Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation
Phase: NA
Conditions: Tobacco Use, Alcohol Use, Unspecified
Sponsor: H. Lee Moffitt Cancer Center and Research Institute

 
 
 
Development of a Mindfulness-Based Treatment for 
the Reduction of Alcohol Use and Smoking 
Cessation 
NCT03734666 
 
Protocol V25 
Dated 07/01/2021 

PI: Vinci, Christine 
 
 
TITLE: Development of a Mindfulness-Based Treatment for the Reduction of Alcohol 
Use and Smoking Cessation 
 
Coordinating Center: 
H. Lee Moffitt Cancer Center 
 
 
 
 
Protocol Version #25 Date: 7/1/21 

PI: Vinci, Christine 
B2 
 
 
 
1. PARTICIPANT SELECTION 
 
1.1 
Eligibility Criteria 
 
Aim 1: Inclusion criteria will be ≥ 18 years of age; currently smoking ≥ 3 cigarettes per day for 
the past year; carbon monoxide level ≥ 8 ppm; should carbon monoxide level yield a result less 
than 8 ppm, the participant will be asked to submit a urine sample to determine cotinine levels 
and the result must be ≥ level 3 ; motivated to quit smoking and decrease alcohol use within the 
next 60 days; if male, consumes ≥ 5 drinks and if female, consumes ≥4 drinks on at least 1 
occasion in the past month; willingness and ability to attend the 8 weekly group sessions; valid 
home address in the Tampa Bay area; functioning telephone number; and can speak, read, and 
write in English. 
 
Aim 2: Inclusion criteria will be ≥ 18 years of age; currently smoking ≥ 3 cigarettes per day for 
the past year; motivated to quit smoking and decrease alcohol use within the next 60 days; if 
male, consumes ≥ 5 drinks and if female, consumes ≥4 drinks on at least 1 occasion in the past 
month; willingness and ability to attend the 8 weekly video group sessions; willingness and ability 
to use an email account for study materials; valid address; functioning telephone number; and 
can speak, read, and write in English. 
 
1.2 
Exclusion Criteria 
 
Exclusion criteria will be contraindication for the nicotine patch; an active substance use 
disorder other than an alcohol use disorder; an active psychotic disorder; current use of tobacco 
cessation medications; pregnancy or lactation; and a household member already enrolled in the 
study. In rare cases, study staff might exclude a participant for a reason not specified here (e.g., 
arrives intoxicated for multiple sessions). 
 
 
1.3 
Inclusion of Women and Minorities 
 
Both men and women and members of all races and ethnic groups are eligible for this trial. 
 
1.4 
Recruitment 
 
Participants will be recruited through print and media ads within the state of Florida. This will 
include radio and TV ads, recruitment through social media, general online advertising, and 
advertising on local busses. Flyers will be distributed throughout the local Tampa-Bay 
community, including to primary care offices, wellness programs/clinics, and physicians (face-to- 
face meetings or presentations will occur as requested by the physicians/staff). We will also 
reach out to human resources departments of local business for them to distribute our study 
flyers to potentially interested employees. Additionally, we will be distributing flyers through 
avenues of the legal system, including, but not limited to, social services departments and district 
courts. We will contact ineligible participants from prior studies at TRIP via our existing and 
longstanding database of participants who have given us permission to contact them for future 
research. TrialFacts will also be used to recruit participants. Participants recruited through 
TrialFacts will be invited to complete a brief online survey and/or telephone pre-screening 
conducted by TrialFacts staff, which will include basic eligibility criteria. Our study team will then 
reach out to potentially eligible participants to complete a full study screen. 
Finally, we will leverage our relationship with The Tampa Bay Community Cancer Network 
(TBCCN), a network of community-academic partners, which is led by two senior faculty 

PI: Vinci, Christine 
B3 
 
 
members in our program. Established in 2005, TBCCN addresses critical access, prevention and 
control issues among medically underserved, low-literacy and low-income populations in the 
Tampa Bay and surrounding catchment area. It is comprised of over 28 diverse partner 
organizations, including community clinics (e.g., federally qualified health centers, health 
departments, social service organizations, grassroots, faith-based and adult education groups) 
and Moffitt. Thus, during the first 3 months of this grant, we will determine which community or 
clinical organizations of TBCCN might be further interested in advertising our study to their 
members. Establishing these targeted relationships will not only bolster recruitment (including 
the possibility to hold group sessions at their locations), but would hopefully lead to maintainable 
relationships that extend beyond this grant period. 
 
2. STUDY DESIGN AND METHODS 
 
Aim 1. 
 
Project Overview. The primary goal of Aim I is to modify an existing treatment – MBRP – to 
include a focus on smoking cessation and reducing alcohol use (MBRP-SA). In this section we 
include a description of MBRP and the proposed modifications to the original protocol to include 
a focus on smoking abstinence and reduced alcohol use (Study 1). 
MBRP Overview. MBRP was designed to target key components in the relapse prevention 
process, with a specific focus on negative mood and craving. Principles of the treatment were 
derived MBRP139 and MBCT.140 MBRP-SA will use the same session structure as MBRP, with 8 
weekly in-person group sessions that are 2 hours each. Group sizes for MBRP-SA will be 8-10 
participants. The current study will follow the existing treatment manual for MBRP,141 with 
necessary modifications as described in the following section. The core aims of MBRP are to aid 
individuals in developing an awareness of the present moment and the ability to shift attention 
(i.e., the opposite of being on autopilot) and to increase tolerance of emotional, cognitive, and 
physical states that are unpleasant or negative. The mindfulness practices within MBRP teach 
individuals how to hone these skills, which allows them to better manage substance use craving 
when it does occur. Examples of these practices include mindfulness meditation, mindful 
movement, body scan, and awareness of the senses. 
Sessions 1 and 2 of MBRP focus on providing a rationale for how mindfulness can be related 
to craving and mood, discussing the tendency to be on “autopilot”, and increasing awareness of 
internal and external triggers for substance use. In these sessions, exercises are designed to aid 
participants in understanding how to “sit with” discomfort, which provides for the opportunity to 
mindfully choose a response, instead of impulsively responding. Sessions 3 and 4 aim to 
increase participants’ awareness of habitual responding in order to expand their options for 
coping when experiencing a craving. One particularly relevant exercise is SOBER (Stop, 
Observe, Breathe, Expand, Respond) Breathing Space, which is practiced in session and 
participants are encouraged to utilize this skill as part of their daily activities. Session 5 focuses 
on the ability to balance acceptance with the need to take skillful action. Session 6 highlights the 
importance of decentering from thoughts, and noticing “thoughts are just thoughts” and not fact. 
Sessions 7 and 8 discuss self-care, generalizing the skills learned in treatment to daily life, and 
increasing social support networks. Loving-kindness meditations are also introduced as a way to 
cultivate self-compassion and forgiveness. As 
participants progress through MBRP, home practices 
are introduced and built upon each week. Examples 
of formal home practice include body scans, sitting 
meditation, walking meditation, and mindful 
movement. Integrating mindfulness into daily activities 
is encouraged via informal exercises (e.g., 
 
