A Text-based Reduction Intervention for Smokeless Tobacco Cessation
Phase: NA
Conditions: Smokeless Tobacco Cessation
Sponsor: Duke University

A text-based reduction intervention for smokeless 
tobacco cessation 
NCT04315506
01/28/2022 

2. SIGNIFICANCE 
Smokeless tobacco use is associated with morbidity and mortality and disproportionally affects rural 
and medically underserved populations. Underserved smokeless tobacco users (those who live in rural 
areas and/or those who live in medically underserved areas, areas with high poverty levels and few primary 
care providers10) are at increased risk for poor health outcomes, given high rates of smokeless tobacco usage.  
Smokeless tobacco is used mostly by males, with national rates of use reported to be more than twelve times 
higher among males (6%) compared to females (0.4%).11  Smokeless tobacco use rates in certain sub-
populations of the U.S., such as male residents of Southern and Western states (13-17%) and rural residents 
(6%), are significantly higher than population norms.11,12 Clearly, we need effective interventions to reduce 
smokeless tobacco use targeted to those most at risk in these underserved areas, where residents have little 
access to and use of proven tobacco cessation treatments. The high rate of use coupled with less access to 
programs creates a disparity that increases underserved residents’ risk for in the short term oral mucosal 
lesions13 14,15, periodontal disease16, and precancerous oral lesions.17 Long-term use may increase the risk for 
ischemic heart disease 18 and head and neck cancers especially oral cancers.19 Just one year of smokeless 
tobacco use is associated with over 6 million Disability Adjusted Life Years lost and over a quarter of a million 
deaths.18 This disparity is compounded by the lack of health care providers and the burden of traveling far 
distances to health care facilities in underserved populations. Further, many rural Americans do not receive 
consistent cessation advice and have less access to cessation services than their urban counterparts.20 
Therefore, innovative interventions that provide consistent access to cessation services are needed.   
Reducing smokeless tobacco use in response to situational cues is imperative for cessation success. 
Research supports that people use tobacco in response to stimuli or environmental and situational cues,21 22 
yet many smokeless tobacco cessation interventions do not address stimulus control. For example, Coffey and 
Lomardo examined the importance of sensory and behavioral cues in smokeless tobacco use and found that 
cues modulated urge, affect, and stress.22 Current smokeless tobacco cessation interventions do not address 
chewing behaviors that may be driven by cravings in response to situational cues (e.g., cup of coffee, meals). 
Behavioral techniques that focus on self-regulation and restraint have the potential to help smokeless tobacco 
users manage their responses to situational cues.23 In fact, investigators found that cue extinction (which 
consisted of each participant identifying 2-3 situations that were associated strongly with smokeless tobacco 
use and breaking those associations by not chewing or dipping for 30 minutes twice a day) produced 
smokeless quit rates of 66% at 9 months.24 Results of this trial should be interpreted with caution given the 
small sample size and lack of comparison arm. However, addressing cues is an important intervention target 
for an intervention. To date this strategy has been largely unexplored in the smokeless tobacco cessation 
literature, and our study was designed to fill this gap. 
Scheduled Gradual Reduction (SGR) helps users to self-regulate and practice restraint in response to 
tobacco use cues and has great potential to improve cessation rates. Scheduled Gradual Reduction 
(SGR) may be especially efficacious in helping smokeless tobacco users to quit as it addresses self-regulation 
of situational cues to chew. SGR is a reduction-based cessation method that first assesses smokeless tobacco 
user patterns, then gradually reduces the number of chews/dips used per day by lengthening the time interval 
between use ending with a definitive quit date at the end of the reduction period. SGR has been minimally 
studied in smokeless tobacco users.9 However, the few studies available demonstrate that SGR promotes 
cessation among smokeless tobacco users.9,25 Our SGR intervention is unique compared to other smokeless 
tobacco cessation interventions in that it provides chewers with a specific schedule for chewing, encouraging 
use of chewing restraint techniques during intervals between alerts to chew. Chewing on a schedule has two 
important functions: (1) nicotine use is evenly spaced to manage withdrawal symptoms; and (2) it provides 
multiple opportunities to employ restraint, defined as conscious, chronic restriction of chewing based on set 
limits.23 Evidence from studies with cigarette smokers have shown that successful use of restraint during 
reduction is predictive of quitting. 5 Very few interventions for smokeless tobacco users have addressed self-
regulation and restraint through scheduled chewing. Our intervention provides a schedule for chewing and 
chewers are asked to chew only when alerted. As a result, chewing becomes unlinked from the cues (i.e., 
psychological, behavioral, and environmental) and smokeless users can learn how to manage cravings using 
restraint during the reduction period prior to quitting.  
