QuitBet Phase II: A Digital Social Game That Pays You to Stop Smoking
Phase: NA
Conditions: Smoking Cessation
Sponsor: WayBetter, Inc.

QuitBet Phase II protocol for clinicaltrials.gov 
 
 
 
 
 
 
Protocol Title:  
QuitBet Phase II: A Digital Social Game that Pays You to Stop Smoking 
 
September 28, 2022 
 
Funding Agency: National Institute on Drug Abuse (NIDA) 
Grant Number: R44DA048668 (Phase II: 4/15/20-3/31/24) 
Sponsor: WayBetter, Inc. (grant awardee) 
Principal Investigator: Jamie Rosen (CEO of WayBetter) 
Project Director: Erika Bloom, PhD (Director of Product and Research at WayBetter) 
NCT05075213 
 
 

QuitBet Phase II protocol for clinicaltrials.gov 
 
 
 
A. SIGNIFICANCE 
 
There is a Critical Need to Increase Acceptability and Accessibility of Smoking Cessation Treatment 
 
Cigarette smoking persists as the leading cause of preventable death in the U.S., annually responsible 
for more than 480,000 deaths [1] and a total economic burden of over $300 billion [1, 2]. Most U.S. smokers 
want to quit and over half try to quit each year [3]. In clinical trials, behavioral and pharmacological treatments 
each increase the likelihood of achieving long-term abstinence. However, most U.S. smokers do not use 
these treatments. During their quit attempts, <30% of smokers use medication, <10% receive behavioral 
treatment, and <5% use both [3, 4]. The majority of quit attempts undertaken without the aid of treatment (i.e., 
unassisted) end in relapse within one week [5, 6]. Only 3-5% of unassisted quit attempts result in long-term (> 
6 months) abstinence [5]. Barriers to engaging in behavioral treatment include perceived (and real) costs of 
treatment, logistical barriers (e.g., transportation, time, scheduling), lack of knowledge of how to access 
programs, low expectancies of effectiveness, stigma related to seeking counseling, beliefs that professionals 
may not understand smokers if they have not smoked, valuing lay knowledge from peers over professional 
help, and the belief that quitting is a personal responsibility that requires only motivation and willpower [7, 8]. 
 
Delivering Behavioral Treatment Via Digital Technology May Increase Access and Uptake 
Arguably the most significant recent innovation in behavioral treatment for smoking cessation has been 
the development of treatments delivered via digital technologies. In particular, interest in smartphone 
applications to aid smoking cessation is growing rapidly. There are hundreds of smoking cessation apps 
currently available in the Apple and Andoid app stores [9, 10], and smokers express strong interest in them 
[11]. However, to date, very few have been empirically validated [9] and they have had limited reach [11-13]. 
Our company, WayBetter, Inc., has already demonstrated the ability to develop and successfully 
commercialize a smartphone application targeting a health behavior change [14]. In this study, we will 
complete the development of and test another new game: QuitBet. QuitBet will target smoking cessation, 
for which there is a critical need for innovative industry solutions. QuitBet is modeled upon and builds 
upon the commercial success of DietBet and our other games. We recently developed the QuitBet prototype 
and conducted an initial test game that established proof-of-concept. 
All of our games, including QuitBet, consist of two primary components intended to foster inspiration, 
motivation, friendly competition, and, above all, fun: 1) social gaming elements, including a digital game 
activity board with an interface similar to Facebook on which a game host and players can post messages, 
photos, and videos and view results in real time, and 2) self-sustaining financial incentives in the form of a 
deposit contract, which we call the “bet.”  
All games are offered with a range of bet amounts to accommodate players of varying motivation and 
income levels; a typical bet is $30 for a 4-week game. All players who achieve their game’s goal are declared 
“winners” and equally split the pot of money bet at game start. Thus, winners are refunded their entire bet plus 
receive extra money from the forfeited bets of players who did not meet the goal. We have established 
systems for objective verification of game outcomes.  
 
Traditional Contingency Management (CM) is Very Effective but Not Feasible for the Real World 
The use of financial incentives to motivate and reinforce desired behavior, termed “contingency 
management” (CM), is an evidence-based intervention rooted in the principles of operant conditioning theory. 
Extensive research supports the efficacy of CM for smoking cessation [15] and other health-related behavior 
changes [16-20]. Indeed, CM is one of the most effective behavioral intervention approaches for smoking 
cessation, especially in underserved and treatment-resistant populations, such as pregnant women [21] and 
smokers with comorbid psychiatric [e.g., 22] and substance use disorders [23]. However, traditional CM as 
developed and tested in research settings has not been widely implemented in community settings [24, 25]. 
In 2010, Petry [26] reviewed the four primary reasons why CM has had limited real world 
implementation. The first is that although CM is very effective while the target behavior is being incentivized, 
high relapse rates are observed when incentives are no longer available [15, 16, 27]. Petry insightfully notes 
that this criticism is “often directed toward CM” but also applies “equally to other treatments” and “it is unclear 
why CM should be held to higher standards.” Second, there is some concern that CM could undermine internal 

QuitBet Phase II protocol for clinicaltrials.gov 
motivation to change, but this concern may be unfounded [28-30]. Third, there are emotional and ethical 
concerns that reduce acceptability. CM has been viewed as “bribery” or unfair (e.g., why should we “pay 
people for what they should be doing anyway”?) (see also [31,p. 909]). Therefore, although CM is potentially 
more cost-effective than other treatments [e.g., 32, 33-35], it has been difficult to obtain funding for the 
incentives. Finally, there are practical concerns about feasibility [26, 36-38]. Traditional CM for smoking 
cessation requires daily clinic visits for biochemical verification of abstinence using exhaled breath carbon 
monoxide (CO) testing. Daily testing is necessary because breath CO only remains elevated for up to about 24 
hours after smoking [39]. This schedule is unlikely to be feasible, especially for disabled, rural, or low income 
smokers who may lack transportation or childcare [37], and given limited clinic hours. Some CM studies have 
employed testing of cotinine instead of CO, which only requires weekly testing. However, since cotinine testing 
detects all sources of nicotine, it is not valid if an individual is using nicotine replacement therapy (NRT), an 
effective treatment [40] that typically costs less per day than smoking [41]. Given these challenges, most CM 
interventions have been of very short duration (≤ 4 weeks) and have not incorporated NRT use.  
 