awareness of brushing teeth, washing hands, SOBER breathing space). Participants will be sent 
Table 1. MBRP Session Topics 
Week 1 
Automatic Pilot and Relapse 
Week 2 
Awareness of Triggers and Craving 
Week 3 
Mindfulness in Daily Life 
Week 4 
Mindfulness in High-risk Situations 
Week 5 
Acceptance and Skillful Action 
Week 6 
Seeing Thoughts as Thoughts 
Week 7 
Self-care and Lifestyle balance 
Week 8 
Social Support and Continuing Practice 

PI: Vinci, Christine 
B4 
 
 
an email each week including the handouts from the session as well as links to the audio files of 
the meditations practiced during the group. Table 1 provides session topics for MBRP. 
MBRP-SA Development. The primary adaptation for MBRP-SA will be to tailor some the 
session content and discussions to smoking cessation and alcohol use. These changes will be 
primarily guided by the existing literature (e.g., studies on mindfulness-based treatments for 
smoking cessation) and the experience/knowledge of the investigative team. It should be noted 
that MBRP already addresses some of the primary underlying mechanisms of smoking cessation 
and reduced alcohol use (e.g., managing negative affect and craving) and that the extant 
literature indicates that key behavior modification constructs (e.g., self-efficacy) are impacted by 
mindfulness.45,50,67,76 Therefore, we will not modify the core components of MBRP, but instead 
supplement the existing protocol with content unique to smoking and alcohol use. 
Content Modifications. Content modifications listed here fall into 3 categories: smoking- 
specific, alcohol-specific, and co-use. Given MBRP has already demonstrated efficacy for 
reduced alcohol use, most of these modifications focus on smoking and co-use content. 
Modifications are based on the existing literature, ability of content to address underlying 
behavior-change mechanisms (e.g., motivation) and Co-I Dr. 
Wetter’s experience developing and testing a mindfulness- 
based cessation intervention.58 SMOKING-SPECIFIC: Quit 
date. Research regarding smoking cessation indicates that 
motivation can be enhanced by setting a specific quit date.142 
Therefore, MBRP-SA will set the smoking quit date at Session 
5, which is supported by existing mindfulness-based cessation 
treatments (e.g., 58). This permits time for individuals to develop 
their mindfulness practice (Sessions 1-4) while still providing 
ongoing support for 3 weeks after the quit day. Losing a friend. 
Many smokers report that smoking a cigarette represents a 
type of “friendship” and that quitting smoking is like losing a 
close friend.143-145 MBRP-SA will acknowledge and process this 
type of cognition in Session 3. Diet and Weight Gain. Many 
individuals endorse motivation to continue smoking for weight 
control purposes,144 and therefore we will include information 
on this topic in Session 3. Nicotine Patch. Current guidelines for 
smoking cessation indicate that when provided with a 
combination of nicotine replacement therapy and counseling, 
chances of success are greatest.142 Thus, participants will be 

PI: Vinci, Christine 
B5 
 
 
provided with nicotine patches at the end of Session 4, with the intention to begin using them at 
Session 5. Psychoeducation about patch use will occur at Session 4. Mindful Smoking is a 
mindfulness activity that brings awareness to the act of smoking a cigarette. An introduction to 
this will occur at the end of Session 2, and the actual practice will be conducted right before the 
beginning of Session 3 group. Participants will be encouraged to continue mindful smoking until 
their quit day at Session 5. ALCOHOL-SPECIFIC: Reduced alcohol use. Alcohol use will be 
monitored at each treatment session. A discussion of goals related to reduced drinking will begin 
at Session 1 and continue through Session 5. Participants will be encouraged to set realistic 
drinking goals for themselves, which is consistent with a harm reduction approach to alcohol use 
and fits within the framework of social determination theory.146,147 Participants will be encouraged 
to implement drinking goals at Session 5 (to coincide with the smoking quit date), although many 
people may have already decreased use. At the orientation session, participants will be provided 
with a handout with psychoeducational information on alcohol use, and they will be encouraged 
to use this when deciding what their alcohol use goal will be. CO-USE: Psychoeducation on the 
health impacts of cigarette and alcohol use. Consistent with recommendations,142 participants 
will be provided with psychoeducation information on the impact of cigarette and alcohol use on 
their health at Session 1. Information on the benefits of quitting smoking and reducing drinking 
(e.g., breathing becomes easier, decrease risk of cancer development) will also be discussed 
and provided. Relationship between smoking and drinking. Given common underlying 
mechanisms of the co-use of alcohol and smoking exist (e.g., cue-induced craving, positive and 
negative reinforcement),11-16 discussions related to the inter-connected relationship among 
smoking and alcohol use will be conducted. This discussion will also include a focus on previous 
attempts to change either or both behaviors by participants. We will also highlight that continued 
alcohol use may serve as a trigger for relapse. Discussions regarding whether complete 
abstinence is the best option for some participants will be conducted. We believe this added 
content will aid participants in making the best decision regarding their own co-use. These 
discussions will occur at Session 2. 
Procedures. The treatment development procedures will follow an iterative multi-step 
process (see Figure 3) based on the treatment development literature.148,149 Step one will 
develop a good working treatment protocol based on the above content modifications. Because 
an already well-developed treatment manual exists for MBRP,141 we anticipate that this can be 
done fairly quickly. Step two will involve training counselors in the new protocol (see Treatment 
Delivery section in Study 2 for additional detail on counselor training). Step three will entail 
administering the protocol to a small group of participants (N=16) to receive feedback on MBRP- 
SA. We expect to enroll about 8 participants per group in order to run 3 groups. Eligibility criteria 
and study procedures will be identical to that outlined in Study 2 below, with the only exception 
being that participants will not complete the follow-up visits and will not complete the breath 
counting task. 
Compensation and Retention Procedures. Participants will be financially compensated for 
completing the assessment measures, and for the costs associated with participation such as 
transportation, child care, etc. Participants will receive $10 at the Orientation visit whether they 
are found to be eligible or not. The first 4 treatment visits will be paid at $15 per session, 
sessions 5-7 will pay $20 per session, and session 8 and the follow-up will pay out $25 per 
session. Participants will be compensated with a $10 gift card for completing the 16-week post- 
cessation follow-up call. For Visits 5 and 8, participants who arrive a half-hour early will receive a 
$5 bonus at the end of their visit. 
Step four will include extensive querying of participants as to the appropriateness, 
acceptability, usefulness, etc. of all materials, assessments, procedures, and treatment. Some 
questions will mimic the acceptability questions outlined below for Study 2. However, more 
specific detail regarding MBRP-SA will also be gathered. A focus group will be conducted by the 
PI with participants on topics related to the content modifications outlined above (e.g., 
understandability of content and what information was most/least helpful regarding smoking and 
alcohol use), along with other general treatment-related issues (e.g., barriers to enrolling in the 

