Comprehensive Tobacco Cessation for Residents of Baltimore City Public Housing
Phase: NA
Conditions: Smoking Cessation, Smoking Reduction, Smoking, Tobacco
Sponsor: Johns Hopkins University

Tobacco Cessation in Public Housing 
    
NCT04889638
1/10/2024

Date:  01/10/2024 
Principal Investigator: Panagis Galiatsatos 
Application Number: IRB00224186 
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JHM IRB - eForm A – Protocol 
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1.
Abstract
Lower socioeconomic populations continue to remain at high risk for tobacco use and suffer
disproportionately from tobacco-related disease. Evidence is lacking of ways to optimally deliver
behavioral and pharmaceutical-based cigarette smoking cessation interventions in real-world
environments among disadvantaged cohorts where geographic, socioeconomic and technological
disparities often undermine the effectiveness of evidence-based smoking cessation efforts. Our
study focuses on residents of public housing in Baltimore City, a population who face multiple
socioeconomic stressors and of whom up to 1/3 are assumed conventional cigarette users.
Our project uses a partnership between the Housing Authority of Baltimore City (HABC) and 
Johns Hopkins School of Medicine to enact a remote (off-site) cessation program in Douglass  
and Brooklyn Homes – two public housing complexes under the management of HABC. Our 
program will institute evidence-based practices in an accessible manner for the residents at both 
sites. Our program’s key features include the remote recruitment, prescription, delivery and 
management of evidence-based nicotine pharmacotherapies, and provision of cessation 
counseling. 
2.
Objectives
To assess the feasibility of a  remotely administered study design with a particular focus upon: 
a) Recruitment of smokers expressing a motivation to reduce or quit smoking
b) Consent process
c) Nicotine and non-nicotine pharmacotherapy selection, screening, prescription, delivery,
storage management (participation education, side-effecting monitoring), and return of
unused drug supplies
d) Administration and perceived utility of motivational interviewing regarding smoking
reduction and cessation
e) Delivery of study reimbursement
f)
Utility of weekly text reminders of study participation and final endpoint
g) Acceptability of outcome measures.
h) Acceptability and evaluation of joint project oversight with HABC
3.
Background

 
Date:  01/10/2024 
Principal Investigator: Panagis Galiatsatos  
Application Number: IRB00224186 
 
 
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Pilot Study: Feasibility of our study’s remote recruitment, implementation, dissemination and 
joint academic-HABC oversight  
We had completed a 4-week pilot study last year (2019)on-site at Douglass Homes (one of two 
study sites to be used during this proposal). This pilot served as the premise of this work and its 
findings helped inform the design of this project. Our pilot delivered on-site weekly nicotine 
replacement therapies [NRTs] (gums, lozenges and patches), along with as-needed, on-site 
psychosocial services delivered by Maryland Legal Aid and Catholic Charities. Among the 40 
participants we recruited, we achieved a 79.5% retention rate by the final week of the study. 
Baseline exhaled CO levels did not significantly decrease from baseline (mean= 9.2 +/- 3.4 ppm) 
to the final 4-week time point (mean= 7.0 +/- 5.7 ppm); however, there were notable technical 
issues appreciate with CO measurements. Technical issues included too rapid/slow exhalation of 
maneuvers despite coaching and inability to fully blow into the device mouthpiece. 
 
The key findings that were agreed upon by all stakeholders included: 
1. There was non-optimal usage of NRTs despite on-site delivery. This was primarily 
attributed to insufficient understanding of the role of each NRT product and 
misconceptions of NRT side effects  
2. Participants did not maximally avail of offered psychosocial services. Referrals to 
offsite services were not undertaken. Legal service needs were often accomplished after 
one interaction with Maryland Legal Aid.  
3. Participants preferred efficient administration of study methodology, whereby they 
wanted to rapidly receive quality tobacco education and NRT products. 
4. Weekly reminders for study follow-up events were required and were well received.  
5. The largest time point of participation occurred when a low-value reimbursement 
(incentive) was offered for study participation.  
6. NRT products alone were insufficient to control nicotine addiction. A non-nicotine 
prescription medication (e.g. Chantix®) could have been helpful in this population but 
this was not provided. 
7. Inadequate usage and non-optimal delivery of cessation-directed behavioral counseling  
 
Ongoing tobacco treatment clinics in multiple Baltimore City public housing sites (McCollough 
and Monument East) [PI: Galiatsatos] 
Dr. Galiatsatos is the Medical Director of the Bayview Medical Center-based Johns Hopkins 
Tobacco Treatment Clinic. The clinic is comprised of a multi-disciplinary team of nurses, 
physicians and other certified tobacco treatment specialists. They provide personalized smoking 
cessation plans that meet the patient’s individualized needs. The clinic formulates personalized 
combinations of behavioral and pharmacologic treatments that maximize the likelihood of 
smoking cessation. The clinic has successfully expanded its treatment philosophy to the 
community by implementing weekly cessation clinics in three East Baltimore-based housing 
sites. 
 
 
4. 
Study Procedures 
 
 
• STUDY DESIGN 

 
Date:  01/10/2024 
Principal Investigator: Panagis Galiatsatos  
Application Number: IRB00224186 
 
 
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Overview: A pilot study is being conducted to determine the feasibility of recruitment, 
implementation, evaluation, dissemination and joint academic-community HABC oversight of a 
tobacco smoking intervention within Baltimore public housing. The intervention will be a quasi-
experimental study using a pre-post intervention (no active comparator group). The project will 
be divided over 7 time points. 
 
 
TIME POINT 1 
Recruitment & screening 
Recruitment will be undertaken in a two-fold manner: 
1. Study flyer: Housing Authority of Baltimore City (HABC) had assisted in 
designing a study flyer used in the first pilot study performed in 2019. The flyer has 
been modified to reflect  the current objectives and methodology. It includes 
references to both in-person and remote components of the intervention. 
References to reimbursement have been removed to better reflect HABC insight 
into enhancing the recruitment of participants who have the internal motivation to 
reduce smoking behaviors. The study flyer includes a contact phone number for 
participants to discuss the intervention with the study team and learn of the dates 
for in-person screening & recruitment.  
2. Personalized promotion by HABC on-site staff: Both study sites have on-site, 
HABC service coordinators who are familiar with the residents and aware of 
individual smoking concerns. They will use an established verbal script to promote 
the study among known smokers in Douglass and Brooklyn Homes (see 
“Supplementary Document 1” for copy of verbal script). The verbal script 
reflects the study’s on-site intervention and its remote components. These in-person 
interactions will also include the provision of the study flyer and emphasizing the 
dates for in-person screening and consent. If needed, the study flyer will be 
reviewed by the service coordinator (e.g., difficulty with reading or understanding 
the contents). The service coordinators will not be involved in screening or consent.  
 
