Clinical trial NCT03276780
Conditions: Smoking Cessation
Sponsor: University of Alabama at Birmingham
Start date: 2018-05-03; Completion date: 2020-10-31
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To determine the preliminary impact on Nicotine Replacement Therapy (NRT)adherence and examine the underlying mechanisms of action associated with adherence.

Detailed description:
Adherence is a critical target for successful smoking cessation, with good adherence associated with a three-fold increase in cessation rates relative to poor adherence. Psychoeducational interventions focused on increasing adherence to NRT do not result in behavioral change (e.g., smoking cessation). Experiential approaches, such NRT sampling with practice quit attempts (PQAs), are based on learning theory models of behavioral change and have resulted in increased motivation, self-efficacy, adherence, and abstinence relative to psychoeducation or motivational interventions. However, nicotine sampling still relies of the participant using NRT outside of session, which may not occur. Providing an experiential intervention in which the NRT is sampled and any problems with NRT reframed during the session may provide a powerful learning experience that can increase in home sampling with PQAs and long-term adherence, ultimately increasing the likelihood of smoking cessation. This may be particularly relevant for low-income smokers who hold more negative views of NRT, have lower health literacy, and are less likely to use medication during cessation attempts.

Arms: arm 1: Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt. arm 2: Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.
Interventions: intervention 1: Counseling intervention 2: combination NRT
Intervention descriptions: intervention 1: Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking intervention 2: Both groups will receive combination NRT to help with smoking cessation

Protocol documents:
SAP_002.pdf: 
Nicotine Replacement Therapy Sampling & Selection 
 
Study Statistical Analysis Plan 
 
 
 
 
 
 
NCT03276780 
 
 
May 19, 2021 
 
 
 
Karen Cropsey, PsyD, Principal Investigator 
University of Alabama at Birmingham 
Birmingham, AL 35294 


A. Significance.   
Smoking Prevalence in Low Income Populations. Cigarette smoking is responsible for 1 in 5 overall deaths 
and remains the leading cause of death and disability in the United States (U.S)1,2. While smoking prevalence 
has declined from a high of 45% in the 1960s to 16.4% in 2014 among the general population1,2, smoking 
prevalence has remained high (26.3%) among those living in poverty as well as those with less than a high 
school education (22.9%-43%)1. Alabama has one of the highest rates of poverty (19.3% of the Alabama 
population lives in poverty compared to 14.8% in the U.S. generally) and is ranked 48th in the nation with only 
New Mexico, Louisiana, and Mississippi having higher poverty rates in the U.S.3,4. Not surprisingly, Alabama 
also has some of the highest prevalence rates of smoking (22.1%; 42nd among states5) in the U.S., with the 
highest prevalence rates among those without a high school diploma (40.9%)5. Alabama ranks among the 
worst for state-wide initiatives to limit tobacco use and exposure5. For example, Alabama does not have 
statewide smoke-free laws, the state allows sampling and the display of tobacco products in commercial 
venues, does not provide state Medicaid-covered tobacco treatment (and rejected Medicaid expansion under 
the Affordable Care Act), and also has some of the lowest cigarette taxes nationally ($0.425 per pack; 46th 
among states) relative to almost any other state in the nation5. The decline in smoking in Alabama has been 
much slower than the national average, likely due to the lack of prevention messaging and treatment 
availability as well as the high rates of poverty and low educational attainment5.  
 
Smoking Interventions among Low Income Populations. Few interventions have been specifically 
designed or tested in low income smokers. The few interventions that have been tested generally were pilot 
studies6-9. Overall, these pilot studies find that it is feasible and acceptable to intervene with low income 
smokers in a variety of settings including psychiatric patients in an urban public hospital6, parents of Head Start 
children7, and primary care safety net settings8-9. Larger clinical trials with low income populations have either 
focused on increasing motivation to utilize existing smoking cessation resources (e.g., tobacco quit lines) 10-14 
or have used proactive tobacco cessation outreach13-14 to increase engagement in treatment. Use of 
motivational interviewing (MI) was found to increase tobacco quit line calls over standard referrals10 as well as 
abstinence11;13. However, MI was not found to increase abstinence compared to standard of care when both 
groups received NRT12. African American smokers engaged in care at a Veteran’s Administration setting had 
higher cessation relative to White smokers, regardless of provision of proactive or standard cessation 
treatment14, suggesting no racial differences when provision of care is equally available. Similarly, in our own 
smoking cessation study of individuals under criminal justice supervision, no racial differences were found 
among participants who were adherent to bupropion15, regardless of the amount of behavioral counseling 
received. Importantly, standard behavioral counseling did not enhance adherence to medication, despite the 
focus on the importance of adherence during counseling sessions. In summary, while motivational approaches 
and proactive referrals did not generally increase cessation on their own, they did improve access to existing 
services. Further, standard smoking cessation counseling did not improve medication adherence and novel 
interventions are needed to increase adherence to medications, particularly in low income populations.  
 
Medication Adherence. More than 75% of individuals prescribed medications for chronic diseases do not use 
them as directed and medication non-adherence costs the healthcare system more than $300 billion annually 
in preventable hospitalizations.16 Several factors have been found to be associated with non-adherence 
including low perceived efficacy of the medication, side effects, complicated medication regimens, poor 
relationship with the provider, low health literacy, and medication costs and co-pays for prescriptions17-19. 
Adherence is particularly low among individuals from disadvantaged communities due to negative perceptions 
of the healthcare system including less trust in medical providers, lower belief about the efficacy of medication, 
difficulty accessing services, and lower health literacy20-21. In fact, developing interventions to improve 
medication adherence in these populations has been identified as the single best means to reduce health 
disparities over other targets such as equalizing access to healthcare or reducing provider discrimination22.  
Adherence to smoking cessation pharmacotherapies is similarly poor as most people do not use 
pharmacotherapy when attempting to quit smoking23, and among individuals who use smoking cessation 
medication, 69% prematurely quit use of medication24. Rates of non-adherence to NRT are particularly high 
with approximately 76% prematurely discontinuing NRT24. However, medication adherence is critical for 
successful cessation and adherence to smoking pharmacotherapies triples the rates of cessation25-27. Similar 
to medication adherence generally, misperceptions about the safety and efficacy of NRT has undermined 
effective use of these medications, particularly among disadvantaged populations24-25; 28-29. African American 
smokers report less lifetime use of smoking cessation pharmacotherapy30, hold less positive attitudes about 


