program (TTRP). A total of 320 socioeconomically disadvantaged men and women will be 
enrolled in the study. The TTRP offers 6 weekly counseling sessions delivered by a Tobacco 
Treatment Specialist, and 12 Weeks of 
pharmacological treatment. To date, 74 
interested and eligible individuals have 
been randomized to either Usual Care 
(UC; n = 39) or UC + adjunctive 
financial incentives (CM; n = 35). The 
incentives schedule was the same as 
described above for the PREVAIL pilot 
study, with the addition of $50 
incentives for biochemically-verified 
abstinence at 8 and 12 Weeks post-quit 
date. To date, CM participants have 
higher rates of 7-day point prevalence abstinence than UC participants at all visits after the quit 
date (see Figure 2). These preliminary findings suggest that the CM intervention continues to 
have an impact on cessation outcomes months after the incentives are discontinued.
PrevailGO. This is an ongoing administrative supplement to R01CA197314 to develop and 
assess the feasibility of an automated, mobile CM approach to smoking cessation for 
socioeconomically disadvantaged adults that can be delivered remotely. The investigators have 
combined technologies including: 1) low-cost portable breath CO monitors that connect with 
mobile phones for remote biochemical verification of abstinence, 2) mobile phone-based facial 
recognition software to verify the identity of the individual while they provide breath samples, 
and 3) automatically delivered incentives to a credit card following biochemical verification of 
abstinence. These features are now integrated into the existing Insight platform developed by the 
SCC mHealth Shared Resource. Internal testing of all PrevailGO features has been completed by 
the study team, and the app has undergone refinements to correct “bugs” and improve usability. 
III. Approach
Study Overview. The purpose of the study is to evaluate the preliminary efficacy of an 
automated, mobile phone-based CM approach (relative to SC) on smoking cessation among 
socioeconomically disadvantaged adults. Eligible adults referred to the TTRP for tobacco 
cessation treatment or recruited via social media (N = 40) will be randomized to: 1) Standard 
Care (SC), which includes 5 Weeks of telephone counseling and 12 Weeks of combination 
nicotine replacement therapy (patches + gum or lozenges) through the TTRP (n = 20), or 2) SC + 
automated, mobile phone-based CM (CM; n = 20). Biochemically-verified 7-day point 
prevalence abstinence at 12 Weeks post-quit will serve as the primary outcome variable. 
Recruitment. Participants (N = 40) will be recruited through the TTRP45 or social media 
(Facebook, etc.). Over the past 12 months, the TTRP has enrolled nearly 300 adults into the 
standard treatment program or ongoing trials. We expect to enroll 6-7 participants per month in 
the proposed study over a 6 month period.
Eligibility Criteria. Eligibility criteria: 1) annual household income of < 200% of the federal 
poverty guideline given household size,46 2) > 6th grade English literacy level47 (i.e., a 7th grade 
reading level is necessary to complete assessments), 3) willingness to quit smoking 7 days after 
enrollment, 4) ≥ 18 years of age, 5) currently smoking ≥ 5 cigarettes per day, 6) no 
Quit
Week 
+1
2
3
4
8
12
Week 
+26
0
10
20
30
40
50
60
70
CM
UC
Figure 2. PREVAIL II, % abstinent by treatment group (N = 74)
Last Incentive