 
COVID-19 PRECAUTIONS:  
Location: We will preferentially implement all on-site work outdoors using a canopy tent. If 
there is inclement weather, the on-site work will occur within the community centers at 
Douglass and Brooklyn Homes. The study team will abide by HABC’s existing 
recommendations for the number of individuals allowable within indoor communal settings. 
Participants will be maintained 6-feet apart and will adhere to Baltimore City 
recommendations for the wearing of masks within indoor settings, Outdoor events will also 
utilize the same COVID precautions for personal distancing and mask wearing. 
Screening: COVID screening will occur prior to engaging in study activities that are being 
undertaken at a table in which both the study team and participants are seated in proximity to 
each other. COVID-19 screening will occur > 6 feet from where participants will be seated for 
screening and recruitment. Screening will involve the implementation of a COVID-19 
screening questionnaire that is based on the content used in Johns Hopkins outpatient clinic 
settings. Screening will also include the assessment for fever using a temporal thermometer, 

 
Date:  01/10/2024 
Principal Investigator: Panagis Galiatsatos  
Application Number: IRB00224186 
 
 
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which will be cleaned between individual usage. If a participant screens positive for any 
COVID-19 related concerns and/or is febrile, they will not be allowed to proceed with the 
study. Those screening positive for COVID-19 will be provided 2 recommendations: 1)  
COVID-19 testing at one of the Baltimore City-recommended locations (a link for Baltimore 
City testing locations will be provided: https://coronavirus.baltimorecity.gov/where-get-tested-
covid-19-baltimore-city ) 2 seeking or discussing medical care from their primary care 
physician, urgent care center, or emergency room.  Participants will also be provided the 
date(s) for further study time points that correspond to the missed event. If they continue to 
demonstrate COVID-19 concerns, the same advice for testing and medical attention will be 
recommended. If no further study dates are available for inclusion into the study, participants 
will be provided the contact information to the Johns Hopkins Bayview Medical Center’s 
Tobacco Cessation Clinic and Maryland Quitline. 
Personal Protective Equipment: Study staff will wear a mask and face shield during the 
engagement of study activities with participants.   
 
 
 
Screening will occur in-person over a minimum of 2 possible dates within a 1-week time 
interval.  . The selected screening criteria was purposely kept broad to maximize 
generalizability and include the following: 
3. ≥18 years of age 
4. Self-reported smoker with either daily or weekly cigarette use, as well as expressed 
desire to reduce or quit smoking  
5. Proof of residence at Douglass or Brooklyn Homes - as confirmed by verbal 
acknowledgement by the service coordinators at each site. 
6. Working mobile phone with texting ability for the duration of the study 
7. Active health insurance (for pharmacotherapy billing) – See “Notes 3 and 4 below” 
 
Exclusion criteria:  
8. Pregnant – women will verbally acknowledge that they are not pregnant or trying 
to become pregnant in the next 8 weeks from the time of screening and recruitment 
to ensure no intake of nicotine and non-nicotine pharmacotherapy 
9. Breastfeeding – women who are verbally acknowledge they are breastfeeding will 
be excluded from the study. This exclusion factor is in place secondary to 
breastfeeding concerns associated with the study’s usage of nicotine and non-
nicotine pharmacotherapy 
10. Ongoing participation in a tobacco cessation program or related tobacco 
intervention study. Past participation in previous iterations of the protocol is not an 
exclusion criteria. 
11. No active health insurance.  
12. Unable to verbally state that they are willing to reduce or quit smoking upon 
recruitment and screening  
13. Adults lacking capacity to consent 
14. Non-English speakers 
15. Self-reported usage of only non-combustible tobacco products, such as smokeless 
tobacco or Electronic Nicotine Delivery Devices (ENDS).  

 
Date:  01/10/2024 
Principal Investigator: Panagis Galiatsatos  
Application Number: IRB00224186 
 
 
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16. Anticipated relocation outside of Douglass or Brooklyn Homes prior to the final 
study visit 
17. Clinical condition(s) that serve as absolute contraindications for the usage of NRT 
and non-NRT products and non-NRT products (Chantix®) (Reference: PMID 
36280333) 
a. Absolute contraindications of NRT products: 
• NRT gum: Dysphagia and subsequent aspiration risk 
• NRT lozenge: Dysphagia and subsequent aspiration risk 
• NRT transdermal patch: Severe diffuse skin disease  
• Women who are pregnant or breastfeeding.  
b. Absolute contraindication of Chantix®: 
• Inability to swallow pills 
• History of serious hypersensitivity or skin reactions to Chantix® 
• Women who are pregnant or breastfeeding 
 
*NOTE 1: We will cease enrollment at 60 participants. Our aim is to enroll 30 
participants at Douglass Homes and 30 participants at Brooklyn Homes. We anticipate 
that ≈20% of screened participants (12 people) will not continue participation at the start 
of the intervention. This allows enrollment and follow-up of 48 participants. 
 
*NOTE 2: Our 1st pilot at Douglass Homes did not result in any participant being 
excluded for being pregnant or breastfeeding. We do not anticipate more than 2 
participants being excluded based on pregnancy or breastfeeding status. All women 
excluded for these criteria will be provided local smoking cessation resources in case 
they again start to smoke (800-QUIT-NOW or Tobacco Treatment Clinic at Bayview 
Medical Center) 
 
*NOTE 3: Proof of insurance will be requested in the form of either the actual insurance 
card or animage of the front and back of their insurance card. The pictures of the health 
insurance card will be uploaded in CRMS. The information will be used for 
pharmacotherapy billing 
 
*NOTE 4: Although we will not enroll those without active health insurance, we will 
provide contact information for the Maryland Health Connection 
(https://www.marylandhealthconnection.gov/). The Maryland Health Connection 
(administered by the Maryland Health Benefit Exchange) is the health insurance 
marketplace for the state. 
 
If they meet all screening criteria, they will then undergo a pharmacologic screening 
questionnaire (see “Supplementary Document 2”) to determine what type of tobacco 
treatment “controller” medication would be appropriate (NRT transdermal patch or 
Varenicline (Chantix®). This screening questionnaire is used in the Tobacco Treatment Clinic 
at Bayview Medical Center (Medical Director: Dr. Galiatsatos)for similar purposes. We are 
undertaking this step at this time point to ensure timely prescription and delivery of NRT 
products and/or Chantix®, if needed, prior to the start of the intervention.  
 

 
Date:  01/10/2024 
Principal Investigator: Panagis Galiatsatos  
Application Number: IRB00224186 
 
 
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*NOTE 1: All participants will receive an as-needed medication to address “acute” 
nicotine urges (NRT gum or lozenge) and a “controller” medication to address the 
overall nicotine addiction (NRT transdermal or Chantix®)  
 
 
*NOTE 3: Participants will be notified of their chosen “acute” and “controller” 
medication during the 4-week intervention. They will be provided a drug information 
handout that contains details of the drug, including common and rare adverse effects 
seen with the therapy [see “Supplementary Document 4”). Contraindications to 
therapy will also be verbally reviewed with the participant and a focus on the following 
4 categories.  
 
 
Absolute contraindications of NRT products: 
 
NRT gum: Dysphagia and subsequent aspiration risk 
NRT lozenge: Dysphagia and subsequent aspiration risk 
NRT transdermal patch: Severe diffuse skin disease  
Women who are pregnant or breastfeeding.  
 
 
Relative contraindication of non-NRT products:  
Recent myocardial infarction (≤ 2 weeks), arrhythmias, angina, ulcers, 
uncontrolled high blood pressure, overactive thyroid, pheochromocytoma, or a 
dental condition or disorder. 
 
Absolute contraindication of Chantix®: 
Inability to swallow pills 
History of serious hypersensitivity or skin reactions to Chantix® 
Women who are pregnant or breastfeeding 
 
Relative contraindication of Chantix®: 
Severe renal impairment (dosage adjustment is necessary) 
Underlying neuropsychiatric disease 
 
*NOTE: If any absolute or relative contraindications or concerns arise during the 
screening questionnaire (see “Supplementary Document 2”) or during the verbal 
summary of the contraindications described above, the team will immediately review 
them with Dr. Galiatsatos, the PI. Modifications in acute and controller therapy dosing 
may be employed in conversations with our team’s medical specialists (e.g., 
Transdermal patch in replacement of Chantix®) 
 
The answers to the pharmacotherapy screening questionnaire will be reviewed by the PI. If 
further clarification in the responses are required, a member of the research team will contact 
the participant. The PI will provide the recommendation for the acute and controller regimens 
for smoking cessation.  