the use of pharmacotherapy for cessation, report more concerns about the addiction potential, efficacy, 
potential for interactions with other medications and harms of pharmacotherapy, and are uncertain about the 
need for pharmacotherapy for cessation relative to White, non-Hispanic smokers31-32. This mistrust of 
medications among disadvantaged populations may be a leading factor contributing to racial disparities in 
smoking cessation and finding novel mechanisms to increase adherence is a critical step to reduce disparities.  
Despite the known problems associated with medication adherence for NRT use in smoking cessation, 
we found only a few published studies that targeted adherence to pharmacotherapy specifically as an 
intervention. These studies showed that brief psychoeducation about NRT can both improve attitudes toward 
NRT33-34 as well as increase intentions for future use35. Similarly, a recent Cochrane review of eight studies on 
interventions designed to increase adherence to smoking pharmacotherapy (all educational in nature) noted an 
increase in reported adherence among the intervention over control conditions (RR:1.14); although this 
dropped to a non-significant difference when using a random-effects model to account for heterogeneity 
among study designs and characteristics36. However, this review and other studies measuring more important 
clinical changes such as smoking cessation did not find psychoeducation alone to be effective34,36. These 
findings mirror results from adherence interventions with chronic diseases37-43 which noted that while self-
reported adherence improved with educational interventions, only 8 out of 57 studies demonstrated 
improvements in measurable clinical outcomes (e.g., a decrease in blood pressure. etc.). The lack of 
meaningful clinical change in both studies of chronic disease as well as smoking cessation demonstrated the 
lack of efficacy for educational interventions alone for improving adherence42. However, experiential 
interventions appear to be a more promising approach for increasing NRT adherence.  
 
Experiential Approaches for Increasing Adherence.  While education about the benefits and safety of NRT 
do not appear to lead to improved utilization of smoking pharmacotherapy during quit attempts, more “hands 
on” experiences with NRT do appear to increase utilization and cessation. For example, participants who 
previously used pharmacotherapy in a quit attempt were more likely to be adherent with pharmacotherapy in 
subsequent attempts44. This suggests that experience with smoking pharmacotherapy may be one way to 
increase medication adherence and subsequent abstinence. Indeed, support for such a strategy has been 
found in studies that have examined the effects of NRT sampling. In at least two clinical trials testing a 
sampling intervention, providing 1-2 week NRT samples for practice quit attempts (PQAs) was shown to 
produce positive change in process measures as well as actual cessation45-46. Thus, providing medication to 
increase experience with pharmacotherapy, even among non-treatment seeking smokers, may be an important 
mechanism to increase motivation and adherence in a future quit attempt. Similarly, providing NRT for in-
session sampling improved perceptions of NRT over psychoeducation without in-session sampling of NRT47-48.  
Although these studies provided nicotine samples to use in practice quit attempts or to improve 
perceptions of NRT in-session47-48, they did not investigate using NRT in-session with the goal of increasing 
experience with NRT to boost cessation. Further, these studies did not examine how patient preference may 
impact cessation. A study that provided participants with different forms of NRT to use at home and then select 
their preferred NRT to use for cessation demonstrated smoking reduction49. However, a subsequent study 
targeting cessation using a patient’s preferred product versus randomized product did not find significant 
differences for cessation50, suggesting results of using a preferred NRT product are mixed and in need of 
additional study. Preferred product selection is an important clinical practice issue since patient preference for 
specific medications is likely a consideration when prescribing treatment. Importantly, and most relevant to the 
proposed project, these studies did not provide in-session experience with these products as part of the patient 
preference process. Our novel approach combines the most promising elements of all of these NRT sampling 
approaches. We will prospectively pilot a 4 week intervention providing in-session NRT sampling of four short 
acting NRT products (gum, inhaler, lozenge, nasal spray) in combination with nicotine patch. Use of these 
products will occur in real time during session and expectancies about NRT will be discussed and perceptions 
of NRT explored. Participants will be given a one week sample of these products for at home practice quit 
attempts to acclimate to these medications. At the end of the 4 week sampling period, participants will select 
their preferred short acting NRT to use in conjunction with nicotine patch to make a sustained quit attempt. 
Importantly, we believe that in-session experience with NRT coupled with at home PQAs are both critical as it 
is experience with medication and determining subsequent NRT preference that may be most strongly 
associated with adherence and subsequent meaningful clinical outcomes such as medication uptake and 
abstinence. But first we need to pilot this intervention to determine if this experiential intervention coupled with 
counseling about NRT expectancies as well as the positive and negative effects of NRT can increase 
adherence over standard cessation treatment. 


 
B.  Innovation  
This proposal builds on and extends previous NRT sampling research. First, while NRT sampling has been 
shown to increase quit attempts, abstinence, indicators of cessation readiness, and perceptions about NRT, 
this approach still relies on the patient to use the NRT on their own after session45-46; 49-50. Even the previous 
studies that have provided NRT in-session have done so for the purpose of determining participant 
preferences and did not use these sessions for addressing misperceptions or experiences of using NRT or 
follow-up on adherence or cessation outcomes47-48. Sampling interventions that allowed participants to take 
home various forms of NRT and then select their preferred NRT did not provide the NRT in-session to 
determine actual use of the medication or address misperceptions of these products49-50. Thus, the most 
important and innovative aspect of our proposed study is that this approach will provide in-session use of NRT 
in a prescriptive and controlled fashion for the purposes of addressing misperceptions and providing 
experience with the medication, thereby increasing medication adherence. Then participants will practice use 
of these medications at home in a naturalistic environment to acclimate and make PQAs. This combined 
approach has several benefits including a) the assurance that the smoker actually tries NRT, b) the ability to 
highlight positive aspects of NRT experiences (e.g., relief of withdrawal and urge), c) the capacity to address 
misperceptions and provide feedback and guidance on any experienced adverse events in real time NRT use, 
d) and the chance to use NRT for PQAs in a naturalistic environment. Smokers on their own may never 
actually try the medication or may discontinue their brief use of NRT if they experience negative effects e.g., 29,35. 
This In vivo approach with PQAs remedies these shortcomings. A second innovation is that we will have allow 
participants to sample all available acute acting NRT formulations in combination with nicotine patch both in 
session and at home for PQAs and then select their preferred acute product to use with the patch for optimal 
effectiveness. Combined NRT has been shown to be as effective as varenicline for smoking cessation51 and 
providing In vivo experience with using these products in combination may be particularly effective to promote 
adherence and cessation. Allowing the participant to select their preferred short acting product is believed to 
increase engagement and abstinence self-efficacy, both of which are believed to increase medication 
adherence. Finally, this intervention can be provided by non-therapy professionals as it does not require 
extensive training in motivational interviewing, cognitive-behavioral therapy, or other significant therapeutic 
skills. This element makes this intervention very translatable to low resource settings. Importantly, In vivo 
approaches may be particularly important for low income smokers who have limited experience with use of 
medications, low health literacy, and a distrust of the medical community18,20.  
 