Our SGR intervention also helps participants manage withdrawal symptoms, an important determinant 
of cessation success through scheduled chewing that gradually reduces their tobacco use down to 
zero. The gradual reduction of the SGR intervention provides even spacing between nicotine self-
administration leading to the down regulation of nicotine receptors over time.26 Given nicotine dependence is a 
predictor of smokeless tobacco cessation and smokeless tobacco users report a similar severity of withdrawal 
symptoms compared to cigarette smokers,27 addressing withdrawal symptoms during a quit attempt is critical 

to success. Prior SGR intervention work in both cigarette smokers and smokeless tobacco users report 
reductions in withdrawal symptoms over the scheduled gradual reduction period.7,8,9 
SGR combined with CBT support texts strengthens 
our intervention and will improve cessation rates 
compared to other evidenced-based cessation 
interventions in this group of tobacco users. Our 
SGR intervention was designed to supplement a 
cognitive behavioral intervention delivered via text 
messaging to help smokeless tobacco users quit.  Past 
SGR studies used a combination of cognitive-behavioral 
telephone counseling to help smokeless tobacco users 
cope with quitting along with the SGR program.8,9 We 
will combine the SGR program with text-based support 
messages to provide participants with advice and 
support for quitting.  Our team adapted the support 
messages for this program from text messages 
developed by Dr. Herbert Severson for local health 
department use and are based off constructs of the 
Social Cognitive Theory 28 and the Health Belief Model 29 including perceived benefits, perceived susceptibility, 
perceived barriers, and self-efficacy. This is an important addition to the SGR program, as smokeless tobacco 
users need to be motivated to quit, believe that quitting will be beneficial, feel confident they can quit, and 
believe that barriers to quitting are surmountable. See Figure 1. 
Delivering our SGR intervention via text message has great potential to increase access to cessation 
services and reach more rural and medically underserved smokeless tobacco users, helping to 
eliminate health disparities. Web-based cessation interventions for adult smokeless tobacco users have 
been modestly effective in reducing smokeless tobacco use, with quit rates around 12%.30 However, many 
underserved Americans often lack consistent computer skills and access; therefore, they are less likely to 
access existing web-based interventions consistently. 2 Text messaging is a method that has strong potential 
to deliver cessation interventions to smokeless tobacco users given its availability, low cost, and widespread 
use.  In addition, text messaging requires a low level of technological expertise and does not require expensive 
equipment or data plans.31 A recent Cochrane review of mobile phone-based interventions for smoking 
cessation supports the use of mobile phone-based smoking cessation interventions in helping people to quit.32 
However, there are no available text-based interventions to help smokeless tobacco users quit. Delivery of 
behavioral interventions via text messaging has the potential for efficacy and widespread dissemination in 
underserved smokeless tobacco users, as cell phone use is widespread. Further, our pilot work supports the 
feasibility and acceptability of a text-based smokeless tobacco cessation approach. Thus, the potential impact 
and reach of a text-based intervention warrants investigation in helping underserved smokeless tobacco users 
quit. Our study was designed to fill this gap. 
Summary. Rural and medically underserved smokeless tobacco users represent a vulnerable group for 
tobacco use. Despite their high risk for tobacco-related cancers, underserved smokeless tobacco users have 
not been widely targeted for cessation intervention trials. Text-based interventions have the potential to 
consistently reach many more underserved smokeless tobacco users compared to both clinic-based and web-
based interventions. Our SGR intervention has the potential to increase quit rates compared to the current 
standard of care as our SGR intervention addresses common barriers (withdrawal symptoms and situational 
and environmental chewing cues) to quitting.  Our pilot work supports the feasibility and acceptability of a text-
based smokeless tobacco cessation intervention approach. The proposed study has public health relevance as 
it will determine if our intervention performs better than standard of care and is worthy of larger scale 
dissemination, will add to evidenced-based cessation treatments for smokeless tobacco users and shed light 
on the important mechanisms of intervention effects in this understudied group of tobacco users.  
2. Innovation 
The proposed project has the potential to improve the health of underserved smokeless tobacco users and will 
have implications for future tobacco cessation initiatives in rural and underserved communities. This project is 
innovative for multiple reasons.  
• 
We propose one of the first large-scale studies using SGR aimed at an underserved group of tobacco 
users. Therefore, this study aims to decrease a tobacco-related health disparity by decreasing rates of use 
and bringing innovative interventions to those with limited access. 

• 
Our study is innovative in that it is the first RTC to compare a text-based reduction intervention to a 
standard of care intervention.  The results of this innovative study have public health relevance and can be 
used to determine if our SGR intervention should be disseminated broadly. 
• 
Our study will explore mechanisms of cessation intervention effects to expand the limited literature in the 
field on this area.  This information will provide valuable data on important intervention targets that can be 
used to inform future more targeted treatment strategies in this group of tobacco users 
• 
Our study targets behavioral techniques that focus on self-regulation and restraint have the potential to 
help smokeless tobacco users manage their responses to situational cues. To date, this strategy has been 
largely unexplored in the smokeless tobacco cessation literature.  
• 
Delivering SGR via text messaging is an innovative way that is a more convenient format and increases the 
potential reach of the intervention to more vulnerable groups of tobacco users at high risk for tobacco-
related morbidity/mortality.  
