NRT Sampling and Selection to Increase Medication Adherence
Phase: PHASE4
Conditions: Smoking Cessation
Sponsor: University of Alabama at Birmingham

Nicotine Replacement Therapy Sampling & Selection 
Study Protocol 
NCT03276780 
May 19, 2021 
Karen Cropsey, PsyD, Principal Investigator 
University of Alabama at Birmingham 
Birmingham, AL 35294 

1 
 
 
Nicotine Replacement Therapy Sampling and Selection 
 
(Nicotine Replacement Therapy Sampling and Selection to Increase Medication Adherence) 
(IRB-151019004) 
Dr. Karen Cropsey 
 
 
Introduction 
 
This Manual of Procedures (MOP) has been created to help build a framework upon 
which all research staff can base their approach to dealing with enrolling participants in the study 
and adhering to study protocol. The goal of this manual is to create more consistency across 
study researchers and students.   
 
Brief Purpose of Study 
 
 
This study is designed to examine whether In Vivo nicotine replacement therapy (NRT) 
experience intervention will be effective in quitting smoking as compared to behavioral standard 
of care smoking cessation treatment. For this study, In Vivo experience is: the use of one of four 
different short-acting NRT products in conjunction with nicotine patches during session. 
Specialized counseling focused around the experience of NRT, including how the use of NRT 
may help with quitting smoking, side effects, and smoking cessation expectancies will also be 
utilized.  
If eligible to participate, subjects will be randomized into one of the four Intervention (In-
Vivo) groups or the control group. They will be asked to fill out forms regarding smoking 
behavior, demographics, medical information, and a contact sheet. Some questionnaires will be 
repeated at every visit and others will be repeated less frequently. Participants are asked to 
complete 13 weeks of intervention, comprised of five weeks of smoking cessation therapy 
(Intervention or Control; Weeks 1-5) and three treatment sessions designed to measure 
medication adherence (Weeks 6, 9 and 13). Following intervention completion, participants will 
be asked to return for a follow up visit at one month.  

2 
 
Participants in the Intervention groups will be asked to go as long as they can without 
smoking the day of the therapy sessions. They will put a nicotine patch on during each of the 
weekly sessions. During the first four weekly sessions, participants in the Intervention groups 
will also use a different form of short-acting NRT each week (nicotine gum, lozenge, inhaler, 
nasal spray) and in the fifth week, will select which short-acting medication they would prefer to 
use for the duration of the study. Participants will discuss the experience of wearing the patch 
and/or using the short-acting NRT while they are in session. The Control group will not use NRT 
medication during the sessions but will be given standard counseling regarding quitting smoking. 
At each visit a carbon monoxide (CO) test will be administered (like an alcohol 
breathalyzer), which will show how much CO is in a participant’s lungs as a result of smoking. 
A cotinine test will always be done at Baseline, and then at subsequent visits if the CO test 
indicates a participant is not smoking. Throughout the study, women of child bearing potential 
will be asked to give a urine sample to test for pregnancy a total of 4 times, and for all 
participants a urine drug screen will be completed at Baseline. See the chart below for more 
details regarding frequency of tests and questionnaires. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

3 
 
 
 
 
Table of Contents 
 
Introduction 
1 
Brief Purpose of Study 
1 
Table of Contents 
3 
Measurement Occurrence Chart 
5 
Accessing the Shared Drive 
6 
Recruitment and Eligibility 
6 
Subject Recruitment 
6 
Subject Enrollment  
6 
Inclusion Criteria 
6 
Exclusion Criteria 
6 
Protocol for Enrollment 
7 
Forms/Links 
7 
Participant Folder Preparation 
7 
Carbon Monoxide Monitor 
8 
Carbon Monoxide Monitor Use Steps 
8 
Carbon Monoxide Monitor and Intervention Sessions 
8 
Carbon Monoxide Gas Ordering 
8 
Calibration Log  
8 
Calibration 
8 
Carbon Monoxide Gas Disposal 
9 
Urine Collection Protocol 
9 
Collection 
9 
Surface Pros, REDCap, Dropbox, Digital Recorders 
10 
Surface Pros 
10 
Login for Surface Pros and REDCap 
10 
Wi-Fi Login 
10 
Troubleshooting Wi-Fi Login 
10 
UAB Psychiatry IT 
10 
REDCap 
11 
UAB REDCap Contact 
11 
REDCap Video Tutorials 
11 
Entering New Participant Data 
11 
Random Assignment 
11 
Adding to Existing Participant Data 
12 
Editing Data 
12 
Survey Queue 
12 
Audio Option in Questionnaires 
13 
Exporting to Excel/SPSS 
13 
Scheduling a New Participant 
14 

4 
 
Changes to Schedule 
14 
No-Show/Cancel 
14 
Reschedule 
14 
Dropbox 
14 
Prescriptions 
15 
Study Physician/Co-Investigator Contact Information 
15 
Pharmacy/Pharmacist Contact Information 
15 
Nicotine Patch 
15 
Nicotine Gum 
15 
Nicotine Lozenge 
15 
Nicotine Inhaler 
16 
Nicotine Nasal Spray 
16 
Medication Ordering 
16 
Medication Inventory 
16 
Medication Storage 
17 
Medication Dispensing 
17 
Intervention Group A 
17 
Intervention Group B 
18 
Intervention Group C 
19 
Intervention Group D 
20 
Control Group 
21 
Medication Instructions 
21 
Appointment Reminder Calls 
22 
Appointment Reminder Text Messages 
22 
Rescheduling Parameters 
23 
Compensation 
23 
Compensation Amount per Study Visit 
23 
Documenting Distributed Compensation 
23 
GreenPhire ClinCard 
24 
Login Information 
24 
How to Look Up a Subject 
24 
How to Register a Subject 
24 
How to Register a Subject in an Additional or Extension Study 
25 
How to Assign a ClinCard to a Subject 
25 
How to Make a Site Visit Payment 
25 
How to Request Assistance 
26 
Adverse Events (AEs) & Serious Adverse Events (SAEs) 
26 
Suicidality 
28 
Baseline Appointments 
29 
Materials 
29 
Procedures 
29 
Intervention Fidelity 
30 
Therapy Protocol 
31 
Week 1 – 5  
31 
Intervention Group A 
31 

5 
 
Intervention Group B 
40 
Intervention Group C 
48 
Intervention Group D 
57 
Control Group 
66 
Week 6 
71 
Week 9 
72 
Week 13 
73 
Month 1 Follow-up 
74 
Ecological Momentary Assessment (EMA) 
74 
Data Entry 
75 
Data Collection Parameters 
76 
Amendments/Protocol Changes 
78 
 

6 
 
Measurement Occurrence Chart 
 
Accessing the Shared Drive 
 
1. Click on the home button at the bottom left hand corner of the computer screen. 
2. Go to “Computer.” 
3. Click on “PBN.” Enter your Blazer ID and password if necessary.  
4. Click on “Cropsey-Lab.” 
5. Click on the “NRT Sampling” folder (this is the folder for our study). 

7 
 
Recruitment and Eligibility 
 
Subject Recruitment 
 
Participants will be recruited from the community. Flyers describing the study will be placed in 
low income areas around the city. Potential participants should be instructed to call the study 
team for eligibility screening (205) 975-7809.  
 
Subject Enrollment 
 
Inclusion Criteria  
 
• At least 18 years old 
• Qualifying as low income (making <150% above the poverty line, or <$22,260 as a 
single, or <$45,570 for a family of four) 
• Smoked at least 10 cigarettes per day (CPD) for the last year 
• Live in an unrestricted environment (e.g., living in a halfway house, or independently) 
• Expire carbon monoxide (CO) >8 ppm at Baseline 
• Positive cotinine test at Baseline 
 
Exclusion Criteria  
 
• Pregnant or nursing  
• Currently receiving treatment to quit smoking (enrolled in smoking cessation treatment 
program, using NRT products, or prescribed bupropion or varenicline) 
• Known sensitivity to nicotine replacement or allergy to adhesive used in nicotine patches 
• Trouble breathing, a pulmonary condition, or sinus problems 
• Untreated severe angina or heart attack within last month 
• TMJ (temporomandibular joint) problems (unable to use nicotine gum) 
• Cognitive impairment or unstable psychiatric condition that interferes with the informed 
consent process 
• Daily or exclusive use of other tobacco products (electronic cigarettes, little cigars, etc.) 
• Non-English Speaking 
 
 
Protocol for Enrollment  
 
1. Check the Ineligible section of the Screening Form folder and/or Screening Database to 
see if the person inquiring has already been screened   
2. Complete a Screening Form for each potential participant  
3. If participant is ineligible, do not tell them they are ineligible until the screening form is 
complete  
4. Enter the Screening Form into the Screening Database 
5. File the Screening Form in the Screening Form folder according to eligibility. The folder 
is kept in the filing cabinet C in room L107B. 

8 
 
Forms/Links 
 
Screening Form   
 
P:\Cropsey-Lab\NRT Sampling\Measures\Screening Form NRT R34  
Screening Database   
Z:\Cropsey-Lab\NRT Sampling\Databases\Screening 
 
 
Carbon Monoxide Monitor 
 
Carbon Monoxide Monitor Use Steps 
 
1. Insert t-valve into the taper on the top of the machine case 
2. Turn on machine 
3. Put on gloves and attach a new white mini mouthpiece to the t-valve 
4. Make sure machine is reading at zero 
• If it does not zero out, move black slider above the Vitalograph logo to left or right 
until it reads zero 
5. Tell participant to take a deep breath, hold for 10 seconds, and breathe out slowly through 
the mouthpiece over a period of 20 seconds or more  
6. Record the highest number from the machine on the NRT adherence sheet and enter into 
REDCap  
 
**You may also want to remind the participant of their CO level when you begin the therapy 
session with them. ** 
 
Carbon Monoxide Monitor and Intervention Sessions 
 
• Participants are to provide a CO sample at each visit.  
• If they blow ≤ 8 on a Baseline visit, they are not eligible to participate 
• If they blow ≤ 3 on subsequent visits, a cotinine test must be done and recorded in 
REDCap 
 
Carbon Monoxide Gas Ordering 
 
• CO gas is to be ordered through the Vitalograph website  
• Email Leslie George to order:  lesliegeorge@uabmc.edu  
• Link to website: https://vitalograph.com/shop  
 
Calibration Log 
 
• T-valves must be replaced after every 50 uses (approximately every two months) 
 
Calibration 
 
1. Turn on CO Breathalyzer Machine 
2. Attach t-valve into the taper on the top of the machine case 

9 
 
3. Take CO calibration gas and insert end of gas tube into t-valve 
4. Slowly open the gas cap (either twist open or push up) and watch the CO machine reader 
go up in number until it slows down. When the reader stays on the same number for 
approximately 5 seconds, you know it is now calibrated.  
5. Close the gas tank by twisting the cap or pulling it down 
6. Disconnect the gas tank 
7. Leave the machine on until it brings the number back down to zero (approximately 30 
seconds) then turn the machine off  
8. Calibration is complete 
 
Carbon Monoxide Gas Disposal 
 
• Throw in trash (safe gas) and make sure cap is opened all the way 
• Each gas container has approximately enough pressure to calibrate a machine 5-6 times 
• Need to replace when it runs low on pressure, or runs out of pressure (at 0 psi). You can 
read the pressure gauge to find out just how much pressure is in each canister.   
 
Instructions: Return unused product to the supplier. If product must be disposed of on-site, 
incineration using a suitable flare is typically used. Disposal of carbon monoxide must be done in 
an environmentally acceptable manner in compliance with all applicable national and local 
codes. (Also known as: Throw in trash) 
 
*CO Machine Training Manual is located at: https://vitalograph.co.uk/downloads/display/8  
Urine Collection Protocol 
 
• WEAR GLOVES AT ALL TIMES WHEN HANDLING URINE SAMPLES. 
• Drug testing should be completed at Baseline appointment for all participants 
• Cotinine testing is to be conducted Baseline appointment for all participants 
• Cotinine testing is done at subsequent visits if the participant blows 3 or below on their 
CO test  
o Instructions for Cotinine tests located at: http://www.xlar.com/I/NICOTINE-
TEST.pdf  
• Pregnancy testing is completed at Baseline, Week 5 and Week 9 
o Instructions for Pregnancy tests are located at: 
https://static.fishersci.com/cmsassets/downloads/segment/Healthcare/pdf/HCGdip
PI23900527.pdf  
• We will conduct the pregnancy and cotinine testing for participants  
 
Collection 
 
1. To prepare you will need:  
 
1. Urine cup  
2. Urine lid 
3. Cotinine test (for Baseline or when participant blows less than 3 on CO test) 

10 
 
4. Pregnancy test (for women at Baseline, Week 5 and Week 9) 
5. Gloves 
2. Urine cups and lids can be found in the filing cabinet in room L107E. 
3. Escort participant to the bathroom 
4. Test female urine for pregnancy 
5. Test urine for cotinine at Baseline and if participant blows ≤ 3 on CO monitor at 
subsequent visits 
6. Record drug and pregnancy test results in REDCap 
 
 
 
Surface Pros, REDCap, Dropbox, Digital Recorders 
 
Surface Pros 
 
Surface Pros can be found in the locked desk drawers located in rooms L107A & B. At the 
beginning of each day, study staff will get both tablets out and turn them on to ensure they are 
fully charged and updated in preparation for the day’s appointments. 
 
Login for Surface Pros and REDCap: Use your Blazer ID and password  
 
Wi-Fi Login: Be sure to use UABSecure network, which is secure (do NOT use UABStartHere 
or UABHS Public). You will only need to enter your credentials once. You will need to do this 
under your own login for each Surface Pro. 
 
Troubleshooting Wi-Fi Login: 
 
• Go to “Start” (flag at bottom left hand corner) and select Settings 
• Select Network 
• Disconnect from Wi-Fi and re-connect 
• If that still does not work, reboot/shut-down surface pro and try again 
 
UAB Psychiatry IT  
UAB Department of Medicine 
1808 7th Avenue South. BDB-455 
Birmingham, AL 35294-0012 
Physical Location: Boshell Diabetes Building (BDB-455) 
Website: http://www.uab.edu/DomIT  
Regular Business Hours 
Monday - Friday: 8:00 AM to 5:00 PM. 
Support website can be accessed 24 hours / 7days a week. 

11 
 
Help Desk Information 
Phone: (205) 975-HELP (975-4357) 
E-mail: domhelp@uab.edu 
Website: https://support.dom.uab.edu 
REDCap 
 
UAB REDCap Contact:  
Shalini Saini   
BlazerID: ssaini  
 
 
Phone: (205) 975-4357  
 
 
 
 
 
 
Email: ssaini@uabmc.edu   
 
REDCap Video Tutorials: Videos are located in REDCap under the Help & Information tab on 
the lower left side of the screen. More are also available on the Welcome Page under Training 
Videos. Specific tutorials will usually be located in the instructions of the application you are 
currently working in. 
 
 
Entering New Participant Data: 
 
1. Go the website https://redcap.dom.uab.edu/redcap/index.php and log into REDCap with 
your UAB BlazerID and password. 
2. Click on My Projects in the upper left hand corner of the page. 
3. From the My Projects page, select the Project Title “NRT Sampling and Selection to 
Increase Medication Adherence” 
4. Click Add/Edit Records on the left side of the screen under the Data Collection tab and 
select Arm 2: Pre-Randomization from the drop down menu. 
5. Click Add New Record to be taken to the Record Home Page of the new participant. 
6. From this page select the Data Collection Instrument CO Level (Make sure to select the 
correct one, which is dependent upon which visit they have come in for) to begin the data 
collection process with the participant. 
 
Random Assignment:  
 
Complete the Data Entry Process as instructed under Entering New Participant. One of the 
forms under the REDCap documents for the Baseline Visit (BL) is titled Group Assignment. 
Once in this form, click the randomize button on this document to randomly assign the 
participant. 
 
 
Adding to Existing Participant Data: 
 

12 
 
1. Go to the website https://redcap.dom.uab.edu/redcap/index.php and log into REDCap 
with your UAB BlazerID and password 
2. Click on My Projects in the upper left hand corner of the page 
3. From the My Projects page, select the Project Title “NRT Sampling and Selection to 
Increase Medication Adherence” 
4. Click Add/Edit Records on the left side of the screen under the Data Collection tab 
5. Select the existing participant’s ID # from the drop-down list that you would like to add 
the new data to 
6. From the Data Collection page choose the desired data form under the correct study visit 
event to enter the data 
 
Editing Data: 
 
1. Go the website https://redcap.dom.uab.edu/redcap/index.php and log into REDCap with 
your UAB BlazerID and password 
2. Click on My Projects in the upper left hand corner of the page 
3. From the My Projects page, select the Project Title “NRT Sampling and Selection to 
Increase Medication Adherence” 
4. Click Add/Edit Records on the left side of the screen under the Data Collection tab 
5. Select the existing participant’s ID # from the drop-down list that you would like to add 
the new data to 
Survey Queue: 
 
The survey queue is a way for participants to fill out questionnaires in REDCap in a more user-
friendly display. When in survey mode, the screen simply shows the questionnaire with a submit 
button at the bottom. Once begun, the questionnaires will automatically load in the appropriate 
order corresponding to whichever session or visit the participant is attending. If a subject 
accidentally forgets to answer something, the survey prevents them from moving on, which gives 
staff the opportunity to assist if necessary. It is very important to note that surveys must be 
completed in the order they are shown.  
 
To access the survey queue:  
 
• Follow the steps as above, titled “Entering New Participant Data” or “Adding to Existing 
Participant Data”, depending on whether you are working with a new or existing subject 
• From the Record Home Page, select the CO Level Data Collection Instrument, 
corresponding to the appropriate appointment, e.g. Baseline, Week 1, etc.  
• Toward the upper right corner of the form, there is a gray drop down box titled “Survey 
Options.” Click this box and select “Open Survey.” A new tab will open displaying the 
form now in survey display. If the tab does not open, try clicking “Open Survey” again 
or double-clicking.  
• Staff should fill out CO Level, select “Submit”, and the next form will auto load. The 
survey queue is set up to stop before loading the questionnaires for participants. The 
screen will indicate you have finished with that set of surveys, and will provide a link at 
the bottom to start the next set to be filled out by the participant.  