C.  Approach 
Design and Overview. This pilot study will examine the feasibility, acceptability, and preliminary impact of 
providing an In vivo intervention with NRT to increase NRT adherence compared to the control group. The 
intervention will be tested and refined initially with 10 participants in the In vivo NRT group (In vivo). Following 
the pre-pilot testing, 80 participants will be randomized to either the 1) In vivo or 2) Standard of Care (SC). All 
participants will complete approximately 60 minutes of baseline assessment to determine smoking history and 
characteristics prior to randomization, including previous experience with NRT. In vivo participants will be 
provided with each of the four forms of acute NRT (gum, lozenge, nasal spray, inhaler per week; 
counterbalanced across sessions by participant) to use in each 30 minute session in conjunction with a 
nicotine patch. In session, they will discuss their In vivo experience of using each combination NRT at each of 
the four sessions. To bolster their in vivo NRT experience, participants will be provided with a weekly sample of 
each NRT product to use between sessions to acclimate to the medication and to make PQAs. After the 4 
week In vivo intervention period, participants will select their preferred acute NRT product to use with the 
nicotine patch (combination NRT; cNRT) to use for cessation over the next eight weeks. SC participants will 
receive four sessions of standard behavioral smoking cessation counseling and will select their preferred acute 
NRT (gum, lozenge, nasal spray, inhaler) based on product description. Thus, both groups will receive cNRT 
for 8 weeks total to make a quit attempt. All participants will continue to receive medication and monitoring for 
side effects, regardless of their medication adherence. Study visits occur at baseline (Week 0), intervention 
Weeks 1-4, medication selection/quit goal setting visit at Week 5, medication check (Week 6) Weeks 9 and 13 
(end-of-treatment), and follow-up at one month later (Week 17; see Figure 1 for Study Design).  
 
Preliminary Studies.  The PI and her team have completed studies directly relevant to the current proposal 
and have worked with several different low income and disadvantaged populations such as individuals in the 
criminal justice system and Persons Living with HIV (PLWH). 
  
 


Figure 1:  Proposed Study Design from Recruitment to One Month Follow-up  
 
 
 
 
1. Importance of Medication Adherence. Our group was the first to provide a cessation intervention to smokers 
under community corrections supervision at their point of monitoring (R01CA141663). We provided 12 weeks 
of bupropion to smokers, and randomized them to 
either four 30 minute sessions of standard smoking 
cessation counseling or brief physician advice to quit 
smoking. We randomized 500 smokers in 40 months 
and our results demonstrate the feasibility and 
acceptability of enrolling low income smokers for 
cessation. Although the majority of our participants 
reduced their cigarettes smoked per day (cpd) by the 
end-of-treatment (EOT) from baseline levels (reduced 
from 15 cpd to 7 cpd), only about 6% were abstinent 
at any particular time point (EOT: 9.3%) with no 
differences in cessation between our two groups. The 
most important predictor of successful cessation was 
medication adherence, with individuals who reported 
at least 80% adherence to 12 weeks of bupropion 
treatment (44% adherence) demonstrating an EOT 
quit rate of 17% vs. 4% for non-adherent participants 
with a biochemical CO verified cutoff of <3 ppm 
(p<0.001). To compare to the existing treatment 
literature which generally uses a CO cutoff of 10 ppm, quit rates were 48% vs. 13% (p<0.001) for adherent and 
non-adherent participants, respectively, at EOT. In either scenario, smoking cessation rates was quadrupled 
among adherent individuals and suggests adherence as critical target for low income smokers15. 
 
2. Prior Medication Use, Adherence, and Cessation. In a follow-up analysis, we examined prior use of 
bupropion in relationship to adherence and cessation. While only 26 participant (5%) reported prior use of 
bupropion, smokers with prior bupropion use were significantly more likely to rate bupropion as helpful for 
smoking cessation at baseline (p=0.025) compared to smokers without prior experience with bupropion. We 
ran univariate analyses to determine the factors associated with adherence. Of the almost 50 variables 
examined including demographics (age, sex, race, income, etc.), dependence, withdrawal, craving, and 
smoking history, (e.g., age of first smoking, number of previous quit attempts, etc.) only five variables were 
significantly associated with bupropion adherence: race, age, prior bupropion use, treatment group, and 
percentage of friends who smoke. When these variables were simultaneously entered into a logistic regression 
model, prior use of bupropion was the single best predictor of adherence (OR=3.50; CI: 1.45-8.47; p=0.005).  
We examined univariate predictors of being abstinent (7 days abstinent, CO < 3ppm) at any time during 
treatment (“floating abstinence”) and found several variables associated with abstinence including age, race, 
age of first tried smoking, cigarettes per day, abstinence self-efficacy, motivation, nicotine dependence, 
craving, difficulty of prior quit attempt, medication adherence, desire to quit in the next 30 days, and prior 
bupropion use. Using logistic regression, we found that medication adherence was the single best predictor of 
abstinence (OR=2.29; 1.32-3.97; p=0.003). Cigarettes per day was the only other variable associated with 
abstinence (OR=0.939; 0.898-0.981; p=0.005).  
 
