Addressing Tobacco Use Among Those At Socioeconomic Disadvantage
Phase: PHASE4
Conditions: Tobacco Smoking
Sponsor: Rutgers, The State University of New Jersey

Protocol version: 03.15.2019
PI Name: Marc L. Steinberg, Ph.D.
Protocol Title: Addressing Tobacco Among 
Public Housing Residents
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STUDY INFORMATION
Title of Project: Addressing tobacco among those at socioeconomic disadvantage
Principal Investigator:
Name: Marc Steinberg, Ph.D. 
Division & Department: Psychiatry
Contact Information: Telephone Number & Email Address: 732-235-4341; 
marc.steinberg@rutgers.edu
PROTOCOL VERSION AND DATE: 03/15/2019
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Table of Contents 
1.0
Research Introduction
1.1
Purpose/Specific Aims
1.2
Research Significance
1.3
Research Design and Methods
1.4
Preliminary Data
1.5
Sample Size Justification
1.6
Study Variables
1.7
Drugs/Devices/Biologics
1.8
Primary Specimen Collection
1.9
Interviews, Focus Groups, or Surveys
1.10
Timetable/Schedule of Events
2.0
Project Management
2.1
Research Staff and Qualifications
2.2
Resources Available
2.3
Research Sites
3.0
Multi-Site Research Communication & Coordination
3.1
Outside Research
4.0
Research Data Source/s
4.1
Primary Data – Subjects and Specimens
4.2
Subject Selection and Enrollment Considerations
4.3
Subject Randomization
4.4
Secondary Subjects
4.5
Number of Subjects
4.6
Consent Procedures
4.7
Special Consent Populations
4.8
Economic Burden and/or Compensation For Subjects
4.9
Risks to Subjects
4.10
Secondary Data – Record/Chart Reviews, Databases, Tissue Banks, Etc.
4.11
Chart/Record Review Selection
4.12
Secondary Specimen Collection
5.0
Special Considerations
5.1
Health Insurance Portability and Accountability Act (HIPAA)
5.2
Family Educational Rights and Privacy Act (FERPA)
5.3
NJ Access to Medical Research Act
5.4
Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations)
6.0
Research Data Protection and Reporting
6.1
Data Management and Confidentiality
6.2
Data Security
6.3
Data Safety And Monitoring
6.4
Reporting Results
7.0
Data and/or Specimen Banking
8.0
Other Approvals/Authorizations
9.0
Bibliography
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PI Name: Marc L. Steinberg, Ph.D.
Protocol Title: Addressing Tobacco Among 
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1.0 Research Introduction
1.1 Purpose/Specific Aims
The purpose of the current investigation is to examine strategies for encouraging smokers at socioeconomic 
disadvantage in New Brunswick, New Jersey to quit in a randomized clinical trial. Tobacco use is a substantial 
problem for individuals at socioeconomic disadvantage (SED). While smoking prevalence has decreased across the 
United States over the past several decades, this decrease has not occurred at all levels of socioeconomic status. 
Those at lower socioeconomic status smoke at higher rates than those at higher socioeconomic status (Tucker-
`Seeley et al., 2015).
A. Objectives 
In order to examine strategies for encouraging smoking cessation in socioeconomically disadvantaged 
smokers, we will randomize self-identified smokers interested in our study to one of three intervention 
conditions: (1) Brief motivational interviewing (MI) and referral to the NJ quitline and local Tobacco 
Dependence Program, (2) provision of a two-week supply of nicotine replacement patch and nicotine 
lozenge (NRT sampling) and referral to the NJ quitline and local Tobacco Dependence Program, or (3) 
referral only. This randomized controlled trial will allow for a direct comparison of three brief and easy to 
implement treatment conditions in relation to various cigarette smoking outcomes.  
B. Hypotheses / Research Question(s)
Brief advice to quit (i.e., referral), brief motivational interviewing, and nicotine replacement therapy are 
recommended approaches to promote smoking cessation and reduce health disparities in low-income 
smokers (Fiore et al., 2008). However, as compared to referring participants to the NJ Quitline, we expect 
brief MI and provision of NRT to be superior in terms of: (1) Increasing motivation to quit; (2) increasing 
self-efficacy to quit; (3) setting a quit date; (4) making a cessation attempt; (5) and achieving initial 
abstinence.  
1.2 Research Significance (Briefly describe the following in 500 words or less):
A disproportionate number of individuals who use tobacco are from low socioeconomic status (Tucker-Seeley et 
al., 2015). By reaching smokers at socioecondomic disadvantage who may not initially be interested in seeking 
cessation services and prompting quit attempts in this population, we can have a positive impact on public health.
Brief motivational interviewing is a psychosocial intervention designed to promote behavioral change and 
recommended as part of the clinical practice guidelines for smoking cessation (Fiore, 2008), in particular for 
populations with low motivation to quit. This intervention assumes clients are motivated and have the ability to 
quit. By avoiding direct advice or convincing, the therapist carefully uses a series of techniques to illicit intrinsic 
motivation from the client to change. Although MI presumably is designed to affect motivation, thereby eliciting 
behavioral change, mechanisms research does not support this relationship and instead suggest that a therapist’s 
ability to engage the client in ‘change talk,’ i.e., talk about what it would look like to engage in different behaviors, 
is central to a favorable outcome. Whereas meta-analytic reviews of MI indicate relatively small effect sizes, a 
recent meta-analytic review that examined the combined effect of brief MI (i.e., <60 minutes) found that it was 
significantly related to long-term cessation (d=.33). A similar significant effect for follow-up was found that MI that 
was not combined with pharmacotherapy (d=.21). 