PI: Vinci, Christine 
B6 
 
 
treatment, concerns about logistically attending sessions, and appealing features of the 
treatment). Step five will include revising the treatment procedures and content based on the 
results from each cohort of development testing. Table 2 provides an overview of the timeline for 
Study 1. 
Statistical Considerations. The primary goal of Study 1 is to develop MBRP-SA. Qualitative 
analysis of focus group will be the primary form of evaluation. The focus group will be audio- 
recorded and verbatim transcripts created for content analysis.150 Using hand coding, the goal 
will be to identify key themes/textual units related to mindfulness and response to the treatment. 
Results from the qualitative interviews will be analyzed using the interview transcripts and 
content analysis. Content analysis will be conducted using an “intuitive” or 
“immersion/crystallizing” analysis plan, whereby the researcher reviews all data and pulls out 
those aspects most relevant to the research questions.151 The research team will identify key 
themes as they read through the interview transcripts. Descriptive statistics of quantitative 
measures will supplement the qualitative analysis. These may provide information for identifying 
aspects of implementation that require change prior to the feasibility study (Study 2). 
 
Aim 2. 
*Note: All procedures reported for Aim 2 will be conducted remotely, primarily via zoom and 
phone calls (but also via mailouts, emails, and text messages as appropriate). Group treatment 
sessions (MBRP-SA and CBT) will be conducted via zoom. 
Project Overview. The primary goal of Study 2 is to measure benchmarks regarding the 
feasibility and acceptability of the MBRP-SA protocol created in Study 1. Participants (N=64) will 
be randomized to either MBRP-SA or CBT and tracked from 5 weeks pre-quit through 16 weeks 
post-quit. The first follow-up appointment will be a phone call scheduled at 8 weeks post- 
cessation (±5 days). The second follow-up appointment will be a phone call scheduled at 16 
weeks post-cessation (±5 days). Table 4 provides a timeline of all procedures and assessments. 
Details are presented in the subsequent sections. Administering the battery of assessments 
below according to this timeline mimics the procedures for a future, large-scale R01 efficacy trial 
and will allow for the evaluation of feasibility for completing all procedures. 
Recruitment. Participants will be recruited through print and media ads within the state of 
Florida and Georgia. This will include radio and TV ads, and recruitment through social media. 
Flyers will be distributed throughout the community, including to primary care offices and 
physicians. These methods mimic the successful recruitment methods for this population in past 
studies conducted at TRIP. All methods used in Recruitment section above will be used here 
Telephone Screening. Interested participants will be contacted via phone and provided a 
detailed overview of the study. Following verbal informed consent, potential participants will be 
screened for inclusion/exclusion criteria. Participants will complete the eligibility screening, 
including the MINI for Alcohol Use, Substance Use, and Psychotic Disorders for DSM-V for 
diagnostic information. The TLFB will confirm participants meet the alcohol criteria for the past 
month. Eligible participants will then be scheduled for a phone orientation session. 
 
 
Table 3. Aim 1 Study Procedures 
Overview 
Pre-cessation Week 
Post-cessation Week 
Phone 
Screen 
-5 
Orientation 
-4 
Start 
of Tx 
-3 
-2 
-1 
0 
Quit 
Day 
1 
2 
3 
End of 
Tx 
8 
Follow 
Up 
16 
Follow 
Up 
Telephone Screening 
X 
TREATMENT (Tx) PROCEDURES 
MBRP-SA or CBT Delivery 
Tx 1 
Tx 
2 
Tx 3 Tx 4 
Tx 5 
Tx 6 Tx 7 
Tx 8 
Nicotine Patch Dispensation 
X 
X 
X 
X 
X 
X 
DEMOGRAPHICS / MENTAL HEALTH 
Demographics 
X 
MINI Psychotic Disorders, Alcohol, and 
Substance Use Disorders for DSM-5 
X 

PI: Vinci, Christine 
B7 
 
 
 
ALCOHOL USE MEASURES 
Alcohol Use Goals 
X 
X 
X 
X 
Alcohol Use History 
X 
Patient Health Questionnaire–Alcohol 
Use 
X 
X 
X 
X 
Penn Alcohol Craving Scale 
X 
X 
X 
X 
Alcohol Abstinence Self Efficacy 
X 
X 
X 
X 
Drinking Motives Questionnaire - 
Revised 
X 
X 
X 
X 
SMOKING MEASURES 
Smoking Use and History 
X 
Brief Wisconsin Inventory of Smoking 
Dependence Motives 
X 
X 
X 
X 
Wisconsin Smoking Withdrawal Scale 
X 
X 
X 
X 
Self-Efficacy Scale-Smoking 
X 
X 
X 
X 
MINDFULNESS 
Five Facet Mindfulness Questionnaire 
X 
X 
X 
X 
Toronto Mindfulness Scale 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
NEGATIVE AFFECT / DEPRESSION / STRESS / ANXIETY 
Center for Epidemiological Studies 
Depression Scale Revised 
X 
X 
X 
X 
Distress Tolerance Scale 
X 
X 
X 
X 
Perceived Stress Scale 
X 
X 
X 
X 
Positive and Negative Affect Scale 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
BEHAVIORAL TASK 
Breath Counting 
X 
X 
ALCOHOL USE AND SMOKING STATUS / BIOCHEMICAL VERIFICATION 
Timeline Followback 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Carbon Monoxide (CO) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Urinalysis hCG, as applicable 
X 
Urine Cotinine as applicable 
X 
Blood Alcohol Content (BAC) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
FEEDBACK FROM PARTICIPANTS 
End of Treatment Feedback 
Questionnaire 
X 
WAI-SR Client Version Modified 
X 
Follow-up Feedback Questionnaire 
X 
 