QuitBet: A Social, Digital Game that Pays You to Stop Smoking 
We designed QuitBet to overcome all limitations of traditional CM. We believe that QuitBet has 
the potential to fulfill a critical need to deliver empirically-supported behavioral treatment to the 
millions of U.S. smokers who want to quit but are unwilling or unable to access traditional behavioral 
treatments. Our intention is that QuitBet players, like the players in our other games, will be able to play 
multiple consecutive games and thereby be incentivized indefinitely until they achieve abstinence. Consecutive 
games could be played for as long as needed to sustain long-term abstinence.  
Second, QuitBet players, like the players in our other games, fund all of the incentives themselves. 
Therefore, there should be no concerns about the fairness of or source of the incentives. Our deposit contract 
[35, 42-45] procedure is rooted in loss aversion theory, which posits that people are more motivated to avoid 
losses than to obtain equivalent gains [46]. Deposit contracts for smoking cessation are not new and were 
tested as early as the 1970s. Early studies found that deposit contracts were effective, but, as with reward-only 
CM, relapse was observed during post-treatment follow-up [42, 45, 47]. As noted above, we address the 
problem of post-treatment relapse by allowing for game play to be extended as long as needed. More recently, 
the efficacy of deposit contracts has been compared directly to traditional, reward-only CM. A study conducted 
by Consultant Dallery and colleagues found no significant difference in abstinence rates between participants 
who paid a $50 deposit that was earned back for abstinence (plus additional incentives once the deposit was 
recouped) vs. a group who earned incentives for abstinence but did not pay a deposit [48]. A trial [44] that 
included over 2500 participants revealed that deposit contract programs in which participants could earn back 
a $150 deposit plus additional rewards for quitting smoking had significantly lower abstinence rates overall 
than reward-only programs (10.2% vs 15.7% abstinent at 6 month follow-up). However, this outcome was 
attributable to a difference in program acceptance rate. Whereas 90% of those who were randomized to a 
reward-only program enrolled in it, only 14% of those randomized to a deposit program made the deposit and 
enrolled. Among those who enrolled in their programs, 6-month abstinence rates were 17.1% in the reward-
only programs vs. 52.3% in the deposit programs. After adjusting for lower willingness to enroll in the 
deposit programs, the deposit programs were found to have an abstinence rate 13% higher than the reward-
only programs. The deposit programs were “superior to rewards even if we assumed that participants who 
would accept deposits had up to 12.5 times greater underlying propensities to stop smoking than participants 
who would accept rewards only.” (p. 5). Our take-away from this study is that $150 is likely to be an 
unacceptably high deposit amount for many smokers. Our $30 deposit should be more acceptable [49]. 
Third, QuitBet is more feasible than traditional CM because it is delivered entirely via the Internet. We 
believe that digital CM (DCM) has even greater potential to reach low income populations, who have the 
highest rates of tobacco use [50], than traditional clinic-based behavioral treatments given the convenience 
and growing ubiquity of Internet-connected smartphones capable of recording video and because this 
technology eliminates barriers to access that disproportionately affect the underserved (e.g., transportation, 
childcare, costs). In 2017, the smartphone ownership rate among U.S. adults was 77% (92% for age 18-29 and 
88% for age 30-49) [51]. Rates did not differ by race or ethnicity [51] and continue to increase toward complete 
saturation [52], including among low income individuals. In two recent studies [12, 53] involving over 700 U.S. 
smokers, the smartphone ownership rate was consistent with general U.S. population data (70-80%).  
Finally, QuitBet is not just CM. It incorporates novel social gaming elements intended to foster social 
support, internal motivation to change, and a sense of fun. Group treatments are theorized to work in part by 

QuitBet Phase II protocol for clinicaltrials.gov 
instilling hope, universality, altruism, group cohesion, and modeling [54]. One might predict that QuitBet players 
would act as adversaries given that they stand to win more money if more players are unsuccessful. However, 
our experience with DietBet has shown that, in contrast, our players are extremely supportive of each other. 
They are having FUN while losing weight. Group smoking cessation treatments have a long history in the U.S. 
Some have been commercialized (e.g., Smokenders, American Lung Assocation’s Freedom from Smoking). 
However, these programs have had limited reach and have not been recently evaluated [55]. More recent 
evaluations of group-based treatments available primarily from the Stop Smoking Services in the United 
Kingdom suggest that group-based treatments are at least as effective, and may be even more effective, than 
individual treatments [55]. Nevertheless, in the U.S., there remain significant challenges to making group-
based treatments readily available in clinical settings [56]. In contrast, QuitBet will be much more accessible, 
representing a viable alternative or adjunct to other treatment options such as quitlines.  
 
Digital Contingency Management (DCM) for Smoking Cessation Has Established Efficacy 
Consultant Dallery and his colleagues pioneered the use of DCM for smoking cessation [36, 37]. DCM 
has already been tested for rural smokers [57, 58], smokers with PTSD [59], and homeless veteran smokers 
[60], with demonstrated feasibility and efficacy. In these studies, participants were mailed a professional CO 
testing device (value $500+) and other necessary equipment (e.g., web camera) for remote verification of 
smoking abstinence, which eliminated the need for daily clinic visits. Dallery and colleagues recently 
demonstrated the feasibility, acceptability, and efficacy of a DCM program that included a $50 deposit contract 
[49]. Given the cost of the CO testing device, only a small number of participants could be accommodated in 
these studies and participants had to mail back the device at the end of the study, which limited the potential 
for real-world dissemination and scalability. In QuitBet, participants test their CO using the Bedfont iCO 
Personal Smokerlyzer. The iCO, released in 2015, is the first low-cost ($60) CO monitor intended for 
personal use by an individual consumer (it cannot be sanitized for use by multiple individuals). The iCO 
connects to the user’s personal smartphone via a free application that can automatically transmit the results via 
email (e.g., to a clinician or research team). It has a range of 0-100 parts per million (ppm) with a sensitivity of 
1ppm, an operating life of about 200 tests or 3 years, and a 6-month warranty.  
 