Clinical practice guidelines additionally recommend the provision of NRT to enhance smoking cessation (Fiore et 
al., 2008) via reduction in nicotine withdrawal. Meta-analytic reviews generally provide support for the efficacy of 
NRT in promoting cessation, but are somewhat mixed. More recently, combination NRT is emerging as a preferred 
method that provides smokers with constant nicotine replacement (e.g., via the nicotine patch) as well as relief for 
‘breakthrough’ cravings via the addition of gum or lozenge (Carpenter et al., 2013). 
1.3 Research Design and Methods
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Protocol version: 03.15.2019
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Overview: We will conduct a pilot randomized clinical trial in which socioeconomically disadvantaged smokers 
receiving services at a New Brunswick, NJ based agency (e.g., New Brunswick Housing Authority (NBHA) or Elijah’s 
Promise) are randomized to one of two brief interventions designed to enhance motivation to quit smoking (see 
Study Interventions below) or to a control group. Participants will be re-contacted at one-month by a research 
assistant who is blind to the condition to which the participant was allocated to assess number of quit attempts 
and abstinence from cigarettes.
 
Participant Recruitment and Screening: In collaboration with staff at the New Brunswick, NJ based community 
partners, we will use flyers to advertise and will recruit daily smokers receiving services at a New Brunswick, NJ 
based agency. Interested participants will complete a brief in-person or telephone screening where they will be 
assessed by trained study personnel who will determine initial eligibility. Participants must be between the age of 
19 and 65, must self-report being a daily smoker and provide biochemical verification of smoking status (expired 
breath carbon monoxide reading >5). Assessing carbon monoxide to verify smoking status is a common approach 
in tobacco use studies.
1.3.1 Biochemical verification
To confirm smoker status, expired breath carbon monoxide (CO) levels (also commonly collected in tobacco 
dependence treatment studies) will be assessed with a carbon monoxide monitor and CO reading in parts per 
million (ppm) will be recorded.  The carbon monoxide monitor used will be the Bedfont Scientific Ltd. Micro+ 
Smokerlyzer. The Micro+ Smokerlyzer is a hand-held, battery powered instrument which uses electrochemical 
technology to sample the gas and a microprocessor to convert the output from the sensor to a carbon monoxide 
(CO) concentration. The result and menus are displayed on a color LCD and an accompanying buzzer sounds in 
response to the CO level. The instrument is controlled using a touch screen operation and has a USB link to a 
computer to download readings.
The Micro+ uses a breath sampling D-Piece with integrated bacterial and viral filter and a one-way valve designed 
to maximize infection control. Each patient uses a fresh mouthpiece for each breath sample. The D-Piece may be 
reused or replaced as required. 
The patient is asked to hold their breath for a 15 second countdown. This is displayed on the screen of the device. 
At the end of the breath hold, the patient blows gently into the Micro+ expiring as much of the breath in their 
lungs as possible. The reading on the device shall rise until the peak reading is held on the display.
A research assistant will provide instructions on how to use the CO monitor and will record the results at visit 1 and 
one-month follow-up appointments. The study PI is accountable for the device.
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Protocol version: 03.15.2019
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Protocol Title: Addressing Tobacco Among 
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Exclusion criteria include taking FDA approved smoking cessation or anti-psychotic medications, self-reported 
medical issues of potential concern to nicotine replacement therapy users (i.e., unstable angina pectoris, 
myocardial infarction, or significant cardiac arrthymia (including atrial fibrillation) in the past 30 days), or self-
reported pending legal issues with potential to result in incarceration. Additionally, women must state in writing 
that they are not pregnant or nursing, planning on becoming pregnant in the next two months, and that they are 
using effective birth control.
Visit 1: Following the initial phone screen study staff will arrange to meet with eligible participants to administer 
additional measures as well as the brief intervention. In addition to verifying inclusion/exclusion criteria as well as 
smoking status, participants will be asked to complete a questionnaire battery online using a laptop provided by 
study staff, and a brief interview to further assess motivation and confidence to quit, substance use, physical 
health, and mental health status and history, as well as smoking cessation history.
Study Interventions: Next, we will use a block randomization procedure to allocate participants to one of three 
groups: A single session motivational intervention (MI), which will include a 30-minute therapy session designed to 
enhance motivation to quit smoking, followed by a referral to the NJ State Quitline and local Tobacco Dependence 
Program; (2) An NRT sample intervention, which will include free two-week supplies of nicotine patches and 
nicotine lozenge with instructions for proper use and a referral to the NJ State Quitline and local Tobacco 
Dependence Program, or (3) An assessment and referral only control. 
Block randomization is a procedure in which participants are randomly allocated to intervention groups within 
blocks such that an equal number are assigned to each intervention. We will use the Sealed Envelope Ltd. 2017 
application to electronically develop a list of 60 allocation outcomes using a block randomization procedure with 3 
intervention groups and block sizes of 3, 6, and 9. The study coordinator will use this list to inform study therapists 
of the intervention to which participants were assigned.
Upon completion of the intervention, participants will be scheduled for a one-month follow-up visit with a 
research assistant. Participants will be reminded of their appointment via text, phone, and email 48 and 24 hours 
prior.
One-month Follow-up: Participants will be asked to complete a brief online survey once again, and smoking status 
will be verified via self-report and carbon monoxide analysis of breath sample. Staff will also conduct brief 
interviews to assess main outcomes of interest.
1.4 Preliminary Data
Drs. Steinberg and Leyro have committed their academic careers to research on tobacco use and dependence. In 
addition to academic research, Dr. Steinberg was Director of the Mercer County Tobacco Program from 2005–2010 
where in addition to providing smoking cessation services, he partnered with community organizations in Mercer 
County to increase awareness of the consequences of smoking and to increase the uptake of tobacco dependence 
treatment services.
Dr. Steinberg recently published data on a motivational interviewing intervention (Steinberg et al., 2016) similar to 
the one proposed in the current application in which he found smokers with schizophrenia receiving a single-
session motivational interviewing intervention were significantly more likely than those receiving an educational 
intervention to make a quit attempt. In addition, Dr. Leyro recently published research indicating that clinical 
management of nicotine withdrawal of severely mentally ill smokers on smoke-free inpatient units is enhanced by 
offering NRT directly upon admission; these findings support the exploration of our NRT in smokers who live in 
newly smoke-free public housing units. 