Given the associations between a) prior use of bupropion and medication adherence and b) medication 
adherence and abstinence, we were interested in testing a mediation model of these relationships. We found 
evidence of mediation such that the relationship between previous use of bupropion and smoking abstinence 
was significantly mediated by medication adherence (see Figure 2)53. We also tested mediation models that 
included motivation to quit, abstinence self-efficacy, interest in quitting, and belief in the efficacy of bupropion 
Pre-pilot 
N= 10 
Randomize 
N= 80 
In vivo  
N= 40 
Standard Care  
N= 40 
Primary Outcomes 
     Feasibility/Acceptability 
NRT Adherence 
 
Previous Use 
of Bupropion 
Medication 
Adherence 
Smoking 
Abstinence 
1.12 (0.44)** 
0.93 (0.24)*** 
0.74 (0.44)* 
Sobel Test: 2.13 (0.49), p =.033 
*p<0.10; **p<0.01; ***p<0.001 
Figure 2: Mediation Model 


and did not find significant mediation effects of these variables for the relationship between previous use of 
medication and smoking cessation. Thus, it appears that previous experience with medication is related to 
improvements in medication adherence, which is then associated with smoking abstinence and these 
associations are not accounted for by motivation, abstinence self-efficacy, or self-reported belief in the efficacy 
of medication. In other words, it is the concrete experience of using a medication that is most strongly 
associated with downstream uptake, adherence, and abstinence.    
 
3. A Pilot of In vivo Nicotine Sampling with PQAs. We randomized 47 community corrections smokers to either 
4 sessions of In vivo NRT sampling with PQAs between sessions: Session 1 (S1): patch, S2: gum, S3: 
combination, S4: review quit attempt or 4 sessions of standard smoking cessation counseling (SC) with 
combination patch and gum. Both interventions were delivered by undergraduate students with minimal 
training in smoking cessation interventions but who were trained to follow the treatment manual. Medication 
was provided up to 12 weeks with additional study visits at weeks 8 and 12. In vivo participants demonstrated 
in session decreases in both withdrawal and craving relative to SC which illustrates the feasibility and 
acceptability of administering NRT in session to effect. When good adherence was calculated (defined as use 
of 80% of prescribed doses), participants in the In vivo group had a higher adherence rates to the patch 
(78.9% vs. 56.3%; p=0.15; converted Cohen’s d=0.502), gum (57.9% vs. 20%; p=0.026; converted Cohen’s 
d=0.828) and combination NRT (cNRT; 42.1% vs. 20%; p=0.17; converted Cohen’s d=0.483) relative to 
Controls at Week 4. By Week 8, good adherence to nicotine patch had attenuated, although differences for 
adherence to gum (54.5% vs. 15.4%; p=0.04; converted Cohen’s d=0.91) and cNRT (36.4% vs. 15.4%, 
p=0.237; converted Cohen’s d=0.498) remained present between groups. By Week 12, no significant 
differences on good adherence were noted between the groups. A trend for better short-term abstinence was 
found for In vivo participants versus SC (10% vs. 0%, p=0.19; converted Cohen’s d=0.44) at Week 4, although 
these differences attenuated by Week 12.  While this study demonstrated good effects of the In vivo construct, 
this approach has several limitations compared to the proposed approach. First, participants only sampled gum 
and did not have a choice in the short-acting NRT to use with patch which does not reflect the real-world 
options for short-acting NRT. In addition, this pilot recruited only participants in community corrections and did 
not recruit low income participants without criminal justice involvement. While developing effective 
interventions for criminal justice populations is important, testing this approach with more general populations 
of low income smokers is needed initially. Finally, this project was a pilot trial with small numbers of 
participants and did not examine long-term outcomes after the 12 weeks of NRT administration and long-term 
outcomes are necessary to determine real-world impact. 
These studies demonstrate our experience developing interventions with low income populations and 
the significance of the proposed approach. However, while our data as well as previous NRT sampling 
interventions are suggestive of the importance of NRT experience for subsequent cessation, pilot data are 
needed to determine the mechanisms of action associated with medication adherence. We will examine 
whether providing an In vivo NRT sampling intervention increases adherence over SC and whether this is due 
to increased positive NRT expectancies and abstinence self-efficacy as well as decreases in withdrawal and 
cravings. This is a necessary first step prior to launching a larger clinical trial examining this In vivo intervention 
for increasing abstinence.  
 
Participant Availability, Feasibility and Rate of Enrollment.  Participants will be recruited from the 
Birmingham metro community with flyers hanging at different community locations that serve low income 
smokers (e.g., bus stops, medical student run medical clinic servicing indigent patients, etc.). Based on our 
previous studies with similar populations as well as the high rates of smoking in Alabama, we do not anticipate 
any problems in recruiting the necessary study population. In our previous study with community corrections 
smokers, we screened 650 potential participants in 40 months to randomize 500, with most participants 
excluded due to medical contraindications for bupropion. Recruiting 10 participants in 3 months and 80 
participants over 20 months would require enrollment of approximately 3-4 participants per month. Given that 
our team recruited a similar low income population of 500 participants within 40 months of recruitment (8 
months earlier than projected), enrollment is very feasible. Further, while we will not focus specifically on 
participants with criminal justice involvement, individuals in the criminal justice system but serving their time in 
the community will not be excluded if they meet the other enrollment criteria. 
 
Inclusion Criteria. a) 18 years or older; b) qualifying as low income (as defined by making <150% above the 
poverty line or <$22,260 as a single or <$45,570 for a family of four); c) Smoking at least 5 cpd for the past 
year and a CO>10ppm to ensure daily smoking. This relatively low cutoff was chosen due to the expectation of 


enrolling a large >50% African-American average <10 CPD compared to Whites who average ~15 CPD.; and 
d) English speaking. 
 
Exclusion Criteria. a) Living in a restricted environment (e.g., prison or jail facility, etc.); b) Pregnant or 
nursing (all women will be required to use an acceptable form of contraception); c) Currently enrolled in a 
smoking cessation treatment program, using NRT products, or prescribed bupropion or varenicline; d) Known 
sensitivity to any of the nicotine replacement products or sensitivity to adhesive used in nicotine patches; e) 
Trouble breathing, a pulmonary condition, or sinus problems; f) Within one month post-myocardial infarction or 
untreated severe angina; g) poor dentation or temporomandibular joint (TMJ) problems such as unable to use 
nicotine gum; h) Cognitive impairment or unstable psychiatric condition that interferes with the informed 
consent process (individuals stable on psychiatric medications will be included); or i) Daily or exclusive use of 
other tobacco products (e.g., electronic cigarettes, little cigars, etc.). 
 
Pre-Pilot Intervention Refinement.  We will conduct a pre-pilot intervention with 10 open-label In vivo 
participants to finalize study procedures and determine therapy fidelity prior to launch of the pilot RCT. All 
sessions will be audio-taped and 50% of the pre-pilot tapes will be coded for treatment fidelity to using the Yale 
Adherence and Competence Guidelines54 to ensure adherence to the In vivo intervention. We will also solicit 
feedback from participants about satisfaction with treatment through a survey that will ask to rate their 
satisfaction with various aspects of treatment as well as assess treatment credibility and expectancy. We will 
make any refinements to the intervention or therapist training prior to initiating the pilot RCT.  
 