Summary of Significance 
We believe that, like our other games, QuitBet will be broadly appealing, produce clinically meaningful 
outcomes, and have the potential for very large reach, thereby having a significant positive impact on public 
health. Furthermore, we did not design QuitBet as a replacement for or competitor to medication or other 
behavioral treatment. Rather, QuitBet should be compatible with virtually all other cessation treatment options. 
 
B. INNOVATION 
 
Our research is innovative in these important respects: 
1) QuitBet will be the first digital smoking cessation program that employs a self-sustaining, 
entirely participant-funded deposit contract model of CM. The use of a deposit contract greatly reduces 
costs as well as concerns about the fairness of incentives and identifying funding sources. 
2) QuitBet will be the first digital smoking cessation program to combine a deposit contract with 
novel social gaming components intended to increase engagement and internal motivation to change. 
The purpose of “serious games” is to apply game elements (competition, prizes, social interaction) to serious 
health issues [61], and make the process of behavior change engaging and fun. Thus, gaming is thought to 
have serious potential for health behavior change [61, 62]. Previous studies have demonstrated the efficacy of: 
1) group-based DCM for smoking cessation that included opportunity for communication among teammates (3-
4 per team) [e.g., 63] and 2) “competitive” deposit programs [44]. Also, recent studies have evaluated video 
games for: 1) preventing tobacco use among youth [64], 2) coping with urges to smoke during a quit attempt 
[65], and 3) promoting smoking cessation with video game-based rather than monetary rewards [66, 67]. 
However, to our knowledge, no studies have yet examined the impact of an evidence-based serious game for 
smoking cessation with our deposit contract model. Novel social gaming components of QuitBet include 
crowdsourced verification of CO test results and a game host. The host facilitates and encourages player 
discussions and provides content that integrates evidence-based education about the process of and 
treatments for smoking cessation with fun activities.  

QuitBet Phase II protocol for clinicaltrials.gov 
3) The research will be conducted entirely via the Internet. We will recruit smokers from throughout 
the U.S. They will play QuitBet on our established digital platform, which can accommodate a virtually unlimited 
number of “players.” If shown effective, QuitBet will be scalable and commercializable.  
 
C. APPROACH 
 
 
Previous Study: QuitBet Phase I Pilot Trial 
 
Our goal for Phase I was to achieve the following three milestones: 
1) Complete development of the QuitBet smartphone application, which will be adapted from the 
applications for our other games and include a custom iCO application with the capability to record 
CO tests on video. We will develop content and links to resources for the game host to post on the 
game activity board that are consistent with best practices for smoking cessation [40, 89] and are 
intended to promote internal motivation to change, engagement with QuitBet, and fun. 
2) Demonstrate that QuitBet is feasible; that is, that there is consumer demand for Quitbet. 
3) Demonstrate that QuitBet is acceptable (pilot trial players are engaged, satisfied, and can be retained). 
Our secondary aim for Phase I was to demonstrate preliminary effectiveness of QuitBet. However, this pilot 
trial was not designed or powered for a formal evaluation of effectiveness.  
Phase II Study Design Overview 
 
Our first step for Phase II is to make minor revisions to the QuitBet program and study procedures based on 
the feedback provided by Phase I participants. There will be no human subjects involved in this portion of the 
project.  
 
Then, we will conduct a randomized controlled trial (RCT) to examine the effectiveness of QuitBet 
compared to an alternative version of QuitBet (QuitBet-NS) consisting of a $30 deposit contract only (no social 
gaming elements). In Phase II, all players will be offered the opportunity to play a second QuitBet game at the 
end of their first game. All Phase II participants will complete follow-up surveys at the end of their first and 
second games (regardless of whether they choose to play the second game) and at 1 and 4-months after the 
second game is over.  
 
Bedfont iCO Personal Smokerlyzer. CoVita, the USA distributor of the iCO, informed our study team after 
the Phase I pilot trial ended that the original iCO has been discontinued. A new updated model, called the 
iCOquit, will be used for Phase II. Wheras the original iCO used a cord to connect to smartphones via the 
headphone jack, the new iCOquit is cordless and uses a Bluetooth connection instead. Otherwise, the two 
devices appear and operate in a nearly identical manner. Also, the new iCOquit has a longer battery life (lasts 
for 500-1000 tests instead of 200) and an upgraded free companion app with more features. We will update 
the QuitBet app so that it is compatible with the new iCOquit for Phase II. Detailed information about the new 
iCOquit may be found here: https://www.icoquit.com/us/. As in Phase I, we will allow participants who 
experience technical difficulties with taking or submitting their CO tests in the QuitBet app to use the free 
(updated version) of the iCOquit app instead to submit a screenshot of their results. 
 
In general, the Phase II RCT procedures including recruitment, enrollment, game play, surveys, and retention 
strategies will be similar to the Phase I pilot trial.   
 
Participants. We will recruit a total of approximately 550 participants in Phase II. Phase II participants will be 
recruited in cohorts. We are aiming for approximately 50 participants per cohort, but the number of participants 
in each cohort may vary with no minimum or maximum limit. We will continue to recruit cohorts until we reach 
our goal of a total of N = 550 participants.  
 
Eligibility Criteria. The official eligibility criteria for Phase II will be as follows: 
 

QuitBet Phase II protocol for clinicaltrials.gov 
Phase II eligibility criteria: 
1) Sufficient English fluency to complete study procedures  
2) at least 21 years of age 
3) U.S. resident of any state 
4) currently smokes at least 5 cigarettes per day 
5) has an email address they check regularly 
6) has a mailing address at which they can receive packages 
7) owns an Internet-connected Apple iPhone or Android smartphone that is compatible with QuitBet (Phase I 
was restricted to Apple; Phase II will include Apple and Android) 
8) willing to deposit $30 (QuitBet “bet”) via PayPal or a credit card 
9) willing to receive financial incentives earned during QuitBet via PayPal or in a paper check sent by mail 
 
Notes about eligibility changes from Phase I: For Phase II, we will include Alaska and Hawaii residents.  We 
also eliminated the exclusion for current pregnancy or planning to become pregnant within one year.  We 
realized it was not necessary to exclude pregnant women as this protocol poses no additional risk to them and 
pregnant women are highly encouraged to quit smoking. Furthermore, many previous studies have shown 
beneficial effects of financial-incentive based interventions for smoking cessation among pregnant women. 
Current clinical guidelines indicate that there is not sufficient evidence to recommend that pregnant women use 
over-the-counter nicotine replacement therapies or other smoking cessation medications but that use may be 
considered under a physician's supervision. Therefore, the game rules as well as education about cessation 
medications provided during the game by game hosts will always include a disclaimer that pregnant women 
should consult a healthcare professional before using these medications. 
 