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1.5 Sample Size Justification
We have a target N of 60 smokers (n=20/treatment condition). In terms of race/ethnicity, we anticipate our 
sample will be reflective of cigarette smokers living in the greater New Brunswick, NJ area:  We expect to enroll 
two participants weekly in order to meet our target N.  Estimating that 50% of the sample will make quit attempt 
during the course of the study, our main outcome of interest, this is adequate to group differences with 95% 
confidence (CI: 0.38, 0.61). 
1.6 Study Variables
A. Independent Variables, Interventions, or Predictor Variables 
Our IV of interest is treatment assignment; please see section 1.3 for a description of the study interventions.
B. Dependent Variables or Outcome Measures 
Our DVs of interest are as follows: (1) pre-treatment to one-month follow-up change in (1a) motivation to quit (i.e., 
motivation), (1b) readiness to quit, and (1c) confidence in quitting; (2) setting a quit date (yes/no); (3) making a 
cessation attempt (yes/no); (4) days of self-reported abstinence, and (5) achieving initial CO verified abstinence 
(yes/no).  
1.7 Drugs/Devices/Biologics 
1)
Nicotine replacement therapy. Nicotine patch and nicotine lozenge are accepted, FDA approved treatments for 
nicotine dependence. Both are available over-the-counter (OTC) without a prescription. Study participants will 
be provided with information written at a 6th grade level describing the proper use of the nicotine patch and 
lozenge, including a description of common side effects. To minimize adverse events, we are excluding 
smokers with potential contraindications (see Participants section within Methods above).
a)
Storage and accountability. We will store nicotine replacement therapy (NRT) in original packaging (box 
containing 2-week supply) in locked cabinets in a room with locked doors at 317 George Street; Suite 105; 
New Brunswick, NJ and at Institute for Health, Rutgers, The State University of New Jersey 112 Paterson 
Street, Rm 212, New Brunswick, NJ 08901-1293. We will document temperature of the room weekly using 
a min/max thermometer.
a.
Transferring medication. Research coordinators, Jessica Ortiz and Mindy Kibbey, will 
arrange to transfer medication between research laboratory sites as needed. Jessica and 
Mindy will be the only people who transfer medication between sites, arranging with 
one another to pick up or drop off the medication. 
b)
Inventory. We will use an NRT inventory log to document the Lot # and Expiration date of each box of 
NRT.
c)
Dispensing NRT. We will use an NRT dispensing log to document which boxes of NRT are provided to 
which subjects (listed by subject number only), by whom, and on what date. We will not collect unused 
portions of the NRT because it is not common practice to specify a time limit by which participants are 
required to use the NRT.
a.
In the event NRT is stored at the Institute for Health, the research coordinators will arrange to 
pick up the medication or to drop off the medication at 317 George Street; Suite 105; New 
Brunswick, NJ for research subjects. 
1.8 Primary Specimen Collection
A. N/A
B. N/A
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C. N/A
D. N/A
E. N/A
1.9 Interviews, Focus Groups, or Surveys 
A. Administration
Following consent, study staff will first verify each participant’s smoking status via expired breath carbon monoxide 
(CO > 5ppm). Participants will complete a questionnaire battery online via Qualtrics, using a laptop computer or 
tablet provided by study staff (see Table 1 below). If any participant indicates high levels of depression, we will 
provide phone numbers and a recommendation to contact Rutgers University Behavioral Health Care or the 
Rutgers RWJMS Department of Psychiatry outpatient practice. 
. 
Timing and Frequency: Following an initial phone screen, participants will be visited by study staff for an in-person 
session that will last approximately 60-90 minutes (including assessment and intervention). After randomization 
and Visit-1 study procedures are completed, they will be scheduled for a final follow-up visit to occur 
approximately one-month later. 
Location: Study participation will take place at the Rutgers RWJMS Division of Addiction Psychiatry / Tobacco 
Research & Intervention lab, at the New Brunswick Housing Authority offices and / or housing units, or on the 
premises of the non-profit agency, Elijah’s Promise, depending on study patient preference.
Procedures for Audio Recording: Participants will be asked permission to allow study staff to audio record their 
intervention as part of the research study, by signing the “Agreement to Audio Record” at the end of the consent 
form. Participants do not have to agree to be recorded in order to participate in the main part of the study. The 
recording(s) will be used for clinical supervision, to validate the integrity of the counseling intervention, and 
potentially to later examine the relationship between what is said during the sessions and various clinical 
outcomes. The recording(s) will include the participant ID number and date of the research appointment. Digital 
audio files will be stored on password protected computers and the files themselves will be password protected 
and encrypted using the Advanced Encryption Standard 256 method (AES-256). Files will be linked with each 
participant’s ID number. Files will be destroyed 6 years after the protocol is closed.       
B. Study Instruments
Below, please find details regarding questionnaire and interview administration.
 
Measures List
Online Measures (Qualtrics)
1) Demographic Questionnaire: To obtain basic social support information as well as descriptive 
information including age, race, ethnicity, marital and SES status. Additionally, we will ask the place 
where they are completing the survey.
2) Fagerström Test for Cigarette Dependence (FTCD; Fagerström, 2012): 6-item scale use to evaluate 
the quantity of cigarette consumption, the compulsion to use, and nicotine dependence. The measure 
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has both yes/no items (scored as 1 or 0) and multiple-choice items (scored from 0-3).  These scores are 
then summed to give a total score from 1-10 where the higher the score the more intense subject’s the 
nicotine dependence is.
3) Smoking History Questionnaire (SHQ;Bonn-Miller & Zvolensky, 2005): 30-item questionnaire used to 
assess participants smoking history and patterns of use.  Items pertain to smoking rate, age of onset of 
smoking initiation, and years being a daily smoker.