Intervention. In vivo Group. Participants in the intervention group will receive In vivo experience with four 
different forms of short acting NRT combined with patch and counseling focused on their experience of using 
NRT, including positive experiences, side effects and smoking cessation expectancies. For each session, 
participants will be instructed to arrive to session wearing the nicotine patch and to have gone as long as 
possible without smoking. The rationale for instructing patch use from the beginning is to promote the use of 
combination NRT as the expectation. Further, instructing participants to go as long as possible without 
smoking is to demonstrate the additive effect of short acting NRT for relieving cravings and withdrawal effects. 
Prior to each session and receipt of the short acting NRT, participants will complete the brief withdrawal 
(Minnesota Nicotine Withdrawal Scale [MNWS]) and craving (Questionnaire of Smoking Urges; QSU) 
measures; see Table 1 for a brief description. Participants will repeat these assessments at the end of their 
session. All sessions (In vivo or SC) will be approximately 30 minutes and will be conducted individually by 
research assistants (RAs) trained to use the In vivo manual and who are not tobacco treatment specialists to 
increase real-world application and dissemination of this approach (see In vivo manual in Appendix A). 
Session 1:  At the end of the Baseline assessment (described below), In vivo participants will be given 
one nicotine patch and instructed to place it on their upper arm the day of their next appointment. If they arrive 
without the patch, they will immediately have a patch placed on their upper arm. They will then complete the 
assessment measures to allow the nicotine patch to demonstrate initial medication effects. The peak effects of 
nicotine patch occurs at 3.8 hours; however, initial detection of the drug occurs at 11.8 minutes55. Thus, 
participants will be wearing the patch for at least 30 minutes of assessment or longer which should be sufficient 
to experience at least some of the effects of the patch for relieving withdrawal. Our pilot work demonstrated 
that In vivo participants experienced reduced withdrawal and craving within 30 minutes of administration. After 
assessment, the first few minutes of the intervention will focus on their in vivo experience of wearing the 
nicotine patch and will query previous experiences with the patch. We will solicit both positive (e.g., “the patch 
helps with cravings”) as well as negative perceptions (e.g., “it makes my arm itch”) of the patch. Participants 
will discuss any side effects they experience with using the nicotine patch in session. Next, participants will be 
given one of four short-acting forms of NRT (gum, lozenge, inhaler, nasal spray; counterbalanced across 
participants by session). Thus some participants may receive gum first, while others will receive inhaler, 
lozenge, or nasal spray. This will wash out any primacy or recency effects of NRT across participants for 
product selection. The gum, lozenge and inhaler demonstrate initial effects for relief of withdrawal around 5 
minutes and peak effects after about 15 minutes, while the nasal spray occurs more rapidly and more closely 
mimics the relief from smoking56-57. Thus, the delivery of nicotine in these short-acting products should be fast 
enough for participants to experience the effects of the medication on withdrawal and craving symptoms during 
session, as we noted with gum in our previous pilot study. Safety and efficacy results specific to both the patch 
and the specific short-acting NRT administered will be reviewed with the participant. They will also discuss 
their expectancies for the effectiveness of these products for cessation. Participants will be given a week 
supply of nicotine patches and whichever short-acting product they were randomized to receive first to use 


after session and will be instructed on its use. The purpose of providing a seven day supply of cNRT product 
will be to encourage participants to use and acclimate to the cNRT and to use for PQAs. They will not be 
required to abstain during the week, but can use the cNRT however they wish, which may include concurrent 
use with smoking, or during practice or legitimate quit attempts. They will be instructed to wear the patch the 
day of their Session 2-4 visits but not to use the short-acting NRT on the day of study visits.   
 
Sessions 2-4: Before completion of assessment measures, participants will be checked to make sure 
they are wearing a nicotine patch and will have a patch placed on their upper arm if they are not wearing it. 
After the assessment, they will be asked about their experience during the past week with using the nicotine 
patch and their experience with their short-acting NRT product, including any positive or negative experiences 
with the either medication and how they have used the NRT (e.g., to reduce) as well as any quit attempts they 
experienced. After this point, they will be given the next short-acting nicotine product and provided instructions 
on how to use the medication in session. They will discuss any prior experiences using the specific short-acting 
NRT as well as their expectancies for the medication to reduce their withdrawal or cravings. Safety and 
efficacy information specific to the use of that specific short-acting NRT will be reviewed with the participant. 
They will discuss any side effects that they notice with use of the specific short-acting NRT in session. Similar 
to above, participants will be given a week supply of both the patch and the assigned short-acting NRT at each 
session to use for practice during the week. They will always be instructed to wear a patch but not use the 
short-acting NRT during the morning of their subsequent sessions.   
 
 
Standard of Care Group. Participants in the SC group will receive behavioral smoking cessation counseling 
based on best practice guidelines26. This same four session counseling intervention was used in our previous 
smoking cessation intervention with participants in the criminal justice system and was found to be acceptable 
and feasible with low income populations. While this intervention does not focus exclusively on use of NRT, 
proper NRT use is covered as part of any standard behavioral intervention for smoking cessation26. However, 
NRT will not be used in vivo during control sessions. Participants will be given a description of all four short-
acting NRTs and will select one during their product selection session to use with the patch for smoking 
cessation throughout the intervention along with standard instructions for use. All counseling sessions will be 
approximately 30 minutes to match for therapeutic contact in the intervention group and will be conducted by 
RAs  trained in the intervention and following the treatment manual (see draft client workbook in Appendix B).  
Session 1: This session focuses on the harms of smoking and benefits of quitting. It will also cover 
behavioral factors associated with smoking including smoking as a habit, smoking cues, cognitive strategies to 
avoid smoking (e.g., distraction) and the physical symptoms related to nicotine withdrawal. Participants will 
learn coping strategies to deal with withdrawal and craving. 
Session 2:  Session 2 will focus on problem solving strategies to use for successful abstinence. The 
counselor will review common pitfalls associated with quitting such as refusing cigarettes from friends, weight 
gain, and sleep problems. Participants will be taught behavioral and cognitive strategies to combat these 
pitfalls. In addition, participants will be taught a brief relaxed breathing exercise to use during times of craving 
or when they have difficulties with sleep. 
Session 3: This session of counseling will focus on behavioral changes made during the intervention 
(e.g., reducing number of cpd) and will discuss the importance of complete abstinence as the goal. Participants 
will be provided with strategies to reward themselves for abstinence including taking the money saved from 
buying cigarettes and using it for short-term and long-term rewards. In addition to reinforcements for 
abstinence, the counselor will review lapse behaviors and will stress the importance of abstinence as the goal.  
Session 4: The session will cover basic information for preparing to quit including setting a quit date, 
eliciting social support from friends/family, and behavioral strategies to quit (e.g., discarding unused cigarettes, 
etc.). Participants will be educated on the use of all of the short-acting NRT products with the patch and will be 
told that they can use these products together for maximal effectiveness, although they will not use these 
products in-session. The importance of using cNRT will be emphasized during this session. Participants will 
take home a description of each NRT product to decide which product they want to use for their quit attempt. 
 