13 
 
• When appropriate, select that link and have the participant proceed through the queue. 
The queue will automatically stop again before loading any other questionnaires intended 
to be filled out after the counseling session or completed by staff, for example.  
 
**You can access the survey queue from any of the measures set up as surveys by again 
selecting “Open Survey” from the gray “Survey Queue” drop down box toward the upper right 
corner of the page.  
**Surveys display on the Record Home Page as complete with a green circle and white check 
mark. 
 
  To edit data once surveys are complete:  
 
• From the Record Home Page for a given subject, select the measure you want to edit  
• In the red box toward the top of the form, select the gray button “Edit Response” 
• Once desired changes have been made, select “Save and Exit Form” at the bottom  
 
Audio Option in Questionnaires: 
Within each questionnaire, click the dropdown box labeled “Survey Options”, then select 
“Open Survey.” This will open up the questionnaire in a new tab. On this new page, have the 
participant click on the speaker icon next to the question. The computer will read the question 
aloud. Once completed, click the submit button on the bottom of the page. Repeat the prior steps 
for the remainder of the necessary questionnaires. 
 
Exporting to Excel/SPSS: 
1. Go the website https://redcap.dom.uab.edu/redcap/index.php and log into REDCap with 
your UAB BlazerID and password 
2. Click on My Projects in the upper left hand corner of the page 
3. From the My Projects select the Project Title “NRT Sampling and Selection to 
Increase Medication Adherence” 
4. Under the Applications Tab in the middle left hand column of the screen click on Data 
Exports, Reports, and Stats 
5. To export all of the data from REDCap to SPSS click Export Data under the 
View/Export Options column for the row A.) All Data.  Check the circle for the 
software you will be exporting the data to and then click Export Data 
6. Download the 3 files to one folder, run the mapping file, then hit Run All (under run tab 
in the SPSS data module) after opening the SPSS folder. A new Untitled database will 
then be created. Name and save the database on the share drive. 
 
 
Scheduling a New Participant: 
1. Go the Google Calendar website https://www.google.com/calendar and log into the 
Cropsey Lab Google Calendar with the Cropsey Lab username and password 
2. Check the NRT Sampling Calendar for availability. 

14 
 
3. Add the participant to the NRT Sampling Calendar by clicking on the designated day 
and time. 
4. Fill out the Title of Event with either the participants’ initials for a Baseline appointment 
or the participants’ study ID, intervention type, session week, and who the session will be 
with. 
5. Select the correct time and duration of the appointment. 
6. Select save and make sure the appointment appears on the NRT Sampling Calendar. 
 
Changes to Schedule: 
No-Show/Cancel 
 
1. Go to the Cropsey Lab Google Calendar and select appointment 
2. Under Title of Event, type in No Show or Canceled 
3. Attempt to reschedule participant 
4. Once a reschedule has been confirmed, follow the instructions below 
 
Reschedule 
 
1. Go to the Cropsey Lab Google Calendar and select appointment 
2. Under Title of Event, type in “Rescheduled” once the appointment is rescheduled. 
3. Change the appointment time and duration. 
4. Select save and make sure the appointment appears on the NRT Sampling Calendar. 
5. If you are adjusting by a whole week or more, select “Yes, adjust all dates” and be sure to 
adjust any that fall on weekends or days you are not available 
6. If you are changing an appointment by a day or two and subsequent appointments will 
not be affected, select “No, just this one” 
 
7. Double check your calendar against other appointments, and make sure you have no 
future conflicts 
 
Box.com 
 
Go to www.uab.edu/adminsys and log into the Box.com on the Surface Pro under your blazerid 
and password. Then proceed with the following steps:  
 
Log-In Information: 
BlazerID:  
Password: 
 
Prescriptions 
 
Study Physician/Co-Investigator 
Dr. Richard Shelton 
Email: rcshelton@uabmc.edu 
Phone: (205) 975-9295 
 
Co-Investigator 

15 
 
Dr. Peter Hendricks 
Email: phendricks@uab.edu 
Phone: (205) 202-1387 
 
Pharmacy:  
 
The Kirklin Clinic Pharmacy, 2000 6th Avenue South, Birmingham, AL  35233 
 
Pharmacist:  
 
Dr. Clay Patterson or Wyna Hebson  
Phone: (205) 801-8731 
Fax: 
(205) 801-8902 
 
Nicotine Patch 
 
• Nicotine patches (21, 14, or 7 mg): One box contains 14 patches. 
• 21 mg : For participants who self-report smoking over 10 CPD 
• 14 mg: For participants who self- report smoking 10 or less CPD 
• 7 mg: Lowest-dose patch and dispensed at Week 9 
 
Nicotine Gum 
 
• Nicotine gum (2 or 4 mg): One box contains 110 pieces 
• 4 mg: For participants who self-report smoking first cigarette within 30 minutes after 
awakening (reported on Fagerström Test for Nicotine Dependence at Baseline) 
• 2 mg: For participants who self-report smoking first cigarette more than 30 minutes after 
awakening (reported on Fagerström Test for Nicotine Dependence at Baseline) 
 
Nicotine Lozenge 
 
• Nicotine lozenges (2 or 4 mg, mint flavor): One box contains 3 Quit Tubes, with 24 
lozenges per tube, for a total of 72 lozenges per box.  
• 4 mg: For participants who self-report smoking first cigarette within 30 minutes after 
awakening (reported on Fagerström Test for Nicotine Dependence at Baseline) 
• 2 mg: For participants who self-report smoking first cigarette more than 30 minutes after 
awakening (reported on Fagerström Test for Nicotine Dependence at Baseline) 
• Participants are encouraged to use 8-10 lozenges per day, and at most 20 per day 
Nicotine Inhaler 
 
• One box contains the device and 168 cartridges 
• 4mg (20 minutes of active puffing): For participants who self-report smoking first 
cigarette within 30 minutes after awakening (reported on Fagerström Test for Nicotine 
Dependence at Baseline) 

16 
 
• 2mg (10 minutes of active puffing): For participants who self-report smoking first 
cigarette more than 30 minutes after awakening (reported on Fagerström Test for 
Nicotine Dependence at Baseline) 
 
Nicotine Nasal Spray 
 
• One box contains four 10ml bottles 
• 2mg: 2 sprays (1mg) in each nostril 
 
Medication Ordering 
 
The patches, gum, lozenges, inhalers, and nasal spray are ordered from The Kirklin Clinic (TKC) 
in bulk prescriptions. 
 
1. Order 75 boxes of 21mg patches at a time, or as needed 
2. Order 90 boxes of 14mg patches at a time, or as needed 
3. Order 90 boxes of 7mg patches at a time, or as needed 
4. Order 15 boxes of 4mg nicotine gum at a time, or as needed 
5. Order 15 boxes of 2mg nicotine gum at a time, or as needed 
6. Order 15 boxes of 4mg mint lozenges at a time, or as needed  
7. Order 15 boxes of 2mg mint lozenges at a time, or as needed  
8. Order 15 boxes of inhalers at a time, or as needed  
9. Order 15 boxes of nasal spray at a time, or as needed  
10. The respective blank RX form(s) and “Pharmacy Memo” should be completed and 
scanned to Dr. Shelton’s assistant for his signature  
11. The scanner can be found in the break room 
12. Send the documents to Dr. Shelton’s assistant Melissa Blair: melissablair@uabmc.edu, 
with the subject line: Cropsey Smoking Cessation RX- Signature Requested 
13. Dr. Shelton’s assistant will then send the signed RX back and then should be faxed along 
with the memo to TKC.  
14. Allow 24 hours for the pharmacy to prepare the bulk prescription   
15. Call pharmacy to confirm prescription is ready prior to picking up 
 
Medication Inventory  
 
We will keep a running inventory for medication. This Excel sheet will be located on the share 
drive. It should be filled out by study staff when medications are acquired and distributed to 
participants.  
 
File 
  
P:\Cropsey-Lab\ NRT Sampling\Medication\Medication Inventory 
 
Medication Storage 
 
All medications should be kept in the medication cabinet in room L107E. Check the medication 
weekly to be sure that the medication is accounted for. 
 

17 
 
Medication Dispensing  
 
All study participants will be receiving medication for this study. The type of medication they 
receive will depend upon the group to which they are assigned. 
 
Intervention Group A 
 
Week 1:  
 
7 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
11 blister packs of gum(dose based on if subject reports at Baseline smoking first cigarette 
within 30 minutes of waking) 
  
Week 2:  
 
7 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
1 box inhaler and cartridges  
 
Week 3:  
 
7 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
1 nasal spray bottle 
 
Week 4:  
 
7 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
2 quit tubes of baseline-indicated lozenge dose, and 1 quit tube of the other dose (for approx. 8-
10/day, with both doses to try, e.g., if subject reports at Baseline smoking first cigarette within 
30 minutes of awakening, he or she will receive 2 tubes of the 4 mg dose and 1 tube of the 2 mg 
dose). 
 
Week 5: 
 
7 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
Participant’s selection of short-acting NRT (week long supply) 
 
Week 6: 
 
21 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
Participant’s selection of short-acting NRT (3 week supply) 
 
Week 9: 
 
28 patches 
Participant’s selection of short-acting NRT (4 week supply) 

18 
 
*21 mg participants will begin to taper dose. They will receive 2 weeks’ worth of 14 mg patches 
and 2 weeks’ worth of 7 mg patches. 
**14 mg participants will receive 4 weeks of 7mg patches. 
**Participants using gum or lozenges will taper amount used. They will use half of their original 
amount for the first two weeks and ¼ of their original amount for the next two weeks. 
 
Intervention Group B 
 
Week 1:  
 
7 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
2 quit tubes of baseline-indicated lozenge dose, and 1 quit tube of the other dose (for approx. 8-
10/day, with both doses to try, e.g., if subject reports at Baseline smoking first cigarette within 
30 minutes of awakening, he or she will receive 2 tubes of the 4 mg dose and 1 tube of the 2 mg 
dose). 
 
Week 2:  
 
7 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
1 nasal spray bottle 
 
Week 3:  
 
7 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
1 box of inhaler and cartridges  
 
Week 4:  
 
7 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
11 blister packs of gum (dose based on if subject reports at Baseline smoking first cigarette 
within 30 minutes of waking) 
  
Week 5: 
 
7 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
Participant’s selection of short-acting NRT (week long supply) 
 
Week 6: 
 
21 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
Participant’s selection of short-acting NRT (3 week supply) 
 
Week 9: 
 
28 patches 
Participant’s selection of short-acting NRT (4 week supply) 

19 
 
*21 mg participants will begin to taper dose. They will receive 2 weeks’ worth of 14 mg patches 
and 2 weeks’ worth of 7 mg patches. 
**14 mg participants will receive 4 weeks of 7mg patches. 
**Participants using gum or lozenges will taper amount used. They will use half of their original 
amount for the first two weeks and ¼ of their original amount for the next two weeks. 
 
Intervention Group C 
 
Week 1: 
 
7 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
1 nasal spray bottle 
 
Week 2:  
 
7 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
11 blister packs of gum (dose based on if subject reports at Baseline smoking first cigarette 
within 30 minutes of waking) 
 
Week 3:  
 
7 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
2 quit tubes of baseline-indicated lozenge dose, and 1 quit tube of the other dose (for approx. 8-
10/day, with both doses to try, e.g., if subject reports at Baseline smoking first cigarette within 
30 minutes of awakening, he or she will receive 2 tubes of the 4 mg dose and 1 tube of the 2 mg 
dose). 
 
Week 4:  
 
7 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
1 box of inhaler and cartridges  
 
Week 5: 
 
7 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
Participant’s selection of short-acting NRT (week long supply) 
 
Week 6: 
 
21 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
Participant’s selection of short-acting NRT (3 week supply) 
 
Week 9: 
 
28 patches 
Participant’s selection of short-acting NRT (4 week supply) 

20 
 
*21 mg participants will begin to taper dose. They will receive 2 weeks’ worth of 14 mg patches 
and 2 weeks’ worth of 7 mg patches. 
**14 mg participants will receive 4 weeks of 7mg patches. 
**Participants using gum or lozenges will taper amount used. They will use half of their original 
amount for the first two weeks and ¼ of their original amount for the next two weeks. 
 
Intervention Group D 
 
Week 1: 
 
7 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
1 box of inhaler and cartridges  
 
Week 2:  
 
7 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
2 quit tubes of baseline-indicated lozenge dose, and 1 quit tube of the other dose (for approx. 8-
10/day, with both doses to try, e.g., if subject reports at Baseline smoking first cigarette within 
30 minutes of awakening, he or she will receive 2 tubes of the 4 mg dose and 1 tube of the 2 mg 
dose). 
 
Week 3:  
 
7 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
11 blister packs of gum (dose based on if subject reports at Baseline smoking first cigarette 
within 30 minutes of waking) 
 
Week 4:  
 
7 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
1 nasal spray bottle 
 
Week 5: 
 
7 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
Participant’s selection of short-acting NRT (week long supply) 
 
Week 6: 
 
21 patches (dose based on # of cigarettes smoked per day as reported by subject at Baseline) 
Participant’s selection of short-acting NRT (3 week supply) 
 
Week 9: 
 
28 patches 
Participant’s selection of short-acting NRT (4 week supply) 

21 
 
*21 mg participants will begin to taper dose. They will receive 2 weeks’ worth of 14 mg patches 
and 2 weeks’ worth of 7 mg patches. 
**14 mg participants will receive 4 weeks of 7mg patches. 
**Participants using gum or lozenges will taper amount used. They will use half of their original 
amount for the first two weeks and ¼ of their original amount for the next two weeks. 
 
Control Group 
 
Week 1-4:  
No medication dispensed 
Week 5:  
7 patches and selected short-acting NRT   
Week 6:  
21 patches and selected short-acting NRT (3 week supply) 
Week 9:  
28 patches and selected short-acting NRT (4 week supply) 
 
If participants using the 21 mg patch report negative side effects, their dose should be 
adjusted down to the 14 mg patch for patient safety and medication adherence.  
 
If participants using the 4mg gum report negative side effects, their dose should be 
adjusted down to the 2mg gum for patient safety and medication adherence.  
 
If participants using the 4 mg lozenge report negative side effects, their dose should be 
adjusted down to the 2 mg lozenge for patient safety and medication adherence.  
 
If participants using the 4mg dosing instructions for the inhaler report negative side effects, 
their dose should be adjusted down to the 2mg dosing instructions for patient safety and 
medication adherence.  
   
Participants must sign the Medication Sign-Out Log when receiving medications. Research 
staff must initial the form and must also log the medication in the Medication Inventory 
Database.   
 
Medication Instructions 
 
Medication instruction sheets are located in folders in the filing cabinet in room L107B. These 
are to be given to participants at Week 5, Week 6, and Week 9,. General instructions on how to 
use the medications are also located within participants’ workbooks.  
 
 
 
Files can be found at: 
 
Pharmacy Memo   
 
 
P:\Cropsey-Lab\NRT Sampling\Medication/RX 
Forms 
Nicotine Patch Blank Rx Form   
 
P:\Cropsey-Lab\NRT Sampling\Medication\RX 
Forms 

22 
 
Nicotine Gum 4mg Rx Form        
P:\Cropsey-Lab\NRT Sampling\Medication\RX 
Forms 
Nicotine Gum 2mg Rx Form        
P:\Cropsey-Lab\NRT Sampling\Medication\RX 
Forms 
Nicotine Lozenge Blank Rx Form       
P:\Cropsey-Lab\NRT Sampling\Medication/RX 
Forms 
Nicotine Inhaler Blank Rx Form       
P:\Cropsey-Lab\NRT Sampling\Medication\RX 
Forms 
Nicotine Nasal Spray Blank Rx Form       P:\Cropsey-Lab\NRT Sampling\Medication\RX 
Forms 
 
Medication Sign-Out Log   
 
P:\Cropsey-Lab\NRT Sampling\Medication 
Medication Instructions Folder          
P:\Cropsey-Lab\NRT 
Sampling\Medication/Medication Instructions 
 
 
 
Appointment Reminder Calls 
 
Please call participants 1-2 days before each scheduled appointment to confirm their appointment 
date and time. It is also helpful to remind participants to bring back their workbooks and 
calendars to their appointments, and remind them of any specific instructions previously 
discussed (for example, reminding an Intervention participant to please not smoke for as long as 
she/he can the night before the session 1 appointment, and to not smoke the morning of). If a 
participant wants to change the time or needs to reschedule an appointment, please work with 
them to do so. Our participants often have hectic lives and are dependent on public transportation 
or others to get to and from appointments. There may be times when someone has to reschedule 
a week or more later than their original appointment time. Try to get them to reschedule within a 
few weeks. If they cannot return for 3 weeks or more, call Dr. Cropsey for guidance. Be sure to 
follow the instructions on how to reschedule on the calendar in REDCap (MOP pg. 14).  
 
Appointment Reminder Text Messages 
 
If the participant has agreed to receive text messages, appointment reminders can be completed 
by sending reminder text messages. All appointment reminder text messages are to be done on 
the study cell phone. It is very important that the reminder texts are only sent to the participant 
and follow the appointment reminder scripts located on the share drive. Be sure that when you 
send an appointment reminder text message, you are sending it to the participant and not the 
contacts. If you are not sure if the participant is okay with receiving text messages, please refer 
to the signed consent form located in office L107B or in the Participant Tracking database.   
 