4) Distress Tolerance Scale (DTS; Simons & Gaher, 2005): 15-item scale used to assess participants’ 
perception of their ability to tolerate mental distress. Items (e.g. “I can’t handle feeling distressed or 
upset”) answered on 5-point Likert-type scales ranging from (1) strongly agree to (5) strongly disagree 
evaluate participants’ ability to experience and endure negative emotional states and includes scales 
that assess appraisal, tolerance, absorption, and regulation. This scale contains good psychometric 
properties, including high internal consistency. Because six of these items are included in the DII, below, 
this measure will be comprised of nine items.
5) Distress Intolerance Index (DII; McHugh & Otto 2011): 10 items (e.g. I can’t bear disturbing feelings) 
rated on a five point Likert-type scale (0 = very little to 5 = very much for question 1, 1 = strongly agree 
to 5 = strongly disagree for questions 2-7, and 1 = absent to 5 = very strong for questions 8-10) assess 
individual differences in perceived capacity to withstand and tolerate general somatic and psychological 
distress.102 One item is pulled from the Anxiety Sensitivity Index (ASI),103 six items from the DTS,104 eight 
items from the FDS105 The DII demonstrates strong internal consistency reliability and concurrent 
validity, and evidence for construct validity.
6) Generalized Anxiety Disorder (GAD-7; Spitzer et al., 2006): 7-item index is a valid and efficient tool 
for screening for GAD and assessing its severity in clinical practice and research.
7) Kessler Psychological Distress Scale (K6; Kessler et al., 2002): This 6-item measure is a validated and 
brief index that is used to screen for the presence of mood and anxiety disorders. 
8) Snaith-Hamilton Pleasure Scale (SHAPS; Snaith et al., 1995): 14-item measure used to assess the 
ability to experience pleasure from typically rewarding activities.157 Participants rate the degree to which 
they believe that they would experience pleasure from hypothetical situations using a 4-point Likert 
type scale ranging from 0 = definitely agree to 3 = definitely disagree. The SHAPS appears to 
demonstrate good construct validity through its significant association with a latent dimension of 
anhedonia158 and test-retest reliability.
9) Change Questionnaire (Miller & Johnson, 2008): Measures ratings of importance of quitting and 
confidence in quitting on a 10-point Likert-type scale from 0=Definitely Not to  10 = Definitely.
10) McArthur Scale of Subjective Social Status (Adler & Stewart, 2007): Self-report measure of an 
individual’s sense of social status across different SES indicators.  The scale is in a pictorial format, and 
presents the participant with a “social ladder” and asks them to place an “X” where they feel they fall.  
There are two separate social ladders that are presented to the participant.  One is linked to traditional 
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SES factors, SES Ladder, while the other is linked to social standing within a community, Community 
Ladder. 
11) Readiness to Quit Ladder: Single-item measure that includes ten response options that assess 
motivation to quit along a continuum.  Options range from 10, “I have quit smoking and I will never 
smoke again”, to 1, “I enjoy smoking and have decided not to quit smoking for my lifetime.  I have no 
interest in quitting”.  As such, higher scores on this measure indicate higher readiness to quit.95 
12) Stages of Change Algorithm (Prochaska, Velicer, DiClemente, & Fava, 1988): This three item 
measure is used to assess readiness for change (i.e., smoking cessation) and will be used to categorize 
participants into precontemplation (i.e., not thinking about quitting), contemplation (yes, within next 6 
mo.), and preparation (i.e., yes, within the next 30 days). This will then be used to inform therapist 
provided brief motivational interviewing.
13) Financial Strain Scale (Pearlin, Menaghan, Lieberman, & Jullan, 1981): This 9-item measure will be 
used to assess participants’ perceptions of financial strain. Subjective indices of financial strain, rather 
than using education or income as the primary indicators of socioeconomic status have the advantage of 
assessing perceived burden and interference. On this measure eight items are rated on a 3-point scale 
(1=no difficulty to 3-very great difficulty; e.g., How difficult is it to afford a home suitable for 
(yourself/your family?). The final item asks participants to report how much money they have left over 
at the end of each month. 
14) Subjective Financial Situation Scale (Williams et al., 2016): This single item measure asks 
participants to describe their subjective view of their overall personal financial situation.
15) Attitudes Toward Nicotine Replacement Therapy scale: This measure assesses previous offering of 
nicotine replacement therapy (NRT), perceived advantages to NRT use, perceived side effects, and if 
relevant, reasons for not using NRT.
16) Quitting Preparation and Actions Questionnaire. This measure is used at followup only and assesses 
actions consistent with preparing for or making an attempt to quit smoking.
Pencil Paper Measures
1) Initial screen: This measure will allow us to determine if the participant is likely to meet inclusion 
criteria before we conduct a full baseline assessment.
2) Timeline Followback (Sobell & Sobell, 1992): method of assessing substance use requires participants 
to retrospectively estimate their daily substance and alcohol use. For the purposes of our study, we will 
be assessing past month alcohol, nicotine, marijuana, and other substance use.  
3) NRT Contraindication Checklist and Expired CO: Participants will be screened for contraindications 
associated with NRT use, including: hypersensitivity to the active ingredient or any component of the 
NRT product, temperomandibular joint disease (should be excluded from using NRT gum), and active 
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gastric or duodenal ulcer (should be excluded from using NRT nasal spray) Any risks that may be 
associated with NRT are substantially outweighed by the dangers of continued smoking. Participants will 
provide expired breath carbon monoxide by blowing into the CO monitor to demonstrate smoker status 
(CO > 5ppm). CO levels will be documented on this form in parts per million (ppm). 
4) Adverse Events Questionnaires: To be filled out by study staff during the follow-up visit with 
participants to assess AEs associated with quitting and use of NRT.