 
Table 4. Aim 2 Study Procedures 
Overview 
Pre-cessation Week 
Post-cessation Week 
Phone 
Screen 
-5 
Orientation 
-4 
Start 
of 
Tx 
-3 
-2 
-1 
0 
Quit 
Day 
1 
2 
3 
End 
of Tx 
8 
Follow 
Up 
16 
Follow 
Up 
Telephone Screening 
Xa 
TREATMENT (Tx) PROCEDURES 
MBRP-SA or CBT Delivery 
Tx 1 Tx 
2 Tx 3 Tx 4 Tx 5 Tx 6 Tx 7 
Tx 8 
Nicotine Patch Dispensation 
X 
X 
X 
X 
X 
X 
DEMOGRAPHICS / MENTAL HEALTH 
Demographics 
X 
MINI Psychotic Disorders, Alcohol, 
and Substance Use Disorders for 
DSM-5 
Xa 
ALCOHOL USE MEASURES 
Alcohol Use Goals 
Xa 
Xa 
Xa 
Xa 
Xa 
Alcohol Use History 
X 
Patient Health Questionnaire–Alcohol 
Use 
X 
X 
X 
X 
Penn Alcohol Craving Scale 
X 
X 
X 
X 
Alcohol Abstinence Self Efficacy 
X 
X 
X 
X 
Drinking Motives Questionnaire - 
Revised 
X 
X 
X 
X 
SMOKING MEASURES 
Smoking Use and History 
X 

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Brief Wisconsin Inventory of Smoking 
Dependence Motives 
X 
X 
X 
X 
Wisconsin Smoking Withdrawal Scale 
X 
X 
X 
X 
Self-Efficacy Scale-Smoking 
X 
X 
X 
X 
MINDFULNESS 
Five Facet Mindfulness Questionnaire 
X 
X 
X 
X 
Toronto Mindfulness Scale 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Avoidance and Inflexibility Scale 
X 
X 
X 
X 
NEGATIVE AFFECT / DEPRESSION / STRESS / ANXIETY 
Center for Epidemiological Studies 
Depression Scale Revised 
X 
X 
X 
X 
Distress Tolerance Scale 
X 
X 
X 
X 
Perceived Stress Scale 
X 
X 
X 
X 
Positive and Negative Affect Scale 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
ALCOHOL USE AND SMOKING STATUS / BIOCHEMICAL VERIFICATION 
Timeline Followback 
Xa 
Xa 
Xa 
Xa 
Xa 
Saliva Cotinine 
X 
FEEDBACK FROM PARTICIPANTS 
Client Satisfaction Questionnaire 
X 
End of Treatment Feedback 
Questionnaire 
X 
WAI-SR Client Version Modified 
X 
Feasibility of Technology Survey 
X 
System Usability Scale 
X 
Follow-up Feedback Questionnaire 
X 
a = data collected during phone call (vs REDCap) 
 
Phone Orientation Visit. Study personnel will call the participant at their scheduled session 
time and provide a detailed description of the study and obtain verbal consent. A copy of the 
informed consent and a PowerPoint describing the study in detail will be mailed and/or emailed 
to participants before the orientation session. If the participant decided to consent to the study, a 
series of self-report questionnaires to complete will be emailed to them(see Aim 3 below). 
Individuals who are ineligible or decline to participate will receive self-help materials and referrals 
for smoking cessation and alcohol use programs. 
Zoom Orientation Visit. Consented participants will be scheduled for a group Zoom 
Orientation session one week before the first treatment session. Prior to the visit, participants will 
be provided a packet of instructions on how to access and navigate the video-conferencing app, 
Zoom, and additional materials related to the study (e.g. session handouts, welcome materials). 
Tablets, webcams, and/or microphones will be provided to participants on an as-needed basis. 
This orientation session will take place via Zoom. During this session, participants will be 
provided with a training on how to use video-conferencing app and will discuss the other relevant 
materials sent to participants in preparation for the first treatment visit. Prior to all Zoom visits in 
the study, participants will join a waiting room before they are admitted to the group, where they 
will see banners with reminders about sessions content, privacy standards, etc. This procedure 
will be followed for all treatment sessions as well as the Zoom Orientation session. 
Randomization. Three stratification variables will be included: gender (men vs women), 
race/ethnicity (non-Hispanic White vs Other), and smoking rate (20+ cigarettes per day [CPD] vs 
less than 20). Within these 8 cells, eligible participants will be assigned to the two treatments 
using balanced-permuted block randomization with a block size of 4. 
Compensation and Retention Procedures. Participants will be financially compensated for 
completing the assessment measures, and for the costs associated with participation such as 
child care, etc. Participants will receive a $10 gift card after completing measures sent after the 
Orientation visit, and will receive an additional $5 bonus gift card if they complete it in 24 hours. 
Participants who decline to consent to the study during the Orientation visit will receive a $10 gift 
card. Participants will receive $10 for completing the Zoom Orientation visit. For measures 
completed prior to visits 1-4, 6, and 7, participants will receive a $5 gift card, and a $5 bonus gift 
card if they complete them within 24 hours.. For measures completed prior to visits 5 and 8, 
participants will receive a $20 gift card, and a $10 bonus gift card if they complete the measures 