Product Selection. At Week 5, after four weeks of product sampling of the four different NRT products and 
review of experiences with the final product, In vivo participants will select which short-acting NRT medication 
to use in conjunction with the patch. SC participants will select a short-acting NRT to use with the patch based 
on the product description only. All participants will be encouraged to continue to use their selected cNRT, 
assisted with setting a quit date, and provided with eight weeks NRT medication to use for cessation. 
 


One Week Follow-up. All participants will return at Week 6 to check for any adverse effects of the medication, 
medication adherence, and initial abstinence status. Any problems with the medication will be checked and 
addressed and problem solving around quit attempts and maintaining abstinence will be covered. This session 
is expected to be 30 minutes. 
 
Interventionist Training and Fidelity. Interventionists will be undergraduate level research assistants (RAs) 
with degrees in psychology or a related field. They will be trained to follow the manual and deliver both 
behavioral interventions by the PI, although they will not have extensive tobacco training. All sessions will be 
audio-taped and 20% will be coded for treatment fidelity to using the Yale Adherence and Competence 
Guidelines54 to ensure no contamination between behavioral interventions. The choice to utilize non-therapist 
interventionists was made to approximate the therapy skill level of most professionals in low resource settings. 
 
Combination Nicotine Replacement (cNRT). Participants will be screened at the time of their baseline 
appointment for the appropriateness of all NRT products. Our physician collaborator will be available to answer 
any questions that may arise when screening participants and will assist the PI in evaluating any adverse 
events believed to be related to the use of NRT. All participants will be evaluated for their initial NRT dose 
based on Federal Drug Administration guidelines. Participants who smoke 10 or fewer cpd will start at 14mg 
patch while smokers who use 11 or more cpd will start at 21mg patch. The nicotine inhaler delivers 4 mg of 
nicotine per cartridge (inhaling for 20 minutes on each cartridge) with participants using about 6 cartridges 
daily. Nicotine nasal spray delivers 0.5mg of nicotine per spray with one spray per nostril (1mg total) 
recommended 1-2 times per hour. Participants will be given the 2mg nicotine gum or lozenge to use. The 
safety and tolerability of using NRT products together or smoking while using NRT has been 
demonstratede.g.51. Further, the rationale for using combination NRT over a single agent is two-fold. First 
combination NRT has demonstrated the best efficacy for promoting abstinence over all other single agents with 
the exception of varenicline58. Second, NRT is short-acting and can be administered in-session to demonstrate 
the effect of this medication in relieving withdrawal symptoms, including craving. NRT can also be used 
sporadically as is proposed during the sampling weeks. Other smoking cessation pharmacotherapies (e.g., 
bupropion, varenicline) take about a week to titrate to full effect26. Both groups will receive 8 weeks of 
medication for a sustained quit attempt, although the In vivo group will be sampling four different short acting 
NRT products during the first four weeks of the intervention.  
 
Baseline and Assessment Measures. After eligibility determination and consent to participate, the baseline 
assessment will be administered. This assessment is expected to take about 60 minutes and will provide basic 
smoking history, smoking behavior, and proposed mediators and moderators such as treatment interest, 
expectancies for NRT, previous use of NRT, craving, withdrawal, and side effects associated with NRT use 
(see Table 1 description) and will be repeated during the study period (see Table 2 for assessment schedule).  
 
 Table 1: Instrument Description  
Screening Questionnaire.  Participants will be asked basic screening questions prior to consent for the study to determine initial 
eligibility including: age, income, currently pregnant or nursing, average CPD, latex allergy, myocardial infarction in past month, and 
years of smoking. (3 min) 
Demographics. Basic demographic information will be collected including age, gender, race/ethnicity, education level, employment 
status, marital and living situation, monthly income, and history of substance use and mental illness. (1 min) 
Urine Drug Screen.  All participants will be screened for drug use during baseline assessment. We will test for alcohol (using ethyl 
glucuronide) as well as amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, and methadone. (1 min) 
Smoking History.  Questions about smoking history will include age of smoking initiation, age of regular use, us of other tobacco 
products, number of years of smoking, average cigarettes smoked per day, previous quit attempts, time since last quit attempt, 
difficulty of last quit attempt, previous smoking cessation treatment (e.g., use of NRT, bupropion, varenicline), family members who 
smoke, and family and personal medical problems related to smoking. (10 min) 
Treatment Expectancies.  This assessment queries expectancies about the efficacy of various forms of smoking pharmacotherapy 
(e.g., nicotine gum, patch, lozenge, inhaler, nasal spray, varenicline, and bupropion) as well as behavioral interventions (e.g., group, 
individual, self-help materials, hypnosis) using the question, “How much do you think  _____  will help you to quit smoking”. These 
questions are answered using 1-7 Likert scale. This is a scale we developed and used in our studies with this population. (5 min) 
Perceived Stress Scale – 10 Item (PSS-1059). This is a self-report questionnaire that assesses a person’s stress in the past month.  
It utilizes a 5-point Likert scale ranging from “Never” to “Very Often”. (1 min) 
Thoughts About Abstinence Questionnaire – 4 Items (TAA) 60.  This survey assesses 1) motivation to quit; 2) expected difficulty 
quitting; 3) confidence in one’s ability to quit (abstinence self-efficacy); and 4) abstinence goals.  (1 min) 
Smoking Abstinence Questionnaire (SAQ61). The SAQ assesses a smoker’s expectancies for the process of smoking cessation 
on 10 scales. The SAQ scales have demonstrated good reliability and robust relationships with tobacco dependence, motivation to 
quit and abstinence self-efficacy, and withdrawal. (5 min) 
Abstinence-Related Motivational Engagement (ARME62). This 16-item scale assesses motivational changes after a quit attempt 