IRB NUMBER: 9717
IRB APPROVAL DATE: 11/06/2020
PI Version
5
contraindications for NRT, and 7) willingness to complete an identity check (i.e., video 
conference call or provide a photo ID). The federal poverty guidelines are used as an eligibility 
criterion by Medicaid and a number of other Federal programs.46 Some federal programs use a 
percentage multiple of the poverty guidelines to determine eligibility. For example, the 
percentage of the poverty threshold required for Medicaid and CHIP eligibility varies widely by 
state, age, pregnancy status, and other factors, and is commonly (though not always) below 200 
percent of the federal poverty guidelines (e.g., see https://www.medicaid.gov/medicaid/program-
information/medicaid-and-chip-eligibility-levels/index.html ). The Principal Investigator has 
previously used <200% of the federal poverty guidelines as an indicator of “low-income” status 
in her peer-reviewed, published research (e.g., Kendzor, Caughy, & Owen, 2012, BMC Public 
Health), as have other investigators (e.g., Kim-Mozeleski & Tsoh, 2018, American Journal of 
Health Promotion; Kalkhoran et al., 2018, American Journal of Preventive Medicine). In sum, an 
annual household income of <200% of the federal poverty guidelines is a reasonable proxy for 
indicating socioeconomic disadvantage as evidenced by similar thresholds used as eligibility 
criteria for federal need-based programs, in addition to the common use of this threshold to 
indicate low-income status in research studies. 
Screening/Enrollment. Enrollment may take place in-person at the TTRP or remotely. For 
details on in-person enrollment TTRP refer to protocol IRB# 6951. Remote enrollment may take 
place in 2 phases. In phase 1, participant eligibility will be assessed. Eligibility criteria includes: 
1) annual household income of < 200% of the federal poverty guideline given household size46, 
2) > 6th grade English literacy (i.e., a 7th grade reading level is necessary to complete 
assessments) 3) willingness to quit smoking 7 days after enrollment, 4) ≥ 18 years of age, 5) 
currently smoking ≥ 5 cigarettes per day, 6) no contraindications for NRT, and 7) willingness to 
complete an identity check (i.e., video conference call or provide a photo ID). Participants who 
meet the criteria will be sent a REDCap link and will have a chance to review the consent form 
and HIPAA electronically. Eligible participants will be given a chance to ask questions about the 
research study and be asked to electronically sign both forms. Participants will also be asked to 
complete the baseline questionnaires and meet with their Tobacco Treatment Counselor (refer to 
TTRP protocol IRB# 6951 procedure). Participants will also have their smartphone assessed to 
determine if the INSIGHT smartphone app is compatible with their phone (currently the 
INSIGHT smartphone app is only compatible with Android phones). Participants who have a 
smartphone that is not compatible with the INSIGHT smartphone app may be mailed a study 
smartphone. Participants who complete phase 1 will be scheduled for a phase 2 visit and be 
mailed a Bedfont iCO smokerlyzer, a Greenphire clinicard, and if applicable a study smartphone. 
At the phase 2 appointment, the participant will be be oriented to the INSIGHT smartphone app. 
The participant will be paid the $30 baseline payment after completing the phase 2 appointment. 
Participants will have 7-10 days to complete the phase 2 appointment. Participants who do meet 
the eligibility criteria or complete phase 2 in time will have the option to enroll in the TTRP for 
(see TTRP protocol IRB #6951) or be connected with the Oklahoma Tobacco Helpline. 
Randomization. Participants will be assigned to the two treatment conditions using a form of 
adaptive randomization called minimization.48 Sex (male vs. female), race/ethnicity (white vs. 
non-white), and CPD (<10 vs. >10) will be balanced between the treatment groups.

IRB NUMBER: 9717
IRB APPROVAL DATE: 11/06/2020
PI Version
6
Intervention Groups. Standard Care (SC). All recommended components of an intensive 
tobacco treatment intervention49 will be provided. Participants will be offered an in-person 
counseling session to create a quit plan (during the baseline/enrollment visit), and then 5 weekly 
telephone counseling sessions with a Certified Tobacco Treatment Specialist. All participants 
will receive 12 weeks of nicotine patches, and nicotine gum or lozenges.
Contingency Management (CM). CM participants will receive SC in addition to small financial 
incentives for biochemically-verified abstinence. The proposed incentive amounts are similar to 
the schedule used in our past work32,33 with $143 in possible earnings by 4 Weeks post-quit, and 
an additional $105 by 6 Weeks post-quit. More specifically, CM participants may earn $20 for 
quitting on the scheduled quit day (with 2 breath samples submitted and identify verification to 
corroborate), and may earn daily payments for quitting each day they are smoke free thereafter. 
Payments will start at $3 per day and increase each week by $1 if they remain abstinent. The 
daily incentive increases weekly with continued abstinence until they reach $8 per day during 
week 6. Participants who smoke at any time, will not earn the incentive that day. However, they 
may begin earning incentives on the next full day of abstinence, though the daily incentive 
amount will reset to $3 per day. Incentives may be earned daily, but they will be credited to the 
study credit card every Friday. (See Table 1. Compensation Schedule).
Yoking/Compensation for Samples.  Participants will be asked to provide a breath sample to 
assess their level of smoking using the Bedfont iCO smokerlyzer from 1 week pre-quit through 
12 weeks post-quit date. Participants will be asked to provide 2 breath samples per day (8 hours 
apart) through 6 weeks post-quit, and 1 breath sample per day through 12 weeks post-quit. 
Participants in the CM group will receive abstinent-contingent incentives as described above. 
Participants assigned to the SC group will be yoked to participants in the CM group. SC 
participants will receive the same payments as their CM counterparts, regardless of their 
abstinence status. This strategy (yoking) will be employed to equate sample submissions and 
payments between the groups, thereby isolating the impact of abstinence-contingent incentives 
on cessation.
Table 1. Compensation Schedule
Abstinence-Contingent 
Incentives/Yoking Payments
Time
Day
Questionnaires 
EMAs
Incentive/
Yoking 
Breath 
Samples
Weekly 
Totals
 
1
2
3
4
5
6
7
 
 
 
 
 