File 
  
P:\Cropsey-Lab\ NRT Sampling\Text Messaging\Text Messaging Scripts 
 
File 
  
P:\Cropsey-Lab\ NRT Sampling\Databases\Participant Tracking 
 
Rescheduling Parameters 

23 
 
 
We recruit from a population that has very little stability. We should work with them as best we 
can when it comes to rescheduling them for missed appointments. However, this is done within 
reason. Here are some parameters to keep in mind when rescheduling participants: 
 
• Baseline appointments will not be rescheduled more than 5 times. After 5 times of the 
participant no showing or cancelling, we will no longer actively call them to reschedule. 
However, they are not barred from taking part in the study at a later date when they can 
actually commit to it. 
• If a participant comes in for their Baseline appointment, but does not show up for any of 
their weekly sessions, they should be called and rescheduled within three months. If they 
refuse to come in or are unreachable after a month, mark them as a Loss to Follow-up 
within our databases. 
• Participants who become incarcerated such that they miss their intervention appointments 
will be able to continue their participation in the study and should resume where they left 
off with appointments.  
• Participants that have completed at least the session 1 appointment should be called every 
other day to try and get them back into the study, until they have been reached. They 
must be rescheduled or verbally indicate they are no longer interested in participating in 
the study for us to stop calling them. 
 
Compensation 
 
Compensation Amount per Study Visit 
 
• $10.00 for Baseline appointment 
• $20.00 for Session appointments (Weeks 1-6) 
• $40.00 for Weeks 9 and 13, and for Follow Up at Month 1 
• If participants complete 90% of the EMAs they will be compensated with a one-time 
payment of $100 at Week 13. If participants complete 80% of the EMAs, they will be 
compensated with a one-time payment of $75 during their Week 13 appointment. If 
participants complete 50% of the EMAs, they will be compensated with a one-time 
payment of $50 during their Week 13 appointment.    
 
 
GreenPhire ClinCard 
 
Login Information 
 
1. Login to www.clincard.com. 
2. Enter your login and password as provided to you. Keep in mind that your login and 
password are case sensitive so make sure to use capital letters as necessary. 
3. If you have difficulty logging into www.clincard.com, please click on the “Forgot 
username and password?” link, enter your email address, and click “Reset my password.” 
This will instantly send you an email with a link allowing you to reset your password. 

24 
 
 
Note: You can also call site support team at 215-609-4378. 
 
How to Look Up a Subject 
 
1. Login to www.clincard.com 
2. Click on “Look Up Subject” 
3. Search for the subject you want to pay by entering one of the following pieces of 
information and click on “Search” 
a. First name and/or last name 
b. Subject ID 
c. Subject’s initials 
4. Click on the underlined name of the Subject 
5. You will be brought to the “Subject Information” screen where you can perform any of 
the actions required for the subject, e.g., add another study or issue payment. 
6. If the subject already exists in the system and has been enrolled in the ALL STUDY - 
UAB, then skip to the section on “How to Register a Subject in an Additional or 
Extension Study.” 
7. If the subject cannot be found, then you must follow the next steps and register that 
subject in the ALL STUDY - UAB, first then our respective study (311701600-2018049-
151019004). 
 
How to Register a Subject 
 
1. Login to www.clincard.com 
2. Click on “Register Subject” 
3. From the “Select Study” drop-down menu, choose “ALL STUDY – UAB” 
4. From the “Site” drop-down menu, select UAB All Study (Central). 
5. Enter the required information into the brief form. At minimum, you must include the 
subject’s first name, last name, initials, SSN, address, and DOB. 
Note: If you would like the Subject to receive payment confirmations or appointment 
reminders, be sure the “Email (Enable)” and/or “Text Messaging (Enable)” checkboxes 
are selected 
6. Click on the “Register” button 
7. You will be brought to the “Subject Information” screen where you can enroll the subject 
in our study, assign a card number, make a payment, schedule an appointment reminder, 
replace a ClinCard or edit a subject’s information 
8. If you have difficulty making a payment for the first time please call the ClinCard site 
support team at 215- 609-4378  
How to Register a Subject in an Additional or Extension Study 
 
1. Locate the existing “Subject Information” page through the “Look Up Subject” menu tab. 
2. Click on the last name of the subject to open the subject’s information tab 
3. Click on the Edit Subject option in the list to the right. 
4. Click on the Add Study link located under the list of the subject’s current study(ies) and 
select our study from the drop-down menu. 
5. Enter the new Subject ID and select the additional study subject Status. 
6. Scroll to the bottom of the page, and click “Save”. 

25 
 
 
This will allow the subject to receive reimbursements for any additional studies on a previously 
assigned ClinCard. 
 
How to Assign a ClinCard to a Subject 
 
Once you have selected an existing subject or registered a new subject, you will be brought to the 
“Subject Information” screen. On the right hand side of the screen, you will see options that 
represent all of the actions you can perform on the Subject. 
 
Note: If the subject already has a ClinCard assigned, you should not assign another card. 
(You can tell the subject already has a ClinCard if the first option in the list of options to 
the right-hand side of the screen is “Replace ClinCard.”) 
1. Click on “Assign ClinCard” and a pop-up screen will appear.   
2. In the “New Card” field, enter the 8 digit token number visible through the window of 
one of the ClinCard card packages you received 
 
Note: There is no need to open the envelope prior to providing to the Subject 
 
3. Click on the “Assign” button 
4. Once the card has successfully been assigned, you will receive a confirmation message at 
the top of the “Subject Information” screen 
5. Now an option to “Replace ClinCard” appears. In the event that a subject loses their card, 
you can replace that card for them by clicking on “Replace ClinCard,” and follow the 
steps above, using the 8 digit token number from a new ClinCard card package 
Note: This will inactivate the lost card and automatically transfer any available/pending 
balance to the newly assigned ClinCard 
 
How to Make a Site Visit Payment  
 
Once you have selected a subject or registered a new subject, you will be brought to the “Subject 
Information” screen.  On the right hand side of the screen, you will see options that represent all 
of the actions you can perform on the Subject.   
 
Note:  If the subject has a ClinCard assigned, follow the next steps. If the subject has no 
ClinCard assigned, see the previous “How to Assign a ClinCard to a Subject” instruction section. 
 
1. Verify that the “Study Name” field displays the name of our study. If the subject is 
enrolled in more than one study, you may have to select our study from the “Study 
Name” drop-down menu. 
2. Click on “Make Site Visit Payment” and a pop-up screen will appear. 
3. Select from the dropdown box which milestone the patient is being paid, e.g., Visit 1, 
Visit 2, etc. 
4. Click on the “Pay” button 
5. Once the payment has successfully been requested the “Pending Payment” area of the 
“Subject Information” screen will reflect the payment. It will also be reflected in your 
“Recent Activity”  

26 
 
6. Once a payment request has been approved and processed, the amount will be removed 
from the “Pending Payment” area and reflected in the “Available Balance” area. 
7. If the subject has opted to receive email and/or text messages, the Subject will receive a 
payment confirmation communication when the payment is made. 
 
How to Request Assistance  
 
If you have questions about using the www.clincard.com Admin Portal, you may reach the 
ClinCard site support team by: 
 
1. Submitting an email request through the “Support” link within the www.clincard.com 
website 
2. Directly emailing at support@greenphire.com 
3. Calling site support team directly at 215-609-4378 between the hours of 8:00AM and 
10:00PM Eastern Time (Monday through Friday) in order to speak with a ClinCard team 
member 
 
Full ClinCard Instructions are located on the share drive: 
 
File 
  
P:\Cropsey-Lab\NRT Sampling\Compensation\ClinCard Reference Guide 
 
Adverse Events (AEs) & Serious Adverse Events (SAEs) 
 
Document all AEs and SAEs in REDCap  
 
 
During participant visits, while in REDCap, document in the AE/SAE arms all side 
effects/AEs/SAEs reported by participant.  
 
Record the AE/SAE ID number in the participant tracking database. 
 
Report all SAEs or moderate/severe AEs to Dr. Cropsey immediately for further guidance.  
 
 
Reporting Mechanisms of AEs/SAEs to the IRB, FDA, and NIDA  
 
All adverse events that occur in the course of the study will be documented in the research 
record. Further, all adverse events will be compiled and reported in summary form on an annual 
basis to the IRB, DSMB, and NIDA, and at the conclusion of the study. Unanticipated (non-
serious) adverse events will be reported to the IRB, DSMB and NIDA within 30 days via 
submission of the UAB IRB Adverse Event Report. Serious adverse events will be reported to 
the IRB, DSMB and NIDA Program Officer within 24 hours by phone, email or fax; a completed 
UAB IRB Adverse Event Report will be submitted within 72 hours of initial IRB and NIDA 
notification. All deaths will be reported to the IRB and NIDA within 48 hours. The following are 
possible Adverse Events associated with participation in this study:  
 

27 
 
Use of combination or single NRT is associated with side effects such as:  
1. Nausea or vomiting  
2. Dizziness  
3. Heart racing  
4. Anxiety  
5. Insomnia  
6. Headache  
7. Itching at the site of patch application  
 
Nicotine withdrawal symptoms if the person stops or reduces their smoking include:  
8. Dysphoric or depressed mood  
9. Difficulty concentrating  
10. Insomnia  
11. Craving  
12. Distress/irritability  
13. Anxiety  
14. Restlessness  
15. Increased appetite or weight gain  
16. Decreased heart rate  
 
Serious Adverse Events: Expedited review will occur for all events meeting the FDA definition 
of Serious Adverse Events (SAEs) that are: a) fatal or life threatening, b) produce or prolong 
inpatient hospitalization, c) results in persistent or significant disability, d) congenital anomaly, 
e) results in an important medical event that may jeopardize the patient or require intervention to 
prevent a serious outcome, f) cancer, g) overdose, or h) results in the development of drug 
dependency or abuse. For purposes of this study, all SAEs will be required to be reported to the 
DSMB, regardless of any judgment of their relatedness to the study drug. All relevant 
information will be reported to the DSMB for each SAE including information about the event 
and its outcome, dosing history of all study drugs, concomitant medications, the subject’s 
medical history and current conditions, and all relevant laboratory data. Notification by e-mail, 
and FAX transmittal of all related study forms shall be made to the DSMB within 24 hours of the 
occurrence of any SAE, followed by a full report within 10 working days. Information will be 
reviewed and a determination made of whether there was any possible relevance to the study 
drug.  
 
Non-Serious Adverse Events: Annually, the DSMB will be provided with un-blinded summaries 
of the numbers and rates of adverse events by treatment. These reports will include types of 
events, severity, and treatment phase. 
 
Suicidality 
 
While unlikely, it is possible that a participant will indicate to you that they want to harm 
themselves. Suicidality can present in two forms, active and passive. 
 

28 
 
• Someone who has active suicidal ideation is frequently termed suicidal, and they will 
not only want to cause serious harm, injury, or death to themselves, but they also have a 
plan to do so.  
• Passive suicidal ideation refers to someone who wishes to die but does not have a plan, 
this is frequently referred to simply as suicidal ideation and it is quite common.  
 
 
 
If your participant presents with active suicidal ideation at any time during session, refer to 
the following: 
 
1. Ask them what their plan is (e.g., I am going to shoot myself in the head). 
2. Determine whether they have the means to carry out their plan (Means: “I have a gun at 
home,” “My dad has a gun”; No means: “I do not have a gun and I don’t know anyone 
with a gun”) 
3. Explain to participant that in order to keep them safe from themselves, you are required 
to break confidentiality. 
4. Ask if they have a close family member or friend you can call. Call this person and 
explain to them that their loved one is suicidal and needs assistance. Arrange for that 
person (or someone else) to pick them up and take them to the emergency room (this is to 
save them ambulance bills). Ask the loved one to confiscate the means to commit suicide 
(pills, gun, etc.). 
5. If participant does not have someone to escort them to the emergency room, or if they are 
unwilling to cooperate, call security to walk with them to the Emergency Room. 
6. Inform the study team what has occurred, including Dr. Cropsey. 
7. An adverse event form will need to be completed and submitted to the IRB. 
8. Be sure to take note of what transpired (who you spoke to, what happened etc.). 
 
If you have any questions during the process, are unsure of what to say/do, call Michelle Sisson, 
Keith Chichester, or Dr. Cropsey for assistance. 
 
 
Baseline Appointments 
 
We are looking to get an accurate reading of CO levels. Therefore, be sure to schedule 
these appointments during late morning or early afternoon. 
 
Administration time: Approximately 150 minutes 
 
Do not schedule any appointments until 2.5 hours after the start of your baseline 
appointment. 
 
Materials  
 
• CO Machine and new white mini mouthpiece 
• Urine cup 

29 
 
• Urine lid and gloves 
• Pregnancy test (if participant is female) 
• Cotinine test 
• Surface Pro 
• Two Consent forms  
• Contact sheet 
• Screening form 
• Greenphire ClinCard 
 
Procedures 
 
1. Go through the Consent Form with the participant, addressing any questions or concerns 
they may have. 
2. Have the participant sign and date where it states “Signature of Participant” on page 6 of 
the Consent Form. Make sure that they also sign on page 7 (Authorization for 
Use/Disclosure of Personal Health Information (PHI) for Research), on which they need 
to print their name at the top of the page and sign/date at the bottom of the page where it 
says “Signature of Participant.” 
3. Be sure that you also sign the consent form on page 6 as the “Person Obtaining Consent.”  
4. The participant will receive one signed copy of the consent, and we will keep one signed 
copy for our records. 
5. Administer the CO test. Refer to the CO directions under the “Carbon Monoxide 
Monitor” section on page 8 of this manual. 
6. Place a lid on urine cup and take the participant to the restroom for the urine screen.   
7. After the participant uses the restroom, have them hand you the cup so that you can 
administer the pregnancy test (for women only) and the cotinine test. After these tests, 
you should discard the urine sample and all tests and head back to the office. 
8. Have the participant complete the contact sheet. 
9. Set up the participant in the Pre-Randomization arm. 
10. Once the Pre-Randomization is completed, complete the last form remaining in REDCap, 
“Group Assignment,” to randomize the participant into one of the groups. 
11. Once the participant is randomized into a group, have the participant fill out the Baseline 
questionnaires for that group on the tablet or on the computer in an office. Do not allow 
them to fill out in waiting room or any other office where we are not present. 
12. Monitor the participant’s progress in REDCap.  
13. Schedule the first intervention session for the following week, at least 5 days from 
Baseline. Also, it is important for participants in the Intervention groups to be scheduled 
for their weekly appointment in the morning. Once you have it scheduled, make sure the 
appointment is placed on your UABMC calendar and google calendar (MOP, pg. 14). 
14. Instructions for participants for Session 1 are as below, according to which group they 
have been assigned:  
• If the participant is in an Intervention group then say, “When you come in for your 
appointment on ___________ at ______ please refrain from smoking the night 
before your appointment, and the morning of.”   
• If the participant is in the Control group, there are no special instructions for the next 
appointment. 

30 
 
15. Complete the $10.00 ClinCard payment. 
16. Give the participant an appointment card. That completes the Baseline appointment! 
 
Intervention Fidelity 
 
Approximately 20% of sessions will be reviewed for fidelity purposes. Specifically, weekly 
sessions will be reviewed by any study member, other than the therapist. The randomization 
scheme is already determined and is located on the share drive along with the fidelity 
worksheets. If a reviewer is randomly assigned their own session, the reviewer will trade with 
the reviewer who comes after them, taking their next assigned session to review. A score of 80% 
or greater is required to pass. Once completed, the reviewer will score the interviewer and record 
the score and their initials in the randomization spreadsheet. Completed fidelity worksheets will 
be stored in the Fidelity folder located in room L107B file cabinet C. Feedback should be 
provided to the therapist about important points that are missed. 
 
 
 
Forms:  
 
Fidelity Control Worksheet   
P:\Cropsey-Lab\NRT Sampling\Manuals\Control 
Fidelity Intervention Worksheet   P:\Cropsey-Lab\NRT Sampling\Manuals\Sampling 
Intervention\Treatment A, B, C, or D 
 
 
Therapy Protocol 
 
Week 1 – Week 5 
 
Participants should work with the same staff member for the 5 weekly counseling sessions. 
 
Intervention Group A 
 
Week 1 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to confirm 
that the participant is using nicotine products.   
3. Gather either the 21 mg patch or the 14 mg patch and give it to the participant. (Patch 
dosage is based on number of cigarettes smoked determined at Baseline 
appointment). Be sure to write down the time that the patch is placed on their arm. 
Ideally, the participant should have the patch on for 30 minutes before the 
intervention begins. 
4. Gather either the 4mg gum or 2mg gum and give it to the participant. (Gum mg is based 
on how soon the participant smokes a cigarette after waking determined at Baseline 

31 
 
appointment). Wait to give the gum to the participant until the session is being 
recorded. 
5. Have the participant fill out all of the questionnaires related to the session in REDCap, 
except the Credibility Expectancies Questionnaire, the SECOND Minnesota 
Nicotine Withdrawal Scale and the SECOND Questionnaire of Smoking Urges.  
6. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
7. Tell the client that you are about to start the recording for the session. Explain that “this is 
a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 
8. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded.  
9. Give the participant the assigned client Intervention workbook and tell them to follow 
along as you go through your Therapist Intervention Manual. Let them know that the 
counseling could take up to 30 minutes and they are urged to write down information 
in their workbooks. 
10. When appropriate, pause the audio recording and have the participant fill out the 
following: 
• The second Minnesota Nicotine Withdrawal Scale 
• The second Questionnaire of Smoking Urges 
• Based on the participant’s response to the Minnesota Nicotine 
Withdrawal Scale and the Questionnaire of Smoking Urges, graph the 
before and after scores in their workbook. 
11. Un-pause the audio recording and continue the intervention by going over the 
participant’s before and after scores for the Minnesota Nicotine Withdrawal Scale and 
Questionnaire of Smoking Urges. 
12. Go over the Tobacco Use and NRT Use calendars. 
13. Provide them with the copies of the calendars (in their folder) to keep in their 
pocket/wallet for use when they do not have their manual with them. 
14. After the therapy, ask the participant if they have any questions. If they do not, tell them 
you are ending the recording. 
15. Schedule the next appointment for the following week (preferably the same day of the 
week and the same morning time). Once you have it scheduled, make sure the 
appointment is placed on your UABMC calendar, desk calendar, and recorded in 
the REDCap Calendar application. 
16. Instruct the participant to bring the calendars and workbook back so they can be 
reviewed next session.  
17. Give the participant 6 patches. The 6 patches and the patch they are currently wearing 
(total of 7) will last through to the next appointment. 
18. Give the participant one package of gum. The pack of gum will last through to the next 
appointment. Be sure to emphasize they are not to use the gum on the morning of the 
next appointment.   
19. Have the participant sign for the medication in the medication sign-out log. 