3. APPROACH  
Research Team 
Our experienced, multidisciplinary research 
team collaboratively developed the SGR 
intervention for the current study. (Table 1). 
This team obtained our initial funding for our 
pilot (1R15CA198841-01) and have worked 
together on this grant application. 
Collectively, our team brings a wealth of 
experience in designing and implementing 
tobacco cessation interventions and working 
with underserved populations. 
Preliminary Data 
Our pilot study of an SGR intervention shows promise for helping participants gradually reduce their 
tobacco use down to zero. We are the first to test a text-based delivered SGR intervention for rural and 
underserved smokeless users (1R15CA198841). Our team conducted a pilot study with 98 rural and medically 
underserved smokeless tobacco users to determine the feasibility and acceptability of an SGR program 
delivered via text message paired with text-based support messages aimed at decreasing smokeless tobacco 
use and promoting cessation. We recruited smokeless tobacco users primarily from social media targeting 
rural and underserved areas in North Carolina and four rural northern counties in South Carolina and 
randomized in a 2:1 fashion to either: (1) the SGR program (N=65), a text-based program aimed at reducing 
chewing over a four-week plus text-based support messages; or (2) text-based support messages only (N=33). 
Participants completed surveys at baseline and end of program to assess feasibility, acceptability, self-report 
and biochemically validated 7-day point prevalence of cessation. We also conducted a 6-month survey to 
assess self-report cessation. To determine rural status, we used Rural-Urban Continuum Codes (RUCC) 
designated as non-metropolitan (designated as a RUCC code of 4 or above) 33 and Medical Underserved 
Areas were defined using Health Resources and Services Administration (HRSA) index of Medical 
Underservice with a score of 62 or indicating medically underserved.34  
We recruited 98 rural and medically underserved smokeless tobacco users in 17 months. We moved to a 
solely social media recruitment approach as clinic recruitment did not work well. With social media, we 
recruited 70 smokeless tobacco users over one year (averaging about 5-6 per month). We retained 70% of the 
study sample. Sensitivity analyses revealed no differences between completers and non-completers on key 
demographic (age, education, marital status and income) and tobacco use variables (baseline number of 
chews and dependence). The mean age of the sample was 35 (SD=11.7), 97% were male and 98% were 
Caucasian. We had solid intervention penetration. Almost all participants in both groups (96%) read all the 
messages they received.  Over half of all participants in both groups found the intervention useful in helping 
them quit smokeless tobacco and over 90% would recommend it to a friend. In the SGR arm, participants 
responded via text to their alerts to chew the majority of the time (72% median response rate/person). At end 
of treatment follow-up, the SGR arm had a higher rate of self-report cessation (Intent-to-treat where missing 
data were coded as using smokeless: SGR= 22% vs Control=9%). As is consistent with the field, biochemical 
validation proved not to be feasible in this text-based intervention.  
Common themes from 16 semi-structured interviews at end of program with SGR participants revealed that 
many thought the program was too short and “if it was just a couple more weeks I probably could have quit” 
Table 1. Study Team 
Team Member 
Unique contribution to project 
Devon Noonan, PhD, MPH, FNP-BC 
Principal Investigator  
Oversee all aspects of study recruitment, 
enrollment, implementation, and dissemination 
of results 
Laura Fish, PhD, MPH 
Co-Investigator 
Intervention development, implementation and 
interpretation of the real-time text data 
Kathryn Pollak, PhD 
Co-Investigator 
Recruitment and intervention implementation 
and delivery 
Susan Silva, PhD 
Co-Investigator 
Statician; Statistical analysis and quantitative 
methods 
Leigh Ann Simmons, PhD, MFT 
Co-Investigator 
Recruitment of rural smokeless tobacco users  
Herb Severson PhD 
Consultant 
Consult on recruitment, intervention delivery, 
Enough Snuff intervention and retention 

and “I will be honest it will probably take more than 4 weeks because it was just too hard some of the drops”.  
Participants also commented that the SGR program helped them manage cravings and helped them to not 
take chew when they were feeling the urge…” I had confidence that I could wait it out and I would get an alert 
to chew soon”.  Participants also found support messages that talked about health effects and money saved 
from quitting very beneficial. Further, SGR participants noted that stopping the support messages on the quit 
day or last day of reduction was like “dropping them off a cliff” with no support when they needed it most. 
We completed self-report follow-up assessments with all participants at 6-months to determine the 
sustainability of our intervention effects and found that cessation rates did not significantly differ between the 
two treatment arms (Intent-to-treat: 
SGR=22% vs Control=21%). We believe due 
to the high level of missing data and the intent 
to treat analysis we did not show a difference 
between interventions and these results need 
to be interpreted with caution. However, it is 
noteworthy that 75% of SGR participants who 
were quit at end of treatment remained quit at 
6-months speaking to the sustainability of the 
SGR intervention. These results support the 
need to add an additional assessment at 3-
months to determine the more proximal time 
to quitting. 