5) Not Pregnant Form: Using this form, women will state in writing that they are not pregnant or nursing, 
planning on becoming pregnant in the next two months, and that they are using effective birth control.
6) Contact Form: Participants will provide contact information to be used for scheduling appointments.
1.10 Timetable/Schedule of Events
Jul
2017
Aug
2017
Sep
2017
Oct
2017
Nov
2017
Dec
2017
Jan
2018
Feb
2018
Mar
2018
Apr
2018
May
2018
Jun
2018
Rutgers / NBHA 
project meeting
X
X
X
X
X
X
X
Train study 
therapist & 
research asst.
X
X
Recruit 
participants (N=60; 
2/week)
X
X
X
X
X
X
X
Complete follow 
up assessments
X
X
X
X
X
X
X
Data analysis
X
X
2.0 Project Management
2.1 Research Staff and Qualifications
Marc Steinberg, Ph.D. is a licensed clinical psychologist, a faculty member in the Rutgers RWJMS Department of 
Psychiatry, and director of the Tobacco Research & Intervention lab. His research focuses on tobacco dependence 
treatment, including tobacco dependence treatment development and tobacco use in vulnerable populations such 
as those with psychiatric comorbidity and lower socioeconomic status. Dr. Steinberg has been PI or Co-I for 
multiple randomized clinical trials of tobacco dependence treatments for high-risk smokers including RCTs of 
motivational interviewing, behavioral therapy, and of nicotine nasal spray for smokers with schizophrenia, of 
persistence-targeted smoking cessation in low SES smokers, and of varenicline for smokers not yet ready to quit.
Teresa M. Leyro, Ph.D. is a faculty in the Department of Psychology and director of the Affective and Biological 
Underpinnings of Substance Use and Anxiety lab. She has completed extensive research on processes that 
promote smoking and interfere with abstinence and has been a project coordinator and graduate and post-
doctoral clinician on several randomized clinical trials of smoking cessation, including those that have employed 
nicotine replacement and motivational interviewing interventions. In addition, she is a licensed clinical 
psychologist in the state of New Jersey.
 
Graduate Students:
Benjamin Billingsley
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Allison Borges
Min-Jeong Yang
Mark Varsella
Rachel Rosen
Graduate students have completed coursework and didactics in substance use treatment, cognitive behavioral 
therapy, and motivational interviewing. Students also have prior experience treating individuals with psychosocial 
impairment in the surrounding area. All graduate students have also interfaced with members of the community to 
facilitate completion of research projects focused on nicotine use. This includes, but is not limited to, structured 
clinical interviewing of research subjects and administration of behavioral tasks.
All graduate students have also completed online coursework on ethical research practices (e.g., HIPAA 
compliance).
Research Coordinator(s):
Jessica Ortiz. Ms. Ortiz is currently a research assistant/coordinator for a NIDA funded trial on smokers with 
schizophrenia. She has an undergraduate degree in psychology and has completed online coursework on ethical 
research practices (e.g., HIPAA compliance).
Mindy Kibbey. Ms. Kibbey is a research assistant/coordinator in Dr. Leyro’s lab. She will also serve as a clinician for 
the current study. Like the above named graduate students, Ms. Kibbey has received extensive training in 
motivational interviewing and will receive ongoing supervision by the PI.
2.2 Resources Available
Facilities-Dr. Leyro has laboratory space at both the Institute for Health and Tillett Hall where RAs will prepare 
study materials, conduct phone screens, schedule participants, complete reminder calls/texts/emails, store study 
materials, and manage data entry. In addition, Dr. Steinberg has similar space located in the Division of Addiction 
Psychiatry, Rutgers RWJMS at 317 George Street in New Brunswick.
Medical Or Psychological Resources- Both Drs. Steinberg and Leyro are licensed clinical psychologists in the state 
of New Jersey and will assist in training study staff in the management of crisis intervention. In addition, they will 
be available 24/7 to field any questions/concerns study staff have regarding how to proceed in the event that 
participants experience unanticipated psychiatric distress during the course of the study. 
Research Staff Training- All graduate students and research assistants will complete intensive training with the 
Drs. Leyro and Steinberg, including proper administration of each intervention condition and proper administration 
and management of nicotine replacement therapies. Training will include didactic instruction, as well as mock-
administration of the interventions with structured feedback. All graduate students will also complete weekly 
supervision with Drs. Leyro and Steinberg.
2.3 Research Sites
Research activities will occur at the offices of Rutgers RWJMS Division of Addiction Psychiatry, Tobacco Research & 
Intervention lab, the Rutgers Department of Psychology Affective and Biological Underpinnings of Substance Use 
and Anxiety lab, at New Brunswick Housing Authority offices and / or housing units, and at the New Brunswick 
non-profit agency, Elijah’s Promise.
3.0 Multi-Site Research Communication & Coordination 
N/A
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3.1 Outside Research
N/A
4.0 Research Data Source/s
4.1 Primary Data-Subjects and Specimens
Research participants will be 60 daily socioeconomically disadvantaged smokers receiving services at a New 
Brunswick, NJ based agency. We will collect questionnaire data and expired breath carbon monoxide.
4.2 Subject Selection and Enrollment Considerations 
A. Recruitment Details
Research assistants will post flyers and place leaflets at New Brunswick, NJ social service agencies and will work 
with staff at said agencies for help in connecting with potential participants.
B. Source of Subjects 
Service agencies in New Brunswick, NJ (e.g., New Brunswick Housing Authority, Elijah’s Promise). 
C. Method to Identify Potential Subjects
Research assistants will post flyers and place leaflets at New Brunswick, NJ social service agencies and will work 
with staff at said agencies for help in connecting with potential participants. Participants responding to flyers or 
otherwise referred will complete a “pre-screen” to determine likely eligibility. Those passing the pre-screen will be 
invited to participate in the study and complete the full baseline battery during which eligibility will be confirmed.