 
Date:  01/10/2024 
Principal Investigator: Panagis Galiatsatos  
Application Number: IRB00224186 
 
 
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After the cessation regimen recommendations have been determined, the study 
coordinator or the PI, will contact the participants by phone or video if Chantix is 
recommended as part of the pharmacotherapy plan. The communication will include 
reviewing the indications and contraindications to Chantix. This encounter will also 
allow participants to ask pharmacotherapy-related questions or concerns.  
 
 
The following figure provides a summary of the prescription workflow: 
 
 
 
 
 
 
 
 

 
Date:  01/10/2024 
Principal Investigator: Panagis Galiatsatos  
Application Number: IRB00224186 
 
 
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After the screening and final determination of the participant’s smoking cessation regimen, the 
patient will then proceed to the research consent process by JHU-affiliated research staff.  
❖ Participants will be notified that they will undergo a two-step consenting process that 
includes a Physician/Mid-level provider consent signature because of the inclusion of a 
prescription medication. The Physician/Mid-level provider will preferentially acquire 
consent at the time that the main consent process is being conducted on-site by the 
research team member. If the Physician/Mid-level provider consent cannot be acquired at 
the time of the main consent process, the provider will conduct a separate remote 
encounter to acquire consent. For remote consent to occur by the Physician/Mid-level 
provider, the designee will sign and place the date/time in the appropriate section of the 
consent under the observation of the on-site research team member. The provider will be 
provided the original consent form by the research team member and the member will 
verbally verify the participant signed the consent. The provider will contact participants by 
their preferred communication method (phone or video conferencing) to complete the 
consent. The Physician/Mid-level provider will review any additional study participant 
questions and discuss the risks, benefits and alternatives of the study in full detail. The 
Physician/Mid-level provider consent form is then signed, dated/timed by the provider. All 
components of the consent are combined to one document. After the informed consent 
process is completed, an IRB approved study team member then files the consent 
document in CRMS, including a note confirming the consent process. The entire consent 
document is also then filed in the research record. A copy of the fully completed consent 
form will be mailed to the participant's home address. 
 
Participants will also be notified during the time of consent that they will be required to return 
to the same site in which screening & consent had occurred to pick up their prescribed 
pharmacotherapies. Participants will receive a phone call, text message and/or personally 
notified by the on-site housing service coordinator of a time and date for the prescription pick-
up.  
 
TIME POINT 2 
Prescription of nicotine pharmacotherapies: 
All participants who complete the screening process will be prescribed two classes of 
medications: 
1. one “acute” or rescue NRT to address immediate nicotine cravings (e.g., NRT gum or 
lozenges) 
2. one “chronic” or long-term controller to address the constant level of nicotine cravings 
or addiction (e.g., NRT transdermal patch or Chantix®) 
 
We will use CRMS as our research management tool [this applies to all time points]. We 
have chosen CRMS primarily due to its ability to interface with Epic. We will be able to create 
participant records in Epic and subsequently prescribe and bill for NRT (gum, lozenge and/or 
patch) and non-nicotine products (Chantix®). CRMS will allow for clinical research care to be 
documented and stored in Epic. Research participants in Epic will have a research active flag 
in Epic to allow other healthcare providers to see the prescribed therapy plan.  
     Note: See Data Management Section for more details on CRMS 
 

 
Date:  01/10/2024 
Principal Investigator: Panagis Galiatsatos  
Application Number: IRB00224186 
 
 
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One month supply (no refills) of prescriptions will be signed by Dr. Galiatsatos [PI]. Dr. 
Galiatsatos is the Medical Director of the Tobacco Treatment Clinic at Johns Hopkins 
Bayview Medical Center (or an equivalent advanced practiced provider with tobacco cessation 
expertise and prescribing privileges). Dr. Galiatsatos is a board-certified clinician in the JHH 
Division of Pulmonary and Critical Care Medicine within the Department of Medicine. Dr. 
Galiatsatos will be responsible for reviewing the participant screening data and confirming the 
appropriate medication type and dosage.  
 
All prescriptions will be sent to the Johns Hopkins Monument Street Outpatient Pharmacy. 
Prescriptions will be marked in the Patient Sig section in Epic to notify pharmacy staff that our 
research team will be picking up the medications for on-site delivery as part of our 
intervention. When the term, [HABCstudy], is seen in the Patient Sig section the pharmacy 
staff will store the therapies at the pharmacy for pick-up and storage by the research team. The 
one-month supply of medications (no refills) will not be available for pick-up directly by the 
participant. The following is an example of the Epic-based prescription: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NOTE 1: The 1-month supply of medications will packaged in a tamper-proof envelope 
by the Monument Street Pharmacy staff. 
NOTE 2: We anticipate all participants to be on public health insurance given their 
residence in public housing. Maryland Medicaid will fully cover the cost of a 1-month 
[HABCstudy] 

 
Date:  01/10/2024 
Principal Investigator: Panagis Galiatsatos  
Application Number: IRB00224186 
 
 
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supply of NRT gum/lozenge, NRT patch and Chantix®  
 
 
 
 
TIME POINT 3 
Part 1: DELIVERING, STORAGE AND RETURN OF UNUSED 
PHARMACOTHERAPIES 
Part 2: START OF THE INTERVENTION (BASELINE VISIT) 
 
 
COVID-19 PRECAUTIONS: All precautions described above in the screening and 
recruitment section will be enforced during the on-site activities described at this study time 
point.  
 
PART 1 – DELIVERING, STORAGE AND RETURN OF UNUSED 
PHARMACOTHERAPIES 
Medications will be prioritized for on-site delivery by study staff to participants within the 
same day of pick-up at the Monument Street Pharmacy – barring unexpected events. 
Participants will be provided the full one-month study supply of pharmacotherapy by study 
staff at the same site in each housing complex used in screening & recruitment (outdoor 
locations will be preferred; if inclement weather, indoor housing community centers will be 
used).  Participants will be notified by phone, text messaging and/or personally notified by the 
on-site housing service coordinator of the time and date for the prescription pick-up. There 
will be at least two dates and times for picking up medications to accommodate for 
participant’s personal or professional schedules.  
 
The tamper proof envelope constructed by Monument Street Pharmacy will be inserted into a 
separate envelope that contain participant identifying information (confirmed in Time Point 1). 
Participants will provide their signature upon receipt of the medication package to 
acknowledge receipt of the medication.  
 
Along with the package of medications, a stamped return envelope (addressed to PI: Dr. 
Galiatsatos) will be provided to allow for participants to return unused medications.  
Medications received by the PI will be dropped off at a drug disposal unit at Johns Hopkins 
Monument Street Pharmacy.      
 
If the medications cannot be delivered by the study team on the day of pick-up from the 
Monument Street Pharmacy, the packaged medications will be stored in a locked cabinet in the 
locked office of Dr. Panagis Galiatsatos (PI). The office is located in the Division of 
Pulmonary and Critical Care Medicine within the Asthma and Allergy Building (4940 Eastern 
Avenue, AAAB, 4B.69, Baltimore, MD 21224). Temperatures will be recorded in the office at 
least on a weekly basis to confirm the environment is appropriate for drug-storage.  
 