32 
 
20. Mark in the Medication Inventory Excel sheet how many of the patches and gum 
packages you have given out so that we maintain a running total of prescriptions we have 
on hand. 
21. Remind the participant of the instructions on how to use the patches and gum and let 
them know they can reference their workbook if they forget. Give the participant the 
instructions sheet. 
22. Compensate the participant on their Greenphire ClinCard. 
23. Give the participant an appointment card. Be sure to remind the participant to try and 
refrain from smoking the night before the appointment and not to use a patch or 
gum on the morning of the appointment. Also, remind them to bring all used and 
unused patches, patch packets, and gum packages back to the next appointment.  
24. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap. 
 
 
Week 2 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to confirm 
that the participant is using nicotine products. 
3. Collect the participant’s Tobacco Use and NRT Use calendars and enter the data for the 
previous week into the appropriate SPSS database, then return the calendars to the 
participant.  
4. Collect the used nicotine patches and gum packages and dispose of them after reviewing 
the calendars. Any unused patches/gum packages can be given back to the participant. 
5. Gather either the 21 mg patch or the 14 mg patch and give it to the participant. (Patch 
dosage is based on number of cigarettes smoked determined at Baseline 
appointment). Be sure to write down the time that the patch is placed on their arm. 
Ideally, the participant should have the patch on for 30 minutes before the 
intervention begins. 
6. Gather the inhaler box and give it to the participant to use. Wait to give the inhaler to 
the participant until the session is being recorded. 
7. Have the participant fill out all of the questionnaires related to the session in REDCap, 
except the SECOND Minnesota Nicotine Withdrawal Scale and the SECOND 
Questionnaire of Smoking Urges.  
8. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
9. Tell the client that you are about to start the recording for the session. Explain that “this is 
a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 
10. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded.  

33 
 
11. Tell the participant to follow along in their client Intervention workbook as you go 
through your Therapist Intervention manual. Let them know that the counseling could 
take up to 30 minutes and they are urged to write down information in their 
workbooks.. 
12. When appropriate, pause the audio recording and have the participant fill out the 
following: 
• The second Minnesota Nicotine Withdrawal Scale 
• The second Questionnaire of Smoking Urges 
• Based on the participant’s response to the Minnesota Nicotine 
Withdrawal Scale and the Questionnaire of Smoking Urges, graph the 
before and after scores in their workbook. 
13. Un-pause the audio recording and continue the intervention by going over the 
participant’s before and after scores for the Minnesota Nicotine Withdrawal Scale and 
Questionnaire of Smoking Urges. 
14. Go over the Tobacco Use and NRT Use calendars. 
15. Provide them with the copies of the calendars (in their folder) to keep in their 
pocket/wallet for use when they do not have their manual with them. 
16. After the therapy, ask the participant if they have any questions. If they do not, tell them 
you are ending the recording. 
17. Schedule the next appointment for the following week (preferably the same day of the 
week and the same morning time). Once you have it scheduled, make sure the 
appointment is placed in the Cropsey Lab Google Calendar. 
18. Instruct the participant to bring the calendars and workbook back so they can be 
reviewed next session.  
19. Give the participant 6 patches. The 6 patches and the patch they are currently wearing 
(total of 7) will last through to the next appointment.  
20. Give the participant the box with the inhaler and cartridges. The inhaler cartridges will 
last through to the next appointment. Be sure to emphasize they are not to use the 
inhaler on the morning of the next appointment.   
21. Have the participant sign for the medication in the medication sign-out log. 
22. Mark in the Medication Inventory Excel sheet how many of the patches and inhaler boxes 
you have given out so that we maintain a running total of prescriptions we have on hand. 
23. Remind the participant of the instructions on how to use the patches and inhaler and let 
them know they can reference their workbook if they forget. Give the participant the 
instructions sheet. 
24. Compensate the participant on their Greenphire ClinCard. 
25. Give the participant an appointment card. Be sure to remind the participant to try and 
refrain from smoking the night before the appointment and not to use a inhaler on 
the morning of the appointment. Also, remind them to bring all used and unused 
patches, patch packets, and inhaler cartridges back to the next appointment.  
26. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap. 
 
 
 
 

34 
 
Week 3 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to confirm 
that the participant is using nicotine products.  
3. Collect the participant’s Tobacco Use and NRT Use calendars and enter the data for the 
previous week into the appropriate SPSS database, then return the calendars to the 
participant. 
4. Collect the used nicotine patches and inhaler cartridges and dispose of them after 
reviewing the calendars. Any unused patches/inhaler cartridges can be given back to the 
participant. 
5. Gather either the 21 mg patch or the 14 mg patch and give it to the participant. (Patch 
dosage is based on number of cigarettes smoked determined at Baseline 
appointment). Be sure to write down the time that the patch is placed on their arm. 
Ideally, the participant should have the patch on for 30 minutes before the 
intervention begins. 
6. Gather the nasal spray bottle and give it to the participant to use. Wait to give the nasal 
spray to the participant until the session is being recorded. 
7. Have the participant fill out all of the questionnaires related to the session in REDCap, 
except the SECOND Minnesota Nicotine Withdrawal Scale and the SECOND 
Questionnaire of Smoking Urges.  
8. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
9. Tell the client that you are about to start the recording for the session. Explain that “this is 
a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 
10. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded.  
11. Tell the participant to follow along in their client Intervention workbook as you go 
through your Therapist Intervention Manual 
12. When appropriate, pause the audio recording and have the participant fill out the 
following: 
• The second Minnesota Nicotine Withdrawal Scale 
• The second Questionnaire of Smoking Urges 
• Based on the participant’s response to the Minnesota Nicotine 
Withdrawal Scale and the Questionnaire of Smoking Urges, graph the 
before and after scores in their workbook. 
13. Un-pause the audio recording and continue the intervention by going over the 
participant’s before and after scores for the Minnesota Nicotine Withdrawal Scale and 
Questionnaire of Smoking Urges. 
14. Go over the Tobacco Use and NRT Use calendars. 

35 
 
15. Provide them with the copies of the calendars (in their folder) to keep in their 
pocket/wallet for use when they do not have their manual with them. 
16. After the therapy, ask the participant if they have any questions. If they do not, tell them 
you are ending the recording. 
17. Schedule the next appointment for the following week (preferably the same day of the 
week and the same morning time). Once you have it scheduled, make sure the 
appointment is placed in the Cropsey Lab Google Calendar. 
18. Instruct the participant to bring the calendars and workbook back so they can be 
reviewed next session.  
19. Give the participant 6 patches. The 6 patches and the patch they are currently wearing 
(total of 7) will last through to the next appointment.  
20. Give the participant one bottle of nasal spray. The nasal spray bottle will last through to 
the next appointment. Be sure to emphasize they are not to use the nasal spray on the 
morning of the next appointment.   
21. Have the participant sign for the medication in the medication sign-out log. 
22. Mark in the Medication Inventory Excel sheet how many of the patches and nasal spray 
bottles you have given out so that we maintain a running total of prescriptions we have on 
hand. 
23. Remind the participant of the instructions on how to use the patches and nasal spray and 
let them know they can reference their workbook if they forget. Give the participant the 
instructions sheet. 
24. Compensate the participant on their Greenphire ClinCard.  
25. Give the participant an appointment card. Be sure to remind the participant to try and 
refrain from smoking the night before the appointment and not to use a patch or 
nasal spray on the morning of the appointment. Also, remind them to bring all used 
and unused patches, patch packets, and nasal spray bottles back to the next 
appointment.  
26. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap. 
 
Week 4 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to confirm 
that the participant is using nicotine products.   
3. Collect the participant’s Tobacco Use and NRT Use Calendars and enter the data for the 
previous week into the appropriate SPSS database, then return the calendars to the 
participant. 
4. Collect the used nicotine patches and nasal spray bottles and dispose of them after 
reviewing the calendars. Any unused patches/nasal spray bottles can be given back to the 
participant. 
5. Gather either the 21 mg patch or the 14 mg patch and give it to the participant. (Patch 
dosage is based on number of cigarettes smoked determined at Baseline 
appointment). Be sure to write down the time that the patch is placed on their arm. 

36 
 
Ideally, the participant should have the patch on for 30 minutes before the 
intervention begins. 
6. Gather the 4mg or 2mg nicotine lozenge and give it to the participant to use. (Lozenge 
dosage is based on how soon participant smokes their first cigarette after waking, as 
reported at Baseline appointment). Wait to give the lozenge to the participant until 
the session is being recorded.  
7. Have the participant fill out all of the questionnaires related to the session in REDCap, 
except the SECOND Minnesota Nicotine Withdrawal Scale and the SECOND 
Questionnaire of Smoking Urges.  
8. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
9. Tell the client that you are about to start the recording for the session. Explain that “this is 
a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 
10. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded.  
11. Tell the participant to follow along in their client Intervention workbook as you go 
through your Therapist Intervention Manual. Let them know that the counseling could 
take up to 30 minutes and they are urged to write down information in their 
workbooks. 
12. When appropriate, pause the audio recording and have the participant fill out the 
following: 
• The second Minnesota Nicotine Withdrawal Scale 
• The second Questionnaire of Smoking Urges 
• Based on the participant’s response to the Minnesota Nicotine 
Withdrawal Scale and the Questionnaire of Smoking Urges, graph the 
before and after scores in their workbook. 
13. Un-pause the audio recording and continue the intervention by going over the 
participant’s before and after scores for the Minnesota Nicotine Withdrawal Scale and 
Questionnaire of Smoking Urges. 
14. Go over the Tobacco Use and NRT Use calendars. 
15. Provide them with the copies of the calendars (in their folder) to keep in their 
pocket/wallet for use when they do not have their manual with them. 
16. After the therapy, ask the participant if they have any questions. If they do not, tell them 
you are ending the recording. 
17. Schedule the next appointment for the following week (preferably the same day of the 
week and the same morning time). Once you have it scheduled, make sure the 
appointment is placed in the Cropsey Lab Google Calendar. 
18. Instruct the participant to bring the calendars and workbook back so they can be 
reviewed next session.  
19. Give the participant 6 patches. The 6 patches and the patch they are currently wearing 
(total of 7) will last through to the next appointment.  
20. Give the participant one box of lozenges (3 quit tubes = 72 lozenges). The 72 lozenges 
should last through to the next appointment if the participant uses 10 daily as advised. Be 

37 
 
sure to emphasize they are not to use the lozenges on the morning of the next 
appointment.   
21. Have the participant sign for the medication in the medication sign-out log. 
22. Mark in the Medication Inventory binder how many of the patches and quit tubes you 
have given out so that we maintain a running total of prescriptions we have on hand. 
23. Remind the participant of the instructions on how to use the patches and lozenges and let 
them know they can reference their workbook if they forget. Give the participant the 
instructions sheet. 
24. Compensate the participant on their Greenphire ClinCard. 
25. Give the participant an appointment card. Be sure to remind the participant to try and 
refrain from smoking the night before the appointment and not to use a patch or 
lozenges on the morning of the appointment. Also, remind them to bring all used 
and unused patches, patch packets, and lozenge quit tubes back to the next 
appointment.  
26. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap. 
 
Week 5 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to confirm 
that the participant is using nicotine products.   
3. Collect the participant’s Tobacco Use and NRT Use calendars and enter the data for the 
previous week into the appropriate SPSS database, then return the calendars to the 
participant. 
4. Collect the used nicotine patches and lozenge quit tubes and dispose of them after 
reviewing the calendars. Any unused patches/lozenges can be given back to the 
participant. 
5. Gather either the 21 mg patch or the 14 mg patch and give it to the participant. (Patch 
dosage is based on number of cigarettes smoked determined at Baseline 
appointment). Be sure to write down the time that the patch is placed on their arm. 
Ideally, the participant should have the patch on for 30 minutes before the 
intervention begins. 
6. Have the participant fill out all of the questionnaires related to the session in REDCap, 
except the Alliance Questionnaire, SECOND Minnesota Nicotine Withdrawal Scale 
and the SECOND Questionnaire of Smoking Urges.  
7. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
8. Tell the client that you are about to start the recording for the session. Explain that “this is 
a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 

38 
 
9. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded.  
10. Tell the participant to follow along in their client Intervention workbook as you go 
through your Therapist Intervention Manual. Let them know that the counseling could 
take up to 30 minutes and they are urged to write down information in their 
workbooks. 
11. When appropriate, pause the audio recording and have the participant fill out the 
following: 
• The Alliance Questionnaire 
• The second Minnesota Nicotine Withdrawal Scale 
• The second Questionnaire of Smoking Urges 
• Based on the participant’s response to the Minnesota Nicotine 
Withdrawal Scale and the Questionnaire of Smoking Urges, graph the 
before and after scores in their workbook. 
12. Un-pause the audio recording and continue the intervention by going over the 
participant’s before and after scores for the Minnesota Nicotine Withdrawal Scale and 
Questionnaire of Smoking Urges. 
13. Review each week and the participant’s experience with the short-acting forms of NRT 
from the participant’s manual. Answer any questions the participant has regarding the 
medications. Present the medication selection sheet, review it with the participant, and 
explain that they will be selecting their preferred short-acting NRT to use in conjunction 
with the patch for the rest of the medication period of the study. Once the participant has 
made a selection, enter it into REDCap and ask them to write it in their manual.   
14. After the therapy, ask the participant if they have any questions. If they do not, tell them 
you are ending the recording. 
15. Schedule the next appointment for the next week (preferably the same day of the week 
and the same morning time). This appointment should be scheduled with another study 
staff member other than the therapist who saw the participant for the five weekly 
sessions. Once you have it scheduled, make sure the appointment is placed in the 
Cropsey Lab Google Calendar. 
16. Give the participant 6 patches. The 6 patches and the patch they are currently wearing 
(total of 7) will last through to the next appointment.   
17. Give the participant enough of the short-acting NRT they chose to last through to the next 
appointment. 
18. Have the participant sign for the medication in the medication sign-out log. 
19. Mark in the Medication Inventory Excel sheet how many of the patches and gum 
packages/lozenge quit tubes/inhaler cartridges/nasal spray bottles you have given out so 
that we maintain a running total of prescriptions we have on hand. 
20. Remind the participant of the instructions on how to use the patches and 
gum/lozenges/inhaler/nasal spray and let them know they can reference their workbook if 
they forget.  
21. Give the participant a study phone and charger and instruct them to complete the EMA’s 
daily. 
22. Compensate the participant on their Greenphire ClinCard. 

39 
 
23. Give the participant an appointment card. Also, remind them to bring all used and 
unused patches, patch packets, and short-acting NRT back to the next appointment.  
24. Upload the session recording toBox.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap. 
 
 
Intervention Group B 
 
Week 1 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to confirm 
that the participant is using nicotine products.   
3. Gather either the 21 mg patch or the 14 mg patch and give it to the participant. (Patch 
dosage is based on number of cigarettes smoked determined at Baseline 
appointment). Be sure to write down the time that the patch is placed on their arm. 
Ideally, the participant should have the patch on for 30 minutes before the 
intervention begins. 
4. Gather the 4mg or 2mg nicotine lozenge and give it to the participant to use. (Lozenge 
dosage is based on how soon participant smokes their first cigarette after waking, as 
reported at Baseline appointment). Wait to give the lozenge to the participant until 
the session is being recorded.  
5. Have the participant fill out all of the questionnaires related to the session in REDCap, 
except the Credibility Expectancies Questionnaire, SECOND Minnesota Nicotine 
Withdrawal Scale and the SECOND Questionnaire of Smoking Urges.  
6. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
7. Tell the client that you are about to start the recording for the session. Explain that “this is 
a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 
8. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded.  
9. Give the participant the assigned client Intervention workbook and tell them to follow 
along as you go through your Therapist Intervention Manual. Let them know that the 
counseling could take up to 30 minutes and they are urged to write down information 
in their workbooks. 
10. When appropriate, pause the audio recording and have the participant fill out the 
following: 
• The second Minnesota Nicotine Withdrawal Scale 
• The second Questionnaire of Smoking Urges 

40 
 
• Based on the participant’s response to the Minnesota Nicotine 
Withdrawal Scale and the Questionnaire of Smoking Urges, graph the 
before and after scores in their workbook. 
11. Un-pause the audio recording and continue the intervention by going over the 
participant’s before and after scores for the Minnesota Nicotine Withdrawal Scale and 
Questionnaire of Smoking Urges. 
12. Go over the Tobacco Use and NRT Use calendars. 
13. Provide them with the copies of the calendars (in their folder) to keep in their 
pocket/wallet for use when they do not have their manual with them. 
14. After the therapy, ask the participant if they have any questions. If they do not, tell them 
you are ending the recording. 
15. Schedule the next appointment for the following week (preferably the same day of the 
week and the same morning time). Once you have it scheduled, make sure the 
appointment is placed in the Cropsey Lab Google Calendar. 
16. Instruct the participant to bring the calendars and workbook back so they can be 
reviewed next session.  
17. Give the participant 6 patches. The 6 patches and the patch they are currently wearing 
(total of 7) will last through to the next appointment.  
18. Give the participant one box of lozenges (3 quit tubes = 72 lozenges). The 72 lozenges 
should last through to the next appointment if the participant uses 10 daily as advised. Be 
sure to emphasize they are not to use the lozenges on the morning of the next 
appointment.   
19. Have the participant sign for the medication in the medication sign-out log. 
20. Mark in the Medication Inventory binder how many of the patches and quit tubes you 
have given out so that we maintain a running total of prescriptions we have on hand. 
21. Remind the participant of the instructions on how to use the patches and lozenges and let 
them know they can reference their workbook if they forget. Give the participant the 
instructions sheet. 
22. Compensate the participant on their Greenphire ClinCard.  
23. Give the participant an appointment card. Be sure to remind the participant to try and 
refrain from smoking the night before the appointment and not to use a patch or 
lozenges on the morning of the appointment. Also, remind them to bring all used 
and unused patches, patch packets, and lozenge quit tubes back to the next 
appointment.  
24. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap. 
 