Pre-Quit
$0 
$0 
$0 
$0 
$0 
$0 
$0 
$30 
$10 
$0 
$12 
$52 
Week 1 
$20 
$3 
$3 
$3 
$3 
$3 
$3  
$10 
$38 
$14 
$62 
Week 2 
$4 
$4 
$4 
$4 
$4 
$4 
$4  
$10 
$28 
$14 
$52 
Week 3 
$5 
$5 
$5 
$5 
$5 
$5 
$5  
$10 
$35 
$14 
$59 
Week 4
$6 
$6 
$6 
$6 
$6 
$6 
$6  
$10 
$42 
$14 
$66 
Week 5
$7 
$7 
$7 
$7 
$7 
$7 
$7 
 
$10 
$49 
$14 
$73 
Week 6
$8 
$8 
$8 
$8 
$8 
$8 
$8 
 
$10 
$56 
$14 
$80 
Week 7
-
-
-
-
-
-
-
 
$10 
-
$7 
$17 
Week 8
-
-
-
-
-
-
-
 
$10 
-
$7 
$17 
Week 9
-
-
-
-
-
-
-
 
$10 
-
$7 
$17 
Week 10
-
-
-
-
-
-
-
 
$10 
-
$7 
$17 
Week 11
-
-
-
-
-
-
-
 
$10 
-
$7 
$17 
Week 12
-
-
-
-
-
-
-
$30 
$10 
-
$1 
$41 
 
 
 
 
 
TOTAL 
POSSIBLE $:
 
 
 
 
 
 
 
$60 
$130 
$248 
$132 
$570 

IRB NUMBER: 9717
IRB APPROVAL DATE: 11/06/2020
PI Version
7
Programming. The mHealth Shared Resource at OUHSC and Stephenson Cancer Center (SCC) 
will provide the programming services for the proposed project. Over the past two years, the 
investigators have worked with programmers at the mHealth Shared Resource to guide the 
development of the automated mobile CM approach to smoking cessation (see preliminary 
studies, PrevailGO). Future programming will focus on refinements to the app to address 
problems and increase usability. 
Intervention Hardware. The investigators have combined technologies including 1) portable 
breath CO monitors that connect with mobile phones42 for remote biochemical verification of 
abstinence, 2) mobile phone-based facial recognition software43 to verify the identity of the 
individual providing the breath sample, and 3) automated delivery of incentives to a credit card44 
following biochemical verification of self-reported abstinence. The Bedfont iCO smokerlyzer is a 
personal, portable carbon monoxide (CO) monitor that interfaces with the Insight platform/app 
on an electronic device (smartphone or tablet). Participants in this study may either use their own 
electronic device or maybe provided an Android smartphone. All participants will be provided a 
Bedfont iCO smokerlyzer, and the Insight platform/app will be installed on the participant’s chosen 
electronic device. The Bedfont iCO smokerlyzer is used by participants in this study to collect CO 
levels (in ppm) in exhaled breath, a biochemical indication of smoking abstinence. Data 
collected via the Bedfont iCO smokerlyzer is saved to the electronic device via the Insight 
platform/app and then uploaded to the secure Microsoft Azure content management system 
(CMS) when the electronic device is synced. The Insight platform/app will also be installed on 
each participant’s chosen electronic device. The camera feature on the electronic device is also 
necessary for coincidental facial recognition of a participant as he/she exhales into the Bedfont 
iCO smokerlyzer. The mHealth Shared Resource at OUHSC and the Stephenson Cancer Center 
empowers researchers to build, test, and launch technology-based assessment and intervention 
tools. The Insight platform/app, and facial recognition app are products of the SCC mHealth 
Shared Resource directed by Michael Businelle, co-investigator of this study. The Insight 
platform/app enables the automated mobile contingency management (CM) approach 
investigated by this study, as threshold facial recognition and CO data prompt automated 
delivery of financial incentives to participants. The Insight platform works cooperatively in this 
study to achieve the desired automation, thus eliminating intensive staff attention or oversight. 
Measurement of Abstinence. Smoking abstinence will be measured via self-report and expired 
carbon monoxide (Bedfont iCO smokerlyzer) twice per day from the scheduled quit date through 
12 weeks post-quit. Quit Day abstinence (self-report being smoke free, 2 breath samples 
submitted <10 and identify verification), 1 Week Post-Quit through 6 Weeks Post-Quit (self-
report being smoke free, 2 breath samples submitted ≤ 6 and identify verification), and 7 Weeks 
Post-Quit through 12 Weeks Post-Quit (self-report being smoke free, 1 breath samples submitted 
≤ 6 and identify verification). 
Questionnaire Measures. We will include measures of mobile CM treatment acceptance, 
stress/adversity,50-52 psychosocial resources,53-55 nicotine dependence/craving,56,57 negative 
affect/distress,58-60 and treatment adherence.61,62 Participants will complete a baseline and 12 
Weeks Post-Quit assessment. Participants will be compensated for completing the $30 for 
completing each assessment. Payments will be applied to participants’ study credit cards. (See 
Table 1. Compensation Schedule). Please refer to the TTRP questionnaire appendix (IRB 6951). 