PART 2 – START OF THE INTERVENTION (BASELINE) 
 

 
Date:  0 1/ 1 0/ 2 0 2 4  
Pri nci pal I n v esti gat or: Pa na gis Galiatsat os   
A p plicati o n N u m ber: I R B 0 0 2 2 4 1 8 6  
 
 
J H MI R B e For m A   0 1  
Versi o n 4  Date d:   0 1/ 2 0 2 1  
Pa ge 1 1  of 2 7  
 
T here are 4 ste ps t hat will occ ur i n t he start of t h e i nter ve nti o n:  
 
1 S T  S T E P –  C O N FI R M A TI O N A N D S U R V E Y S C R E E NI N G  
T his ste p i ncl u des t he f oll o wi n g:  
➢ C o nfir mati o n t hat t he partici pa nt u n der we nt pr e -scree ni n g i n Ti me P oi nt 1 
●We will c o nfir m t hat t he partici pa nt was pre -s cree n e d a n d c o nse nte d. T his 
c o nfir mati o n will occ ur b y as ki n g t he partici pa nt t o ver ball y state t heir n a me, date -of -
birt h a n d place of resi de n ce. T his i nf or mati o n will be ca pt ur e d d uri n g t he scree ni n g 
a n d st ore d i n C R M S. 
➢ C o nti n ue d self -re p ort of dail y ci garette usa ge 
●    If t he p artici pa nt re p orts t hat t he y are n o l o n g er s m o ki n g ci garettes, t h e y will be 
pr o vi de d t he c o nta ct i nf or mati o n of l ocal s m o ki n g cessati o n res o urces i n c ase t he y 
a gai n start t o s m o ke ( 8 0 0 -Q UI T -N O W or T o bacc o Treat me nt Cli nic at Ba y vie w 
Me dical Ce nter). T he me dicati o ns will be dr o p pe d off at a dr u g dis p osal u nit at J o h ns 
H o p ki ns M o n u me nt Street P har mac y.  
➢ Baseli ne s ur ve y c o m pleti o n t hat c o ntai ns q uesti o ns a b o ut s oci o de m o gra p hi c a n d 
s m o ki n g c haract eristics (see “ S u p ple me nt ar y D oc u me nt 3 ”). 
●    Partici pa nts will c o m plete baseli ne s ur ve ys t hat ca pt ure s o ci o de m o gra p hic a n d 
s m o ki n g c haract eristics (see “ S u p ple me ntar y D oc u me nt 3”). Partici pa nts will be 
all o we d s ufficie nt ti me ( n o li mit) t o c o m plete t he s ur ve y. F or partici pa nts wit h 
diffic ult y re a di n g t he s ur ve y, t he q uesti o ns will be rea d al o u d a n d t he res p o nses will be 
rec or de d.  We a ntici pate t hat t he s ur ve y will ta ke n o m ore t ha n 5-1 0 mi n utes t o 
c o m plete si nce w e p ur p osel y are ac q uiri n g fe wer b ut i m pactf ul q uesti o ns t o mi ni mize 
partici pa nt st u d y b ur de n.  
➢ R E -c o nfir mati o n of a n y p ote ntial c o ntrai n dicati o ns f or t he pres cri be d N R T a n d n o n -
nic oti ne p har mac ot h era pi es –  as c h ose n d uri n g scree ni n g. T his re vie w of 
c o ntrai n dicati o ns will oc c ur b y o ur researc h tea m.  
 
T his ste p will d u plicate t he re vie w of a bs ol ute a n d relati ve c o ntr ai n dicati o ns 
u n derta ke n d uri n g t he scree ni n g pr ocess:  
 
➢ A bs ol ute c o ntr ai n dic ati o ns of N R T pr o d ucts  
•  N R T g u m: Dys p h a gi a a n d s u bse q ue nt as pir ati o n risk  
•  N R T l oze n ge: Dys p h a gi a a n d s u bse q ue nt as pir ati o n risk  
•  N R T tr a ns der m al p atc h: Severe diff use ski n dise as e  
•  W o me n w h o are pre g n a nt or bre astfee di n g.  
 
➢ Rel ative c o ntr ai n dic ati o n of n o n -N R T pr o d ucts:   
•  Rece nt m y oc ar di al i nf arcti o n ( ≤ 2 weeks), arr hyt h mi as, a n gi n a, ulcers, 
u nc o ntr olle d hi g h bl o o d press ure, over a ctive t hyr oi d, p he oc hr o m ocyt o m a, or a 
de nt al c o n diti o n or dis or der.  
 
➢ A bs ol ute c o ntr ai n dic ati o n of C h a ntix ® : 
•  I n a bility t o s w all o w pills 
•  Hist ory of seri o us hy perse nsitivity or ski n re acti o ns t o C ha nti x ®  
•  W o me n w h o are pre g n a nt or bre astfee di n g  

 
Date:  01/10/2024 
Principal Investigator: Panagis Galiatsatos  
Application Number: IRB00224186 
 
 
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➢ Relative contraindication of Chantix®: 
• Severe renal impairment (dosage adjustment is necessary) 
• Underlying neuropsychiatric disease 
 
➢ *NOTE: If contraindications are noted, the team will immediately review them with 
the study’s advanced practice provider (physician and/or pharmacist). If 
contraindications exist and the medical specialists determine the patient is not a 
suitable candidate any longer for the prescribed pharmacotherapies, the patient will be 
disenrolled from the study; they will be provided contact information of local smoking 
cessation resources (800-QUIT-NOW and Tobacco Treatment Clinic at Bayview 
Medical Center). Modifications in acute and controller therapy dosing may be 
employed in conversations with our team’s medical specialists (e.g., transdermal NRT 
patch in replacement of Chantix®).  
 
2ND STEP – DRUG EDUCATION AND SIDE-EFFECT MONITORING 
 
The in-person baseline visit will include education about potential common and rare side 
effects of the prescribed medication. This is based on drug information that will be available to 
the patient in the enclosed package sent to the patient with nicotine pharmacotherapies (see 
“Supplementary Document 4”). See Drugs/Substances/Devices and Risks sections in this 
protocol for more information on side effects.  
 
Participants will be provided a 24-hour contact phone number to discuss concerns about side 
effects with our study team for the duration of the 4-week study. The study team will refer 
these concerns within 24 hours to the PI or study coordinator. They will assist in providing 
recommendations regarding the continued administration, replacement or discontinuation of 
the medication). Participants will receive a text and/or voice response to the identified concern 
within 1 day of receipt. Participants may be advised to stop therapies. If both controller and 
rescue medications are stopped, the patient will be disenrolled from the study. If disenrolled, 
they will be provided contact information of local smoking cessation resources (800-QUIT-
NOW or tobacco treatment clinic at Bayview).  
 
NOTE: All adverse effects or concerns about pharmacotherapy will be documented. The time, 
date, description of issue and response will be included in the documentation. All concerns 
will be documented within CRMS. 
 
3RD STEP – CESSATION-DIRECTED MOTIVATIONAL INTERVIEWING 
 
Brief motivational interviewing (MI) will also be delivered by the on-site research staff. The 
MI principles are derived from principles from the MDQuit.org program (see 
mdquit.org/cessation-programs/brief-interventions). 
 
We will assist by enhancing motivation, ability and confidence through the following 
methods: 
• Offer personalized, relevant feedback about the importance of quitting 

 
Date:  01/10/2024 
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Application Number: IRB00224186 
 
 
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• Explore the individuals’ perceived pros and cons of smoking and quitting 
• Discuss the 4 R’s of quitting tobacco use  
i. Relevance: Help the individual identify why quitting tobacco is relevant 
to him/her. 
ii. Risk: Encourage the individual to verbalize possible negative outcomes 
of tobacco use. 
iii. Rewards: Help the individual identify the possible benefits of quitting 
tobacco use. 
iv. Roadblocks: Help the individual to identify possible obstacles to 
quitting, including those from his/her past quit attempts. 
 
 
4TH STEP – DRUG AND STUDY VISIT REMINDERS 
 
Participants will also be reminded that at all future study visits will occur remotely.  
 