Week 2 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to confirm 
that the participant is using nicotine products.   

41 
 
3. Collect the participant’s Tobacco Use an NRT Use calendars and enter the data for the 
previous week into the appropriate SPSS database, then return the calendars to the 
participant. 
4. Collect the used nicotine patches and lozenge quit tubes and dispose of them after 
reviewing out the calendars. Any unused patches/lozenges can be given back to the 
participant. 
5. Gather either the 21 mg patch or the 14 mg patch and give it to the participant. (Patch 
dosage is based on number of cigarettes smoked determined at Baseline 
appointment). Be sure to write down the time that the patch is placed on their arm. 
Ideally, the participant should have the patch on for 30 minutes before the 
intervention begins. 
6. Gather the nasal spray bottle and give it to the participant to use. Wait to give the nasal 
spray to the participant until the session is being recorded. 
7. Have the participant fill out all of the questionnaires related to the session in REDCap, 
except the SECOND Minnesota Nicotine Withdrawal Scale and the SECOND 
Questionnaire of Smoking Urges.  
8. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
9. Tell the client that you are about to start the recording for the session. Explain that “this is 
a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 
10. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded.  
11. Tell the participant to follow along in their client Intervention workbook as you go 
through your Therapist Intervention Manual. Let them know that the counseling could 
take up to 30 minutes and they are urged to write down information in their 
workbooks. 
12. When appropriate, pause the audio recording and have the participant fill out the 
following: 
• The second Minnesota Nicotine Withdrawal Scale 
• The second Questionnaire of Smoking Urges 
• Based on the participant’s response to the Minnesota Nicotine 
Withdrawal Scale and the Questionnaire of Smoking Urges, graph the 
before and after scores in their workbook. 
13. Un-pause the audio recording and continue the intervention by going over the 
participant’s before and after scores for the Minnesota Nicotine Withdrawal Scale and 
Questionnaire of Smoking Urges. 
14. Go over the Tobacco Use and NRT Use calendars. 
15. Provide them with the copies of the calendars (in their folder) to keep in their 
pocket/wallet for use when they do not have their manual with them. 
16. After the therapy, ask the participant if they have any questions. If they do not, tell them 
you are ending the recording. 

42 
 
17. Schedule the next appointment for the following week (preferably the same day of the 
week and the same morning time). Once you have it scheduled, make sure the 
appointment is placed in the Cropsey Lab Google Calendar. 
18. Instruct the participant to bring the calendars and workbook back so they can be 
reviewed next session.  
19. Give the participant 6 patches. The 6 patches and the patch they are currently wearing 
(total of 7) will last through to the next appointment. 
20. Give the participant 1 bottle of nasal spray. The nasal spray bottle will last through to the 
next appointment. Be sure to emphasize they are not to use the nasal spray on the 
morning of the next appointment.   
21. Have the participant sign for the medication in the medication sign-out log. 
22. Mark in the Medication Inventory Excel sheet how many of the patches and nasal spray 
bottles you have given out so that we maintain a running total of prescriptions we have on 
hand. 
23. Remind the participant of the instructions on how to use the patches and nasal spray and 
let them know they can reference their workbook if they forget. Give the participant the 
instructions sheet. 
24. Compensate the participant on their Greenphire ClinCard. 
25. Give the participant an appointment card. Be sure to remind the participant to try and 
refrain from smoking the night before the appointment and not to use a patch or 
nasal spray on the morning of the appointment. Also, remind them to bring all used 
and unused patches, patch packets, and nasal spray bottles back to the next 
appointment.  
26. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap. 
 
Week 3 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to confirm 
that the participant is using nicotine products.   
3. Collect the participant’s Tobacco Use and NRT Use calendars and enter the data for the 
previous week into the appropriate SPSS database, then return the calendars to the 
participant. 
4. Collect the used nicotine patches and nasal spray bottles and dispose of them after 
reviewing the calendars. Any unused patches/nasal spray bottles can be given back to the 
participant. 
5. Gather either the 21 mg patch or the 14 mg patch and give it to the participant. (Patch 
dosage is based on number of cigarettes smoked determined at Baseline 
appointment). Be sure to write down the time that the patch is placed on their arm. 
Ideally, the participant should have the patch on for 30 minutes before the 
intervention begins. 
6. Gather the inhaler box and give it to the participant to use. Wait to give the inhaler to 
the participant until the session is being recorded. 

43 
 
7. Have the participant fill out all of the questionnaires related to the session in REDCap, 
except the SECOND Minnesota Nicotine Withdrawal Scale and the SECOND 
Questionnaire of Smoking Urges.  
8. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
9. Tell the client that you are about to start the recording for the session. Explain that “this is 
a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 
10. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded.  
11. Tell the participant to follow along in their client Intervention workbook as you go 
through your Therapist Intervention Manual. Let them know that the counseling could 
take up to 30 minutes and they are urged to write down information in their 
workbooks. 
12. When appropriate, pause the audio recording and have the participant fill out the 
following: 
• The second Minnesota Nicotine Withdrawal Scale 
• The second Questionnaire of Smoking Urges 
• Based on the participant’s response to the Minnesota Nicotine 
Withdrawal Scale and the Questionnaire of Smoking Urges, graph the 
before and after scores in their workbook. 
13. Un-pause the audio recording and continue the intervention by going over the 
participant’s before and after scores for the Minnesota Nicotine Withdrawal Scale and 
Questionnaire of Smoking Urges. 
14. Go over the Tobacco Use and NRT Use calendars. 
15. Provide them with the copies of the calendars (in their folder) to keep in their 
pocket/wallet for use when they do not have their manual with them. 
16. After the therapy, ask the participant if they have any questions. If they do not, tell them 
you are ending the recording. 
17. Schedule the next appointment for the following week (preferably the same day of the 
week and the same morning time). Once you have it scheduled, make sure the 
appointment is placed in the Cropsey Lab Google Calendar. 
18. Instruct the participant to bring the calendars and workbook back so they can be 
reviewed next session.  
19. Give the participant 6 patches. The 6 patches and the patch they are currently wearing 
(total of 7) will last through to the next appointment.  
20. Give the participant 1 box of inhaler/cartridges. The inhaler cartridges will last through to 
the next appointment. Be sure to emphasize they are not to use the inhaler on the 
morning of the next appointment.   
21. Have the participant sign for the medication in the medication sign-out log. 
22. Mark in the Medication Inventory Excel sheet how many of the patches and inhaler boxes 
you have given out so that we maintain a running total of prescriptions we have on hand. 

44 
 
23. Remind the participant of the instructions on how to use the patches and inhaler and let 
them know they can reference their workbook if they forget. Give the participant the 
instructions sheet.  
24. Compensate the participant on their Greenphire ClinCard.  
25. Give the participant an appointment card. Be sure to remind the participant to try and 
refrain from smoking the night before the appointment and not to use a patch or 
inhaler on the morning of the appointment. Also, remind them to bring all used and 
unused patches, patch packets, and inhaler cartridges back to the next appointment.  
26. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap. 
 
Week 4 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to confirm 
that the participant is using nicotine products.   
3. Collect the participant’s Tobacco Use and NRT Use calendars and enter the data for the 
previous week into the appropriate SPSS database, then return the calendars to the 
participant. 
4. Collect the used nicotine patches and inhaler cartridges and dispose of them after 
reviewing the calendars. Any unused patches/inhaler cartridges can be given back to the 
participant. 
5. Gather either the 21 mg patch or the 14 mg patch and give it to the participant. (Patch 
dosage is based on number of cigarettes smoked determined at Baseline 
appointment). Be sure to write down the time that the patch is placed on their arm. 
Ideally, the participant should have the patch on for 30 minutes before the 
intervention begins. 
6. Gather either the 4mg gum or 2mg gum and give it to the participant. (Gum mg is based 
on how soon the participant smokes a cigarette after waking determined at Baseline 
appointment). Wait to give the gum to the participant until the session is being 
recorded. 
7. Have the participant fill out all of the questionnaires related to the session in REDCap, 
except the SECOND Minnesota Nicotine Withdrawal Scale and the SECOND 
Questionnaire of Smoking Urges.  
8. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
9. Tell the client that you are about to start the recording for the session. Explain that “this is 
a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 
10. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded.  

45 
 
11. Tell the participant to follow along in their client Intervention workbook as you go 
through your Therapist Intervention Manual. Let them know that the counseling could 
take up to 30 minutes and they are urged to write down information in their 
workbooks.  
12. When appropriate, pause the audio recording and have the participant fill out the 
following: 
• The second Minnesota Nicotine Withdrawal Scale 
• The second Questionnaire of Smoking Urges 
• Based on the participant’s response to the Minnesota Nicotine 
Withdrawal Scale and the Questionnaire of Smoking Urges, graph the 
before and after scores in their workbook. 
13. Un-pause the audio recording and continue the intervention by going over the 
participant’s before and after scores for the Minnesota Nicotine Withdrawal Scale and 
Questionnaire of Smoking Urges. 
14. Go over the Tobacco Use and NRT Use calendars. 
15. Provide them with the copies of the calendars (in their folder) to keep in their 
pocket/wallet for use when they do not have their manual with them. 
16. After the therapy, ask the participant if they have any questions. If they do not, tell them 
you are ending the recording. 
17. Schedule the next appointment for the following week (preferably the same day of the 
week and the same morning time). Once you have it scheduled, make sure the 
appointment is placed in the Cropsey Lab Google Calendar. 
18. Instruct the participant to bring the calendars and workbook back so they can be 
reviewed next session.  
19. Give the participant 6 patches. The 6 patches and the patch they are currently wearing 
(total of 7) will last through to the next appointment. 
20. Give the participant 1 package of gum. The package of gum will last through to the next 
appointment. Be sure to emphasize they are not to use the gum on the morning of the 
next appointment.   
21. Have the participant sign for the medication in the medication sign-out log. 
22. Mark in the Medication Inventory Excel sheet how many of the patches and gum 
packages you have given out so that we maintain a running total of prescriptions we have 
on hand. 
23. Remind the participant of the instructions on how to use the patches and gum and let 
them know they can reference their workbook if they forget. Give the participant the 
instructions sheet. 
24. Compensate the participant on their Greenphire ClinCard.  
25. Give the participant an appointment card. Be sure to remind the participant to try and 
refrain from smoking the night before the appointment and not to use a patch or 
gum on the morning of the appointment. Also, remind them to bring all used and 
unused patches, patch packets, and gum packages back to the next appointment.  
26. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap. 
 
 

46 
 
Week 5 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to 
confirm that the participant is using nicotine products.   
3. Collect the participant’s Tobacco Use and NRT Use calendars and enter the data for the 
previous week into the appropriate SPSS database, then return the calendars to the 
participant. 
4. Collect the used nicotine patches and gum packages and dispose of them after reviewing 
the calendars. Any unused patches/gum packages can be given back to the participant. 
5. Gather either the 21 mg patch or the 14 mg patch and give it to the participant. (Patch 
dosage is based on number of cigarettes smoked determined at Baseline 
appointment). Be sure to write down the time that the patch is placed on their arm. 
Ideally, the participant should have the patch on for 30 minutes before the 
intervention begins. 
6. Have the participant fill out all of the questionnaires related to the session in REDCap, 
except the Alliance Questionnaire, SECOND Minnesota Nicotine Withdrawal Scale 
and the SECOND Questionnaire of Smoking Urges.  
7. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
8. Tell the client that you are about to start the recording for the session. Explain that “this is 
a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 
9. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded.  
10. Tell the participant to follow along in their Client Intervention workbook as you go 
through your Therapist Intervention Manual. Let them know that the counseling could 
take up to 30 minutes and they are urged to write down information in their 
workbooks. 
11. When appropriate, pause the audio recording and have the participant fill out the 
following: 
• The Alliance Questionnaire 
• The second Minnesota Nicotine Withdrawal Scale 
• The second Questionnaire of Smoking Urges 
• Based on the participant’s response to the Minnesota Nicotine 
Withdrawal Scale and the Questionnaire of Smoking Urges, graph the 
before and after scores in their workbook. 
12. Un-pause the audio recording and continue the intervention by going over the 
participant’s before and after scores for the Minnesota Nicotine Withdrawal Scale and 
Questionnaire of Smoking Urges. 
13. Review each week and the participant’s experience with the short-acting forms of NRT 
from the participant’s manual. Answer any questions the participant has regarding the 

47 
 
medications. Present the medication selection sheet, review it with the participant, and 
explain that they will be selecting their preferred short-acting NRT to use in conjunction 
with the patch for the rest of the medication period of the study. Once the participant has 
made a selection, enter it into REDCap and ask them to write it in their manual.   
14. After the therapy, ask the participant if they have any questions. If they do not, tell them 
you are ending the recording. 
15. Schedule the next appointment for the next week (preferably the same day of the week 
and the same morning time). This appointment should be scheduled with another study 
staff member other than the therapist who saw the participant for the five weekly 
sessions. Once you have it scheduled, make sure the appointment is placed in the 
Cropsey Lab Google Calendar. 
16. Give the participant 6 patches. The 6 patches and the patch they are currently wearing 
(total of 7) will last through to the next appointment.   
17. Give the participant enough of the short-acting NRT they chose to last through to the next 
appointment. 
18. Have the participant sign for the medication in the medication sign-out log. 
19. Mark in the Medication Inventory Excel sheet how many of the patches and gum 
packages/lozenge quit tubes/inhaler cartridges/nasal spray bottles you have given out so 
that we maintain a running total of prescriptions we have on hand. 
20. Remind the participant of the instructions on how to use the patches and 
gum/lozenges/inhaler/nasal spray and let them know they can reference their workbook if 
they forget.  
21. Give the participant a study phone and charger and instruct them to complete the EMA’s 
daily. 
22. Compensate the participant on their Greenphire ClinCard. 
23. Give the participant an appointment card. Also, remind them to bring all used and 
unused patches, patch packets, and short-acting NRT back to the next appointment.  
24. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap. 
 
 
Intervention Group C 
 
Week 1 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to confirm 
that the participant is using nicotine products.   
3. Gather either the 21 mg patch or the 14 mg patch and give it to the participant. (Patch 
dosage is based on number of cigarettes smoked determined at Baseline 
appointment). Be sure to write down the time that the patch is placed on their arm. 
Ideally, the participant should have the patch on for 30 minutes before the 
intervention begins. 

48 
 
4. Gather the nasal spray bottle and give it to the participant to use. Wait to give the nasal 
spray to the participant until the session is being recorded. 
5. Have the participant fill out all of the questionnaires related to the session in REDCap, 
except the Credibility Expectancies Questionnaire, SECOND Minnesota Nicotine 
Withdrawal Scale and the SECOND Questionnaire of Smoking Urges.  
6. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
7. Tell the client that you are about to start the recording for the session. Explain that “this is 
a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 
8. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded.  
9. Give the participant the assigned client Intervention workbook and tell them to follow 
along as you go through your Therapist Intervention Manual. Let them know that the 
counseling could take up to 30 minutes and they are urged to write down information 
in their workbooks. 
10. When appropriate, pause the audio recording and have the participant fill out the 
following: 
• The second Minnesota Nicotine Withdrawal Scale 
• The second Questionnaire of Smoking Urges 
• Based on the participant’s response to the Minnesota Nicotine 
Withdrawal Scale and the Questionnaire of Smoking Urges, graph the 
before and after scores in their workbook. 
11. Un-pause the audio recording and continue the intervention by going over the 
participant’s before and after scores for the Minnesota Nicotine Withdrawal Scale and 
Questionnaire of Smoking Urges. 
12. Go over the Tobacco Use and NRT Use calendars. 
13. Provide them with the copies of the calendars (in their folder) to keep in their 
pocket/wallet for use when they do not have their manual with them. 
14. After the therapy, ask the participant if they have any questions. If they do not, tell them 
you are ending the recording. 
15. Schedule the next appointment for the following week (preferably the same day of the 
week and the same morning time). Once you have it scheduled, make sure the 
appointment is placed in the Cropsey Lab Google Calendar. 
16. Instruct the participant to bring the calendars and workbook back so they can be 
reviewed next session.  
17. Give the participant 6 patches. The 6 patches and the patch they are currently wearing 
(total of 7) will last through to the next appointment. 
18. Give the participant 1 bottle of nasal spray. The nasal spray bottle will last through to the 
next appointment. Be sure to emphasize they are not to use the nasal spray on the 
morning of the next appointment.   
19. Have the participant sign for the medication in the medication sign-out log. 

49 
 
20. Mark in the Medication Inventory Excel sheet how many of the patches and nasal spray 
bottles you have given out so that we maintain a running total of prescriptions we have on 
hand. 
21. Remind the participant of the instructions on how to use the patches and nasal spray and 
let them know they can reference their workbook if they forget. Give the participant the 
instructions sheet. 
22. Compensate the participant on their Greenphire ClinCard.  
23. Give the participant an appointment card. Be sure to remind the participant to try and 
refrain from smoking the night before the appointment and not to use a patch or 
nasal spray on the morning of the appointment. Also, remind them to bring all used 
and unused patches, patch packets, and nasal spray bottles back to the next 
appointment.  
24. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap. 
 
Week 2 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to confirm 
that the participant is using nicotine products.   
3. Collect the participant’s Tobacco Use and NRT Use calendars and enter the data for the 
previous weeks into the appropriate SPSS database, then return the calendars to the 
participant. 
4. Collect the used nicotine patches and nasal spray bottles and dispose of them after 
reviewing the calendars. Any unused patches/nasal spray bottles can be given back to the 
participant. 
5. Gather either the 21 mg patch or the 14 mg patch and give it to the participant. (Patch 
dosage is based on number of cigarettes smoked determined at Baseline 
appointment). Be sure to write down the time that the patch is placed on their arm. 
Ideally, the participant should have the patch on for 30 minutes before the 
intervention begins. 
6. Gather either the 4mg gum or 2mg gum and give it to the participant. (Gum mg is based 
on how soon the participant smokes a cigarette after waking determined at Baseline 
appointment). Wait to give the gum to the participant until the session is being 
recorded. 
  