IRB NUMBER: 9717
IRB APPROVAL DATE: 11/06/2020
PI Version
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Ecological Momentary Assessment. Participants will complete mobile phone-based EMAs 
from 1 Week pre-quit through 12 Weeks post-quit. Compensation is based on weekly completion 
percentages. Specifically, those who complete 50%-79% of prompted assessments will receive a 
$5 credit and those who complete 80%-100% of assessments will receive a $10 credit. EMA 
items were selected based on their hypothesized relations to smoking behavior, temptation and 
lapse episodes, and/or their potential importance in understanding the influence of 
socioeconomic disadvantage. Participants will self-report on smoking status and provide a breath 
CO sample twice per day. Participants will be prompted to complete a daily diary and 2 random 
assessments each day from 1-week pre-quit through 6 weeks post-quit. From 7 through 12 weeks 
post-quit, this will reduce to one daily diary prompt per day. Daily diaries are scheduled for each 
morning 30 minutes after the usual wake time. Random assessments are scheduled for twice per 
day during waking hours. GPS coordinates (i.e., latitude and longitude) may be collected via the 
smartphone during each assessment.
Sample Size/Analysis Plan. Forty participants will be enrolled during a 6-month period. The 
TTRP enrolls ≈24 participants per month, and PREVAIL II enrolls a subset of ≈7 participants 
per month. This sample size will allow for project completion within the funding period to 
provide effect size estimates for the full-scale trial.  
Expected Outcomes. It is expected that those randomized to the mobile CM intervention will 
have higher rates of abstinence at 12 Weeks post-quit (and all other time points) than those 
randomized to SC. 
Potential Problems. Some participants will have limited experience using smart phones, 
therefore all will receive hands-on training, including a brief step-by-step video tutorial that 
demonstrates use of the phone and app features (also loaded onto the phone). To overcome loss 
of data if participants lose or change phones, phones will be programmed to connect to our 
secure server daily to upload encrypted data. This will also allow the researchers to remotely 
monitor each participant’s EMA completion rate and call the participant when this rate is low. 
Importantly, EMA data are password protected, encrypted within the Insight app, and only 
accessible by the research team. If a phone is lost, participant data will be remotely deleted.
IV. Relevance. The proposed project will evaluate the prelimary efficacy of an automated, 
mobile phone-based approach to offering financial incentives for smoking cessation in order to 
reach socioeconomically disadvantaged individuals  and reduce tobacco-related health disparities 
without requiring in-person visits.
C. Bibliography and References Cited
D. Protection of Human Subjects
Human Subjects Involvement, Characteristics, and Design. Eligible adults (N = 40) will be 
randomized to: 1) Standard Care (SC), which includes 5 Weeks of telephone counseling and 12 
Weeks of combination nicotine replacement therapy (patches + gum or lozenges) through the 
TTRP (n = 20), or 2) SC + automated, mobile phone-based CM through 12 Weeks post-quit 
(CM; n = 20). Biochemically-verified 7-day point prevalence abstinence at 12 Weeks post-quit 
will serve as the primary outcome variable. Participants will be followed weekly from 1 Week 
pre-quit through 4 Weeks post-quit, with a follow-up assessments at 12 Weeks post-quit. 
Participants will complete assessments on their phones or other preferred device for all 
assessments. Based on recruitment for an ongoing study in the TTRP (PREVAIL II), we expect 
more women than men to participate (73% women). Participants are expected to be primarily of 
non-Hispanic White/Caucasian (63%), Black/African American (27%), or American 