Participants will also be asked if they prefer to have the remaining study visits occur remotely 
by phone or video conferencing by Zoom. Participants will be notified that they will receive at 
least weekly text-messaging reminders providing updates regarding prescribed 
pharmacotherapies and study visit reminder dates/times. 
 
They will be made aware that they will be contacted by text message (preferred) or phone on a 
scheduled basis as each week progresses. Messages will be of 2 types: 
 
• Type 1: Reminder of the two offered dates & times of the following week’s study visit 
video conference or phone call. The participant will choose one of the two dates for the 
study visit. Reminders will be sent 72 hours and 24 hours prior to each event.  
 
• Type 2: For those prescribed Chantix®, follow-up will occur every 72 hours. The text or 
phone messages will ask if experiencing any medical issues on therapy [See 
Drugs/Substances/Devices and Risks sections in this protocol for more information on 
adverse effects]. The voice or text messages will state the question, “Are you experiencing 
any side effects or are you having any problems with taking Chantix?” If they text back 
“Yes”, the participant will receive a phone call by our research staff. The concerns will be 
reviewed with our medical specialist. The medical specialists may call the participant for 
further details and/or relaying the treatment plan. Concerns about the clinical status may 
warrant referral to the JHH Emergency Room or the Tobacco Treatment Clinic at Bayview 
Medical Center if acute medical care concerns arise. 
➢ If the medical recommendation is to discontinue BOTH the “acute” and “controller” 
pharmacotherapy, the patient will be disenrolled from the study. Participants who are 
disenrolled will be contacted by phone at the end of the intervention to employ the 
survey used at the final time point (See “Supplementary Document 6”). They will be 
provided contact information of local smoking cessation resources, including the state 
quitline (800-QUIT-NOW) and Tobacco Treatment Clinic at Bayview Medical Center. 
❖ NOTE: We do not anticipate the discontinuation of both the “acute” and 
“controller” therapies based on our initial smoking cessation pilot at Douglass 

 
Date:  01/10/2024 
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Application Number: IRB00224186 
 
 
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(see Preliminary data). Based on the low frequency of observed side effects, 
there is a very low likelihood of a participant not being a good candidate for 
NRT patch (“controller”) or NRT gum/lozenge (“acute”). This means that an 
individual who may not qualify for “Chantix” could be converted “NRT 
transdermal patch”, while continuing on their NRT gum/lozenge.  
 
 
 
 
TIME POINT 4 – follow/up visit 
WEEKLY FOLLOW-UP VISIT 
Each weekly follow-up visit will occur remotely based on participant preference for a 
videoconference platform (Zoom) or mobile phone. Two separate times for study visit will be 
offered to allow participants the option to choose a time more preferable to their schedule. If 
Zoom is not preferable or communication issues arise, standard audio phone-based options 
without video capacity will be instituted. There will be NO video or audio recordings of any of 
the study visits. Paper or electronic copies of participant answers will be stored in CRMS. 
 
The intervention at these follow-up visits will have 4 key features: 
1. Survey completion that contains questions about interval smoking characteristics (see 
“Supplementary Document3”). 
2. Pharmacotherapy education that reinforces appropriate medication administration and 
commonly observed side effects. See Drugs/Substances/Devices and Risks sections in 
this protocol for more information on side effects.  
3. Cessation-directed motivational interviewing 
 
1ST STEP – CONFIRMATION AND SURVEY SCREENING 
➢ Participants will check-in with research staff to confirm that they were enrolled at the 
baseline study event (Week 0).   
 
➢ A short survey (approximately 5 minutes) will be undertaken to acquire key smoking 
characteristics (see “Supplementary Document3”). The survey will ask about the 
usage of the prescribed pharmacotherapies and possible explanations for non-optimal 
adherence. The survey will also query the degree of nicotine dependence. The study 
follow-up visits are using shortened surveys to capture immediately relevant study 
outcomes, reduce study fatigue, and to improve participant acceptability of the project.  
 
Surveys will be displayed on the video conference call if Zoom is the preferred 
modality for the study. For participants with difficulty reading the survey, the questions 
will be read aloud and the responses will be recorded.  For phone-based visits, our 
research team will read the questions aloud and record the answer choices. 
 
➢ We will also confirm if any updates in contact information has occurred. 
 
 
2ND STEP – DRUG EDUCATION AND SIDE-EFFECT MONITORING 

 
Date:  01/10/2024 
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Application Number: IRB00224186 
 
 
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➢ Confirmation of the prescribed pharmacotherapies will be undertaken. This will also 
include self-reported frequency of daily usage of controller and rescue medications. 
 
NOTE: We will confirm that NRT products and Chantix was prescribed to the correct 
participants through the completion of medication dispensing form (see 
“Supplementary Document 5”). The form also provides documentation that drug 
education has occurred.  
 
➢ All participants will undergo repeat education on the appropriate means to self-
administer the medications and commonly observed side effects.  
 
We will again educate participants that they may avail of our 24-hour phone number to 
access research staff if concerns or questions arise regarding pharmacotherapy. 
Research staff will review concerns with medical specialists and respond through 
either text messaging and/or phone calls. If both controller and rescue medications are 
stopped, the patient will be disenrolled from the study. If disenrolled, they will be 
provided contact information of local smoking cessation resources in case they again 
start to smoke (800-QUIT-NOW or tobacco treatment clinic at Bayview). 
 
NOTE: All adverse effects or concerns about pharmacotherapy will be documented. 
The time, data, description of issue and response will be included in the 
documentation. 
 
 
3RD STEP – CESSATION-DIRECTED MOTIVATIONAL INTERVIEWING 
➢ Brief motivational interviewing (MI) delivered by research staff.  
. 
We will assist by enhancing willingness or motivation, as well as ability or confidence 
through the following methods: 
o Offer personalized, relevant feedback about the importance of quitting 
o Explore the individuals’ perceived pros and cons of smoking and quitting 
o Discuss the 4 R’s of quitting tobacco use  
▪ Relevance: Help the individual identify why quitting tobacco is 
relevant to him/her. 
▪ Risk: Encourage the individual to verbalize possible negative 
outcomes of tobacco use. 
▪ Rewards: Help the individual identify the possible benefits of 
quitting tobacco use. 
▪ Roadblocks 
Help the individual to identify possible obstacles 
to quitting, including those from his/her past quit attempts. 
 
 
4H STEP – STUDY VISIT REMINDERS 
 
a) Participants will again be reminded that they will be contacted by text message 
(preferred) or phone on a scheduled basis as each week progresses. Reminder 

 
Date:  01/10/2024 
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Application Number: IRB00224186 
 
 
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of the two offered dates & times of the following week’s study visit. The 
participant will choose one of the two dates for the study visit. Reminders will 
be sent 72 hours and 24 hour prior to each phone call or videoconference. 
b) For those prescribed Chantix®, follow-up will again occur every 72 hours. The 
text or phone messages will ask if experiencing any medical issues on therapy 
[See Drugs/Substances/Devices and Risks sections in this protocol for more 
information on adverse effects]. The text messages will state the question, “Are 
you experiencing any side effects or are you having any problems with taking 
Chantix?” If they text back “Yes”, the participant will receive a phone call by 
our research staff. The concerns will be reviewed with our medical specialists. 
The medical specialists may call the participant for further details and/or 
relaying the treatment plan. Concerns about the clinical status may warrant 
referral to the JHH Emergency Room or the Tobacco Treatment Clinic at 
Bayview Medical Center if acute medical care concerns arise.  
• If the medical recommendation is to discontinue BOTH the “acute” and 
“controller” pharmacotherapy, the patient will be disenrolled from the 
study. They will be provided contact information of local smoking 
cessation resources. They will be provided information for the state quit 
line (800-QUIT-NOW) and the Tobacco Treatment Clinic at Bayview 
Medical Center. Participants who are disenrolled will be contacted by 
phone at the end of the intervention to employ the final survey used at 
the time=+4 week point (See “Supplementary Document 3”) 
 
Participants will again be provided with a 24-hour phone contact to communicate with 
our research team. Participants will be able to text regarding any concerns about the 
study. Participants will receive a text and/or voice response to the identified within 1 
day of receipt. All concerns will be documented and reviewed with the PIs and/or 
identified medical specialists of the research team.  
 