Strengths of our pilot work include strong 
evidence of feasibility and acceptability of the 
intervention. The SGR group had an excellent 
response rate to the SGR texts (72%), 
showing that smokeless tobacco users will interact with our intervention.  Further, our self-report quit rates 
were promising and much higher in the SGR group (22% vs 9%, Cohen’s d equivalent=0.55, medium effect) in 
the short term, and these quit rates were sustained in the SGR group at 6-months; most chewers who quit at 
end of treatment remained quit at 6-months (75%). After critically evaluating our pilot work, we found areas for 
improvement for the current study (see Table 2). Thus, our pilot work found that a text-based SGR 
intervention is both feasible and acceptable among underserved smokeless tobacco users and 
warrants further testing. For the current study we have included an evidenced-based control condition 
to determine if our SGR intervention improves quit rates compared to an available evidenced-based 
cessation intervention. Results of this study will inform future treatment strategies in this population of 
tobacco users.   
Overall Strategy 
We will recruit smokeless tobacco users (N=500) and randomize them to receive 
the SGR intervention (N=250) or the Enough Snuff intervention (N=250). We will 
conduct phone-based or smart phone-based assessments with participants at 
baseline prior to randomization, end of treatment, 3 and 6-month follow-up after 
intervention completion. The primary outcome will be self-reported 7-day point 
smokeless tobacco use at 6-months (yes/no). We will biochemically confirm a 
subset of participants who report quitting via saliva samples using NicAlert test 
Strips (20% of sample who report quitting split between intervention and control 
group). NicAlert strips can be used with all tobacco types and have been used 
with smokeless tobacco users.35 We will randomly select these participants at 
end of program, 3 and 6-month survey time points as to not confound 
intervention results. We will conduct a supplemental analysis to compare self-
report and biochemically confirmed quit results. The secondary aims are to 
assess: 1) the efficacy of the text-based SGR intervention compared to the 
control intervention on changes in withdrawal, craving, self-regulation and restraint across the 6-month period 
and 2) explore whether changes in withdrawal, craving, self-regulation and restraint mediate intervention effects 
on self-reported cessation at 6 months post-intervention (Figure 2). We will follow participants regardless of 
whether they complete or adhere to the intervention.   
Design Considerations. We chose our control comparator using guidance from the Pragmatic Model for 
Compartive selection in Health Related Behavioral Trials.36 The main goal of our trial is to compare our new 
SGR intervention to a well established evidenced-based alternative like the Enough Snuff Intervention. We 
decided against adding nicotine replacement therapy or varenicline for smokeless tobacco users. A recent 

Cochrane review found that the quality of evidence for NRT among smokeless tobacco users is low.37 
Varenicline has shown efficacy in the short term for smokeless tobacco cessation, however this is based on a 
recent meta-analysis that contained only three published trials. 38 Further, varenicline has increased exclusion 
criteria, side effects and low adherence levels in smokeless tobacco users.36 Our goal is to have a trial that has 
the broadest inclusion criteria to reach the largest number of underserved smokeless tobacco users possible.  
We also decided against biochemical verification of cessation in this study given that we found it was not 
feasible in our pilot. Other smokeless tobacco cessation studies also use self-report cessation as the primary 
outcome.37,39 Much like these studies, our study is community-based and has comparable demand 
characteristics as both arms are interactive. Thus, according to the SRNT Subcommittee on Biochemical 
Verification (2000) guidelines,40 biochemical verification is not feasible or warranted as there is no reason to 
believe that one treatment will group will lie or give false information relative to another treatment group in this 
study. However, to further assess feasibility for future work we will biochemically confirm via saliva samples 
using NicAlert test strips. Twenty percent of the sample who report quitting (split between intervention and 
control group) of participants will be randomly selected at end of treatment, 3 and 6-month survey time points 
as to not confound intervention results. We will conduct an analysis to compare self-report and biochemically 
confirmed quit results overall and by each treatment group. 
We chose our primary outcome follow-up time-point at 6 months for several reasons. First, most comparable 
behavioral smokeless tobacco trials have used 6-months as the primary outcome37,39 therefore we can easily 
compare our results to these previous trials. Further relapse following cessation usually occurs within six 
months, with no significant changes from 6 to 12 months.41 A 6-month rather than a 12-month follow-up also 
allows for more rapid decisions on treatment efficacy.42  
Study Setting and Sample. We will leverage 
successful recruitment strategies from our pilot 
study, our previous work, and work of our consultant 
Dr. Herbert Severson, who has recruited smokeless 
tobacco users via social media for several cessation 
studies. Further, we now will work with Kevin 
Danaher Consulting to aid in recruitment (See Letter 
of Support and Recruitment and Retention Plan). 
This is the same recruitment consultant firm that Dr. 
Severson has worked with to recruit thousands of 
smokeless tobacco users to treatment trials. We will 
recruit nationally, specifically targeting states with high smokeless tobacco use rates (Table 3). We will recruit 
from the Rural and Medically Underserved Areas in these states. Rural status will be determined by Rural-
Urban Commuting Codes (RUCC) designated as non-metropolitan 
(designated as a RUCC code of 4 or above) 33 and Medical Underserved 
Areas as designated by Health Resources and Services Administration 
(HRSA) by an index of Medical Underservice of 62 or less.34 We will 
recruit participants and verify upon screening that each participant county 
address has a 4 or higher RUCC code and/or has an IMU of 62 or lower. 