IRB NUMBER: 9717
IRB APPROVAL DATE: 11/06/2020
PI Version
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Indian/Alaska Native (5%) race/ethnicity. Eligibility criteria are: 1) annual household income of 
< 200% of the federal poverty threshold given household size,46 2) > 6th grade English literacy 
level47 (i.e., a 7th grade reading level is necessary to complete assessments), 3) willingness to quit 
smoking 7 days after enrollment, 4) ≥ 18 years of age, 5) currently smoking ≥ 5 cigarettes per 
day, 6) no contraindications for NRT, and 7) willingness to complete an identity check (i.e., 
video conference call or provide a photo ID).
Sources of Materials. Demographic, psychosocial, environmental and behavioral data will be 
collected via: 1) traditional self-report questionnaires completed in-person and via smartphone or 
other preferred device, and 2) EMA completed daily diary via smartphone (2 random 
assessments daily, 1 daily dairies). Smoking status will be evaluated up via expired carbon 
monoxide (iCO) and self-report. If the baseline visit is in-person then we will measure height and 
weight. Weight will also be measured if the 12 Week Post-Quit visit is in-person. If the baseline 
visit is taking place remotely then the participant may self-report height and weight. Counseling 
session completion will be noted by the staff each week. 
Potential Risks. Participation in this study poses minimal risk to participants. However, one 
potential, although unlikely, risk to participants 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 standard care, as loss of confidentially may be experienced in either case. In 
addition, participant data residing on laptop/tablet computers and smart phones will be encrypted 
and password protected.
Adequacy of Protection against Risks
Recruitment and Informed Consent. Eligible individuals will be provided with detailed 
information about the study via a REDCap link or in person at the TTRP. The REDCap link will 
include information about the study, study staff contact information, and a signature field for the 
individual to sign. Participants will have an opportunity to speak with study staff and have their 
questions answered over the phone or in person at the TTRP. Written informed consent either 
remotely via REDCap or in person or in will be obtained from those who are interested in 
participating.
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 file containing the links 
between participant names and identifiers will be kept in a separate password-protected file, 
which will be destroyed 12 months after the completion of the study. All print information 
including informed consent, screening questionnaires, and smoking status questionnaires will be 
stored in a locked filing cabinet in the Principal Investigator’s office. Electronic data (with 
names omitted) will be maintained on the investigators computers, and all computers and 
electronic files will be password protected. Anthropometric measures and CO will be collected in 
a private room in the TTRP. All project staff will complete extensive training focused on each of 
the following topics: 1) project rationale and objectives, 2) the informed consent process, 3) 
general data collection procedures (e.g., computer data collection, privacy), 4) measurement of 
anthropometric data, and 5) use of the carbon monoxide smokelyzer. The financial incentive 
amounts for abstinence (see Table 1. Compensation Schedule) were chosen because they are 
small (inexpensive) relative to those used in other research studies and could therefore 
conceivably be implemented into standard clinic practice. Gift card amounts through 4 Weeks 
post-quit are similar to the successful incentive strategy used in our pilot study. During two 

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additional payment Weeks, incentives of up to $105 (at 5 and 6 Weeks post-quit) will be 
provided to motivate and reinforce abstinence. The proposed intervention offers a maximum of 
$248 for smoking abstinence over a 6 Week post-quit period.  Thus, the amount of incentives 
offered in the current study is low relative to the average weekly amounts offered in most other 
CM interventions for smoking cessation. 
EMA Confidentiality Procedures. The following features are designed to address EMA data 
security issues: 1) the data stored on the smartphone device is in a SQLite database in a sandbox 
environment where read/write operations are only available through the programming 
application. No file or output is readable to end users, 2) a password (only known to researchers) 
is required to authenticate the current user before data can be downloaded from the smartphone 
device to the server, 3) the web browser application linking the principal 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.
Potential Benefits of the Proposed Research to Human Subjects and Others. Potential 
benefits to participants include the possibility that the automated mobile CM intervention will 
have a beneficial impact on smoking cessation outcomes. 
Importance of the Knowledge to be Gained. The knowledge gained from this study may be 
utilized to expand the reach of effective smoking cessation interventions, improve smoking 
abstinence rates in socioeconomically disadvantaged populations, and thereby reduce tobacco-
related disease and health disparities. 
Data and Safety Monitoring Plan The study poses minimal risk to participants, therefore 
continuous monitoring and reporting of events will be undertaken by the Principal investigator 
(Dr. Darla Kendzor) and unanticipated problems will be promptly reported to the IRB. Since the 
standard smoking cessation treatment is offered by the TTRP independent of this research 
proposal, adverse event monitoring will focus on events related to study assessments and the 
administration of financial incentives. Possible adverse events might include compromised data 
security, and severe emotional reactions by participants due to non-payment of incentives 
following conflicting self-reports of abstinence and expired CO levels suggestive of non-
abstinence. 
E. Inclusion of Women and Minorities. The study has no inclusion/exclusion criteria based on 
gender or race/ethnicity. Based on the demographics of our PREVAIL II participants recruited 
through the TTRP, we expect more women than men to participate (73% women). Participants 
are expected to be primarily of non-Hispanic White/Caucasian (63%), Black/African American 
(27%), or American Indian/Alaska Native (5%) race/ethnicity.
F. Targeted/Planned Enrollment Table. See attached.
G. Inclusion of Children. The current study focuses only on individuals who are 18 years of age 
and older. Smoking cessation treatment through the TTRP is available to patients who are ≥ 18 
years of age. Potential participants < 18 years of age (children) will be excluded from the study 
and connected with the Oklahoma Tobacco helpline through our online portal. Separate smoking 
cessation interventions designed for children are warranted and preferable as the smoking 
characteristics and cessation-related needs of children and adults are likely to be very different.
H. Vertebrate Animals. Not Applicable.
I. Select Agent Research. Not Applicable.
J. Consortium/Contractual Arrangements. Not Applicable.
K. Resource Sharing Plan. De-identified data will be made available to outside investigators 
upon request. However, it is noteworthy that data collected as part of the current proposal will be 