PI: Vinci, Christine 
B9 
 
 
within 24 hours. For completing the phone call assessment prior to visits 5 and 8, participants 
will be compensated with a $15 gift card. Payment for these visits differ based on the length 
(e.g., participants are compensated more when asked to complete lengthier questionnaire 
packets). Participants will be compensated with a $20 gift card for completing the first follow-up 
call and measures, and will receive a $10 bonus gift card if they complete the measures within 
24 hours. For completing the second follow-up call (16 weeks post-cessation), participants will 
receive a $25 gift card. Participants will receive a $10 bonus for sending back a saliva sample to 
confirm tobacco abstinence. For any unreturned iPads after a period of two months of phone 
calls/emails from staff, a $50 gift card incentive will be offered for the return of the iPad. 
This payment schedule will apply only to Aim 2. We will also conduct the following 
procedures to reduce attrition: reminder phone calls or texts prior to all study visits, flexible 
scheduling of the group sessions (e.g., evenings, various days of the week) to accommodate 
different schedules, requiring a functioning phone number and home address to contact 
participants by phone or mail as needed, and obtaining the name, address, and phone number 
of at least 2 collaterals (i.e., relatives, friends) who can provide contact information for the 
participants, should we be unable to contact them during the study. Participants who are unable 
to complete the measures or phone assessments will be mailed the materials to complete. 
Treatment Overview. All participants will receive nicotine replacement therapy (NRT) and 
either MBRP-SA or CBT. Table 4 provides an overview of all treatment and follow-up visits. 
NRT. The nicotine transdermal patch is the most widely used pharmacotherapy and the 
Treating Tobacco Dependence Clinical Practice Guideline has identified it as frontline therapy.142 
The patch is safe, tolerable, and available over-the-counter. Patch therapy for participants who 
smoke >10 CPD will consist of 6 weeks of 21 mg patches and 2 weeks of 14 mg patches. Patch 
therapy for participants who smoke 5-10 CPD will consist of 6 weeks of 14 mg patches and 2 
weeks of 7 mg patches. Patch dispensation will occur at weekly treatment visits. Participants 
receive only the number of patches needed to last until the next visit plus several extra patches 
should one fall off, become torn, etc, or should the visit be delayed. Based on our previous 
research, compliance is improved when participants are provided with only enough patches to 
last until the subsequent visit. A reduction in dosage or cessation of the patch regimen will be 
implemented for any participants who show signs of being on too high of a dose, which is 
expected for very few participants since blood nicotine levels are usually much lower on the 
patch than while smoking. Note that for Aim 2, patches will be mailed each week. 
MBRP-SA and CBT. MBRP-SA was already described above. CBT is a well-established and 
commonly used treatment for substance use behaviors that primarily utilizes a problem solving 
and coping skills approach rooted in relapse prevention theory,152 combined with standards from 
the Guideline.142 Session content will generally follow the manual used in the original MBRP 
RCT64, the MBAT RCT58, and standards from the Guideline (e.g., setting a quit date, providing 
NRT).142 CBT will consist of 8 sessions (2 hours each), with 8-10 participants in each group. 
Thus, participants in both MBRP-SA and CBT will be matched on treatment contact time. All 
treatment activities focus on promoting/maintaining smoking abstinence and reducing drinking, 
with specific treatment objectives for each session. Participants will receive weekly emails that 
outline the group session as well as include relevant links and attached handouts for their 
review. Participants will also receive referrals for mental health and substance use at the end of 
treatment. 
Treatment Delivery and Fidelity. Explicit therapist selection criteria, extensive training, and 
on-going monitoring and supervision of treatment delivery, fidelity, and therapist competence will 
ensure that treatments are of the highest quality, follow the protocols precisely, and prevent 
counselor drift and contamination. 
Selection Criteria. For both MBRP-SA and CBT, therapists must have a minimum of a 
master’s degree in counseling, psychology, social work, or a related field and experience running 
group therapy. For MBRP-SA, therapists also need to: complete the 5-day intensive MBRP 
training, have a daily formal and informal mindfulness practice, and attend, or have attended a 
silent meditation retreat. For CBT, therapists must have been trained in CBT. The decision to 

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B10 
 
 
utilize different therapists for each treatment was made to decrease the likelihood of treatment 
crossover and subsequent treatment contamination if a therapist provided both treatments. 
Although we are aware that the risk in using different therapists may allow for therapist-specific 
effects to occur, we believe that MBRP-SA and CBT would be difficult to provide concurrently 
while adhering to both protocols. Therapist-specific effects will be evaluated (see below for more 
detail). 
Training, Supervision, Adherence. As reported above, counselors providing MBRP-SA will 
already have a strong background in mindfulness-based techniques. Counselor training in CBT 
and the smoking cessation and alcohol use portion of MBRP-SA will be conducted by Drs. Vinci 
and Brandon, who have extensive experience in delivering behavioral treatments for nicotine 
dependence and alcohol use. This training will include a focus on smoking and alcohol use 
through readings of the MBRP-SA and CBT manuals, practicing and role playing each session of 
MBRP-SA and CBT, and working through anticipated issues that might arise during sessions. 
Training will occur in a regular series of half-day blocks (1-2 per week) with the counselor 
studying and role-playing between training sessions. Training will continue until the counselor 
reaches performance criteria for competence and adherence to the protocols, which will be 
made on counselor rating forms during mock counseling sessions using the validated 
Mindfulness-Based Relapse Prevention Adherence and Competence Scale (MBRP-AC)153 for 
MBRP-SA and a modified version of the Cognitive Therapy Adherence and Competence Scale 
(CTACS) for CBT.154 To ensure fidelity to the MBRP-SA treatment once participants are enrolled 
in the study, we will follow the recommended supervision guidelines for MBRP. This will involve 
weekly supervision with MBRP-trained clinicians to review tapes, discuss miscellaneous 
counseling issues, and problem-solve as needed. These supervision sessions will ensure that 
MBRP-SA is being delivered consistent with the spirit of MBRP. CBT counselors will follow 
identical supervision procedures. 
Treatment Fidelity. To monitor therapist adherence and competence to the protocol and to 
prevent drift, all sessions will be recorded and a random sample of 10% will be rated by the 
investigators using the MBRP-AC and CTACS. Additionally, applicable staff at the University of 
New Mexico will receive audio recordings of the sessions to further monitor therapist adherence 
to the protocol. A counselor who falls below performance criteria will receive additional training. 
In order to observe any counselor-specific characteristics that may be unique to some groups 
and not others, participants will complete a measure at the final treatment session that assesses 
topics relevant to their therapist such as, warmth, empathy, credibility, confidence, 
trustworthiness, and responsiveness to questions. The audio recordings may also be used for 
participants who miss a group session. They may come into the research facility to listen to the 
audio recording from group to make up the missed session. Finally, homework completion will be 
monitored weekly via questionnaire to assess treatment adherence (e.g., amount of time each 
day spent meditating, types of mediations practiced each week). 
Benchmarks for Feasibility and Acceptability. Table 5 provides a list of benchmarks that 
are the primary outcomes for Study 2. The development of these benchmarks was informed by 
the extant literature on feasibility measurement.155-157 In addition to the measurable outcomes 
below, other areas to be monitored include the ability to: randomize participants to group, 
effectively screen for eligibility criteria, organize all questionnaires to be completed in-full for 
thorough data processing and analysis, and schedule participants for treatment sessions and 
follow-ups. For any participant who drops out early, a structured phone interview will be 
attempted to determine reasons for withdrawal and overall reaction to the treatment protocol. 
We will invite a subset of participants (N=16) back for in-depth interviews, and questions will 
mimic those from the interviews we will conduct as part of Aim 1. Interviews will be audio- 
recorded and transcribed for content analysis. We will specifically query participants on the 
appropriateness, acceptability, usefulness, etc. of the intervention, as well as other general 
treatment-related issues (e.g., transportation; barriers to enrolling in treatment). The analysis of 
these data will also model what we have written for Aim 1. 