Recruitment and Enrollment Process. Participants will be recruited from throughout the continental U.S. We 
will recruit using the marketing strategies that we use for our other games: advertising throughout the U.S. on 
social media, emails sent to our database of registered subscribers, and messages posted within the feeds of 
our other games and in our social media accounts. Additionally, we will advertise on other websites that allow 
postings about research studies, on email lists that we have access to (e.g., professional society listservs for 
tobacco researchers and clinicians), by emailing our professional networks and encouraging them to share the 
study information with their colleagues and clients/patients, and by hanging paper flyers in public locations. All 
advertisements will indicate an opportunity for smokers to participate in a research study testing QuitBet, a quit 
smoking game that is modeled upon DietBet and our other games. We acknowledge that many people who are 
exposed to QuitBet marketing will be current or former WayBetter game players and may not be smokers; 
therefore, we will encourage sharing the information about QuitBet with friends and family members who 
smoke. Additional advertising methods will include: 1) contracting with companies that specifically offer 
services to help researchers recruit participants for studies and other marketing agencies,  2) using social 
media influencers to help promote the study, and 3) advertising on other websites. 
 
WayBetter, Inc. has previously enlisted social media influencers and celebrities to promote their games.  
During Phase II, we will identify influencers who willing to promote QuitBet by posting about the study on their 
social media accounts, following procedures in our previously Advarra-approved Social Media Influencer Plan.  
 
We will streamline the enrollment process for Phase II to make it easier for people to find out about the study 
and enroll.  For Phase II, the QuitBet app will be publicly available in the App Stores.  People who are 
interested may find this app by searching directly in the App Store (e.g., they might search for "quit smoking" 
apps) or by seeing a link to the app store page in a study ad or on the study website (www.quit.bet).  Anyone 
may download the QuitBet app for free. Upon downloading the app, they will proceed through the study 
enrollment process. Upon opening the app for the first time, they will see a screen that provides a brief 
description of QuitBet and the study eligibility criteria (we have eliminated the formal screening survey), as well 
as links to the full game rules and the consent form. The consent form will be a page on the QuitBet website. 
This page will be accessible to participants throughout the study (on the website and within the app) and they 
may request a copy via email (pdf). They will click a box that says "sign up with email" and be asked provide 
their name, email address, and a password to create a QuitBet account.  The screen will indicate that by 
providing this information and creating an account, they are acknowledging that they meet the eligibility criteria, 
have read the game rules, and have read the consent form and consent to participate in the study. After their 

QuitBet Phase II protocol for clinicaltrials.gov 
account has been created, they have the option to join a QuitBet game, which requires that they pay the $30 
bet.   
 
After paying their bet and joining a game, participants will complete a baseline (pre-game) survey and a 
contact information form (in a Google Form or Alchemer survey) that includes their mailing address for the 
purpose of sending them an iCOquit and a baseline (pre-game) survey. This form and survey will be displayed 
in the QuitBet app upon joining a game or a link will be sent to the participant via email and/or text message. 
Upon completing this form and survey, we will send the participant an iCOquit in the mail that will arrive prior to 
the game start date.  
 
Their iCOquit package will include instructions for how to operate the iCOquit and take a CO test within the 
QuitBet app.  We will encourage participants to take a practice test prior to the game start date to ensure their 
iCOquit is working properly. Participants are permitted to request a refund of their $30 bet until the end of Day 
1 of the game. No refunds will be offered after Day 1 but we may make exceptions for unusual circumstances, 
consistent with WayBetter’s policy for all WayBetter games. At any time, we can remove players from the 
game (with or without also refunding their $30 bet) if they request to be removed, if they have not completed 
the requirements for participation (e.g., did not complete baseline survey), or if they violate a WayBetter policy. 
 
Randomization. The first QuitBet game in Phase II will be considered a test game and will be fixed to include 
the social feed and leaderboard.  Each subsequent cohort will be randomly assigned to QuitBet (with the social 
feed and leaderboard) or an alternative version of QuitBet (QuitBet-NS, “no social” - details below) by a 
statistician who has no direct contact with participants nor any access to any data that could identify a 
participant. Participants will be informed of which version their game is after they pay their $30 bet and join the 
game. This information will be displayed in the app inside their game. Therefore, there will be no bias or 
influence of group assignment knowledge on recruitment or on participants’ decisions to enroll or their 
decisions to provide the deposit, as all of these events will occur prior to randomization. Randomization will be 
conducted using a permuted block randomization scheme, using small, random sized blocks. We will ensure 
that an approximately equal number of cohorts are assigned to each condition (QuitBet or QuitBet-NS) and 
that the total number of participants in each condition is approximately equal (e.g., approximately 225 per 
condition).  
 
QuitBet Components 
1) Social Gaming Features.  Consistent with our other games, the QuitBet smartphone application will 
feature a link to the QuitBet website with a detailed description of the game rules, a Frequently Asked 
Questions (FAQ) page, and a game activity board on which players may post their CO test videos for 
crowdsourced verification, view game results in real time, and interact by posting messages and other 
photos and videos. The game activity board will have an interface and communication functions that are 
similar to Facebook (e.g., where users can “like” and post comments, photos, and videos). The host 
serves as a game moderator and also posts discussion topics and other activities. We will complete the 
development of host content for QuitBet based on the content in the QuitBet test game (see Table 1). 
However, we expect that if QuitBet were commercialized, game hosts could develop additional content.   
 