7. Have the participant fill out all of the questionnaires related to the session in REDCap, 
except the SECOND Minnesota Nicotine Withdrawal Scale and the SECOND 
Questionnaire of Smoking Urges.  
8. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  

50 
 
9. Tell the client that you are about to start the recording for the session. Explain that “this is 
a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 
10. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded.  
11. Tell the participant to follow along in their Client Intervention workbook as you go 
through your Therapist Intervention Manual. Let them know that the counseling could 
take up to 30 minutes and they are urged to write down information in their 
workbooks. 
12. When appropriate, pause the audio recording and have the participant fill out the 
following: 
• The second Minnesota Nicotine Withdrawal Scale 
• The second Questionnaire of Smoking Urges 
• Based on the participant’s response to the Minnesota Nicotine 
Withdrawal Scale and the Questionnaire of Smoking Urges, graph the 
before and after scores in their workbook. 
13. Un-pause the audio recording and continue the intervention by going over the 
participant’s before and after scores for the Minnesota Nicotine Withdrawal Scale and 
Questionnaire of Smoking Urges. 
14. Go over the Tobacco Use and NRT Use calendars. 
15. Provide them with the copies of the calendars (in their folder) to keep in their 
pocket/wallet for use when they do not have their manual with them. 
16. After the therapy, ask the participant if they have any questions. If they do not, tell them 
you are ending the recording. 
17. Schedule the next appointment for the following week (preferably the same day of the 
week and the same morning time). Once you have it scheduled, make sure the 
appointment is placed in the Cropsey Lab Google Calendar. 
18. Instruct the participant to bring the calendars and workbook back so they can be 
reviewed next session.  
19. Give the participant 6 patches. The 6 patches and the patch they are currently wearing 
(total of 7) will last through to the next appointment.  
20. Give the participant 1 package of gum. The package of gum will last through to the next 
appointment. Be sure to emphasize they are not to use the gum on the morning of the 
next appointment.   
21. Have the participant sign for the medication in the medication sign-out log. 
22. Mark in the Medication Inventory Excel sheet how many of the patches and gum 
packages you have given out so that we maintain a running total of prescriptions we have 
on hand. 
23. Remind the participant of the instructions on how to use the patches and gum and let 
them know they can reference their workbook if they forget. Give the participant the 
instructions sheet. 
24. Compensate the participant on their Greenphire ClinCard.   
25. Give the participant an appointment card. Be sure to remind the participant to try and 
refrain from smoking the night before the appointment and not to use a patch or 

51 
 
gum on the morning of the appointment. Also, remind them to bring all used and 
unused patches, patch packets, and gum packages back to the next appointment.  
26. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap. 
 
Week 3 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to confirm 
that the participant is using nicotine products.   
3. Collect the participant’s Tobacco Use and NRT Use calendars and enter the date for the 
previous week into the appropriate SPSS database, then return the calendars to the 
participant. 
4. Collect the used nicotine patches and gum packages and dispose of them after reviewing 
the calendars. Any unused patches/gum packages can be given back to the participant. 
5. Gather either the 21 mg patch or the 14 mg patch and give it to the participant. (Patch 
dosage is based on number of cigarettes smoked determined at Baseline 
appointment). Be sure to write down the time that the patch is placed on their arm. 
Ideally, the participant should have the patch on for 30 minutes before the 
intervention begins. 
6. Gather the 4mg or 2mg nicotine lozenge and give it to the participant to use. (Lozenge 
dosage is based on how soon participant smokes their first cigarette after waking, as 
reported at Baseline appointment). Wait to give the lozenge to the participant until 
the session is being recorded.  
7. Have the participant fill out all of the questionnaires related to the session in REDCap, 
except the SECOND Minnesota Nicotine Withdrawal Scale and the SECOND 
Questionnaire of Smoking Urges.  
8. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
9. Tell the client that you are about to start the recording for the session. Explain that “this is 
a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 
10. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded.  
11. Tell the participant to follow along in their client Intervention workbook as you got 
through your Therapist Intervention Manual. Let them know that the counseling could 
take up to 30 minutes and they are urged to write down information in their 
workbook. 
12. When appropriate, pause the audio recording and have the participant fill out the 
following: 
• The second Minnesota Nicotine Withdrawal Scale 
• The second Questionnaire of Smoking Urges 

52 
 
• Based on the participant’s response to the Minnesota Nicotine 
Withdrawal Scale and the Questionnaire of Smoking Urges, graph the 
before and after scores in their workbook. 
13. Un-pause the audio recording and continue the intervention by going over the 
participant’s before and after scores for the Minnesota Nicotine Withdrawal Scale and 
Questionnaire of Smoking Urges. 
14. Go over the Tobacco Use and NRT Use calendars. 
15. Provide them with the copies of the calendars (in their folder) to keep in their 
pocket/wallet for use when they do not have their manual with them. 
16. After the therapy, ask the participant if they have any questions. If they do not, tell them 
you are ending the recording. 
17. Schedule the next appointment for the following week (preferably the same day of the 
week and the same morning time). Once you have it scheduled, make sure the 
appointment is placed in the Cropsey Lab Google Calendar. 
18. Instruct the participant to bring the calendars and workbook back so they can be 
reviewed next session.  
19. Give the participant 6 patches. The 6 patches and the patch they are currently wearing 
(total of 7) will last through to the next appointment. 
20. Give the participant one box of lozenges (3 quit tubes = 72 lozenges). The 72 lozenges 
should last through to the next appointment if the participant uses 10 daily as advised. Be 
sure to emphasize they are not to use the lozenges on the morning of the next 
appointment.   
21. Have the participant sign for the medication in the medication sign-out log. 
22. Mark in the Medication Inventory binder how many of the patches and quit tubes you 
have given out so that we maintain a running total of prescriptions we have on hand. 
23. Remind the participant of the instructions on how to use the patches and lozenges and let 
them know they can reference their workbook if they forget. Give the participant the 
instructions sheet. 
24. Compensate the participant on their Greenphire ClinCard. 
25. Give the participant an appointment card. Be sure to remind the participant to try and 
refrain from smoking the night before the appointment and not to use a patch or 
lozenges on the morning of the appointment. Also, remind them to bring all used 
and unused patches, patch packets, and lozenge quit tubes back to the next 
appointment.  
26. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap. 
 
 
Week 4 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to confirm 
that the participant is using nicotine products.   

53 
 
3. Collect the participant’s Tobacco Use and NRT Use calendars and enter the data for the 
previous week into the appropriate SPSS database, then return the calendars to the 
participant. 
4. Collect the used nicotine patches and lozenge quit tubes and dispose of them after 
reviewing the calendars. Any unused patches/lozenges can be given back to the 
participant. 
5. Gather either the 21 mg patch or the 14 mg patch and give it to the participant. (Patch 
dosage is based on number of cigarettes smoked determined at Baseline 
appointment). Be sure to write down the time that the patch is placed on their arm. 
Ideally, the participant should have the patch on for 30 minutes before the 
intervention begins. 
6. Gather the inhaler box and give it to the participant to use. Wait to give the inhaler to 
the participant until the session is being recorded. 
7. Have the participant fill out all of the questionnaires related to the session in REDCap, 
except the SECOND Minnesota Nicotine Withdrawal Scale and the SECOND 
Questionnaire of Smoking Urges.  
8. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
9. Tell the client that you are about to start the recording for the session. Explain that “this is 
a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 
10. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded.  
11. Tell the participant to follow along in their client Intervention workbook as you got 
through your Therapist Intervention Manual. Let them know that the counseling could 
take up to 30 minutes and they are urged to write down information in their 
workbook. 
12. When appropriate, pause the audio recording and have the participant fill out the 
following: 
• The second Minnesota Nicotine Withdrawal Scale 
• The second Questionnaire of Smoking Urges 
• Based on the participant’s response to the Minnesota Nicotine 
Withdrawal Scale and the Questionnaire of Smoking Urges, graph the 
before and after scores in their workbook. 
13. Un-pause the audio recording and continue the intervention by going over the 
participant’s before and after scores for the Minnesota Nicotine Withdrawal Scale and 
Questionnaire of Smoking Urges. 
14. Go over the Tobacco Use and NRT Use calendars. 
15. Provide them with the copies of the calendars (in their folder) to keep in their 
pocket/wallet for use when they do not have their manual with them. 
16. After the therapy, ask the participant if they have any questions. If they do not, tell them 
you are ending the recording. 

54 
 
17. Schedule the next appointment for the following week (preferably the same day of the 
week and the same morning time). Once you have it scheduled, make sure the 
appointment is placed in the Cropsey Lab Google Calendar. 
18. Instruct the participant to bring the calendars and workbook back so they can be 
reviewed next session.  
19. Give the participant 6 patches. The 6 patches and the patch they are currently wearing 
(total of 7) will last through to the next appointment.  
20. Give the participant 1 box of inhaler/cartridges. The inhaler cartridges will last through to 
the next appointment. Be sure to emphasize they are not to use the inhaler on the 
morning of the next appointment.   
21. Have the participant sign for the medication in the medication sign-out log. 
22. Mark in the Medication Inventory Excel sheet how many of the patches and inhalers you 
have given out so that we maintain a running total of prescriptions we have on hand. 
23. Remind the participant of the instructions on how to use the patches and inhaler and let 
them know they can reference their workbook if they forget. Give the participant the 
instructions sheet. 
24. Compensate the participant on their Greenphire ClinCard.  
25. Give the participant an appointment card. Be sure to remind the participant to try and 
refrain from smoking the night before the appointment and not to use a patch or 
inhaler on the morning of the appointment. Also, remind them to bring all used and 
unused patches, patch packets, and inhaler cartridges back to the next appointment.  
26. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap. 
 
Week 5 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to 
confirm that the participant is using nicotine products.   
3. Collect the participant’s Tobacco Use and NRT Use calendars and enter the data for the 
previous week into the appropriate SPSS database, then return the calendars to the 
participant. 
4. Collect the used nicotine patches and inhaler cartridges and dispose of them after 
reviewing the calendars. Any unused patches/inhaler cartridges can be given back to the 
participant. 
5. Gather either the 21 mg patch or the 14 mg patch and give it to the participant. (Patch 
dosage is based on number of cigarettes smoked determined at Baseline 
appointment). Be sure to write down the time that the patch is placed on their arm. 
Ideally, the participant should have the patch on for 30 minutes before the 
intervention begins. 
6. Have the participant fill out all of the questionnaires related to the session in REDCap, 
except the Alliance Questionnaire, SECOND Minnesota Nicotine Withdrawal Scale 
and the SECOND Questionnaire of Smoking Urges.  

55 
 
7. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
8. Tell the client that you are about to start the recording for the session. Explain that “this is 
a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 
9. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded.  
10. Tell the participant to follow along in their client Intervention workbook as you go 
through your Therapist Intervention Manual. Let them know that the counseling could 
take up to 30 minutes and they are urged to write down information in their 
workbooks. 
11. When appropriate, pause the audio recording and have the participant fill out the 
following: 
• The Alliance Questionnaire 
• The second Minnesota Nicotine Withdrawal Scale 
• The second Questionnaire of Smoking Urges 
• Based on the participant’s response to the Minnesota Nicotine 
Withdrawal Scale and the Questionnaire of Smoking Urges, graph the 
before and after scores in their workbook. 
12. Un-pause the audio recording and continue the intervention by going over the 
participant’s before and after scores for the Minnesota Nicotine Withdrawal Scale and 
Questionnaire of Smoking Urges. 
13. Review each week and the participant’s experience with the short-acting forms of NRT 
from the participant’s manual. Answer any questions the participant has regarding the 
medications. Present the medication selection sheet, review it with the participant, and 
explain that they will be selecting their preferred short-acting NRT to use in conjunction 
with the patch for the rest of the medication period of the study. Once the participant has 
made a selection, enter it into REDCap and ask them to write it in their manual.   
14. After the therapy, ask the participant if they have any questions. If they do not, tell them 
you are ending the recording. 
15. Schedule the next appointment for the next week (preferably the same day of the week 
and the same morning time). This appointment should be scheduled with another study 
staff member other than the therapist who saw the participant for the five weekly 
sessions. Once you have it scheduled, make sure the appointment is placed in the 
Cropsey Lab Google Calendar. 
16. Give the participant 6 patches. The 6 patches and the patch they are currently wearing 
(total of 7) will last through to the next appointment.   
17. Give the participant enough of the short-acting NRT they chose to last through to the next 
appointment. 
18. Have the participant sign for the medication in the medication sign-out log. 
19. Mark in the Medication Inventory Excel sheet how many of the patches and gum 
packages/lozenge quit tubes/inhaler cartridges/nasal spray bottles you have given out so 
that we maintain a running total of prescriptions we have on hand. 

56 
 
20. Remind the participant of the instructions on how to use the patches and 
gum/lozenges/inhaler/nasal spray and let them know they can reference their workbook if 
they forget.  
21. Give the participant a study phone and charger and instruct them to complete the EMA’s 
daily. 
22. Compensate the participant on their Greenphire ClinCard. 
23. Give the participant an appointment card. Also, remind them to bring all used and 
unused patches, patch packets, and short-acting NRT back to the next appointment.  
24. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap. 
 
Intervention Group D 
 
Week 1 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to confirm 
that the participant is using nicotine products.   
3. Gather either the 21 mg patch or the 14 mg patch and give it to the participant. (Patch 
dosage is based on number of cigarettes smoked determined at Baseline 
appointment). Be sure to write down the time that the patch is placed on their arm. 
Ideally, the participant should have the patch on for 30 minutes before the 
intervention begins. 
4. Gather the inhaler and give it to the participant to use. Wait to give the inhaler to the 
participant until the session is being recorded. 
5. Have the participant fill out all of the questionnaires related to the session in REDCap, 
except the Credibility Expectancies Questionnaire, SECOND Minnesota Nicotine 
Withdrawal Scale and the SECOND Questionnaire of Smoking Urges.  
6. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
7. Tell the client that you are about to start the recording for the session. Explain that “this is 
a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 
8. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded.  
9. Tell the participant to follow along in their client Intervention workbook as you got 
through your Therapist Intervention Manual. Let them know that the counseling could 
take up to 30 minutes and they are urged to write down information in their 
workbook. 
10. When appropriate, pause the audio recording and have the participant fill out the 
following: 
• The second Minnesota Nicotine Withdrawal Scale 

57 
 
• The second Questionnaire of Smoking Urges 
• Based on the participant’s response to the Minnesota Nicotine 
Withdrawal Scale and the Questionnaire of Smoking Urges, graph the 
before and after scores in their workbook. 
11. Un-pause the audio recording and continue the intervention by going over the 
participant’s before and after scores for the Minnesota Nicotine Withdrawal Scale and 
Questionnaire of Smoking Urges. 
12. Go over the Tobacco Use and NRT Use calendars. 
13. Provide them with the copies of the calendars (in their folder) to keep in their 
pocket/wallet for use when they do not have their manual with them. 
14. After the therapy, ask the participant if they have any questions. If they do not, tell them 
you are ending the recording. 
15. Schedule the next appointment for the following week (preferably the same day of the 
week and the same morning time). Once you have it scheduled, make sure the 
appointment is placed in the Cropsey Lab Google Calendar. 
16. Instruct the participant to bring the calendars and workbook back so they can be 
reviewed next session.  
17. Give the participant 6 patches. The 6 patches and the patch they are currently wearing 
(total of 7) will last through to the next appointment.  
18. Give the participant 1 box of inhaler/cartridges. The inhaler cartridges will last through to 
the next appointment. Be sure to emphasize they are not to use the inhaler on the 
morning of the next appointment.   
19. Have the participant sign for the medication in the medication sign-out log. 
20. Mark in the Medication Inventory Excel sheet how many of the patches and inhalers you 
have given out so that we maintain a running total of prescriptions we have on hand. 
21. Remind the participant of the instructions on how to use the patches and inhaler and let 
them know they can reference their workbook if they forget. Give the participant the 
instructions sheet. 
22. Compensate the participant on their Greenphire ClinCard. 
23. Give the participant an appointment card. Be sure to remind the participant to try and 
refrain from smoking the night before the appointment and not to use a patch or 
nasal spray on the morning of the appointment. Also, remind them to bring all used 
and unused patches, patch packets, and inhaler cartridges back to the next 
appointment.  
24. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap. 
Week 2 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to confirm 
that the participant is using nicotine products.   
3. Collect the participant’s Tobacco Use and NRT Use calendars and enter the data for the 
previous week into the appropriate SPSS database, then return the calendars to the 
participant. 

58 
 
4. Collect the used nicotine patches and inhaler cartridges and dispose of them after 
reviewing the calendars. Any unused patches/inhaler cartridges can be given back to the 
participant. 
5. Gather either the 21 mg patch or the 14 mg patch and give it to the participant. (Patch 
dosage is based on number of cigarettes smoked determined at Baseline 
appointment). Be sure to write down the time that the patch is placed on their arm. 
Ideally, the participant should have the patch on for 30 minutes before the 
intervention begins. 
6. Gather the 4mg or 2mg nicotine lozenge and give it to the participant to use. (Lozenge 
dosage is based on how soon participant smokes their first cigarette after waking, as 
reported at Baseline appointment). Wait to give the lozenge to the participant until 
the session is being recorded.  
7. Have the participant fill out all of the questionnaires related to the session in REDCap, 
except the SECOND Minnesota Nicotine Withdrawal Scale and the SECOND 
Questionnaire of Smoking Urges.  
8. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
9. Tell the client that you are about to start the recording for the session. Explain that “this is 
a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 
10. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded.  
11. Tell the participant to follow along in their client Intervention workbook as you got 
through your Therapist Intervention Manual. Let them know that the counseling could 
take up to 30 minutes and they are urged to write down information in their 
workbook. 
12. When appropriate, pause the audio recording and have the participant fill out the 
following: 
• The second Minnesota Nicotine Withdrawal Scale 
• The second Questionnaire of Smoking Urges 
• Based on the participant’s response to the Minnesota Nicotine 
Withdrawal Scale and the Questionnaire of Smoking Urges, graph the 
before and after scores in their workbook. 
13. Un-pause the audio recording and continue the intervention by going over the 
participant’s before and after scores for the Minnesota Nicotine Withdrawal Scale and 
Questionnaire of Smoking Urges. 
14. Go over the Tobacco Use and NRT Use calendars. 
15. Provide them with the copies of the calendars (in their folder) to keep in their 
pocket/wallet for use when they do not have their manual with them. 
16. After the therapy, ask the participant if they have any questions. If they do not, tell them 
you are ending the recording. 
17. Schedule the next appointment for the following week (preferably the same day of the 
week and the same morning time). Once you have it scheduled, make sure the 
appointment is placed in the Cropsey Lab Google Calendar. 