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from a small sample, and will not provide sufficient information from which to draw 
conclusions. Rather these data will support a larger, adequately powered trial, from which data 
may be more complete and useful to other investigators.
L. Statement of Work (1 page)
Timeline. Study preparation will be completed during the first month of the funding period. 
Recruitment and enrollment will continue during months 2-7. All 12-Week follow-up visits will 
conclude by month 10. Data analysis and manuscript preparation will begin in month 10 and 
continue through the end of the year.
References
1.
Jamal A, Phillips E, Gentzke AS, et al. Current Cigarette Smoking Among Adults — 
United States, 2016. MMWR Morb Mortal Wkly Rep. 2018;76(2):53-59.
2.
Siahpush M, Carlin JB. Financial stress, smoking cessation and relapse: Results from a 
prospective study of an Australian national sample. Addiction. 2006;101(1):121-127.
3.
Fernández E, Schiaffino A, Borrell C, et al. Social class, education, and smoking 
cessation: Long-term follow-up of patients treated at a smoking cessation unit. Nicotine 
Tob Res. 2006;8(1):29-36.
4.
Wetter DW, Cofta-Gunn L, Irvin JE, et al. What accounts for the association of education 
and smoking cessation? Prev Med. 2005;40(4):452-460.
5.
Businelle MS, Kendzor DE, Reitzel LR, et al. Mechanisms linking socioeconomic status 
to smoking cessation: a structural equation modeling approach. Health Psychol. May 
2010;29(3):262-273.
6.
Fagan P, Shavers VL, Lawrence D, Gibson JT, O'Connell ME. Employment 
characteristics and socioeconomic factors associated with disparities in smoking 
abstinence and former smoking among U.S. workers. J Health Care Poor Underserved. 
2007;18(4 SUPPL.):52-72.
7.
Kendzor DE, Businelle MS, Costello TJ, Castro Y, Reitzel LR, Cofta-Woerpel LM. 
Financial strain and smoking cessation among racially/ethnically diverse smokers. 
AmJPublic Health. 2010;100.
8.
Kotz D, West R. Explaining the social gradient in smoking cessation: It's not in the 
trying, but in the succeeding. Tob Control. 2009;18(1):43-46.
9.
Dunn KE, Sigmon SC, Reimann EF, Badger GJ, Heil SH, Higgins ST. A Contingency-
Management Intervention to Promote Initial Smoking Cessation Among Opioid-
Maintained Patients. Exp Clin Psychopharmacol. 2010;18(1):37-50.
10.
Dunn KE, Sigmon SC, Thomas CS, Heil SH, Higgins ST. Voucher based contingent 
reinforcement of smoking abstinence among methadone maintained patients: A pilot 
study. Journal of Applied Behavior Analysis. 2008;41(4):527-538.
11.
Alessi SM, Petry NM, Urso J. Contingency management promotes smoking reductions in 
residential substance abuse patients. Journal of Applied Behavior Analysis. 
2008;41(4):617-622.
12.
Hunt YM, Rash CJ, Burke RS, Parker JD. Smoking cessation in recovery: Comparing 2 
different cognitive behavioral treatments. Addictive Disorders and their Treatment. 
2010;9(2):64-74.