TIME POINT 5 – follow/up visit 
WEEKLY FOLLOW-UP VISIT 
All elements of this time point mirror the description represented above (TIME POINT 4). The 
only difference is that one interval text messaging type will be used. We will no longer ask 
Chantix® users about medication concerns every 72 hours, if they have not reported any 
adverse effects to date on therapy. Participants will continue to receive reminders at 72 hours 
and 24 hours prior to the next scheduled follow-up study visit.  
 
TIME POINT 6 – follow/up visit 
WEEKLY FOLLOW-UP VISIT 
All elements of this time point mirror the description represented above (TIME POINT 5)  
 
 
TIME POINT 7 – FINAL follow/up visit 
FINAL VISIT 
This final study visit will occur by videoconference (Zoom) or a phone call. Two separate 
times for the study visit will be offered to allow participants the option to choose a time more 

 
Date:  01/10/2024 
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Application Number: IRB00224186 
 
 
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preferable to their schedule. The intervention at this time point will have 3 key features: 
1. Survey completion that contains questions about smoking characteristics and 
completion of open-ended questions that explore the feasibility of the study pilot (see 
“Supplementary Document 3”). 
2. Referral to 800-QUIT-NOW or Tobacco Treatment Clinic at Bayview Medical Center 
if continued smoking cessation resources are requested 
3. $15 cash equivalent reimbursement for study participation.  
 
1ST STEP – CONFIRMATION AND SURVEY SCREENING 
 
➢ Participants will check-in with research staff to confirm their enrollment in the study.  
 
➢ A short survey (approximately 5 minutes) will be undertaken to acquire key smoking 
characteristics (see “Supplementary Document 3”). The survey will ask the usage & 
frequency that the prescribed pharmacotherapies are being used, as well as query the 
degree of nicotine dependence over the 4-week pilot period. Surveys will be displayed 
on the video conference call if Zoom is the preferred modality for the study. For 
participants with difficulty reading the survey, the questions will be read aloud and the 
responses will be recorded.  For phone-based visits, our research team will read the 
questions aloud and record the answer choices. 
 
➢ Participants will also be asked 10 open-ended questions that will assess study 
feasibility (see “Supplementary Document 3”). Questions will be real aloud and the 
responses will be summarized solely in a written format by the research team. The 
questions explore participant thoughts on the objective, data collection, recruitment, 
pharmacotherapy experience (administration, education, delivery and monitoring), 
motivational interviewing, study schedule and text messaging/phone follow-up. 
 
 
 
2ND STEP – UNUSED DRUG SUPPLIES 
 
➢ Participants will be encouraged to return any unused drug supplies. The medications 
will be able to be returned in a pre-stamped envelope that was provided with the initial 
medication package prior to the study. The return envelope is to labelled to the 
attention of the PI (Dr. Galiatsatos). The unused medications will be dropped off at a 
drug disposal unit at Johns Hopkins Monument Street Pharmacy.      
 
 
3RD STEP – POST-PILOT CESSATION RESOURCES 
➢  
All participants will be provided contact information of local smoking cessation 
resources for continued participation in the cessation effort. They will be provided 
information for the state quit line (800-QUIT-NOW) and the Tobacco Treatment Clinic 
at Bayview Medical Center. 
 
4TH STEP – REIMBURSEMENT OF STUDY VISIT PARTICIPATION BY EMAIL OR 

 
Date:  01/10/2024 
Principal Investigator: Panagis Galiatsatos  
Application Number: IRB00224186 
 
 
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TEXT MESSAGING. 
➢ $15 cash equivalent reimbursement for study participation.  
  
 
• Data and Safety Monitoring Plan 
For the proposed research, Dr Galiatsatos will take the responsibility for coordinating and 
assuring data storage and access. We do not expect the project to produce more data than can 
be appropriately managed by the research team. This research will generate data resulting 
from surveys and questionnaires.  
 
Clinical Research Management System (CRMS) is being used for data management and 
research implementation. CRMS will contain the following information: 
o Protocol information from eIRB2 
o Registry of study participants 
o Management of study accruals 
o Consent tracking 
o Secure location for study-related documents (e.g. surveys, questionnaires and 
screening tools) 
o Pre-configured and adhoc reports 
o Multiple interfaces with Epic, including sending data to Epic about the study and the 
study participants  
 
Written surveys, questionnaires and screening tools completed by participants (or assisted by 
research staff) will be scanned into CRMS. All written material will be destroyed after 
scanning has been completed. Files will only be shared with research team members listed on 
the IRB application. 
 
SAFE, the Secure Analytic Framework Environment, will also be used as a secure 
environment to analyze and share sensitive data (e.g. PHI) with research staff. Statistical 
analyses and report generation/sharing will occur on the SAFE network. Data will be stored 
in SAFE in one of the following formats: Stata, Microsoft Excel, PowerPoint, Microsoft 
Word and/or Acrobat PDF. 
 
Data analysis will occur individually and collectively in group meetings. Analysis will occur 
only at JHU. Results may be tabulated and summarized for ease in understanding the 
analysis. All analysis will occur within SAFE desktop software apps. 
 
Findings of the de-identified data will be used among research team for the development of 
larger-scaled tobacco intervention studies. Data containing PHI will not be shared outside of 
the JHU research team. All public discussions and/or scientific publications will use de-
identified datasets.  
 
All affiliates within the Housing Authority of Baltimore City will only be provided de-
identified, aggregated data. 
 
Data will be maintained on SAFE desktop for five years after the conclusion of the project. 

 
Date:  01/10/2024 
Principal Investigator: Panagis Galiatsatos  
Application Number: IRB00224186 
 
 
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• STUDY DURATION AND NUMBER OF STUDY VISITS REQUIRED OF 
RESEARCH PARTICIPANTS 
 
a) Duration of Study Participation 
The total duration of study subject participation is 6 weeks – including screening, consent 
and intervention phases. 
 
b) Number of study visits 
A total of 6 study visits will occur over the 6-week duration of the study. 
• Visit 1: Screening and consent  
• Visit 2: Baseline time point of the intervention (including delivery of 
pharmacotherapies) 
• Visit 3: Follow-up time point of the intervention  
• Visit 4: Follow-up time point of the intervention 
• Visit 5: Follow-up time point of the intervention 
• Visit 6: Final intervention time point  
 
All participants will be screened, consented, receive their cessation pharmacotherapy and 
undergo their baseline study visits in-person. All remaining study visits will occur 
remotely through video conferencing or standard audio phone calls. 
 
• BLINDING, INCLUDING JUSTIFICATION FOR BLINDING OR NOT 
BLINDING THE TRIAL, IF APPLICABLE. 
 
This is a pre-post study design with no active comparator. All participants will receive 
the intervention. There is no blinding during the trial. 
 
• JUSTIFICATION OF WHY PARTICIPANTS WILL NOT RECEIVE ROUTINE 
CARE OR WILL HAVE CURRENT THERAPY STOPPED. 
 
Not applicable 
 
• JUSTIFICATION FOR INCLUSION OF A PLACEBO OR NON-TREATMENT 
GROUP. 
 