This is easily done by having participants provide their zip code. A large 
percentage of the counties in the states we are specifically targeting are 
rural (Table 4) and >75% of the counties are medically underserved. 
Most rural counties also qualify as medically underserved counties. 
However, many non-rural counties are also designated as medically 
underserved and would benefit from our intervention given the lack of medical providers and high poverty rates 
in these counties.10 
We plan to recruit all participants for the current study using social media and other media advertisement 
outlets (i.e., Facebook, Instagram, Google Ads). As we did in our pilot, we will create an advertising profile for 
the study targeted to our study population (e.g., smokeless tobacco users (chewer/dipper), over age 18, 
profiled for tobacco use) for rural and medically underserved counties in the U.S. The advertisement briefly 
describes the study and links to a project-specific landing page that includes project branding (e.g., study logo, 
name, and Duke University association), a simple contact form with name, phone number, email and two 
simple baseline questions (e.g., “Do you use smokeless tobacco (chew/dip) every day and use at least one or 
more tins/cans per week or more?” and “Please provide your zip code”). After they enter their information, a 
member of the study team can call to collect more information to determine if they meet the criteria for 
participation in the study. Targeting rural and medically underserved counties in North Carolina and four rural 
counties in South Carolina for our pilot study, we were able to recruit 70 smokeless tobacco users in one year 

(approximately 5-6 per month) using these methods. Data from our targeted marketing profiles show Facebook 
and Instagram ads reached 15,147 people total over 30 days resulting in 22,055 ad views and 121 link clicks 
per month with a monthly advertisement budget of $200. To increase our recruitment numbers for the current 
study we plan to: 1) target rural and medically underserved counties nationally with high smokeless tobacco 
use rates; 2) increase our Facebook budget and work with Kevin Danaher recruitment consulting firm to 
manage our media platforms and 3) change ad messaging, demographic targeting and geographic targeting 
weekly to ensure we are recruiting a diverse sample. Even if we estimate similar, very conservative recruitment 
metrics as seen in our pilot, given our increased reach with national recruitment we anticipate we can recruit at 
least 168 participants a year (or 14 per month) from our proposed (social) media recruitment methods. Given 
our 3-year recruitment time frame, we anticipate having ample time to achieve the target enrollment of 
participants for this study.  
Inclusion criteria will include: 1) 18 years of age and older, 2) Have used smokeless tobacco for the last year, 
currently (past 30 days) uses smokeless tobacco daily, and use of at least one or more tins/cans per week 3) 
Have an address in a rural census tract defined by a RUCC code of 4-10 and/or an IMU of 62 or lower; 4) 
Interested in participating in a cessation program; and 5) Have access to a cell phone with unlimited texting 
ability. Exclusion criteria include: 1) Non-English speaking; 2) Have smoked cigarettes or used any other 
tobacco product in the past 30 days (i.e., dual user); and 3) Currently participating in a smokeless tobacco 
cessation study. We are excluding dual users (those who use both cigarettes and smokeless tobacco) who plan 
to continue to smoke cigarettes. It is too challenging to promote scheduled gradual reduction when participants 
use more than smokeless tobacco. We will track how many participants are not eligible for this study because 
they do not meet this eligibility requirement. We did not exclude anyone from our pilot for not having his or her 
own cell phone or for using multiple tobacco products.   
Recruitment and Data Collection. Advertisements for the study will be placed on Facebook, Instagram and 
Google Ads. For example, Facebook users will be shown an advertisement 
that shows a quit smokeless tobacco related image and quit smokeless 
tobacco related messaging (Figure 3). Users who click on that advertisement 
will then be taken to a project-specific landing page that includes project 
branding (e.g., study logo, name, and Duke University association), a simple 
contact form with name, phone number, email and simple baseline question 
(e.g., “Do you use smokeless tobacco (chew/dip) every day and use at least 
one or more tins/cans per week or more?” and “Please provide your zip 
code”).  Research staff will call these participants to screen them for eligibility 
and set up a baseline/enrollment phone visit where informed consent will be 
obtained and baseline study measures collected. All participants will be asked 
to provide the three best contact methods and times to reach them and 
contact information of two people the study staff could contact should they have issues reaching the participant. 
Follow-up assessments will be conducted over the phone or a smartphone option will be available for survey 
completion at the end of treatment, 3 and 6-months post-intervention. Study data collectors will be blinded to 
study arm. Our two research assistants will document who randomized each participant and will not conduct the 
follow-up assessment with those participants. We will obtain follow-up data on all participants regardless of 
adherence or completion of treatment.  The follow-up rate in our pilot study was >70%, and we will use similar 
strategies to obtain follow-up data. To increase this follow-up rate, we also will maintain regular contact with 
participants in-between the end of program 3 and 6-month follow-up using cards, e-mails, and study updates 
summarizing study results. We will also use a graded compensation for surveys with $10 for baseline $15 for 
end of program, $20 for 3 months and $25 for 6-month follow-up. Participants will receive a bonus of $25 for 
completing all assessments.  