IRB NUMBER: 9717
IRB APPROVAL DATE: 11/06/2020
PI Version
12
13.
Heil SH, Higgins ST, Bernstein IM, et al. Effects of voucher-based incentives on 
abstinence from cigarette smoking and fetal growth among pregnant women. Addiction. 
2008;103(6):1009-1018.
14.
Higgins ST, Washio Y, Heil SH, et al. Financial incentives for smoking cessation among 
pregnant and newly postpartum women. Prev. Med. 2012;55, Supplement:S33-S40.
15.
Higgins ST, Bernstein IM, Washio Y, et al. Effects of smoking cessation with voucher-
based contingency management on birth outcomes. Addiction. 2010;105(11):2023-2030.
16.
Donatelle RJ, Prows SL, Champeau D, Hudson D. Randomised controlled trial using 
social support and financial incentives for high risk pregnant smokers: Significant Other 
Supporter (SOS) program. Tob Control. September 1, 2000 2000;9(suppl 3):iii67-iii69.
17.
Correia CJ, Benson TA. The use of contingency management to reduce cigarette smoking 
among college students. Exp Clin Psychopharmacol. 2006;14(2):171-179.
18.
Tevyaw TOL, Colby SM, Tidey JW, et al. Contingency management and motivational 
enhancement: A randomized clinical trial for college student smokers. Nicotine Tob Res. 
2009;11(6):739-749.
19.
Volpp KG, Levy AG, Asch DA, et al. A randomized controlled trial of financial 
incentives for smoking cessation. Cancer Epidemiology Biomarkers and Prevention. 
2006;15(1):12-18.
20.
Volpp KG, Troxel AB, Pauly MV, et al. A randomized, controlled trial of financial 
incentives for smoking cessation. New England Journal of Medicine. 2009;360(7):699-
709.
21.
Secades-Villa R, García-Rodríguez O, López-Núñez C, Alonso-Pérez F, Fernández-
Hermida JR. Contingency management for smoking cessation among treatment-seeking 
patients in a community setting. Drug Alcohol Depend. 7/1/ 2014;140(0):63-68.
22.
Ledgerwood DM, Arfken CL, Petry NM, Alessi SM. Prize contingency management for 
smoking cessation: A randomized trial. Drug Alcohol Depend. 2014.
23.
Halpern SD, French B, Small DS, et al. Randomized Trial of Four Financial-Incentive 
Programs for Smoking Cessation. New England Journal of Medicine. 
2015;372(22):2108-2117.
24.
Giles EL, Robalino S, McColl E, Sniehotta FF, Adams J. The effectiveness of financial 
incentives for health behaviour change: Systematic review and meta-analysis. PLoS ONE. 
2014;9(3).
25.
Etter JF, Schmid F. Effects of Large Financial Incentives for Long-Term Smoking 
Cessation A Randomized Trial. J. Am. Coll. Cardiol. Aug 2016;68(8):777-785.
26.
Thorndike EL. The Elements of Psychology. New York: A.G. Seiler; 1905.
27.
Skinner BF. The Behavior of Organisms: An Experimental Analysis. New York: 
Appleton-Century-Crofts; 1938.
28.
Bonevski B, Bryant J, Lynagh M, Paul C. Money as motivation to quit: A survey of a 
non-random Australian sample of socially disadvantaged smokers' views of the 
acceptability of cash incentives. Prev Med. 2012;55(2):122-126.
29.
Sindelar JL, O'Malley SS. Financial versus health motivation to quit smoking: A 
randomized field study. Prev Med. 2// 2014;59(0):1-4.
30.
Haff N, Patel MS, Lim R, et al. The Role of Behavioral Economic Incentive Design and 
Demographic Characteristics in Financial Incentive-Based Approaches to Changing 
Health Behaviors: A Meta-Analysis. American Journal of Health Promotion. 
2015;29(5):314-323.

IRB NUMBER: 9717
IRB APPROVAL DATE: 11/06/2020
PI Version
13
31.
Mantzari E, Vogt F, Shemilt I, Wei Y, Higgins JPT, Marteau TM. Personal financial 
incentives for changing habitual health-related behaviors: A systematic review and meta-
analysis. Prev Med. 6// 2015;75:75-85.
32.
Kendzor DE, Businelle MS, Poonawalla IB, et al. Financial Incentives for Abstinence 
Among Socioeconomically Disadvantaged Individuals in Smoking Cessation Treatment. 
Am J Public Health. 2015/06/01 2015;105(6):1198-1205.
33.
Businelle MS, Kendzor DE, Kesh A, et al. Small financial incentives increase smoking 
cessation in homeless smokers: A pilot study. Addict Behav. 3// 2014;39(3):717-720.
34.
Dallery J, Raiff BR, Grabinski MJ. Internet-based contingency management to promote 
smoking cessation: A randomized controlled study. Journal of Applied Behavior 
Analysis. 2013;46(4):750-764.
35.
Raiff BR, Jarvis BP, Turturici M, Dallery J. Acceptability of an internet-based 
contingency management intervention for smoking cessation: Views of smokers, 
nonsmokers, and healthcare professionals. Exp Clin Psychopharmacol. 2013;21(3):204-
213.
36.
Stoops WW, Dallery J, Fields NM, et al. An Internet-based abstinence reinforcement 
smoking cessation intervention in rural smokers. Drug Alcohol Depend. 2009;105(1-
2):56-62.
37.
Dallery J, Meredith S, Jarvis B, Nuzzo PA. Internet-based group contingency 
management to promote smoking abstinence. Exp Clin Psychopharmacol. 
2015;23(3):176-183.
38.
Hertzberg JS, Carpenter VL, Kirby AC, et al. Mobile Contingency Management as an 
Adjunctive Smoking Cessation Treatment for Smokers With Posttraumatic Stress 
Disorder. Nicotine Tob Res. November 1, 2013 2013;15(11):1934-1938.
39.
Carpenter VL, Hertzberg JS, Kirby AC, et al. Multicomponent Smoking Cessation 
Treatment Including Mobile Contingency Management in Homeless Veterans. Journal of 
Clinical Psychiatry. Jul 2015;76(7):959-964.
40.
Kong G, Goldberg AL, Dallery J, Krishnan-Sarin S. An open-label pilot study of an 
intervention using mobile phones to deliver contingency management of tobacco 
abstinence to high school students. Exp Clin Psychopharmacol. 2017;25(5):333-337.
41.
OTRC. Mobile Health. 2016; http://otrc.stephensoncancercenter.org/MobileHealth.aspx. 
Accessed December 21, 2017.
42.
Bedfont. iCO Smokerlyzer: The world's first smokerlyzer breath CO monitor for your 
smartphone/tablet. 2017; https://www.bedfont.com/shop/smokerlyzer/ico-smokerlyzer. 
Accessed March 29, 2018.
43.
Microsoft. Microsof Azure: Face API. 2018; https://azure.microsoft.com/en-
us/services/cognitive-services/face/. Accessed March 28, 2018.
44.
greenphire. ClinCard: Automated Participant Payments 2018; 
https://greenphire.com/clincard/. Accessed March 28, 2018.
45.
OTRC. Tobacco Treatment Research Program (TTRP). Treatment 2016; 
http://otrc.stephensoncancercenter.org/Treatment.aspx. Accessed October 25, 2017.
46.
DHHS. Annual Update of the HHS Poverty Guidelines. Federal Register: The Daily 
Journal of the United States Government 2018; 
https://www.federalregister.gov/documents/2018/01/18/2018-00814/annual-update-of-
the-hhs-poverty-guidelines. Accessed June 4, 2018.