on a 0-7 Likert scale. (5 min) 
Attitudes about Nicotine Replacement-12 scale (ANRT-1263). This 12-item scale asses smoker’s attitudes about NRT and 
measures two factors: advantages (e.g., NRT will help with withdrawal symptoms and cravings) and disadvantages of NRT (e.g., 
NRT is addictive, side effects, etc). (5 min) 
Fagerström Test for Nicotine Dependence (FTND64). The FTND is a 6-item self-report measure of nicotine dependence from the 
Fagerström Tolerance Questionnaire65. The FTND has satisfactory internal consistency and high test-retest reliability. (5 min) 
Brief Wisconsin Inventory of Smoking Dependence Motives (WISDM-3766). The Brief WISDM has 37 items that load onto 11 
subscales. The psychometric properties of the reduced-item WISDM subscales is comparable to the WISDM-68. (10 min) 
Questionnaire of Smoking Urges-Brief Form (QSU67). The shortened version of the QSU assesses cravings associated with 
quitting smoking. The 10-item scale is scored on a Likert-style scale ranging from 1 (strongly disagree) to 7 (strongly agree). During 
Sessions 1-4, participants will complete this measure before and after their counseling sessions. (5 min) 
Minnesota Nicotine Withdrawal Scale (MNWS68) using DSM-IV criteria it assesses the physical and psychological symptoms 
associated with withdrawal. During Sessions 1-4, participants will complete this measure before and after their sessions. (5 min) 
Treatment Satisfaction Survey (TSS).  This survey will be administered at the Product Selection session and subsequent sessions 
to determine satisfaction with both treatments. In addition to standard questions about different aspects of treatment (e.g., 
satisfaction with medication, satisfaction with therapy, etc.), participants will queried about what aspects of the intervention they 
would change and how they would change it. (5 min).  
Credibility and Expectancy Questionnaire (CEQ)69. This 6-item brief scale asks patients about how they think and feel about the 
treatment. It is broken down into two main scales; credibility and expectancy for treatment. It has demonstrated good internal 
consistency and good test-retest reliability. (2 min). 
Side Effects.  We will use a side effect scale to determine common side effects associated with pharmacotherapy and quitting 
smoking. This self-administered, 1-7 Likert scale instrument was used during our previous smoking cessation trial with correctional 
populations and captured the range of side effects experienced during the trial. (5 min) 
Carbon Monoxide (CO) and Tobacco Use Assessment. Expired breath samples will be obtained at every study visit. Participants 
will be asked questions related to recent smoking behavior, including time since last cigarette, 24 hour quit attempts, overnight 
abstinence status, number of cpd, and average cpd smoked for that week. CO >3 ppm will be considered smoking70-72. (1 min) 
NRT Adherence.  All participants will be assessed on their self-reported daily use of NRT using a Time Line Follow-Back (TLFB) 
method during the 8 weeks of treatment. All participants will also be assessed during all intervention weeks for their use of NRT by 
returning used patches and returning used blister packaging/used canisters/cartridges from short-acting NRT. Use of 80% of more of 
the medication will be considered adherent. We used a similar technique to assess NRT adherence in our pilot trial with good 
compliance with returning used patches/blister packaging. (5 min) 
 
Note: BL=Baseline Assessment; S=session; WK=week; M=month; PS=Product Selection; 1All participants will complete these surveys twice (at the beginning and end of session) during sessions 1-4.  
 
Randomization.  We anticipate enrolling 10 pre-pilot participants in 3 months and 80 participants in 20 months 
and, based on our previous study with this population, expect to retain at least 70% through the one month 
follow-up point. Randomization will occur after completion of the initial screening and assessment.  
 
Primary Outcomes. Feasibility and acceptability will be measured through high study retention (70%) and 
recruitment (recruitment of all participants within 24 months) in our groups. Additional items of acceptability 
include high scores on treatment satisfaction and credibility/expectancies that are equal or higher to the SC 
Table 2: Study 
Assessment Schedule 
 
BL 
 
 
 
R
A
N
D
O
M
I
Z
A
T
I
O
N 
 
 
 
Post-Randomization Assessment Schedule 
Measures or 
Procedures 
(weekly compensation) 
Day 
0 
($10) 
WK1 
S1 
($20) 
WK2 
S2 
($20) 
WK3 
S3 
($20) 
WK4 
S4 
($20) 
WK5 
PS 
($20) 
WK6 
 
($20) 
WK9 
 
($40) 
WK13 
 
($40) 
M1 
FU 
($40) 
Screening Questionnaire 
X 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
Urine Drug Screen 
X 
 
 
 
 
 
 
 
 
 
Smoking History 
X 
 
 
 
 
 
 
 
 
 
Treatment Expectancies 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
PSS – 10 Item 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
TAA 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
SAQ 
X 
 
 
 
 
X 
X 
X 
X 
X 
ARME 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
ANRT-12 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
FTND 
X 
 
 
 
 
X 
X 
X 
X 
X 
WISDM 
X 
 
 
 
 
X 
X 
X 
X 
X 
QSU 
X 
X1 
X1 
X1 
X1 
X 
X 
X 
X 
X 
MNWS 
X 
X1 
X1 
X1 
X1 
X 
X 
X 
X 
X 
TSS 
 
 
 
 
 
X 
 
 
X 
X 
CEQ 
 
 
 
 
 
X 
 
 
X 
X 
Side Effects 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Carbon Monoxide (CO) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
NRT Adherence 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 


group. Medication adherence is a third primary outcome with expected differences between our groups. 
Adherence is notoriously difficult to determine. Self-reported adherence is not always reliable, particularly 
during treatment studies where there is a demand characteristic to report the desired targeted behavior73-74 
(e.g., adherence to NRT). The behavioral methods described under the assessment section represent the best 
available self-report tools for determining NRT adherence (e.g., TLFB report, returning used NRT patches and 
used product blister packs/packaging). Adherence will be defined by self-report using the TLFB and verified 
through returned patches and packaging. Good adherence is defined by taking greater than 80% of doses of 
medication at each time point. We have used these techniques in previous studies with low income populations 
with good compliance for use of TLFB verified by return of NRT materials75. 
 