PI: Vinci, Christine 
B11 
 
 
 
 
Table 5. Measureable Benchmarks 
Area of Interest 
Description of Outcome to be Evaluated 
Measure and/or Expected Outcome 
Acceptability 
Participant Satisfaction 
Client Satisfaction Questionnaire158 
(satisfaction of ≥80%) 
Intention to continue to use skills learned 
from the treatments 
Questionnaire developed for this study 
Perceived appropriateness of the 
treatments for smoking and alcohol use 
Questionnaire developed for this study 
Demand 
Accrual rates for study 
For recruitment, the cost of each 
participant will be ≤$100 
Completed sessions 
≥40% of participants will complete all 8 
sessions; ≥60% will complete between 
4 and 7 sessions* 
Homework Completion 
For MBRP-SA, participants will engage 
in mindfulness homework at a minimum 
of 3.5 days per week* 
Implementation/ 
Practicality 
Screening/eligibility for study 
Record number of call attempts for each 
participant and reasons for ineligibility 
Recruitment 
Recruit 8 eligible participants per 
month; 60% of recruitment will be 
completed by the end of year 2 
Retainment 
Retain 80% through end of treatment, 
70% through follow-up 
Questionnaire completion 
For sessions attended, 90% of 
questionnaires will be completed 
Note. * based on data from Bowen et al., 2014; Vidrine et al., 2016; Witkiewitz et al., 201464,66,107 
 
Aim 3. 
 
The primary goal of Aim 3 is to collect and examine descriptive data on proximal variables 
associated with smoking abstinence and reduced drinking (e.g., negative affect, craving), as well 
as distal variables (smoking abstinence, heavy alcohol use) from Study 2. Aim 3 will be 
underpowered to test for any main effects of treatment on clinical outcomes. Nonetheless 
collecting these data will contribute to our assessment of feasibility and will provide guidance as 
we determine the sample size for a full-scale efficacy trial. 
Rationale for Assessment Strategy and Methodology. Several major considerations 
guided our assessment procedures. First, assessment selection criteria included established 
reliability and validity. Second, assessments had to either a) represent hypothesized treatment 
mechanisms/effects or b) have been empirically demonstrated to predict smoking abstinence 
and/or reduced drinking. Third, to reduce the inconvenience associated with completing the 
assessments we will provide compensation for participants’ time and provide snacks and 
beverages at all visits. In sum, our assessments comprehensively assess all necessary 
variables, the ability of the team to implement these procedures, and participant completion of 
the measures. Such information will inform future methods for a larger efficacy trial. 
Demographics/Description of Sample Measures. Demographics Questionnaire collects 
data on gender, age, race, ethnicity, education, income, employment, partner status, insurance 
status, and preferred language. MINI International Neuropsychiatric Interview DSM-5 is a semi- 
structured interview to assess for the presence of psychiatric disorders and substance use 
disorders and will be used in the current study to describe the sample and determine eligibility 
criteria. The following modules will be administered: I. Alcohol Use Disorder, J. Substance Use 
Disorder (Non-Alcohol), and K. Psychiatric Disorders and Mood Disorder with Psychotic 
Features. 
Alcohol Use Measures. Alcohol Use History will collect information on past year alcohol use 
(e.g., quantity/frequency of use, typical alcoholic drinks consumed), alcohol use history (e.g., age 
of first drink), other household drinkers, number of friends/family who drink, and treatment 

PI: Vinci, Christine 
B12 
 
 
history. As part of the inclusion/exclusion criteria, participants will also be asked if they have a 
history of experiencing severe alcohol withdrawal symptoms and if they are motivated to reduce 
their drinking in the next 60 days. Penn Alcohol Craving Scale (PACS) consists of 5 self-report 
items assessing the intensity, duration, and frequency of craving, the ability to resist alcohol, and 
average level of craving in the past week.160 Alcohol Abstinence Self-Efficacy Scale (AASE) 
evaluates an individual’s confidence to abstain from drinking according to 4 different scenarios: 
negative affect, social/positive, physical and other concerns, and withdrawal.161 Drinking Motives 
Questionnaire Revised (DMQ-R) utilizes self-reported data to measure drinking motives 
including social, enhancement, coping, and conformity.179 At baseline, on the quit day, and at 
the follow-up visit, participants will be asked about their alcohol reduction goal, and any progress 
toward achieving their chosen alcohol reduction goal. 
Smoking Measures. Smoking Use and History will collect information on the onset of 
regular smoking, smoking behavior (e.g., CPD, years spent smoking, time to first cigarette in the 
morning), smoking history (e.g., age smoked first cigarette), quit attempts, other household 
smokers, number of friends/family who smoke, and use of other tobacco products (e.g., e- 
cigarettes, cigars, hookah, snus). Participants will also be asked if they are motivated to quit 
smoking in the next 60 days, as part of the inclusion/exclusion criteria. Brief Wisconsin Inventory 
of Smoking Motives (WISDM) is a 37-item self-report measure used to assess nicotine 
dependence as a multi-dimensional construct via 11 different smoking motives.162 Wisconsin 
Smoking Withdrawal Scale (WSWS) includes 7 subscales assessing nicotine withdrawal 
symptoms according to 28 items.163 Self-efficacy Scale - Smoking is a 20-item self-report 
measure that determines an individual’s level of confidence for not smoking in positive/social 
situations, negative affect situations, and out of habit.164 
Mindfulness Measures. Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item Likert- 
scale measure assessing 5 facets of trait mindfulness.40 Toronto Mindfulness Scale (TMS) is a 
13-item Likert-scale self-report measure of state mindfulness.41 The TMS yields two factors: 
Curiosity and Decentering. 
Negative Affect/Depression/Stress/Anxiety Measures. Center for Epidemiological Studies 
Depression Scale  (CESD) is a 20-item self-report questionnaire that assesses depressive 
symptoms experienced within the past week.165 Distress Tolerance Scale (DTS) is a 15-item, 
Likert-scale self-report measure of an individual’s perception of his/her own emotional distress 
tolerance.166 Perceived Stress Scale (PSS) is a widely used self-report measure that assesses 
the degree to which participants find their lives to be stressful.167 Positive and Negative Affect 
Scale (PANAS) is a 20-item self-report Likert-scale measure that assesses an individual’s 
positive and negative affect at a given point in time.168 
Alcohol and Smoking Outcomes. Alcohol Use. The Timeline Followback (TLFB)171-173 will 
be used to determine daily, recent alcohol use via retrospective self-report. A calendar is 
provided to participants, and they indicate any key events that occurred on certain dates to aid 
their memory. Participants then indicate how much alcohol they drank on each day. The TLFB 
has been widely used, evaluated, and has strong psychometric properties.171-173 The TLFB will 
collect alcohol use from the past 4 weeks at the phone screen. The TLFB will be administered at 
each of the following visits and will ask participants to report their use since the last time they 
completed the TLFB: before visits 4 and 8, and at the 8-week and 16-week follow-up. From the 
TLFB, the primary outcome measure derived will be the percent of heavy drinking days (defined 
as: on a single occasion, ≥5 drinks for men and ≥ 4 drinks for women). Other alcohol use 
outcomes, such as percent days’ abstinent and alcoholic drinks per drinking day, will also be 
derived. 
Smoking Abstinence. To determine smoking abstinence, we will use the 7-day point 
prevalence, which is a combination of a self-report of no smoking in the last 7 days, combined 
with a biochemical verification of abstinence viasaliva cotinine. . Participants who report 
abstinence will be mailed a saliva cotinine kit to confirm abstinence at their 16-week follow-up 
call. The TLFB will be used to collected tobacco use throughout the study, and the schedule will 
mimic that used to collect alcohol use. 