Randomization. The target sample will be eligible and enrolled participants randomized to either the SGR 
(N=250) or control (N=250) intervention group. Computerized randomization will be used to deliver a permuted 
block randomization with block sizes of four that will be used to randomly assign participants to one of the two 
intervention groups. The randomization scheme generated by the study statistician will be administered using 
the REDCap system.  
Interventions:  
SGR Intervention Group. We will send those in the SGR intervention group a 6-week text-based scheduled 
gradual reduction intervention and 6 weeks of support text-messages. Typical SGR interventions have lasted 
for 4 weeks.  We have increased our program to 6 weeks based on feedback from our pilot.  
Figure 3. Facebook Ad 

SGR program: The SGR program will occur over a six-week period to reduce frequency of smokeless tobacco 
use to zero by program completion. On the baseline survey, we will ask participants to report their typical wake 
and sleep times to determine average waking hours per day. During Week 1 of the program, we will ask 
participants to use smokeless tobacco according to their usual habit and text “s” before they chew. The purpose 
of this is to have participants self-monitor their behavior and become more aware of their smokeless tobacco 
use habit.  At the completion of week one, the average number of times they chewed per day will be calculated 
and texted to participants, who will be asked to confirm the average number of chews per day.  This will confirm 
that we are basing our reduction on the correct number of chews/dips, as under- or overestimating the number 
of chews/dips in our reduction schedule could impact quitting success. For example, if we underestimate the 
amount of smokeless tobacco use at baseline and base our reduction on this, the reduction schedule may be 
too difficult for participants and lead to failure.   
For the reduction schedule we will use an 
algorithm similar to that of Cinciripini 7 8 and 
colleagues as well as Jerome and colleagues,9 
which involves taking the average number of 
chews or dips per day and reducing this 
number by 1/3 each week by progressively 
lengthening 
the 
interval 
between 
chewing/dipping and lengthening the time to 
first chew. The program ends at the end of Week 6 with a reduction to zero chews/dips (quit day). During the 
reduction period (Weeks 2-6), we will ask participants to only chew when they receive a text message telling 
them to do so. We also will ask them to only keep chew or dip in their mouth for 30 minutes and then remove it 
as smokeless tobacco users may try to compensate for fewer dips by leaving their current dip in longer. We will 
ask them to respond to the aforementioned text with an “s” when they chew. They will be asked to respond within 
30 minutes of receiving the message; reminder texts will be sent if responses are not received within 30 minutes 
to bolster adherence and stress the importance of following the schedule in order to successfully quit. We also 
will ask them to text us if they chew at different times than when we text them. We will also text participants at 
the end of each day and ask how many times they chewed that day and compare that to what they texted to us 
during the day.  This will help us to learn 
when participants are not following the 
schedule. Should participants indicate they 
are regularly chewing off-schedule, we will 
continue the intervention but contact the 
participants 
through 
automated 
SMS 
messages to reassess their smokeless 
tobacco use patterns and adjust their 
schedule as needed. Table 5 provides a 
sample SGR schedule.  
Support Messages: SGR group participants 
will receive text-based support messages three times per day over six weeks. They will start receiving these 
messages 2 weeks before their quit date (e.g. last day of reduction) and will continue to receive these support 
messages for 4-weeks post quit date or reduction to zero chews. This will prevent the SGR group from getting 
an intolerable number of messages during their reduction period.  The messages are based on constructs of 
Social Cognitive Theory28 and the Health Belief Model. 29 Messages were developed from our pilot work and 
work from our consultant Dr. Herbert Severson. We interviewed 21 smokeless tobacco users (5 pre- pilot 
intervention and 16 post- pilot intervention) to obtain feedback on our messages, including readability, and gather 
information on what type of messages would be helpful when quitting. We found that messages around money 
and the health effects of chewing/dipping were most effective, so we have increased the number of these 
messages in the current study. Messages contain information on the health effects of chewers, benefits and 
barriers of quitting, making a quit plan, self-efficacy and motivation, and dealing with cravings, relapse and cost-
savings (Table 6). Much like commonly available cessation interventions like smokefree.TXT and Dipfree.TXT, 
pre-quit messages will focus on health benefits of quitting, building confidence, and making a quit plan.  Post-
quit messages will focus on dealing with cravings and urges and relapse prevention. The text-based system with 
have interactive capabilities, can text the word CRAVE if they are having a craving and will receive a message 
to help them deal with the craving.  Participants can also text the word SLIP if they have a slip after their quit 
date and will receive a message to get them back on track.  Finally. participants can text MOOD if they need a 
positive message to boost their mood (Table 7).  