 
Table 1. Content of Host Messages in QuitBet Test Game 
Day Content 
Day 
Content 
1 
Welcome - share your reasons for quitting 
15 
Education about “non-smoker” CO levels (i.e., will 
fluctuate, 1ppm not is “better” than 3ppm) 
2 
Share anticipated benefits of quitting 
16 
Was a holiday - wished everyone a safe and fun 
holiday 
3 
General quitting tips from the Truth Initiative (link) 
17 
Share how much money you have saved 
4 
Helpful tips for using the iCO app 
18 
Share what you will do with money saved 
5 
Smokefree.gov resources (link) 
19 
“Funny Friday” - share a song title that describes 
how you’re “breaking up” with cigarettes 
6 
Encouragement for upcoming quit date, share 
what you’re doing to prepare 
20 
Share tips for getting back on track after a slip 
and for coping with weekend cravings 
7 
Quit date (day 8) reminder 
21 
Relapse prevention tips from webmd.com (link) 

QuitBet Phase II protocol for clinicaltrials.gov 
8 
Quit Day! Provided basic education about 
duration of nicotine withdrawal 
22 
Quitting on Mondays is most popular (The 
Monday Campaigns link) 
9 
Congrats to everyone who quit and thanks for 
sharing your tips 
23 
Share how you successfully coped with a 
temptation to smoke 
10 
10 ways to cope with cravings from the Mayo 
Clinic (link) 
24 
Share benefits of quitting so far; website about 
benefits (American Lung Association link) 
11 
Share benefits of quitting so far; posted image 
from smokefree.gov about benefits over time 
25 
Share a helpful app or website you’ve found 
12 
“Funny Friday” - share a funny meme or gif that 
describes your quitting experience so far 
26 
“Funny Friday” - share a funny meme or gif about 
your overall quitting experience 
13 
Share tips for coping with weekend cravings 
27 
Share how you will stay smoke-free after QuitBet 
14 
Halfway reminder of game rules and general 
encouragement 
28 
Last day - congrats to the winners! 
 
 
2) Deposit Contract. The Phase II game bet ($30) and length (28 days) will be identical to the QuitBet test 
game and Phase I pilot trial. The "warm-up" period will be shortened from 1 week (7 days) to 1 day, such 
that the quit day will be day 2 of the game instead of day 8 as in Phase I. We will eliminate the $1/day 
incentive for each day that a "negative" CO test of < 6ppm is submitted. Phase I participants indicated 
that this $1/day incentive did not promote continued participation or quit attempts as we had 
hypothesized. The criteria to be a winner for Phase II will be as follows: winners must submit a CO test of 
< 6ppm on at least 24 of the 26 days (2 slip or missed days allowed) between day 3-28. All winners will 
split the grand prize pot equally. As noted above, Phase II participants will not receive any other 
incentives for abstinence (we will not provide $1/day for each individual day of abstinence as in Phase I).  
However, consistent with Phase I, the quit day (day 2), will not count toward winning because it can take 
up to 24 hours for CO to drop to 6ppm or lower after quitting. All participants within each game who 
submit a CO test on at least 75% of game days (at least 21 tests in total), regardless of the test results 
(<6ppm or >7ppm), will be entered into a raffle to win a $75 Amazon.com gift card. The purpose of this 
raffle is to replace the $1/day incentive from Phase I as a way to encourage continued participation in the 
game and continued efforts to quit smoking even after a participant has 2 or more slip days and is no 
longer eligible to be a winner.  
 
QuitBet-NS. Participants randomized to QuitBet-NS (no social) will receive an alternative version of QuitBet 
(QuitBet-NS) that does not include any social interaction with other players or game hosts. QuitBet-NS will 
include: 1) the deposit contract, with identical rules to QuitBet for being a winner, 2) the $75 raffle for 
submitting 21 CO tests, 3) a display of the participant's daily CO test results that is updated in real time, and 4) 
a game feed on which only the game host has the ability to post. Players will not be able to post on this feed or 
respond to the host's posts. At the beginning of the game, the host will post limited information, including the 
game type (i.e., QuitBet "Individual") and a list of smoking cessation resources (e.g., links to websites such as 
smokefree.gov, information about medications and counseling). This resource list will include some of the 
content that game hosts will be posting in QuitBet. QuitBet-NS will not include any other social features. That 
is, the QuitBet-NS app will not include the social feed (QuitBet-NS participants will be unable to communicate 
other game players or a game host within the app) or the leaderboard (QuitBet-NS participants will not see any 
information about other players' CO test submissions during the game). The QuitBet-NS app will otherwise 
have an appearance that is identical to QuitBet (same general design and colors, etc) other than the missing 
features (no social feed or leaderboard). QuitBet-NS will include the same capabilities as QuitBet to take CO 
tests, record these tests on video, and submit these videos to WayBetter.  
 
Second Game. At the end of their first game, all participants (QuitBet and QuitBet-NS) will be offered the 
opportunity to play a second game for an additional bet of $30. The second game will be the same version and 
have rules identical to their first game (i.e., QuitBet or QuitBet-NS). Given that we have eliminated the warm-up 
week based on Phase I participant feedback, such that in Phase II, all participants will quit right away in their 
first game (i.e., on day 2), we decided not to split the second game into separate standard and Maintainer 
versions according to smoking status at the end of the first game. All players within a cohort who decide to play 
the second game will be grouped together for the second game regardless of their smoking status at the end of 
their first game.  

QuitBet Phase II protocol for clinicaltrials.gov 
 
Assessment Procedures. Phase II assessments will consist of brief (≤ 15 min) online surveys administered at 
baseline (before the first game), after the first game (1-month post-quit date), after the second game 
regardless of whether they participated in it (2 months post-quit date) and at 1 and 4 months after the second 
game (i.e., 3 and 6 months after the original quit date). Additionally, all participants will be asked to submit a 
CO test after completing each survey. 
 
Phase II survey questions will be mostly the same as in Phase I, with some slight differences and some 
additional questions added. As in Phase I, Phase II participants will receive a prize with a value of $10 (e.g., an 
Amazon.com gift card, a water bottle, or portable charging bank) for completing each survey (total up to $50). 
Participants will not have the ability to choose which prize they receive. Physical prizes for Phase II surveys will 
be shipped directly from the retailer (e.g., Amazon.com). As of September 2022, we have discontinued 
physical prizes and all participants will receive a $10 Amazon.com gift card for each survey.  
 