PI: Vinci, Christine 
B13 
 
 
G. Data Management and Statistical Considerations for Study 2 
To ensure participant confidentiality, no unique identifiers will be recorded into the dataset 
to be analyzed. Data will be collected via REDCap. The entered and reviewed data will be 
transferred monthly to a SPSS database.174 
Sample Size. Randomizing 64 participants to MBRP-SA and CBT will provide sufficient data 
for assessing feasibility of the RCT, based on existing recommendations in the literature for 
sample size estimates in feasibility studies.175,176 A full set of statistical analyses focusing on 
treatment differences will be performed as part of the feasibility assessment. However, the 
sample size will not be sufficient for detecting treatment differences for anything less than large 
effect sizes (e.g., Cohen’s d > .72) for simple, two-group comparisons of a continuous variable 
with alpha=.05, power > .80, and a two-tailed test. Binary variables assessed under the same 
testing conditions would require an OR > 5.95. 
Data Analysis Overview. Analyses will be conducted with SPSS and SAS version 9.4174 
and Mplus Version 7.177 Descriptive statistics of demographics, smoking history, and alcohol 
history variables will be calculated and group comparisons will be performed. Descriptive 
statistics of all study measures (i.e., proximal and distal measures of alcohol use and smoking) 
will be calculated. Although underpowered to detect small- or medium sized sex differences, all 
analyses will examine sex as a covariate. Furthermore, analyses will include treatment group 
(i.e., each subset of participants who are treated with MBRP-SA or CBT together) when the 
intraclass correlation coefficient is > 0.10. 
Aim 2 - Evaluate benchmarks regarding feasibility and acceptability. Feasibility will be 
assessed by the multiple indices described in Table 5. Each index will either be compared to 
published norms (e.g., CSQ) or our prior experience with clinical trials. We expect to recruit 
adequate numbers of eligible participants during the study timeframe with efficient cost 
expenditures, retain at least 80% through the end of treatment, and retain at least 70% through 
the end of the study. Treatment acceptance and satisfaction are expected to be 80% or higher, 
and participants are expected to comply with treatment requirements. The team will determine 
whether corrective actions for future studies are needed when an index suggests 
underperformance. Evaluation of all indices will inform and guide modification prior to the 
proposal of a full-scale RCT. 
Aim 3 - Collect and examine descriptive data on proximal and distal variables associated 
with alcohol use and smoking. Descriptive statistics of proximal measures (e.g., negative affect, 
self-efficacy) will be presented in figures to review change over time and treatment differences. 
Generalized estimating equations (GEE) will be used to fit population-averaged models with the 
main variables of treatment, time, and their interaction. An AR(1) working correlation matrix will 
be used with r=.70. Covariates and potential confounding variables will be included, as 
warranted. This approach preserves data for analysis by avoiding listwise deletion of 
observations when at least one dependent variable was observed. Qualitative analyses (e.g., 
thematic analysis) may also be conducted on aspects of the treatment process. 
A similar approach to analysis will be taken for the primary outcomes (the distal measures). 
TLFB will be used to derive a measure of heavy alcohol use and the 7-day point prevalence will 
be created for smoking abstinence at five targeted 1-week periods prior to a session: start of 
treatment (week -4), quit date (week 0), end of treatment (week +3), and two follow-ups (week 
+8 and week +16). Descriptive statistics will be presented in figures. GEE with an AR(1) working 
correlation matrix (r=.60) will be used to assess the effects of treatment, time (-4, 0, +3, +8, +16), 
and their interaction on the primary outcome measures. Means, percentages, and 95% 
confidence intervals will provide useful guidance as we determine sample sizes for a full-scale 
RCT. There is not adequate power to detect small- to medium-sized treatment group differences 
given the sample size. However, we would interpret any within-subject decreases in the number 
of heavy drinking days from pre- to post-treatment and/or any within-subject increases in 
smoking abstinence as evidence that the MBRP-SA intervention may be beneficial for these two 
problematic health behaviors. Given the small sample size, these changes are not likely to be 
significant. However, sample means and standard deviations will provide valuable data for 

PI: Vinci, Christine 
B14 
 
 
estimating sample size in a large-scale RCT. Changes in craving, self-efficacy, and general use 
of alcohol and smoking will also be examined as proximal outcomes that will also inform the 
development of a large-scale trial. 
 
3. REGULATORY AND REPORTING REQUIREMENTS 
 
3.1 
Institutional Review Board 
 
No subject is to be enrolled on this protocol until the Center’s Institution Review Board has 
approved it. 
 