 

Control Intervention Group (Enough Snuff Cessation Booklet and 
Motivational Text Messages) 
Original Enough Snuff 
Intervention: The Enough Snuff 
Intervention is a self-help 
cessation booklet paired with two 
brief motivational phone 
counseling calls that occur one 
week after the cessation booklet 
is sent and the week of the set 
quit date.  The first call focuses 
on increasing motivation for 
quitting (e.g. reasons for quitting), 
setting a quit date, and choosing a quit method.  The second call 
focuses on dealing with tough situations when quitting and following 
through on quit plans. The Enough Snuff program has been shown to 
be efficacious in promoting smokeless tobacco cessation with quit 
rates ranging from 16-18% 43,44 and is an intervention endorsed by the 
NCI in their Research-Tested Intervention Programs (RTIPs).45 For the 
current study we are delivering the program as follows:  
Enough Snuff Cessation Booklet: We will provide all control participants with the Enough Snuff Cessation Booklet 
developed by our consultant Dr. Herbert Severson. The manual is organized around four key steps to quitting: 
1) evaluating readiness and motivation to quit; 2) setting a quit date and selecting a quit plan; 3) dealing with 
withdrawal symptoms; and 4) maintaining quit status.  We will send all participants a link to the manual via text-
message as well as mailed a hard-copy of the booklet.  
Motivational Text-Messages: To deliver the most 
equivalent intervention to the original Enough Snuff 
Program, we will send participants motivational text 
messages that map to the content of the phone 
counseling sessions.  One week after the cessation 
booklet is sent we will text participants twice a week for 
the next 5 weeks.  We will model the messages after 
the phone content and messages will focus on: 
motivation to quit (Week 1), setting a quit date (Week 
2), picking a quit plan (Week 3), motivation to follow-
through with plan (Week 4) and dealing with tough situations when quitting (Week 5). Messages will refer to the 
Enough Snuff booklet ask for a response from participants (See Table 8). We chose to send text messages to 
participants instead of phone calls as texting is consistent with our mode of contact with participants, less 
expensive, expands our reach, and is highly acceptable according to our pilot work. 
Intervention Delivery. Mosio will manage the technical aspects of the SGR computer-based program, the support 
messages and the motivational messages in the control group. Mosio will provide the two-way text messaging 
platform that we will use for this study. This platform allows to communicate with participants, collect data and 
contact participants via mobile text-messaging for follow-up. This is the same company and program our team 
successfully used as the texting platform for our pilot and was approved by our Information Security Office. The 
Participant interface with the intervention will be entirely through SMS messaging. Outbound messages from 
the intervention to participant will pass through an SMS gateway that queues each message, delivers it to the 
cell provider (which passes to the participant’s phone), and returns delivery status (success or failure) to the 
intervention application. Inbound messages from participants to the intervention, such as a reply indicating 
whether they chewed, will be queued at the gateway and retrieved each minute by the application. Study staff 
interface with the intervention through a web-based dashboard and email messages from the application. 
Through the dashboard, staff will see aggregate information and can identify individual participants by criteria 
such as SGR status and drill down to their detailed data. Manual outbound SMS messages can be delivered 
from the dashboard using templates or freeform (for example, to respond to a participant who has requested 
help via SMS).  
 
 
Table 7. Example of Interactive text messages 
Content 
Example Message      
CRAVE 
When you have an urge 
to chew ride it out by 
taking five deep breaths. 
It will go away, but don’t 
fool yourself into thinking 
you can have just one 
dip. (160 characters) 
MOOD 
Talk and do things with 
other people, even if you 
don’t feel up for it. This 
will increase your mood. 
(100 characters) 
SLIP 
Having a slip does not 
mean you can’t quit. It 
does not mean you can’t 
quit for good. You can do 
it! (100 characters) 

Measures  
Outcomes and Mediators 
Self-report smokeless tobacco cessation will be assessed at the end of treatment, 3 and 6-months post-
intervention. Self-report smokeless tobacco cessation at month 6 will be the primary outcome. 
Secondary outcomes, which will be subsequently evaluated as mediators of the intervention effects, will be 
assessed at baseline, end of treatment, and 3 and 6-months post-intervention. 
Primary Outcome: Smokeless Tobacco Cessation Outcome. Self-reported abstinence from tobacco use will be 
collected at end of treatment, 3 and 6-months post-intervention. We will measure 7-day point prevalence 
abstinence by asking participants, “In the past 7 days, have you used smokeless tobacco (chew or dip)?” This 
binary outcome will be dichotomized as 0=no and 1=yes.  We will also randomly select a 20% (10% in control 
and 10% in intervention arm) of those who report quitting at the end of treatment, 3 and 6 months to 
biochemically confirm cessation using saliva cotinine strips. NicAlert Semiquantitative test strips will be used 
and a 10 ng/ml cutoff will indicate exposure. Biochemically validated cessation at each of these assessment 
points will be coded as 0=no and 1=yes. 