Phase II Survey Platform. During Phase I, surveys were administered via SurveyMonkey. During Phase II, we 
will use Alchemer (this company was formerly called SurveyGizmo; they recently changed their name to 
Alchemer) instead of SurveyMonkey. Alchemer is a company that is a direct competitor to SurveyMonkey and 
their survey platform has very similar features including the appearance of the surveys and data security. Our 
primary reason for switching to Alchemer for Phase II is that Alchemer has superior capabilities for sending 
survey links via text messages using automated processes (i.e., can schedule in advance to send both emails 
and text messages containing survey links at designated times, whereas SurveyMonkey only allowed advance 
scheduling of emails and text messages had to be sent manually). This advance scheduling function for text 
messages will save the study team a significant amount of labor time.  Screenshots of the surveys as they 
appear in SurveyGizmo/Alchemer were previously submitted to Advarra. 
 
Phase II Data Analysis 
 
Power Analysis and Sample Size Justification. Sample size was calculated to have sufficient power 
(>80%) to detect a 10% difference between QuitBet and QuitBet-NS, which we consider clinically meaningful, 
with respect to the primary outcome (CO-verified 7-day point-prevalence abstinence, PPA, rates at follow-ups). 
In Consultant Dallery’s recent DCM study [90], in which the DCM was similar to our proposed QuitBet-NS, the 
abstinence rates were 40% at 3-weeks, 29% at 3 months, and 23% at 6-months post-quit date [112].  Some 
features differ between our proposed QuitBet-NS and Dallery et al.’s DCM (e.g., eligibility criteria, total 
incentives available, intervention duration), but we believe these differences would balance out with regard to 
effects of abstinence rates. Therefore, we believe 23% is a reasonable estimate for the QuitBet-NS abstinence 
rate at 6-month follow-up. Furthermore, 23% abstinence at the final follow-up is typical for a smoking cessation 
trial, even when the intervention does not include financial incentives for abstinence [40]. Therefore, we have 
powered for an estimated absolute difference of 10% in abstinence rate between QuitBet-NS (23%) and 
QuitBet (33%). If the actual abstinence rates are lower, we will have more than adequate power as a smaller 
sample size would be required (e.g., detecting 10% vs. 20% requires fewer participants than 23% vs. 33%). 
Thus, given an odds ratio of 1.65 for the longitudinal effect across follow-ups (i.e., 3- and 6-month post-quit 
follow-ups) with hypothesized 7-day PPA rates of 23% in QuitBet-NS and 33% in QuitBet at the 6-month 
follow-up and an alpha level of 0.05, a total sample size of 550 participants is required to have sufficient (80%) 
power to test the longitudinal effect on the intent-to-treat (ITT) 7-day PPA.  
Preliminary analyses. As a preliminary step, we will assess potential between-group differences in 
baseline characteristics (demographics, smoking history, nicotine dependence, etc.) using graphical methods, 
non-parametric and parametric tests as appropriate (e.g., Wilcoxon rank-sum test for skewed data, t-tests for 
normally distributed continuous data, and chi-squared tests for categorical data). Any variables not balanced 
by randomization will be controlled for as covariates in subsequent analyses.  
Data Analysis Plan. Consistent with the Phase II Aim, we will estimate the effect of the interventions 
on CO-verified 7-day PPA at 1, 3 and 6 months after original quit dates [113, 114] using a single repeated 
measures regression model implemented with generalized estimating equations (GEE) with robust standard 
errors. Specifically, we will regress smoking status on intervention group (QuitBet vs. QuitBet-NS) and potential 
covariates (e.g., medication use, other variables not balanced by randomization) using binomial errors, a logit 
link function, and a working unstructured correlation to accommodate within-subject correlation.  

QuitBet Phase II protocol for clinicaltrials.gov 
Subsequently, using a longitudinal mixed effects model, we will explore the effects of QuitBet vs. 
QuitBet-NS on secondary outcomes, including smoking heaviness (treated as a continuous variable) at follow-
ups. Specifically, we will regress mean cigarettes per day during the past week at each follow-up on baseline 
cigarettes per day, intervention group, time, group*time and potential confounders (including those variables 
not balanced by randomization). Models will include a participant-specific intercept to adjust for repeated 
measurements within participant over time.  Using a similar modeling approach as for 7-day PPA, we will 
assess group effects on medication use over time.  
Finally, we will explore the roles of engagement and satisfaction as mediators of intervention effects on 
abstinence using a product of coefficients approach with bootstrapped standard errors (5000 samples with 
replacement) [115]. We will estimate the path coefficients (e.g., a path: effects of intervention on changes in 
engagement and b path: effects of engagement on 7-day PPA at 6-month follow-up), as well as the indirect 
effect of intervention (ab path: effect of intervention on 7-day PPA at 6-month follow-up through engagement). 
Interest is in estimating the path coefficients, effect sizes, and confidence intervals. 
Missing data approaches. We will censor the data at the point of loss for drop-outs. Our analyses will 
focus on the ITT sample, meaning that all participants randomized will be included in the analysis. Analysis will 
use estimating equations and maximum likelihood (ML) approaches to produce estimates of the regression 
parameters. One advantage of a ML approach is that it makes use of all available data without requiring 
imputation of missing values. ML estimates have been shown to be consistent when missing data is related 
only to covariates and observed values of the outcome [116]. As it is possible (although not testable) that 
missingness may be related to the missing outcome itself (e.g., not random), we will run a sensitivity analysis 
to explore the robustness of our findings to other assumptions of the missing data. 
 
PROTECTION OF HUMAN SUBJECTS 
 
Human Subjects Involvement, Characteristics, and Design 
 
Participants are adults who meet the eligibility criteria specified in Human Subjects and Clinical Trials 
Information section 2.2. Eligibility Criteria. 
 