Not applicable 
 
• DEFINITION OF TREATMENT FAILURE OR PARTICIPANT REMOVAL 
CRITERIA. 
 
Participants will be removed if any of the following criteria are met: 
a) Smoking cessation reported at the start of the intervention (BASELINE VISIT)  
b) Based on reported adverse medication effects, our medical specialists may 
recommend for discontinuation or modification of the pharmacotherapy regimen. 

 
Date:  01/10/2024 
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Application Number: IRB00224186 
 
 
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Participants who are recommended to discontinue BOTH the “acute” and 
“controller” pharmacotherapy will be disenrolled from the study.  
 
• DESCRIPTION OF WHAT HAPPENS TO PARTICIPANTS RECEIVING 
THERAPY WHEN STUDY ENDS OR IF A PARTICIPANT’S PARTICIPATION 
IN THE STUDY ENDS PREMATURELY. 
 
If the participant’s participation ends prematurely, they will receive their reimbursement 
from their final study visit. They will also be provided the contact information of local 
smoking cessation resources, include the state quitline (800-QUIT-NOW) and Tobacco 
Treatment Clinic at Bayview Medical Center.  
 
For participants who complete the study, they too will be provided the contact 
information of local smoking cessation resources, include the state quitline (800-QUIT-
NOW) and Tobacco Treatment Clinic at Bayview Medical Center. 
 
Subjects may withdraw from the study at any time without impact to their care. 
 
5. 
INCLUSION/EXCLUSION CRITERIA 
 
Inclusion criteria: 
1. ≥18 years of age 
2. Self-reported smoker with either daily or weekly cigarette use, as well as expressed desire 
to reduce or quit smoking  
3. Proof of residence at Douglass or Brooklyn Homes - as confirmed by verbal 
acknowledgement by the service coordinators at each site. 
4. Working mobile phone with texting ability for the duration of the study 
5. Active health insurance (for pharmacotherapy billing)  
 
Exclusion criteria:  
1. Pregnant – women will verbally acknowledge that they are not pregnant or trying to 
become pregnant in the next 8 weeks from the time of screening and recruitment to 
ensure no intake of nicotine and non-nicotine pharmacotherapy 
2. Breastfeeding – women who are verbally acknowledge they are breastfeeding will be 
excluded from the study. This exclusion factor is in place secondary to breastfeeding 
concerns associated with the study’s usage of nicotine and non-nicotine pharmacotherapy 
3. Ongoing participation in a tobacco cessation program or related tobacco intervention 
study. Past participation in previous iterations of the protocol is not an exclusion criteria. 
4. No active health insurance.  
5. Unable to verbally state that they are willing to reduce or quit smoking upon recruitment 
and screening  
6. Adults lacking capacity to consent 
7. Non-English speakers 

 
Date:  01/10/2024 
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8. Self-reported usage of only non-combustible tobacco products, such as smokeless 
tobacco or Electronic Nicotine Delivery Devices (ENDS).  
9. Anticipated relocation outside of Douglass or Brooklyn Homes prior to the final study 
visit 
 
 
6. 
DRUGS/ SUBSTANCES/ DEVICES 
 
• The rationale for choosing the drug and dose or for choosing the device to be used. 
Nicotine and non-nicotine pharmacotherapy to treat tobacco addiction will be prescribed 
in Epic by Dr. Galiatsatos [PI], Medical Director of the Tobacco Treatment Clinic at 
Bayview Medical Center. Dr. Galiatsatos is a faculty member in the Division of 
Pulmonary Critical Care & Medicine.  
 
Pharmacotherapy oversight will also be led the PI, an expert in pharmacotherapy for 
tobacco dependence and smoking cessation. 
 
The selection and prescription of pharmacotherapies will approximate an approach 
currently employed the PI. The PI currently provides medical care in two public housing 
complexes in Baltimore: Monument East and McColloh Homes. 
 
Patients will undergo a multistep process to screen and monitor adverse effects on 
therapy. The medications chosen based on initial screening will be prescribed and 
delivered to participants. Prior to initiating the administration of the medications, 
participants will again be evaluated for the presence of absolute or relative 
contraindications of the prescribed pharmacotherapy regimen (BASELINE VISIT: Time 
Point 3) . Participants will be provided a 24-hour contact phone number to report 
concerns or adverse effects on therapy. All concerns will be reviewed by the PI within 24 
hours of receipt.  
 
All pharmacotherapy is FDA approved and dosing will be based on FDA drug labelling.   
 
o NRT gum or lozenge: 
 
Baseline to end of study = 4 weeks 
STEP 1 
Determine dosage 
 
Do you smoke your 1st cigarette within 30 minutes of waking up? 
     Yes → Use 4 mg gum or lozenge 
     No → Use 2 mg gum or lozenge 
STEP 2 
Frequency of administration 
 
Take the recommended dose (1-piece) by mouth every 1-2 hours 
 
o NRT patch: 
 
Baseline to end of study = 4 weeks 
STEP 1 
Determine dosage 

 
Date:  01/10/2024 
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Application Number: IRB00224186 
 
 
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Do you smoke ≥ 10 cigarettes per day?     
     Yes → Use 21 mg patch 
     No →  Use 14 mg patch 
STEP 2 
Frequency of administration 
 
Apply one new patch per day 
 
o Chantix®: 
 
Baseline to end of study = 4 weeks 
STEP 1 
Dosing & administration 
 
Day 1 – 3: 0.5 mg by mouth daily 
Day 4 – 7: 0.5 mg by mouth twice-daily 
Day 8 – 30: 1 mg by mouth twice-daily 
 
• Justification and safety information if FDA approved drugs will be administered for 
non-FDA approved indications or if doses or routes of administration or participant 
populations are changed. 
 
Not applicable 
 
• Justification and safety information if non-FDA approved drugs without an IND 
will be administered.  
 
Not applicable 
 
7. 
STUDY STATISTICS 
 
a. Primary outcome variable 
The primary endpoint will be study feasibility. Feasibility will be measured using 
open-ended questions administered by the research team and targeting the study 
stakeholders (study participants, community stakeholders and research team). The 
answers will serve as a means to evaluate the need for further modification in the 
recruitment, screening, consent, study implementation and evaluation phases of future 
study testing..  
 
b. Exploratory outcome variables 
 
Pre- & post-changes in nicotine dependence levels – Results will be stratified by 
baseline smoking behaviors, sociodemographic characteristics and socioeconomic 
stressors. For group-wise comparisons, t-test or analysis of variance will be used.  
Regression analyses will be performed to investigate the relationship between 
baseline measures and changes in smoking characteristics as the pilot study 
progressed. 
 
c. Statistical plan including sample size justification and interim data analysis 

 
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Application Number: IRB00224186 
 
 
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This study will not be powered for significance. The primary purpose of this study is 
to assess feasibility of the pilot study design.  
 
d. Early stopping rules 
 
Not applicable 
 
8. 
RISKS 
 
a. Medical risks, listing all procedures, their major and minor risks and expected 
frequency 
NRT Gum or Lozenge 
Although adverse effects from NRT gum or lozenge are uncommon. These may 
include: 
a) Nausea 
b) Abnormal dreams (vivid, unusual, strange) 
c) Constipation 
d) Flatulence 
e) Vomiting 
f) Rash 
g) Hypersensitivity reactions 
h) Sleep walking 
i) Accidental injury 
j) Interaction with alcohol 
k) Seizures 
l) Changes in mood 
m) Hallucinations 
n) Paranoia 
o) Delusions 
p) Homicidal ideation 
q) Aggression 
r) Hostility 
s) Agitation 
t) Anxiety 
u) Panic 
v) Suicidal Ideation 
w) mouth ulcers 
x) jaw muscle aches 
y) dizziness 
z) hiccups 
aa) headache 
bb) gastrointestinal symptoms (nausea, vomiting, diarrhea, dyspepsia) 
cc) dyspnea or difficulty breathing 
dd) abnormal heart beat (tachycardia, arrhythmias or palpitations) 
ee) rash 
 

 
Date:  01/10/2024 
Principal Investigator: Panagis Galiatsatos  
Application Number: IRB00224186 
 
 
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NRT Patch 
 
Reported adverse effects include the following: 
a) Skin irritation 
b) dizziness,  
c) gastrointestinal symptoms (nausea, vomiting, diarrhea, dyspepsia) 
d) headaches 
e) rash 
f) abnormal heart beat (tachycardia, arrhythmias or palpitations) 
g) dyspnea or difficulty breathing 
 
Chantix 
Adverse reactions 
• Most common adverse reactions (>5% and twice the rate seen in placebo-
treated patients) were nausea, abnormal (e.g., vivid, unusual, or strange) 
dreams, constipation, flatulence, and vomiting.  
 