IRB NUMBER: 9717
IRB APPROVAL DATE: 11/06/2020
PI Version
14
47.
Arozullah AM, Yarnold PR, Bennett CL, et al. Development and Validation of a Short-
Form, Rapid Estimate of Adult Literacy in Medicine. Medical Care. 2007;45(11):1026-
1033 1010.1097/MLR.1020b1013e3180616c3180611b.
48.
Taves DR. Minimization: A new method of assigning patients to treatment and control 
groups. Clinical Pharmacology and Therapeutics. 1974;15(5):443-453.
49.
Fiore MC, Jaen CR, Baker TB, Bailey WC, Benowitz NL, Curry SJ. Treating Tobacco 
Use and Dependence: 2008 Update. Clinical Practice Guideline 2008; 
https://www.ncbi.nlm.nih.gov/books/NBK63952/. Accessed October 26, 2017.
50.
Jaffee KD, Liu GC, Canty-Mitchell J, Qi RA, Austin J, Swigonski N. Race, urban 
community stressors, and behavioral and emotional problems of children with special 
health care needs. Psychiatric Services. 2005;56(1):63-69.
51.
MacArthur. Detroit Area Study Assessment of Everyday Discrimination Research 
Network on SES & Health 2008; 
http://www.macses.ucsf.edu/research/psychosocial/detroit.php Accessed December 17, 
2012.
52.
Pearlin LI, Lieberman MA, Menaghan EG, Mullan JT. The stress process. J Health Soc 
Behav. 1981;22(4):337-356.
53.
Velicer WF, Diclemente CC, Rossi JS, Prochaska JO. Relapse situations and self-
efficacy: An integrative model. Addict Behav. 1990;15(3):271-283.
54.
Carver CS. You want to measure coping but your protocol's too long: Consider the brief 
COPE. International Journal of Behavioral Medicine. 1997;4(1):92-100.
55.
Lubben J, Blozik E, Gillmann G, et al. Performance of an Abbreviated Version of the 
Lubben Social Network Scale Among Three European Community-Dwelling Older 
Adult Populations. The Gerontologist. August 1, 2006 2006;46(4):503-513.
56.
Kozlowski LT, Porter CQ, Orleans CT, Pope MA, Heatherton T. Predicting smoking 
cessation with self-reported measures of nicotine dependence: FTQ, FTND, and HSI. 
Drug Alcohol Depend. 1994;34(3):211-216.
57.
Smith SS, Piper ME, Bolt DM, et al. Development of the brief wisconsin inventory of 
smoking dependence motives. Nicotine Tob Res. 2010;12(5):489-499.
58.
Irwin M, Artin K, Oxman MN. Screening for depression in the older adult: Criterion 
validity of the 10-item center for epidemiological studies depression scale (ces-d). Arch. 
Intern Med. 1999;159(15):1701-1704.
59.
Watson D, Clark LA, Tellegen A. Development and validation of brief measures of 
positive and negative affect: the PANAS scales. Journal of Personality & Social 
Psychology. Jun 1988;54(6):1063-1070.
60.
Spitzer RL, Kroenke K, Williams JBW. Validation and utility of a self-report version of 
PRIME-MD: The PHQ Primary Care Study. Journal of the American Medical 
Association. 1999;282(18):1737-1744.
61.
Morisky DE, Green LW, Levine DM. Concurrent and Predictive Validity of a Self-
Reported Measure of Medication Adherence. Medical Care. 1986;24(1):67-74.
62.
Horne R, Weinman J, Hankins M. The beliefs about medicines questionnaire: The 
development and evaluation of a new method for assessing the cognitive representation 
of medication. Psychology and Health. 1999;14(1):1-24.