Males and females of all racial and ethnic backgrounds who meet inclusion and exclusion criteria and 
are continental U.S. residents will be eligible. We will target our nationally distributed advertisements in areas 
with high populations of racial and ethnic minorities, with a goal for our sample to be consistent with recent 
estimates (2012-2014) of U.S. smoker demographics [111]: at least 20% non-Caucasian and at least 10% 
Hispanic. 
 
Sources of Materials  
Data will be obtained specifically for research and product development purposes.  Data will be stored 
in password-protected electronic files on secure servers or in locked physical files with only code numbers 
identifying participants. Research materials include (a) electronic surveys administered via SurveyMonkey or 
Alchemer (note: surveys may be administered via telephone or on paper and transmitted via postal mail to be 
hand-entered into SurveyMonkey/Alchemer in the event that a participant becomes unable to complete them 
electronically); (b) video recordings and photos of CO tests for the purpose of verifying smoking abstinence; 
and (c) participants’ logged behavior on the QuitBet/QuitBet-NS application (e.g., time and duration of log-ins, 
pictures and comments posted). The QuitBet/QuitBet-NS game content will be password-protected and 
accessible only to authorized WayBetter employees, other members of research team, and study participants. 
Game content will not be accessible to players in other WayBetter games or to the general public. 
 
Potential Risks 
Potential risks include nicotine withdrawal, loss of money, breach of confidentiality and loss of privacy, 
and perception of coercion to participate in the study. 
 
Adequacy of Protection against Risks 
 
Recruitment and Informed Consent 
Participants will be recruited as described above. All advertisements will indicate an opportunity for 
smokers to participate in a research study in which they will receive financial incentives for quitting smoking. 
The $30 deposit and other requirements should strongly discourage minors and non-smokers from attempting 

QuitBet Phase II protocol for clinicaltrials.gov 
to enroll. We have set 21 years as the minimum age to enroll because in some jurisdictions individuals must be 
21 to purchase cigarettes). Nevertheless, it is possible that a highly motivated applicant could lie about age or 
smoking status. However, lying about age or smoking status can occur in any study, even when traditional 
written consent is obtained in-person. Furthermore, should a minor and/or non-smoker enroll, there are no 
additional risks other than those described below.  
 
Protection Against Risk 
 
Nicotine withdrawal 
Risks. Participants who quit smoking may experience some nicotine withdrawal symptoms, including 
anxiety, restlessness, anger, irritability, sadness, problems concentrating, appetite change and weight gain, 
insomnia, and decreased heart rate.  
 
 
Minimization. All participants will receive general information about other smoking cessation treatment 
options including FDA-approved medications. Participants will be permitted to use approved medications that 
should diminish the overall severity of withdrawal discomfort. Withdrawal symptoms are usually short-lived, 
with most symptoms abating within 1-2 weeks. Participants will be advised to consult with a health care 
provider if they have any concerns about withdrawal symptoms and before taking smoking cessation 
medication. Participants will assume all risks of medication use. Study staff will monitor game activity during 
business hours, and will contact by phone any participant about whom there is a concern or who is engaging in 
risky, inappropriate, or offensive behavior. Per WayBetter policy, participants may be removed from their game 
at any time or a health care provider’s note may be required for continued participation. 
 
Loss of money 
 
 
Risk. There is a risk that participants could lose some or all of their $30 deposit if they do not quit 
smoking and therefore do not earn any incentives in their QuitBet/QuitBet-NS game(s) (i.e., forfeit their 
deposit). 
Minimization. We acknowledge that requiring research participants to “pay” to participate in research is 
unusual. However, there is ample precedent and evidence for the efficacy of deposit contracts, and the deposit 
contract is a central feature of all WayBetter games. It will be emphasized to all participants that “winners” will 
earn back their entire $30 deposit plus additional money from the forfeited deposits of non-winners. In the very 
unlikely event that all participants within a QuitBet/QuitBet-NS game achieve sustained abstinence (i.e., all 
players are winners), all participants will receive their full $30 deposit back but no additional reward. Therefore, 
winners are guaranteed not to lose money. We will compensate all participants, regardless of whether they quit 
smoking, for their time and effort in completing survey assessments with prizes that have a value of up to $50. 
They will also receive an iCOquit device at no cost that they will keep after the study is over (value of $65). 
Participants in this study are likely to be spending at least $20 per week on cigarettes, given that cigarettes 
cost ~$5-10 per pack depending on U.S. state of purchase and all participants are required to be smoking at 
least 5 cigarettes per day at baseline.  
 
Breach of confidentiality and loss of privacy 
Risks. The risk of breach of confidentiality and loss of privacy is judged to be minimal. 
Minimization. All study staff, including those who are WayBetter employees, are or will be fully trained in 
relevant ethical principles and procedures for the conduct of research with human participants, particularly 
around confidentiality. Breach of confidentiality with regard to the electronic survey assessments is highly 
unlikely because all electronic surveys will be administered via SurveyMonkey or Alchemer and all data will be 
stored on password-protected servers. Within SurveyMonkey/Alchemer, participants are identified by their e-
mail address and/or their phone number so that we can link a participant’s responses to each of the 5 surveys 
together and match participants’ survey responses to their QuitBet game data (e.g., CO test results). For each 
survey, participants may be asked to enter their email address and/or phone number as a question in the 
survey or may be sent a custom unique link that is associated with their email address and/or phone number. 
Only authorized study staff will have access to participant names and contact information (i.e., only those that 
need this information to carry out study procedures, such as auditing CO test videos, contacting participants to 
conduct assessments, and preparing data for analysis). Identifying information will be removed from data that 
is exported from SurveyMonkey/Alchemer prior to analysis. Participant identifying information will not be 
included in any published reports. The SurveyMonkey Privacy Policy is located here: 