3.2 
Monitoring 
 
Monitoring plan development for this project is commensurate with the risks proposed 
by the project. Monitoring will be ongoing by the principal investigator (PI-Dr. Vinci), and the 
Institutional Review Boards (IRB) of Advarra. Overall, the plan for monitoring includes: 1) 
Monitoring the progress of the study; 2) Assuring compliance with the requirements for 
reporting adverse events that may occur during the study; and 3) assuring data accuracy and 
protocol compliance. For all study protocols, the PI is responsible for the reporting of adverse 
events to the IRB. 
Dr. Vinci will oversee the implementation of the study and daily monitoring. This will 
include weekly meetings to discuss any issues related to the progression of the project and 
factors that may affect the outcome, including a review of data quality and security, 
recruitment, and retention. Adverse events will also be discussed. A brief report will be 
created and submitted annually for the study record and submitted to the Chesapeake IRB. 
For any problems that may arise, Dr. Vinci will consult with the co-investigators to discuss how 
to best proceed. 
 
3.3 
Informed Consent 
 
The investigators and the research associated are responsible for obtaining consent by the 
participants. The consent process will be conducted remotely, and a waiver of written consent 
will be requested from the IRB to allow us to obtain verbal consent. Informed consent will be 
obtained over the phone prior to entry of any participant. 
 
3.4 
Investigator Study Files 
 
Research records for patients on this study are the responsibility of the investigator. They will be 
available for review by the sponsors of the trial, health care personnel involved in this study, the 
IRB, DHHS, and the FDA. 
 
Sources of Materials 
Data collected from participants for research purposes include a saliva testing for Cotinine (a 
nicotine metabolite) and self-report measures and interview data that collect demographic, 
medical history, psychiatric symptoms, smoking-related information, alcohol-use information, and 
questions about personality traits and current affective and cognitive states. Data will be 
collected electronically via REDCap. The treatment sessions for the MBRP-SA group involve 
mindfulness (meditation) practice that is tailored to smoking cessation and reducing alcohol use. 
The treatment sessions for the CBT group involve coping and reappraisal skill training that is 
tailored to smoking cessation and reducing alcohol use. Participants will be asked about the 
feasibility and acceptability of the treatments, in addition to monitoring their homework practice 
each week. 

PI: Vinci, Christine 
B15 
 
 
 
Potential Risks 
Minimal risks are anticipated for this study. Data including self-report, interview 
(psychological and medical), and biological samples (e.g., saliva) involve risk of breaches in 
confidentiality. Although everyone will be asked to keep the information shared during the group 
sessions confidential and to maintain anonymity outside of sessions, a breach of confidentiality 
is always possible. Participants will always be given the option to refuse to answer any questions 
on the measures that may be distressing. Successful abstinence may cause irritability, anxiety, 
general distress and difficulty concentrating. The nicotine patch that participants will wear 
beginning on the quit date will be the appropriate dose for their level of smoking, and the patch 
should aid in the management of withdrawal symptoms. The nicotine patch and smoking 
cessation counseling have been shown to be safe and effective for smokers attempting to quit. 
However, side effects to the patch may occur and include skin irritation/ rash, nausea, dizziness, 
dry mouth, diarrhea, nervousness, headache, vivid dreams or sleep disturbances, irritability, and 
irregular heartbeat. 
 
Protections Against Risks 
We believe that this study poses minimal risks. Potential side effects from the nicotine patch 
will be closely monitored by study staff and the PI. Participants will be told of potential allergic 
reactions and side effects in response to the patch and nicotine side effects, and also told that 
they are free to remove the patch at any point in time. Should participants feel any possible side 
effects, they will be advised to discontinue the patch, and also told that they can call the PI and 
study staff. Counseling will be provided by clinicians who have received ample training regarding 
ethical principles of counseling. Emergency procedures will be in place should any psychiatric 
emergency arise during the screening and/or treatment processes. Although this is likely to be 
very rare, all study personnel and counselors will be trained in these procedures. Should a 
person drop-out of treatment early, community referrals for smoking, alcohol use, and mental 
health services will be provided. To ensure that any data (e.g., psychological, medical, personal) 
collected from this study remains confidential, hardcopy and electronic storage of data will be 
identified by participant number, so that data will not be directly associable with names. 
Association between participant names and numbers will not be kept in the same location as the 
data. Electronic files will be protected by password access, and hard copies will remain in a 
locked cabinet when not in use. Saliva samples will be discarded and have no identifying 
information after analyses. 
 
Any electronic data will be stored on internal drives and in password-protected files without 
participant identifiers. Storage of any paper files will be kept in locked filing cabinets. Only study 
personnel will have access to these files. 
 
6.5. Data and Safety Monitoring Plan 
 
The PI, Dr. Christine Vinci, will be responsible for executing the Data and Safety Monitoring 
Plan (DSMP), and complying with all reporting requirements. The PI will provide a summary of 
the Data and Safety Monitoring (DSM) report to NIH as requested. The DSM report may include 
participants’ sociodemographic characteristics, recruitment rates, any quality assurance or 
regulatory issues during the past year, summary of Adverse Events (AEs) and Serious Adverse 
Events (SAEs), unanticipated problems, and any actions or changes with respect to the protocol. 
The DSM report to NIH may also include results of any interim data analyses. 
Questionnaire/interview data will be collected using paper forms and will only be identified 
with the participant’s study ID. Study staff will keep the codes that link the name of the 
participant and the study ID confidential in a password-protected file. Data accuracy will be 
subject to random audit. Data management reports will be made to the PI on an ongoing basis, 
which may include data entry progress, error rates, range checks, and general descriptive 

PI: Vinci, Christine 
B16 
 
 
statistics. The investigators will conduct all data analyses using SPSS and/or SAS software. 
Trained study staff will monitor participants closely throughout each treatment session, and 
either the study PI or a Co-Investigator will be at the study site to address any concerns that 
arise. Research staff will report Adverse Events (AE) to the PI and capture the AE data in 
Oncore, Moffitt’s Clinical Trials Database. Serious Adverse Events (using the FDA definition of 
SAEs) will be reported according to the requirements of NIH, Moffitt’s Protocol Monitoring 
Committee, and the IRB. Any IRB actions in relation to this protocol will also be reported to NIH. 
In the event, and only in the event, that study staff must work from home due to mandated 
orders (e.g., COVID-19 stay home orders), documents that contain protected health information 
may be temporarily kept at a personal residence for data entry and analysis. Documents will be 
secured in such a manner that they will be protected from being accessed by other individuals and 
pets who live in or visit the home. Any remote meetings (e.g., zoom meeting) or conference calls 
where protected health information may be discussed will be performed in a location that does not 
have listening devices (e.g., amazon echo) and are not likely to be overheard by those who live in 
or visit the personal residence. 
 
 
 
4. STATISTICAL CONSIDERATIONS 
 
Each Aim above outlines the analytic plan. 

PI: Vinci, Christine 
B17 
 
 
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