D. Subject Screening
Interested participants will complete a brief in-person or telephone screening where they will be assessed by 
trained study personnel who will determine initial eligibility.
Inclusion Criteria
Participants must be between the age of 19 and 65, must self-report being a daily smoker and provide biochemical 
verification of smoking status (expired breath carbon monoxide reading >5), must be at socioeconomic 
disadvantage, defined as receiving services at a New Brunswick, NJ based social services agency (i.e., living in New 
Brunswick Housing Authority-run public housing units or requesting social services from the community social 
service agency, “Elijah’s Promise”), and must be able to speak and read English.
Exclusion Criteria
Exclusion criteria include taking FDA approved smoking cessation or anti-psychotic medications, self-reported 
medical issues of potential concern to nicotine replacement users (i.e., See Table 1, e.g., unstable angina pectoris, 
myocardial infarction, or significant cardiac arrthymia (including atrial fibrillation) in the past 30 days), or self-
reported pending legal issues with potential to result in incarceration. Additionally, using the not pregnant form, 
women must state in writing that they are not pregnant or nursing, planning on becoming pregnant in the next 
two months, and that they are using effective birth control.
E. Recruitment Materials 
We will rely upon flyers and leaflets. Please see attachments. We additionally anticipate recruitment of 
participants via word-of-mouth.
4.3 Subject Randomization
We will use a block randomization procedure to allocate participants to one of three groups. Block randomization 
is a procedure in which participants are randomly allocated to interventions groups within blocks such that an 
equal number are assigned to each intervention. We will use the Sealed Envelope Ltd. 2017 application to 
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electronically develop a list of 60 allocation outcomes using a block randomization procedure with 3 intervention 
groups and block sizes of 3, 6, and 9. A research assistant will use this list to create envelopes for therapists to 
open (revealing allocation to intervention) after each participant provides informed consent and is deemed eligible 
to participate in the study.
4.4 Secondary Subjects
N/A
4.5 Number of Subjects
A. Total Number of Subjects
N=64
B. Require Number of Subjects to Complete Research
N=60
C. Feasibility Of Recruiting
We anticipate enrolling 2-3 participants weekly over the course of 7 months. Based on previous research 
conducted by the principal investigators, and the reports from staff at Elijah’s Promise, this should be feasible. 
4.6 Consent Procedures
A. Consent
All participants will provide written informed consent after being given the opportunity to read the consent form 
in full and to ask questions about the research. A research assistant will also sign the consent form as a witness.
B. Consent Process
Location of Consent Process
Verbal consent will be obtained for the initial phone screen. The PI or RA will first explain the purpose of the phone 
screen and limits of confidentiality and provide an overview of the study. If potential participants remain 
interested, they must verbally agree to phone screen completion. 
During the initial in-person meeting at our research offices, or at the agency at which the participant is associated, 
study personnel will verbally go over the consent form including details regarding the procedure, time 
commitment, payment, risks/benefits, and option to discontinue at any time without penalty, and ask the 
participant questions to ensure they understand.  
Individual Roles for Researchers Involved in Consent
PI supervised/trained graduate students and research assistants will complete all aspects of the consent 
procedures. 
1. Consent Discussion Duration
Staff will go over details regarding the procedure, time commitment, payment, risks/benefits, and option to 
discontinue the study at any time without penalty. We anticipate that it will take participants 5 minutes to read the 
consent and up to an addition 5 for staff to review relevant information.  
2. Coercion or Undue Influence
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During the consent process, staff will make clear to participants that regardless of their ability to make a cessation 
attempt, they will receive full compensation, and that early termination will result in payment for the portion 
completed (i.e., visit 1 only), and will not result in loss of ability to participate in future research. 
3. Subject Understanding
In addition to providing written informed consent, participants must verbally indicate that they understand the 
study procedures and that they have no further questions. 
4.7 Special Consent/Populations
N/A
4.8 Economic Burden and/or Compensation for Subjects
A. Expenses 
N/A
B. Compensation/Incentives
Participants will be compensated $20 for their initial study visit and an additional $40 for completion of the follow-
up visit. Participants must complete all questionnaires and participate in the discussion at the first appointment to 
receive the $20 at the first appointment and must complete all questionnaires at the second appointment 30 days 
later to receive the $40. Participants will receive the $20 for the first appointment even if they do not attend the 
second appointment.
4.9 Risks to Subjects
A. Description of Subject Risk
Risks are expected to be minimal for our proposed study procedures, and we do not anticipate that participants 
will experience any adverse consequences associated with participation in this research, aside from mild distress 
associated with answering questions about physical and mental health.
Telephone pre-screening and Pre-visit Questionnaires. Following a phone screen to determine basic eligibility 
requirements, participants will complete a battery of self-report indices as outlined above. Participants will be 
scheduled for their study appointment within one week.
B. Procedures for Risks to Embryo, Fetus, and/or Pregnant Subjects
N/A
C. Risks to Non-Subjects
N/A
D. Assessment of Social Behavior Considerations
Reasonably Foreseeable Risks
Study risks are minimal and include a small, temporary increase in distress as a result of the assessments; however, 
the methodologies employed have been utilized in many labs and clinical settings with hundreds of participants 
suffering from a range of psychopathology, and approved by as many IRBs. 
Risk Of Imposing An Intervention On Subject With Existing Condition
N/A
Other Foreseeable Risks
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Our research team employs standard procedures to ensure confidential information about study participation is 
not disclosed. All data are linked to an arbitrary 3-digit study ID unrelated to personal information. The file linking 
participants to their study ID will be stored in a password-protected file, located within a password-protected 
database on an encrypted computer. Only select trained laboratory personnel will have access to the file. All 
computer files or printed data used for analysis also will be de-identified. Consent forms and payment forms will 
be stored in a locked file cabinet separate from data in an office that is locked when not occupied. Participants’ 
confidentiality also is protected by never associating a participant’s name with results in any published or 
otherwise publicly presented report. Demographic information, including information about participants’ age, 
ethnicity, education, marital status and employment status, will be reported using averages and percentages 
computed over multiple participants and never reported at the level of individual participants. 