59 
 
18. Instruct the participant to bring the calendars and workbook back so they can be 
reviewed next session.  
19. Give the participant 6 patches. The 6 patches and the patch they are currently wearing 
(total of 7) will last through to the next appointment. 
20. Give the participant one box of lozenges (3 quit tubes = 72 lozenges). The 72 lozenges 
should last through to the next appointment if the participant uses 10 daily as advised. Be 
sure to emphasize they are not to use the lozenges on the morning of the next 
appointment.   
21. Have the participant sign for the medication in the medication sign-out log. 
22. Mark in the Medication Inventory binder how many of the patches and quit tubes you 
have given out so that we maintain a running total of prescriptions we have on hand. 
23. Remind the participant of the instructions on how to use the patches and lozenges and let 
them know they can reference their workbook if they forget. Give the participant the 
instructions sheet. 
24. Compensate the participant on their Greenphire ClinCard.  
25. Give the participant an appointment card. Be sure to remind the participant to try and 
refrain from smoking the night before the appointment and not to use a patch or 
lozenges on the morning of the appointment. Also, remind them to bring all used 
and unused patches, patch packets, and lozenge quit tubes back to the next 
appointment.  
26. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap. 
 
Week 3 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to confirm 
that the participant is using nicotine products.   
3. Collect the participant’s Tobacco Use and NRT Use calendars and enter the data for the 
previous week into the appropriate SPSS database, then return the calendars to the 
participant. 
4. Collect the used nicotine patches and lozenge quit tubes and dispose of them after 
reviewing calendars. Any unused patches/lozenges can be given back to the participant. 
5. Gather either the 21 mg patch or the 14 mg patch and give it to the participant. (Patch 
dosage is based on number of cigarettes smoked determined at Baseline 
appointment). Be sure to write down the time that the patch is placed on their arm. 
Ideally, the participant should have the patch on for 30 minutes before the 
intervention begins. 
6. Gather either the 4mg gum or 2mg gum and give it to the participant. (Gum mg is based 
on how soon the participant smokes a cigarette after waking determined at Baseline 
appointment). Wait to give the gum to the participant until the session is being 
recorded. 

60 
 
7. Have the participant fill out all of the questionnaires related to the session in REDCap, 
except the SECOND Minnesota Nicotine Withdrawal Scale and the SECOND 
Questionnaire of Smoking Urges.  
8. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
9. Tell the client that you are about to start the recording for the session. Explain that “this is 
a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 
10. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded.  
11. Tell the participant to follow along in their client Intervention workbook as you got 
through your Therapist Intervention Manual. Let them know that the counseling could 
take up to 30 minutes and they are urged to write down information in their 
workbook. 
12. When appropriate, pause the audio recording and have the participant fill out the 
following: 
• The second Minnesota Nicotine Withdrawal Scale 
• The second Questionnaire of Smoking Urges 
• Based on the participant’s response to the Minnesota Nicotine 
Withdrawal Scale and the Questionnaire of Smoking Urges, graph the 
before and after scores in their workbook. 
13. Un-pause the audio recording and continue the intervention by going over the 
participant’s before and after scores for the Minnesota Nicotine Withdrawal Scale and 
Questionnaire of Smoking Urges. 
14. Go over the Tobacco Use and NRT Use calendars. 
15. Provide them with the copies of the calendars (in their folder) to keep in their 
pocket/wallet for use when they do not have their manual with them. 
16. After the therapy, ask the participant if they have any questions. If they do not, tell them 
you are ending the recording. 
17. Schedule the next appointment for the following week (preferably the same day of the 
week and the same morning time). Once you have it scheduled, make sure the 
appointment is placed in the Cropsey Lab Google Calendar. 
18. Instruct the participant to bring the calendars and workbook back so they can be 
reviewed next session.  
19. Give the participant 6 patches. The 6 patches and the patch they are currently wearing 
(total of 7) will last through to the next appointment. 
20. Give the participant 1 package of gum. The package of gum will last through to the next 
appointment. Be sure to emphasize they are not to use the gum on the morning of the 
next appointment.   
21. Have the participant sign for the medication in the medication sign-out log. 
22. Mark in the Medication Inventory Excel sheet how many of the patches and gum 
packages you have given out so that we maintain a running total of prescriptions we have 
on hand. 

61 
 
23. Remind the participant of the instructions on how to use the patches and gum and let 
them know they can reference their workbook if they forget. Give the participant the 
instructions sheet. 
24. Compensate the participant on their Greenphire ClinCard. 
25. Give the participant an appointment card. Be sure to remind the participant to try and 
refrain from smoking the night before the appointment and not to use a patch or 
gum on the morning of the appointment. Also, remind them to bring all used and 
unused patches, patch packets, and gum packages back to the next appointment.  
26. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap. 
 
Week 4 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to confirm 
that the participant is using nicotine products.   
3. Collect the participant’s Tobacco Use and NRT Use calendars and enter the data for the 
previous week into the appropriate SPSS database, then return the calendars to the 
participant. 
4. Collect the used nicotine patches and gum packages and dispose of them after reviewing 
the calendars. Any unused patches/gum packages can be given back to the participant. 
5. Gather either the 21 mg patch or the 14 mg patch and give it to the participant. (Patch 
dosage is based on number of cigarettes smoked determined at Baseline 
appointment). Be sure to write down the time that the patch is placed on their arm. 
Ideally, the participant should have the patch on for 30 minutes before the 
intervention begins. 
6. Gather the nasal spray bottle and give it to the participant to use. Wait to give the nasal 
spray to the participant until the session is being recorded. 
7. Have the participant fill out all of the questionnaires related to the session in REDCap, 
except the SECOND Minnesota Nicotine Withdrawal Scale and the SECOND 
Questionnaire of Smoking Urges.  
8. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
9. Tell the client that you are about to start the recording for the session. Explain that “this is 
a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 
10. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded.  
11. Tell the participant to follow along in their client Intervention workbook as you got 
through your Therapist Intervention Manual. Let them know that the counseling could 
take up to 30 minutes and they are urged to write down information in their 
workbook. 

62 
 
12. When appropriate, pause the audio recording and have the participant fill out the 
following: 
• The second Minnesota Nicotine Withdrawal Scale 
• The second Questionnaire of Smoking Urges 
• Based on the participant’s response to the Minnesota Nicotine 
Withdrawal Scale and the Questionnaire of Smoking Urges, graph the 
before and after scores in their workbook. 
13. Un-pause the audio recording and continue the intervention by going over the 
participant’s before and after scores for the Minnesota Nicotine Withdrawal Scale and 
Questionnaire of Smoking Urges. 
14. Go over the Tobacco Use and NRT Use calendars. 
15. Provide them with the copies of the calendars (in their folder) to keep in their 
pocket/wallet for use when they do not have their manual with them. 
16. After the therapy, ask the participant if they have any questions. If they do not, tell them 
you are ending the recording. 
17. Schedule the next appointment for the following week (preferably the same day of the 
week and the same morning time). Once you have it scheduled, make sure the 
appointment is placed in the Cropsey Lab Google Calendar. 
18. Instruct the participant to bring the calendars and workbook back so they can be 
reviewed next session.  
19. Give the participant 6 patches. The 6 patches and the patch they are currently wearing 
(total of 7) will last through to the next appointment. Be sure to emphasize they are not 
to wear the patch the morning of the next appointment.   
20. Give the participant 1 bottle of nasal spray. The nasal spray bottle will last through to the 
next appointment. Be sure to emphasize they are not to use the nasal spray on the 
morning of the next appointment.   
21. Have the participant sign for the medication in the medication sign-out log. 
22. Mark in the Medication Inventory Excel sheet how many of the patches and nasal spray 
bottles you have given out so that we maintain a running total of prescriptions we have on 
hand. 
23. Remind the participant of the instructions on how to use the patches and nasal spray and 
let them know they can reference their workbook if they forget. Give the participant the 
instructions sheet. 
24. Compensate the participant on their Greenphire ClinCard.  
25. Give the participant an appointment card. Be sure to remind the participant to try and 
refrain from smoking the night before the appointment and not to use a patch or 
nasal spray on the morning of the appointment. Also, remind them to bring all used 
and unused patches, patch packets, and nasal spray bottles back to the next 
appointment.  
 
Week 5 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 

63 
 
• If the CO level is 3 or below, you need to administer a urine cotinine test to 
confirm that the participant is using nicotine products.   
3. Collect the participant’s Tobacco Use and NRT Use calendars and enter the data for the 
previous week into the appropriate SPSS database, then return the calendars to the 
participant. 
4. Collect the used nicotine patches and nasal spray bottles and dispose of them after 
reviewing the calendars. Any unused patches/nasal spray bottles can be given back to the 
participant. 
5. Gather either the 21 mg patch or the 14 mg patch and give it to the participant. (Patch 
dosage is based on number of cigarettes smoked determined at Baseline 
appointment). Be sure to write down the time that the patch is placed on their arm. 
Ideally, the participant should have the patch on for 30 minutes before the 
intervention begins. 
6. Have the participant fill out all of the questionnaires related to the session in REDCap, 
except the Alliance Questionnaire, SECOND Minnesota Nicotine Withdrawal Scale 
and the SECOND Questionnaire of Smoking Urges.  
7. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
8. Tell the client that you are about to start the recording for the session. Explain that “this is 
a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 
9. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded.  
10. Tell the participant to follow along in their client Intervention workbook as you got 
through your Therapist Intervention Manual. Let them know that the counseling could 
take up to 30 minutes and they are urged to write down information in their 
workbook. 
11. When appropriate, pause the audio recording and have the participant fill out the 
following: 
• The Alliance Questionnaire 
• The second Minnesota Nicotine Withdrawal Scale 
• The second Questionnaire of Smoking Urges 
• Based on the participant’s response to the Minnesota Nicotine 
Withdrawal Scale and the Questionnaire of Smoking Urges, graph the 
before and after scores in their workbook. 
12. Un-pause the audio recording and continue the intervention by going over the 
participant’s before and after scores for the Minnesota Nicotine Withdrawal Scale and 
Questionnaire of Smoking Urges. 
13. Review each week and the participant’s experience with the short-acting forms of NRT 
from the participant’s manual. Answer any questions the participant has regarding the 
medications. Present the medication selection sheet, review it with the participant, and 
explain that they will be selecting their preferred short-acting NRT to use in conjunction 
with the patch for the rest of the medication period of the study. Once the participant has 
made a selection, enter it into REDCap and ask them to write it in their manual.   

64 
 
14. After the therapy, ask the participant if they have any questions. If they do not, tell them 
you are ending the recording. 
15. Schedule the next appointment for the next week (preferably the same day of the week 
and the same morning time). This appointment should be scheduled with another study 
staff member other than the therapist who saw the participant for the five weekly 
sessions. Once you have it scheduled, make sure the appointment is placed in the 
Cropsey Lab Google Calendar. 
16. Give the participant 6 patches. The 6 patches and the patch they are currently wearing 
(total of 7) will last through to the next appointment.   
17. Give the participant enough of the short-acting NRT they chose to last through to the next 
appointment. 
18. Have the participant sign for the medication in the medication sign-out log. 
19. Mark in the Medication Inventory Excel sheet how many of the patches and gum 
packages/lozenge quit tubes/inhaler cartridges/nasal spray bottles you have given out so 
that we maintain a running total of prescriptions we have on hand. 
20. Remind the participant of the instructions on how to use the patches and 
gum/lozenges/inhaler/nasal spray and let them know they can reference their workbook if 
they forget.  
21. Give the participant a study phone and charger and instruct them to complete the EMA’s 
daily. 
22. Compensate the participant on their Greenphire ClinCard.  
23. Give the participant an appointment card. Also, remind them to bring all used and 
unused patches, patch packets, and short-acting NRT back to the next appointment.  
24. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap. 
 
 
Control Group 
 
Week 1 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO.  
• If the CO is 3 or below, you need to administer a urine cotinine test to confirm 
that the participant is using nicotine products.   
3. Have the participant fill out all of the questionnaires related to the Session in REDCap, 
except the SECOND Minnesota Nicotine Withdrawal scale, and the SECOND 
Questionnaire of Smoking Urges. 
4. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
5. Tell the client that you are about to start the recording for their session. Explain that “this 
is a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 

65 
 
6. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded. 
7. Give the participant the assigned client Control workbook and tell them to follow along 
as you go through your therapist control manual. Remind them that the counseling could 
take up to 30 minutes and they are urged to write down information in their 
workbooks.   
8. Make sure that you have gone over the Tobacco Use calendar before you finish the 
recording. Provide them with copies of the calendar to keep in their pocket/wallet for use 
when they do not have their manual. Ask that they bring back the calendar and workbook 
to each visit. 
9. After the therapy ask the participant if they have any questions.  If they do not, tell them 
you are ending the recording. 
10. Have the participant complete the remaining session measures (Credibility Expectancies 
Questionnaire, second Minnesota Nicotine Withdrawal Scale, and second Questionnaire 
of Smoking Urges). 
11. Schedule the next appointment for the following week (preferably the same day of the 
week and same time). Once you have it scheduled, make sure the appointment is 
placed in the Cropsey Lab Google Calendar.    
12. Compensate the participant on their Greenphire ClinCard. 
13. Give the participant an appointment card. 
14. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap.  
 
 
 
Week 2 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO.  
• If the CO is 3 or below, you need to administer a urine cotinine test to confirm 
that the participant is using nicotine products.   
3. Collect the participant’s Tobacco Use calendar and enter the data for the previous week 
into the appropriate SPSS database, then return the calendar to the participant.  
4. Have the participant fill out all of the questionnaires related to the Session in REDCap, 
except the SECOND Minnesota Nicotine Withdrawal scale, and the SECOND 
Questionnaire of Smoking Urges. 
5. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
6. Tell the client that you are about to start the recording for their session. Explain that “this 
is a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 

66 
 
7. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded. 
8. Tell the participant to follow along in their client control workbook as you go through 
your therapist control manual. Remind them that the counseling could take up to 30 
minutes and they are urged to write down information in their workbooks.  
9. Make sure that you have gone over the Tobacco Use calendar before you finish the 
recording. Provide them with copies of the calendar to keep in their pocket/wallet for use 
when they do not have their manual. Ask that they bring back the calendar and workbook 
to each visit. 
10. After the therapy ask the participant if they have any questions.  If they do not, tell them 
you are ending the recording. 
11. Have the participant complete the remaining session measures (Credibility Expectancies 
Questionnaire, second Minnesota Nicotine Withdrawal Scale, and second Questionnaire 
of Smoking Urges). 
12. Schedule the next appointment for the following week (preferably the same day of the 
week and same time). Once you have it scheduled, make sure the appointment is 
placed in the Cropsey Lab Google Calendar.    
13. Compensate the participant on their Greenphire ClinCard. 
14. Give the participant an appointment card. 
15. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap.  
 
 
 
Week 3 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO.  
• If the CO is 3 or below, you need to administer a urine cotinine test to confirm 
that the participant is using nicotine products.   
3. Collect the participant’s Tobacco Use calendar and enter the data for the previous week 
into the appropriate SPSS database, then return the calendar to the participant.  
4. Have the participant fill out all of the questionnaires related to the Session in REDCap, 
except the SECOND Minnesota Nicotine Withdrawal scale, and the SECOND 
Questionnaire of Smoking Urges. 
5. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
6. Tell the client that you are about to start the recording for their session. Explain that “this 
is a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 
7. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded. 

67 
 
8. Tell the participant to follow along in their client control workbook as you go through 
your therapist control manual. Remind them that the counseling could take up to 30 
minutes and they are urged to write down information in their workbooks.  
9. Make sure that you have gone over the Tobacco Use calendar before you finish the 
recording. Provide them with copies of the calendar to keep in their pocket/wallet for use 
when they do not have their manual. Ask that they bring back the calendar and workbook 
to each visit. 
10. After the therapy ask the participant if they have any questions.  If they do not, tell them 
you are ending the recording. 
11. Have the participant complete the remaining session measures (Credibility Expectancies 
Questionnaire, second Minnesota Nicotine Withdrawal Scale, and second Questionnaire 
of Smoking Urges). 
12. Schedule the next appointment for the following week (preferably the same day of the 
week and same time). Once you have it scheduled, make sure the appointment is 
placed in the Cropsey Lab Google Calendar.    
13. Compensate the participant on their Greenphire ClinCard. 
14. Give the participant an appointment card. 
15. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap.  
 