 
 
Warnings & precautions 
• 
Neuropsychiatric Adverse Events: Postmarketing reports of serious or 
clinically significant neuropsychiatric adverse events have included 
changes in mood (including depression and mania), psychosis, 
hallucinations, paranoia, delusions, homicidal ideation, aggression, 
hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide 
attempt, and completed suicide. They will be advised to seek immediate 
medical attention if they experience signs and symptoms of 
neuropsychiatric events. 
• 
Seizures: New or worsening seizures have been observed in patients 
taking CHANTIX. CHANTIX should be used cautiously in patients with a 
history of seizures or other factors that can lower the seizure threshold. 
They will be advised to seek immediate medical attention if they 
experience signs and symptoms of seizure activity. 
• 
Interaction with Alcohol: Increased effects of alcohol have been reported. 
We will instruct patients to reduce the amount of alcohol they consume 
until they know whether CHANTIX affects them.  
• 
Accidental Injury: Accidental injuries (e.g., traffic accidents) have been 
reported. We will instruct patients to use caution driving or operating 
machinery until they know how CHANTIX may affect them.  
• 
Cardiovascular Events: Patients with underlying cardiovascular (CV) 
disease may be at increased risk of CV events; however, these concerns 
must be balanced with the health benefits of smoking cessation. We will 
instruct patients to notify our team and their healthcare provider of new or 
worsening CV symptoms. They will be advised to seek immediate medical 
attention if they experience signs and symptoms of myocardial infarction 
(MI) or stroke.  
• 
Somnambulism: Cases of somnambulism have been reported in patients 
taking CHANTIX. Some cases described harmful behavior to self, others, 

 
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Application Number: IRB00224186 
 
 
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or property. We will instruct patients to discontinue CHANTIX and notify 
their healthcare provider if they experience somnambulism.  
• 
Angioedema and Hypersensitivity Reactions: Such reactions, including 
angioedema, infrequently life-threatening, have been reported. We will 
instruct patients to discontinue CHANTIX and immediately seek medical 
care if symptoms occur.  
• 
Serious Skin Reactions: Rare, potentially life-threatening skin reactions 
have been reported. We will instruct patients to discontinue CHANTIX 
and contact a healthcare provider immediately at first appearance of skin 
rash with mucosal lesions.  
• 
Nausea: Nausea is the most common adverse reaction (up to 30% 
incidence rate). Dose reduction may be helpful. 
 
 
b. Steps taken to minimize the risks 
 
• Reporting of Adverse Events, Adverse Device Effects and Unanticipated Problems 
 
Definition of medication adverse event: An adverse event (AE) is any symptom, sign, or 
experience that develops during the course of administering NRT (gum, lozenges or 
patches) or non-nicotine pharmacotherapies (Chantix®)  
 
The following report will be supplied as a narrative for all NRT-reported adverse events: 
• Study identifier 
• A description of the event 
• Date of onset 
• Current status 
• Whether study medication was 
discontinued 
• Whether alternative NRT or non-
nicotine pharmacotherapy was 
prescribed 
• Investigator assessment of the 
association between the event and study 
intervention 
 
Patients will undergo a multistep process to screen and monitor adverse effects on 
therapy. The medications prescribed & delivered based on initial screening will only be  
recommended for administration after participants undergo confirmation of 
appropriateness of drugs selection at the time of the baseline study visit (WEEK 3). 
Participants will be provided a 24-hour contact phone number to reports concerns or 
adverse effects on therapy. All concerns will be reviewed by the PI within 24 hours of 
receipt. 
 
All adverse events will be followed until resolution, stabilization, or until it has been 
determined that the study intervention or participation is not the cause.  Further action 
and/or candidacy for an alternative pharmacotherapy (e.g. Chantix® changed to NRT 
patch) will occur under the direction of the medical specialists (PI). 
 

 
Date:  01/10/2024 
Principal Investigator: Panagis Galiatsatos  
Application Number: IRB00224186 
 
 
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Version 4 Dated:   01/2021 
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We will also ensure that Chantix is being administered to the correct participants and 
drug education is being delivered at each study visit through the completion of 
medication dispensing form (see “Supplementary Document 5”). The form requires the 
signature of the study team member who will verify administration and education of the 
medication to the correct participant.  
 
c. Plan for reporting unanticipated problems or study deviations 
 
All unanticipated problems and study deviations will be  reviewed by the PI Dr. 
Galiatsatos.  
 
We have built the protocol to accommodate minor deviations. For example, our protocol 
is still maintained despite participants unable to attend the study visits or if all outcomes 
are not obtained during the 4 week trial. These will be reported in an IRB continuing 
review. 
 
Major deviations will be reported immediately to the IRB. A major deviations are events 
that cause or could cause harm to subjects or others or that affect the fidelity of our 
research. 
 
d. Legal risks such as the risks that would be associated with breach of 
confidentiality 
 
Not applicable 
 
e. Financial risks to the participants 
 
There are no financial risks for participants 
 
9. 
BENEFITS 
 
Description of the probable benefits for the participant and for society 
o There may be the possibility of direct benefit of this research protocol to a similar 
population of tobacco smokers in public housing depending on the findings of this 
study. This pilot study is testing the feasibility of this multicomponent 
intervention for future, scaled-up testing in more public housing zones in 
Baltimore City. 
 
10. 
PAYMENT AND RENUMERATION 
 
Detail compensation for participants including possible total compensation, proposed 
bonus, and any proposed reductions or penalties for not completing the protocol 
 
 
o Participants will receive a maximum of $15 for their participation in the study. 
Renumeration will occur at only the final time point: 

 
Date:  01/10/2024 
Principal Investigator: Panagis Galiatsatos  
Application Number: IRB00224186 
 
 
JHMIRB eFormA  01 
Version 4 Dated:   01/2021 
Page 27 of 27 
 
 
o There are no penalties for not completing the protocol. 
 
11. 
COSTS 
 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and identify 
who will pay for them 
 
o The pharmacotherapies will be billed to Maryland Medicaid. We anticipate all 
participants, whose income qualify for public housing, use Maryland Medicaid or 
Medicare as their health insurance. Patient are required to pay nothing ($0) for a 1-
month supply of NRT gum/lozenge, patch and Chantix®.   
▪ In the rare case, that a participant is using a commercial health insurance, we 
still anticipate $0 copay. Two current commercial health insurances (Humana 
Medicare and Medimpact) have co-pay ranging from $47 - $54 for NRT 
products. In these cases, we will apply for vouchers using the assistance of 
JHH Community Pharmacy Resources.