Mediator: Craving. We will assess craving using the Smokeless Tobacco Evaluation Questionnaire (STEQ) 
based on the Cigarette Evaluation Questionnaire (mCEQ) modified for ST users.46 The STEQ is a 12-item 
scale assessing the degree to which participants experience the reinforcing effects of smokeless tobacco on a 
7-point Likert scale. The scale has five domains: chewing satisfaction, psychological reward, enjoyment of 
sensations in cheek/gum, craving reduction, and aversion.  
Mediator: Withdrawal. We will assess withdrawal using the self-report seven item Minnosota Nicotine 
Withdrawal Scale47 as has been used in other smokeless tobacco cessation trials assessing withdrawal. This 
seven-item scale measures withdrawal symptoms (i.e., irritability, anxiety, difficulty concentrating, restlessness, 
increased appetite or weight gain, depression, and insomnia) and measured on an ordinal scale (0= not 
present) to 4 (severe). A total score ranging from 0 to 28 will be derived to measure severity of withdrawal 
symptoms, with higher total scores representing greater withdrawal. Internal consistency of the scales are 
reported to be between α= 0.76-0.91. 
Mediator: Self-regulation. We will assess self-regulation using the Short-form Self-Regulation Questionnaire, 
which is a 31 item self-report survey measuring the ability to regulate behavior and achieve goals.48 
Participants indicate the extent to which they agree with each item using a 5-point Likert scale: 1 (Strongly 
Disagree), 2 (Somewhat Disagree), 3 (Neutral), 4 (Somewhat Agree), and 5 (Strongly Agree). The measure 
has a total scale computed by summing the items, with higher total scores indicating increased self-regulation. 
Internal consistency of the scale is reported to be α=0.92. 
Mediator: Restraint. We will measure restraint using a modified version of the Smoking Restraint 
Questionnaire49 for smokeless tobacco by replacing all smoking references with smokeless tobacco.  The 
Smoking Restraint Questionnaire is a four-item survey. The two binary questions of the questionnaire are 
scored 1 (No) and 5 (Yes). The two multiple-choice items are scored from 1 to 5. Total smokeless tobacco 
restraint is calculated as the sum of the four items. The minimum possible score is 4 and the maximum 
possible score is 20, with higher total scores indicating higher levels of restraint. Internal consistency of the 
scale is reported to be α=0.74. 
Sample Characteristics : Baseline sociodemographic and clinical measures will be collected to describe the 
characteristics of the total sample and intervention arms. Many of these measures are potential important 
moderators or mediators of intervention effects that will be explored after the specific aims are fully examined. 
• Demographics and Relevant Biological Variables. We will assess age, sex, race, education, marital status, 
and socio-economic status (SES) at baseline using measures adapted from our prior research.  
• Smokeless and other Tobacco Use History. At baseline, participants will be asked about their tobacco use 
habit including: number of chews/dips per day, number of quit attempts in the past year, age of chewing/dipping 
initiation and past use of other tobacco products including electronic cigarettes. 
• Nicotine Replacement Therapy (NRT) Use: We will ask participants at all follow-up time points if they have 
used any NRT including the patch, gum or lozenge. 
• Nicotine Addiction. We will assess nicotine addiction at all time-points using the Severson Smokeless Tobacco 
Dependence Scale-Short Form (SSTDS). The SSTDS is a validated questionnaire has eight items with a range 
of scores from 0-19 with higher scores being most addicted to nicotine.47    
• Self-efficacy. At all time-points we will measure self-efficacy using a similar 9 item scale to the Temptations 
scale. We will adapt the scale by switching out smoking with chewing/dipping. Sample items read, "How 

confident are you that you would not chew in the following situations: when you are very angry about something 
or someone, when you feel you need a lift, etc.” (1=Not at all confident and 5=Extremely confident). 
• Alcohol Use Disorder Identification Test (AUDIT-3).  At all time-points we will use the AUDIT, a 3 item self-
report scale that measures risky drinking, as this may influence quit rates. 50
Process Measures: Process measures that could impact outcomes will be collected at baseline, during 
intervention administration, at the end of treatment, 3 and 6 month follow-up. 
• Adherence (Intervention Group). Adherence to the SGR intervention will be calculated two ways. First, we will
measure time to response from the SGR message. Second, we will create a categorical variable (0=respond
in more than 30 minutes, 1=respond after 30 minutes. If a participant responds to less than half of
chewing/dipping prompts in one day, we will exclude this day from the adherence analysis examining whether
overall adherence predicts quit rate and/or smokeless reduction in the SGR group.
• Adherence (Control Group). Participants will be asked at all follow-up time points how often they read the
cessation booklet using a using a 5-point Likert scale (1 = none, 2 = some, 3 = most, 4 = the entire guide,
and 5 = the entire guide more than once). 44
• Satisfaction with Intervention. Participants in both arms will be asked at end of treatment survey 1) “How
useful was the intervention in helping you to quit smokeless tobacco?” (Not at all useful=1, Extremely useful
=5) and 2) “Would you recommend the program to a friend?” (Definitely would not recommend=1, Definitely
would recommend=5).