Observation And Sensitive Information
N/A
E. Minimizing Risks
Participants who indicate psychological distress during participation will be provided with several strategies to 
reduce distress as needed, including, distraction and deep breathing. Staff will conduct a thorough risk assessment 
with participants who report suicidal ideation or intent.
Any participants who report suicidal ideation or intent will be provided with information and phone numbers for 
three local options for mental health care: Rutgers University Behavioral Health Care (800-969-5300), Rutgers 
Health Psychiatry/Psychology Clinic (732-235-7647), and the Rutgers Psychological Clinic in (848-445-6111). In the 
unlikely event that a participant reports an imminent intent to harm themself, we will contact Acute Psychiatric 
Services (855-515-5700).
F. Certificate of Confidentiality
We have obtained a Certificate of Confidentiality from the National Institutes of Drug Abuse.
G. Potential Benefits to Subjects
Each of the three treatment conditions in our proposed project are associated with improved cessation outcomes, 
which may have a long-term positive impact on health and psychological well-being.
H. Provisions to Protect the Privacy Interests of Subjects
Participants will be asked to engage with trained research staff throughout the course of the study. However, if 
participants indicate a desire not to work with a particular staff member, we will oblige.
Our research team employs standard procedures to ensure confidential information about study participation is 
not disclosed. All data are linked to an arbitrary 3-digit study ID unrelated to personal information. The file linking 
participants to their study ID will be stored in a password-protected file, located within a password-protected 
database on an encrypted computer. Only select trained laboratory personnel will have access to the file. All 
computer files or printed data used for analysis also will be de-identified. Consent forms and payment forms will 
be stored in a locked file cabinet separate from data in an office that is locked when not occupied. Participants’ 
confidentiality also is protected by never associating a participant’s name with results in any published or 
otherwise publicly presented report. Demographic information, including information about participants’ age, 
ethnicity, education, marital status and employment status, will be reported using averages and percentages 
computed over multiple participants and never reported at the level of individual participants. 
I. Research Team Access To Subject Data
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Only IRB approved staff will have access to participant data. All data will be coded by arbitrary study number to 
ensure confidentiality and will be stored in a locked filing cabinet or stored on the lab server where access will be 
password-protected. Data collected online will be de-identified (e.g., associated with an arbitrary study ID number) 
and only accessible to trained study personnel. Consent forms with identifying information (names) will be filed 
separately from actual study data in a separate locked filing cabinet. This cabinet the office in which it is kept will 
ensure that it is also double-locked.
4.10 Secondary Data – Records/Chart Reviews/Databases/Tissue Banks/etc.
N/A
4.11 Chart/Record Review Selection
N/A
4.12 Secondary Specimen Collection
N/A
5.0 Special Considerations
5.1 Health Insurance Portability and Accountability Act (HIPAA)
N/A
5.2 Family Educational Rights and Privacy Act (FERPA)
N/A
5.3 NJ Access to Medical Research Act
N/A
5.4 Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations)
N/A.
6.0 Research Data Protection and Reporting
6.1 Data Management and Confidentiality
A. Success of randomization will be checked via summary statistics of baseline demographic and psychosocial 
characteristics.  Depending on the measurement scale of each variable, we will use either χ² or independent 
samples t-tests, corrected for unequal variances if indicated.  Variables found to show significant baseline 
differences between groups will be included as covariates. Logistic regression analyses will be conducted to 
examine differences in dichotomous outcomes such as abstinence (yes/no), quit attempts (yes/no), and treatment 
seeking (yes/no). Because this is a small, pilot study, we will report effect sizes representing each of the two active 
interventions (MI and NRT sampling) as compared to the control intervention (referral only). 
B. Provide a power analysis. (As applicable, e.g. quantitative research).
N/A. This is a small, pilot study. We will use the data collected in this study to estimate effect sizes for a larger NIH 
grant application.
C. Describe the steps that will be taken secure the data (e.g., training, authorization of access, password 
protection, encryption, physical controls, certificates of confidentiality, and separation of identifiers and data) 
during storage, use, and transmission. The link between participants to their study ID will be stored in a 
password-protected file, located within a password-protected database on an encrypted computer. Only select 
trained laboratory personnel will have access to the file. All computer files or printed data used for analysis also 
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will be de-identified. Consent forms and payment forms will be stored in a locked file cabinet separate from data 
in an office (of Division of Addiction Psychiatry, 317 George Street, Suite 105, New Brunswick) that is locked when 
not occupied. All research personnel will complete CITI Human Subjects Research training and pass the CITI 
quizzes.
Additionally, we will obtain a Certificate of Confidentiality from the NIH
D. Describe any procedures that will be used for quality control of collected data.
Qualtrics and Excel databases will be created in such a way as to not allow for out of range data.
E. Describe how data will be handled study-wide: 
Data (described in Table 1) will only be accessed and handled by IRB approved study personnel and kept in 
password protected databases. Dr. Steinberg is ultimately responsible for the receipt and transmission of all data. 
Paper copies of data (e.g., names on consent forms) collected at the New Brunswick Housing Authority will be 
brought immediately to Rutgers offices where they will be locked in a cabinet housed behind a locked door (of 
Division of Addiction Psychiatry, 317 George Street, Suite 105, New Brunswick).
6.2 Data Security
Our research team employs standard procedures to ensure confidential information about study participation is 
not disclosed. All data are linked to an arbitrary 3-digit study ID unrelated to personal information. The file linking 
participants to their study ID will be stored in a password-protected file, located within a password-protected 
database on an encrypted computer. Only select trained laboratory personnel will have access to the file. All 
computer files or printed data used for analysis also will be de-identified. Consent forms and payment forms will 
be stored in a locked file cabinet separate from data in an office that is locked when not occupied. 