QuitBet Phase II protocol for clinicaltrials.gov 
https://www.surveymonkey.com/mp/legal/privacy-policy/. The SurveyMonkey Security Statement is located 
here: https://www.surveymonkey.com/mp/legal/security/.  The Alchemer Privacy Policy is located here: 
https://www.alchemer.com/privacy/. 
With regard to the use of the QuitBet/QuitBet-NS application and the uploading and posting of CO test 
videos on the social feed, participants will assume the same risks and agree to the same Privacy Policy and 
Terms of Use as all WayBetter players. The Privacy Policy and Terms of Use will be available within the 
application and on the QuitBet website. Participants will be required to indicate that they have reviewed these 
policies as part of the informed consent process. WayBetter employs the use of encryption, firewalls, and 
hashing to protect players’ privacy, including secure socket layer (SSL) technology during information 
transmission. For the Phase II RCT, anyone may download the QuitBet app but only individuals who indicate 
that they have read the consent form and agree to participate in the study, created an account with an email 
address and password, and paid the $30 bet (i.e., enrolled study participants) will be allowed to join a game 
and view game information. Participants have the option to receive payments by submitting the e-mail address 
of their PayPal account or by requesting a paper check that will be sent to their mailing address. Only 
WayBetter employees who need access to a player’s personal information can access it. Participants may 
delete their QuitBet account if they no longer wish to participate.  Study games will not be visible on any public 
website. All participants assigned to QuitBet will have the option to display their first name or select a 
“nickname” that will be visible to other players. Participants may be removed from their game at any time for 
violations of the Terms of Use (e.g., inappropriate or offensive behavior).   
 
Perception of coercion to participate in the study 
Risks. Issues related to coercion are judged to be minimal given the use of reactive recruitment 
strategies. 
Minimization.  Advertisements will not specify the amount of compensation, and the amount of 
compensation is not judged to be overly coercive. Based on the outcomes of the QuitBet test game, we expect 
a maximum abstinence rate in the pilot trial of 40-50% and therefore we expect that game winners will receive 
at least 2x their original $30 deposit ($60, a $30 net gain). In typical CM studies, participants can often receive 
much larger incentives for abstinence (i.e., hundreds of dollars) [44, 49]. Informed consent must be obtained 
from each participant prior to entering the study. The informed consent document will explain in simple terms, 
before the participant is entered into the study, the risks and benefits to the participant. The informed consent 
document will contain a statement that the consent is freely given, that the participant is aware of the risks and 
benefits of entering the study, that the participant is free to withdraw from the study at any time (although the 
$30 deposit is non-refundable once the game begins), and that the choice to participate will not affect 
participants’ current or future standing (i.e., future treatment or employment) with any of the organizations or 
institutions at which the investigators are located/employed. Also, study participation will not affect participants’ 
ability to join other WayBetter games, with the exception that if they are removed from a game for inappropriate 
or offensive behavior, WayBetter may also choose to ban them from joining other WayBetter games.  
 
Potential Benefits of the Proposed Research to Human Subjects and Others and Importance of 
Knowledge to be Gained  
 
 
The risks to participants are judged to be acceptable relative to the anticipated benefits. All participants 
should benefit from the smoking cessation treatment provided. Additionally, all participants will be assessed on 
various factors related to their cigarette smoking, thereby potentially increasing their knowledge of their 
cigarette smoking and related issues. Given the minimal risks to participants (about half of smokers make a 
quit attempt each year and most have made at least 1 quit attempt in their life; therefore, quitting smoking is an 
experience that is commonly encountered in everyday life outside of research contexts) and the likelihood of 
benefit from the treatment provided (and from the additional assessment contacts) and the even greater 
possibility of benefits to the larger population of smokers, the risk/benefits ratio seems favorable. 
 
DATA AND SAFETY MONITORING PLAN 
 
The PI will have overall responsibility for monitoring the integrity of the study data and participant 
safety. The PI will be in frequent contact with study staff. Potential risks as described in Protection of Human 
Subjects include nicotine withdrawal symptoms, loss of money, breach of confidentiality and loss of privacy, 

QuitBet Phase II protocol for clinicaltrials.gov 
and perception of coercion to participate in the study. 
 
 
We believe that the risks associated with participating in the proposed research are considered to be 
minimal, especially given that we are not providing any medications and there are no invasive procedures. 
However, if any adverse events (AEs) should occur, they will be documented and reported to the PI. All AEs 
will be assessed by the PI to determine if they meet criteria for a serious adverse event (SAE). All AEs will be 
followed to the point of a satisfactory resolution. We do not expect any SAEs to occur in this study that are 
related to study involvement. However, if any AEs meet criteria for serious adverse event (SAE), as defined by 
the FDA, they will be systematically evaluated at each visit and treated in a similar fashion as AEs with regards 
to monitoring and reporting. SAEs will be reported to the IRB of record (Advarra) in accordance with their policy 
for reporting SAEs. The report of SAEs will include whether they were expected or unexpected, a rating of 
severity of the event, a brief narrative summary of the event, a determination of whether a causal relationship 
existed between the study procedures and the event, whether the informed consent should be changed as a 
result of the event and whether all enrolled participants should be notified of the event.  
 
 
Participants may upload videos of their CO tests to the social feed within the QuitBet/QuitBet-NS 
application and may also post other text-based messages and photos. These videos, text-based messages, 
and photos are considered part of the study data. Game activity will be subject to WayBetter’s standard 
Privacy Policy and Terms of Use. The Privacy Policy and Terms of Use will be available in the QuitBet 
application for players’ reference at all times. Players will also have to agree to these policies as part of the 
informed consent process. Surveys (baseline and post-QuitBet) will be administered and managed using 
SurveyMonkey or Alchemer. Exported data from SurveyMonkey/Alchemer will be stored on a password-
protected server. We will implement cleaning routines that will be used on all data in order to identify miscoded 
or duplicate variables, mismatched assessment dates, and out-of-range values. Discrepancies will be 
presented to PI Rosen who will make final decisions about coding. 
All data files that contain information that could identify a participant will be stored on cloud-based 
servers managed by WayBetter. Study staff will be able to access identifying information as needed by logging 
in remotely to a WayBetter server and accessing this information in Google Docs on a secure cloud-based 
server managed by WayBetter. Study staff will communicate with participants using WayBetter phone numbers 
and email addresses. 
A data safety and monitoring board has been assembled for the phase 2 trial.  It will consist of 3 
reserachers with expertise in digital health interventions and/or smoking cessation.  The study biostatistician 
will be a non-voting member of the board.  The board will meet annually to review the safety and integrity of the 
study, or more frequently, if the board deems it necessary. 
 
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