 
Week 4 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO.  
• If the CO is 3 or below, you need to administer a urine cotinine test to confirm 
that the participant is using nicotine products.   
3. Collect the participant’s Tobacco Use calendar and enter the data for the previous week 
into the appropriate SPSS database, then return the calendar to the participant.  
4. Have the participant fill out all of the questionnaires related to the Session in REDCap, 
except the SECOND Minnesota Nicotine Withdrawal scale, and the SECOND 
Questionnaire of Smoking Urges. 
5. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
6. Tell the client that you are about to start the recording for their session. Explain that “this 
is a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 
7. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded. 
8. Tell the participant to follow along in their client control workbook as you go through 
your therapist control manual. Remind them that the counseling could take up to 30 
minutes and they are urged to write down information in their workbooks 

68 
 
9. Make sure that you have gone over the Tobacco Use calendar before you finish the 
recording. Provide them with copies of the calendar to keep in their pocket/wallet for use 
when they do not have their manual. Ask that they bring back the calendar and workbook 
to each visit. 
10. After the therapy ask the participant if they have any questions.  If they do not, tell them 
you are ending the recording. 
11. Have the participant complete the remaining session measures (Credibility Expectancies 
Questionnaire, second Minnesota Nicotine Withdrawal Scale, and second Questionnaire 
of Smoking Urges). 
12. Schedule the next appointment for the following week (preferably the same day of the 
week and same time). Once you have it scheduled, make sure the appointment is 
placed in the Cropsey Lab Google Calendar.    
13. Compensate the participant on their Greenphire ClinCard. 
14. Give the participant an appointment card. 
15. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap.  
 
 
 
Week 5 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to 
confirm that the participant is using nicotine products.   
3. Collect the participant’s Tobacco Use calendar and enter the data for the previous week 
into the appropriate SPSS database, then return the calendars to the participant.  
4. Have the participant fill out all of the questionnaires related to the session in REDCap, 
except the Alliance Questionnaire, SECOND Minnesota Nicotine Withdrawal Scale 
and the SECOND Questionnaire of Smoking Urges.  
5. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
6. Tell the client that you are about to start the recording for the session. Explain that “this is 
a manualized intervention; therefore it will not feel like traditional therapy. We will be 
working from a manual and will adhere to the manual content, exclusively.” 
7. Turn on the recording and state your name, the date, and the time that you are 
starting the therapy. Do your best not to say the participant’s name while being 
recorded.  
8. Tell the participant to follow along in their client control workbook as you go through 
your therapist control manual. Remind them that the counseling could take up to 30 
minutes and they are urged to write down information in their workbooks 
9. Make sure that you have gone over the Tobacco Use and NRT Use calendars before 
you finish the recording. Provide them with copies of the calendars to keep in their 

69 
 
pocket/wallet for use when they do not have their manual. Ask that they bring back the 
calendar and workbook to each visit. 
10. When appropriate, pause the audio recording and have the participant fill out the 
following: 
• The Alliance Questionnaire 
• The second Minnesota Nicotine Withdrawal Scale 
• The second Questionnaire of Smoking Urges 
• Based on the participant’s response to the Minnesota Nicotine 
Withdrawal Scale and the Questionnaire of Smoking Urges, graph the 
before and after scores in their workbook. 
11. Un-pause the audio recording and continue the intervention by going over the 
participant’s before and after scores for the Minnesota Nicotine Withdrawal Scale and 
Questionnaire of Smoking Urges. 
12. Review each of the short-acting forms of NRT with the participant. Answer any questions 
the participant has regarding the medications. Present the medication selection sheet, 
review it with the participant, and explain that they will be selecting their preferred short-
acting NRT to use in conjunction with the patch for the rest of the medication period of 
the study. Once the participant has made a selection, enter it into REDCap and ask them 
to write it in their manual.   
13. After the therapy, ask the participant if they have any questions. If they do not, tell them 
you are ending the recording. 
14. Schedule the next appointment for the next week (preferably the same day of the week 
and the same morning time). This appointment should be scheduled with another study 
staff member other than the therapist who saw the participant for the five weekly 
sessions. Once you have it scheduled, make sure the appointment is placed in the 
Cropsey Lab Google Calendar. 
15. Give the participant 7 patches. The patches will last through to the next appointment.   
16. Give the participant enough of the short-acting NRT they chose to last through to the next 
appointment. 
17. Have the participant sign for the medication in the medication sign-out log. 
18. Mark in the Medication Inventory Excel sheet how many of the patches and gum 
packages/lozenge quit tubes/inhaler cartridges/nasal spray bottles you have given out so 
that we maintain a running total of prescriptions we have on hand. 
19. Remind the participant of the instructions on how to use the patches and 
gum/lozenges/inhaler/nasal spray and let them know they can reference their workbook if 
they forget.  
20. Make sure to give the participant the slip card. 
21. Give the participant a study phone and charger and instruct them to complete the EMA’s 
daily. 
22. Compensate the participant on their Greenphire ClinCard. 
23. Give the participant an appointment card. Also, remind them to bring all used and 
unused patches, patch packets, and short-acting NRT back to the next appointment.  
24. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap. 
 
 

70 
 
Weeks 6, 9 & 13 
 
Week 6 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to 
confirm that the participant is using nicotine products.   
3. Have the participant fill out all of the questionnaires related to the session in REDCap. 
4. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
5. Ask the participant if they experienced any issues in the past week with the short-acting 
NRT they selected. If they report experiencing issues, follow the discussion guidelines in 
the therapist manual.  
6. If the participant reports issues, determine whether the dosage of the short-acting NRT 
they selected should be lowered.  
7. Remind the participant of the instructions on how to use the patches and 
gum/lozenges/inhaler/nasal spray and let them know they can reference their workbook if 
they forget.  
8. Ask the participant if they have any questions. 
9. Schedule the next appointment in three weeks (preferably the same day of the week and 
the same morning time). This appointment should be scheduled with another study staff 
member other than the therapist who saw the participant for the five weekly sessions. 
Once you have it scheduled, make sure the appointment is placed in the Cropsey 
Lab Google Calendar. 
10. Give the participant 21 patches. The patches will last through to the next appointment.   
11. Give the participant enough of the short-acting NRT they chose to last through to the next 
appointment. 
12. Have the participant sign for the medication in the medication sign-out log. 
13. Mark in the Medication Inventory Excel sheet how many of the patches and gum 
packages/lozenge quit tubes/inhaler cartridges/nasal spray bottles you have given out so 
that we maintain a running total of prescriptions we have on hand. 
14. Compensate the participant on their Greenphire ClinCard. 
15. Give the participant an appointment card. Also, remind them to bring all used and 
unused patches, patch packets, and short-acting NRT back to the next appointment.  
 
Week 9 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to 
confirm that the participant is using nicotine products.   
3. Have the participant fill out all of the questionnaires related to the session in REDCap. 

71 
 
4. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires.  
5. Ask the participant if they experienced any issues in the past three weeks with the short-
acting NRT they selected. If they report experiencing issues, follow the discussion 
guidelines in the therapist manual.  
6. If the participant reports issues, determine whether the dosage of the short-acting NRT 
they selected should be lowered.  
7. Remind the participant of the instructions on how to use the patches and 
gum/lozenges/inhaler/nasal spray and let them know they can reference their workbook if 
they forget.  
8. Discuss the purpose of tapering medication dosage and review tapering instructions. 
9. Ask the participant if they have any questions. 
10. Schedule the next appointment in a month (preferably the same day of the week and the 
same morning time). This appointment should be scheduled with another study staff 
member other than the therapist who saw the participant for the five weekly sessions. 
Once you have it scheduled, make sure the appointment is placed in the Cropsey 
Lab Google Calendar. 
11. Give the participant 28 patches (14 14mg patches and 14 7mg patches). The patches will 
last through to the next appointment. See therapist manual for tapering guidelines.   
12. Give the participant enough of the short-acting NRT they chose to last through to the next 
appointment. See therapist manual for tapering guidelines.  
13. Have the participant sign for the medication in the medication sign-out log. 
14. Mark in the Medication Inventory Excel sheet how many of the patches and gum 
packages/lozenge quit tubes/inhaler cartridges/nasal spray bottles you have given out so 
that we maintain a running total of prescriptions we have on hand. 
15. Compensate the participant on their Greenphire ClinCard.  
16. Give the participant an appointment card. Also, remind them to bring all used and 
unused patches, patch packets, and short-acting NRT back to the next appointment.  
17. Upload the session recording to Box.com (MOP, pg. 14) and complete the Audio 
Recording Length form in REDCap. 
 
 
Week 13 
 
1. Check to see if any information on participant’s contact sheet needs to be updated. 
2. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to confirm 
that the participant is using nicotine products.   
3. Collect the study phone and charger given to the participant. 
4. Have the participant fill out all of the questionnaires related to the session in REDCap. 
5. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires. 

72 
 
6. Schedule the next appointment in a month (preferably the same day of the week and the 
same morning time). This appointment should be scheduled with another study staff 
member other than the therapist who saw the participant for the five weekly sessions. 
Once you have it scheduled, make sure the appointment is placed in the Cropsey 
Lab Google Calendar. 
7. Compensate the participant on their Greenphire ClinCard. 
 
Month 1 Follow-up 
 
8. Check to see if any information on participant’s contact sheet needs to be updated. 
9. Administer the CO test. Refer to the CO directions under the “CO Monitor” section on 
Page 8 of this manual. Record the CO level in REDCap. 
• If the CO level is 3 or below, you need to administer a urine cotinine test to confirm 
that the participant is using nicotine products.   
10. Have the participant fill out all of the questionnaires related to the session in REDCap. 
11. While the participant is filling out the questionnaires on REDCap, have REDCap open on 
the desktop and double check for participant entry errors as they progress through the 
questionnaires. 
12. Compensate the participant on their Greenphire ClinCard. 
13. Thank the participant for being a part of the study. 
 
Ecological Momentary Assessment (EMA) 
 
Ecological Momentary Assessment (EMA) is a platform we will be using to conduct daily 
assessments of smoking behavior, medication adherence, mood, sleep, and social support. This 
technology is provided by the University of Oklahoma Health Services Center, and they will be 
assisting with set up. Participants will be given a smart phone during their Week 5 appointment 
and will return the smart phone to study staff during their Week 13 appointment. Each day, 
within 30 minutes of waking, participants will receive a text on this smart phone with a link to 
the following survey questions: 
 
1. How many cigarettes did you smoke yesterday? 
2. Did you use any other tobacco products yesterday? 
3. I am motivated to AVOID smoking. 
4. Did you receive the nicotine patch at your last visit? 
5. Did you use your nicotine patch yesterday? 
6. What are the main reasons you did not use the patch? 
7. How many hours did you wear your patch? 
8. What other medication did you receive? 
9. Did you use your (other medication) yesterday? 
10. What are the main reasons you did not use the (other medication)? 
11. How much of (other medication) did you use yesterday? 
12. How confident are you that you will be able to fully quit smoking? 
13. Did you drink alcohol yesterday? 
14. How many standard drinks did you have yesterday? 
15. Did you use marijuana yesterday? 

73 
 
16. Do you believe you experienced discrimination yesterday? 
17. What do you believe was the main reason(s) for the discrimination? 
18. Sometimes people do not fall asleep right away when they go to bed at night. What time 
did you actually fall asleep last night? 
19. What time did you wake up this morning? 
20. How would you rate the quality of your sleep last night? 
21. How much support from friends/family members did you receive yesterday to help you 
with quitting smoking? 
22. Did you feel like you needed the support yesterday to help you with quitting? 
23. I have an urge to smoke. 
24. I feel stressed. 
25. I feel irritable. 
26. I feel happy. 
27. I feel frustrated /angry. 
28. I feel sad. 
29. I feel worried. 
30. I feel miserable. 
31. I feel restless. 
32. I feel calm. 
33. I feel bored. 
34. I feel depressed. 
35. I feel anxious. 
36. Cigarettes are available to me. 
 
Response options will be no/yes, Likert-type, or continuous scale depending on the question.  
 
Participants who complete 90% of the EMAs and return the smart phone will be compensated 
with a one-time payment of $100 during their Week 13 appointment. If participants complete 
80% of the EMAs, they will be compensated with a one-time payment of $75 during their Week 
13 appointment. If participants complete 50% of the EMAs, they will be compensated with a 
one-time payment of $50 during their Week 13 appointment.  
 
 
Data Entry 
 
Includes all aspects of data planning, handling, analysis, documentation, and storage, and takes 
place during all stages of a study. The objective is to create a reliable data base containing high 
quality data.  Management is a too often neglected part of study design, and includes: 
 
• Planning the data needs of the study 
• Data collection 
• Data entry 
• Data validation and checking 
• Data manipulation 
• Data files backup 
• Data documentation 

74 
 
Each of these processes requires thought and time; each requires painstaking attention to detail. 
The main elements of data management are database files. The data will be managed via 
REDCap.  
 
 
Data Collection Parameters 
 
Below is a guide to best understand the forms we are using within this study and how they 
should be collected in the most efficient manner: 
 
• CO Level: Based on reading from CO Machine and entered in REDCap. Completed at 
all visits. 
• Cotinine Test: Based on result from cotinine strip test and entered in REDCap. 
Completed at Baseline and as needed for all other visits. 
• Medication Given: Select the dosage of patch and gum/lozenge/inhaler/nasal spray that 
the participant is receiving at the session that day. Select N/A for either or both 
medication types if the participant is not receiving medication. Completed at all visits.  
• Tobacco/NRT Calendars (Weekly/Monthly): While the participant fills out the 
questionnaires in REDCap through the Survey Queue, you will bring up REDCap on the 
desktop computer and enter in the information from the calendars into the proper 
REDCap forms. Completed at each session visit. 
• Demographics Form: Subject fills out form within REDCap survey cue. Verify form is 
completed before allowing participant to leave. Only completed at Baseline. 
• Minnesota Nicotine Withdrawal Scale: Subject fills out form within REDCap Survey 
Queue. Verify form is completed before allowing participant to leave. Completed at all 
visits. 
• Questionnaire of Smoking Urges-Short Form (QSU): Subject fills out form within 
REDCap Survey Queue. Verify form is completed before allowing participant to leave. 
Completed at all visits. 
• Smoking History Form: Subject fills out form within REDCap Survey Queue. Verify 
form is completed before allowing participant to leave. Only completed at Baseline. 
• Weekly Smoking Behavior: Subject fills out form within REDCap Survey Queue. 
Verify form is completed before allowing participant to leave. Completed at all visits. 
• Thoughts About Abstinence: Subject fills out form within REDCap Survey Queue. 
Verify form is completed before allowing participant to leave. Completed at all visits. 
• Fagerström Test for Nicotine Dependence (FTND): Subject fills out form within 
REDCap Survey Queue. Verify form is completed before allowing participant to leave. 
Completed at Baseline, Week 5, Week 6, Week 9, Week 13, and Month 1 Follow-up. 
• Perceived Stress Scale (PSS): Subject fills out form within REDCap Survey Queue. 
Verify form is completed before allowing participant to leave. Completed at all visits. 
• Wisconsin Inventory of Smoking Dependence Motives: Subject fills out form within 
REDCap Survey Queue. Verify form is completed before allowing participant to leave.  
Completed at Baseline, Week 5, Week 6, Week 9, Week 13, and Month 1 Follow-up. 

75 
 
• Attitudes About Nicotine Replacement Therapy: Subject fills out form within 
REDCap Survey Queue. Verify form is completed before allowing participant to leave. 
Completed at all visits. 
• Abstinence-Related Motivational Engagement (ARME): Subject fills out form within 
REDCap Survey Queue. Verify form is completed before allowing participant to leave. 
Completed at all visits. 
• Smoking Abstinence Questionnaire (SAQ): Subject fills out form within REDCap 
Survey Queue. Verify form is completed before allowing participant to leave. Completed 
only at Baseline, Week 5, Week 6, Week 9, Week 13, and Month 1 Follow-up. 
• Symptoms/Side Effects Scale: Subject fills out form within REDCap Survey Queue. 
Verify form is completed before allowing participant to leave. Completed at all visits, 
except Month 1 Follow-up. 
• Treatment Expectations: Subject fills out form within REDCap Survey Queue. Verify 
form is completed before allowing participant to leave. Completed at all visits. 
• Treatment Satisfaction Survey: Subject fills out form within REDCap Survey Queue. 
Verify form is completed before allowing participant to leave. Completed only at Week 
5, Week 13, and Month 1 Follow-up. 
• Credibility Expectancy Questionnaire (CEQ): Subject fills out form within REDCap 
Survey Queue. Verify form is completed before allowing participant to leave. Completed 
only at Week 5, Week 13, and Month 1 Follow-up. 
• Minnesota Nicotine Withdrawal Scale 2: Subject fills out form within REDCap Survey 
Queue. Verify form is completed before allowing participant to leave. Completed only 
at Week 1, Week 2, Week 3, Week 4, and Week 5. 
• Questionnaire of Smoking Urges-Short Form 2 (QSU): Subject fills out form within 
REDCap Survey Queue. Verify form is completed before allowing participant to leave. 
Completed only at Week 1, Week 2, Week 3, Week 4, and Week 5. 
• Alliance Questionnaire: Subject fills out form within REDCap Survey Queue. Verify 
form is completed before allowing participant to leave. Completed only at Week 5. 
• Alliance Questionnaire-Therapist: The staff fills out this questionnaire in REDCap 
after the conclusion of the appointment. This can be filled out after the participant has 
left. Completed only at Week 5. 
• Mini International Neuropsychiatric Interview (M.I.N.I): This is a paper interview 
that is given by the staff and is entered into REDCap at the completion of the study visit. 
Completed only at Baseline. 
• Pittsburgh Sleep Quality Index: Subject fills out form within REDCap Survey Queue. 
Verify form is completed before allowing participant to leave. Completed at all visits. 
• Barratt Impulsivity Scale: Subject fills out form within REDCap Survey Queue. Verify 
form is completed before allowing participant to leave. Completed only at Baseline. 
• Group Assignment: This form in REDCap randomizes the participants into one of the 
Intervention or Control groups for the remainder of the study. Completed only at 
Baseline. 
• Audio Recording Length (Counseling Session): This is the length of the counseling 
session for each weekly session appointment and will be recorded in REDCap at the 
conclusion of the study visit. Completed only at Week 1, Week 2, Week 3, Week 4, 
and Week 5.  

76 
 
Amendments/Protocol Changes 
 
• 7-17-18 - This amendment clarified errors to reflect the protocol; added a compensation 
of $5 for baseline failures, method of compensation, EMA compensation, removed 
documenting distributed compensation section, revised materials, procedures, and 
therapy protocol sections. 
• 8-6-19- For this amendment, we added amendment dates to the Amendments/Protocol 
Changes section and made changes to correctly reflect our existing protocol.