6.3 Data and Safety Monitoring 
A. Periodic Data Evaluation
We conduct relevant interim data analyses at 1/3 (n=20), and 2/3 (n=40) of the way through data collection to 
examine differences between groups with respect to serious adverse events. If there is a significant difference in 
number of adverse events between groups, we will halt data collection and consult with the IRB.
B. Type of Data Evaluated
We will track reported adverse events using the Adverse Events Tracking log and categorize such events as mild, 
moderate and severe and take appropriate action accordingly, as determined by IRB guidelines for reporting. AEs 
and outcomes will be tracked using the Adverse Events Specifics log.
C. Collection of Safety Information
Participants will be queried regarding their experience of nicotine replacement at the follow-up session. 
Participants who report adverse events will be counseled on discontinuation.
D. Frequency Of Data Collection
We will collect data at baseline and at study follow-up.
E. Reviewer of Data
Data will be reviewed by the study coordinators, Ortiz and Kibbey, weekly, and by Drs. Steinberg and Leyro 
monthly.
F. Schedule Of Review Of Cumulative Data
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Quality assurance of data will be assessed weekly by the study coordinators, Ortiz and Kibbey. They will alert to PIs 
to any discrepancies or observations that suggest risk of appropriate data management procedures.
G. Tests for Safety Data
Analysis of variance will be conducted to determine if there are statistically significant differences between the 
three groups with regards to serious adverse events.
H. Suspension of Research
If we found significant differences between groups with regards to serious adverse events, we would consult with 
the IRB to discuss suspending the research.
6.4 Reporting Results
A. Sharing of Results with Subjects 
N/A
B. Individual Results 
N/A
C. Aggregate Results 
Participants will be told that published aggregate study results will be available to them upon their request by 
contacting the laboratory. 
D. Professional Reporting
Data from our research will be presented at annual professional organization conferences (e.g., Society for 
Research on Nicotine and Tobacco) and published in peer-reviewed journals. 
E. ClinicalTrials.Gov Registration And Data Reporting
We will register the trial with ClinicalTrials.gov
7.0 Data and/or Specimen Banking
N/A
 
8.0 Other Approvals/Authorizations
N/A
9.0 Bibliography
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Bonn-Miller M. O., Zvolensky M. J. (2005). The Marijuana Smoking History Questionnaire. The Anxiety and Health 
Research Laboratory, University of Vermont.
Brown, R. A., Lejuez, C. W., Kahler, C. W., & Strong, D. R. (2002). Distress tolerance and duration of past smoking 
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Crawford, J. R. and Henry, J. D. (2004), The Positive and Negative Affect Schedule (PANAS): Construct validity, 
measurement properties and normative data in a large non-clinical sample. British Journal of Clinical Psychology, 
43: 245–265. doi:10.1348/0144665031752934. 
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Fagerström, K. (2012). Determinants of tobacco use and renaming the FTND to the Fagerström Test for Cigarette 
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D. A. Fiellin, S. C. Miller, & R. Saitz (Eds.), Principles of Addiction Medicine (pp. 803–817) (4th ed.). Philadelphia, PA: 
Wolters Kluwer. 
R. C. Kessler, G. Andrews, L. J. Colpe, E. Hiripi, D. K. Mroczek, S. L. T. Normand, E. E. Walkters and A. M. Zaslavsky. 
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Cambridge University Press.
McHugh, R. K., & Otto, M. W. (2011). Domain-general and domain-specific strategies for the assessment of distress 
intolerance. Psychology of Addictive Behaviors, 25, 745–749. 
Miller, W. R., & Johnson, W. R. (2008). A natural language screening measure for motivation to change. Addictive 
Behaviors, 33(9), 1177–1182. http://doi.org/10.1016/j.addbeh.2008.04.018
Pearlin, L. I. ., Menaghan, E. G. ., Lieberman, M. A. ., & Mullan, J. T. (1981). The Stress Process. Health, 22, 337-356.
Pizacani, B. A., Maher, J. E., & Rohde, K. (2012). Impact of a No-Smoking Policy in Public Housing 
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Prochaska, J. O., Velicer, W. F., DiClemente, C. C., & Fava, J. (1988). Measuring processes of change: applications to 
the cessation of smoking. Journal of consulting and clinical psychology, 56(4), 520.
Rollnick, S. (1998). Readiness, importance, and confidence: Critical conditions of change in treatment. In W. R. 
Miller & N. Heather (Eds.), Treating addictive behaviors (2nd ed.). New York, NY: Plenum Press. 
Sealed 
Envelope 
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Simons, J. S., & Gaher, R. M. (2005). The Distress Tolerance Scale: Development and validation of a self-report 
measure. Motivation and Emotion, 29(2), 83-102.
Sobell, L. C., & Sobell, M. B. (1992). Timeline follow-back. In Measuring alcohol consumption (pp. 41-72). Humana 
Press.
Spitzer RL, Kroenke K, Williams JBW, Löwe B. (2006). A Brief Measure for Assessing Generalized Anxiety Disorder 
The GAD-7. In Arch Intern Med. 166(10):1092-1097.
Snaith, R. P., Hamilton, M., Morley, S., Humayan, A., Hargreaves, D., & Trigwell, P. (1995). A scale for the 
assessment of hedonic tone the Snaith-Hamilton Pleasure Scale. The British Journal of Psychiatry, 167(1), 99-103.
Williams, V. F., Smith, A. A., Villanti, A. C., Rath, J. M., Hair, E. C., Cantrell, J., … Vallone, D. M. (2016). Validity of a 
Subjective Financial Situation Measure to Assess Socioeconomic Status in US Young Adults. Journal of Public Health 
Management and Practice, 0(0), 1–9. http://doi.org/10.1097/PHH.0000000000000468
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