Participant Tracking and Retention. Participants will attend four weekly intervention sessions and a Product 
Selection session at Week 5. They will receive a one week follow-up after starting medication as well as 
monthly follow-up at weeks 9 and 13 during the NRT administration. The final follow-up will occur one month 
post-intervention. For this study, we will follow our participants for one month after the end of NRT 
administration (~4 months total in the study).  We will continue to use our standard methods for ensuring high 
retention including collecting contact information on the participant as well as obtaining the contact information 
of three close friends or family members and providing follow-up and reminder phone calls. We have used 
these methods with good success with our ongoing and previous projects with this population. Thus, we 
believe we can maintain high retention and follow-up throughout the study.  
  
Data Management and Statistical Analysis.  Data will be entered and stored on the UAB secured network. 
Data analyses will performed by the PI who has a master’s degree in biostatistics using SPSS. 
To test Aim 1, the development and refinement of the In vivo intervention, we will pre-pilot the 
intervention with 10 participants. We will examine participant’s responses on the Treatment Satisfaction Survey 
as well as examine other factors that participants mention to improve treatment. As the intervention is already 
developed, this phase will be primarily used to finalize study procedures and make modifications to the study 
protocol. We will not conduct any in depth interviews or use qualitative methods, but will rather use this is an 
opportunity to make minor adjustments to the protocol. 
To Test Aim 2, feasibility and acceptability of the intervention, we will determine our rate of recruitment, 
retention and the credibility and expectancies for the intervention using descriptive statistics. We expect that 
the novel In vivo intervention will be both feasible and acceptable as evidenced by a high rate of recruitment 
and over 70% retention through follow-up, with no differences in attrition between the groups. In addition, we 
expect that In vivo intervention will be rated as high on treatment satisfaction, credibility, and expectancies for 
treatment relative to SC. We will use Chi-Square analyses to examine attrition and t-tests to examine treatment 
satisfaction scores, credibility, and expectancy differences between the groups.  
To test Aim 3, we will examine medication adherence during the 8 week intervention period between 
the intervention groups using Chi Square analyses at weeks 6, 9 and 13. Medication adherence will be defined 
as a self-reported use of taking 80% of medication as prescribed at each time point for both groups (adherent 
or not adherent). We can also look at adherence as a continuous proportion variable: adherence = number of 
doses taken / the number of doses given. We will also examine demographic and smoking characteristics 
(particularly withdrawal, cravings, abstinence self-efficacy, and NRT perceptions) that would be associated with 
medication adherence at weeks 6, 9 and 13 using logistic regression. These analyses will allow us to examine 
important associations with medication adherence in these groups.  
To examine underlying factors believed to be important for medication adherence, particularly 
withdrawal, craving, self-efficacy, and perceptions of NRT, we will also examine these factors by intervention 
groups across time using paired t-tests, as appropriate. We are primarily interested in determining if our In vivo 
group had decreases in withdrawal and cravings, while increasing abstinence self-efficacy and NRT 
perceptions relative to the SC group. Given the pilot nature of this intervention, we will be able to examine 24-
hour quit attempts and abstinence, but these factors are not the main focus on analyses as we will likely be 
underpowered to find significant differences on these outcomes with this small of a sample. While 80 
participants may seem like a fairly large sample for a pilot study, a sample size between 500-600 participants 
is typical for most smoking cessation interventions and would be needed to examine important moderators and 
mediators of cessation. However, we will be able to obtain initial effect sizes that will be useful for determining 
the appropriate sample size for a fully-scaled R01 project in the future, if this intervention appears promising. 
 
Missing data. There is a high likelihood that we will have participants who may miss an appointment, do not 
complete the study, or are otherwise lost to follow-up. Because of the potential of bias due to non-missing 


completely at random data, we will perform sensitivity analyses to assess whether differences in treatment 
outcome are a function of study completion.  We will assess the magnitude of missing data upon completion of 
the study.  If the amount of missing data is large (>30%), we will utilize multiple imputation (MI) methods in 
order to not suffer a loss of power due to the loss in sample. However, our previous smoking cessation 
intervention with a criminal justice sample had the same number of intervention sessions had a 74% retention 
rate at one year. We expect to have a 70-80% retention rate throughout the time of this study. 
 
Study Design Considerations. We made several design choices that should be discussed. First, as is 
appropriate for a pilot trial, issues of feasibility and acceptability are the primary outcomes of interest. In 
addition, adherence to NRT is the smoking-related primary outcome of interest, rather than cessation. In our 
sample of participants and using a CO cutoff of 3 ppm, we generally only achieve about a 6-10% abstinence 
rate at any one time. While this seems low to researchers who are used to using 10 ppm cutoffs, our previous 
studies do achieve similar abstinence rates when we use the higher cutoff point of 10 ppm as other smoking 
cessation interventions. We believe that a 10 ppm cutoff is artificially high and classifies light smokers or 
chippers as abstinent70-72 and we would rather be rigorous in our outcome of cessation. We know from 
previous studies as well as the existing literature on adherence that approximately half of smokers are 
adherent to their medications. Given these proportions, we will be able to do better comparisons to determine 
the underlying factors associated with adherence with a small sample such as 80 participants and would need 
much larger samples (N=500-600) to examine factors associated with cessation. Further, evidence suggests 
that adherence to medications is a critical factor in cessation and no interventions have been developed to 
successfully increase adherence as well as smoking abstinence. This project is the first step in developing an 
adherence intervention that we believe will also increase cessation. In addition, some may question the 
rationale for giving the patch with acute NRT product at all sessions and not separating the experience of these 
products. This design choice was made for two reasons: First, we wanted to normalize the use of combination 
NRT by setting the expectation from the start that the patch is to be used with short acting NRT. Second, we 
want smokers to realize that the patch alone may be insufficient to reduce all cravings and withdrawal but that 
a short acting NRT can be used to relieve these symptoms acutely. Finally, we considered doing a standard 
NRT education intervention as our control group such as has been tried in the past to examine the impact on 
adherence and cessation and this would be a good comparator. However, we wanted to pilot this In vivo 
intervention against what is considered the best practices for smoking cessation as we believe In vivo could 
potentially be a stand-alone treatment for cessation that would require less therapeutic knowledge and training 
to implement relative to standard smoking cessation counseling. This is important for dissemination in low-
resource settings and for broad dissemination and adoption. 
 
Strengths and Limitations of the Study. This study has modest limitations that should be mentioned. First, 
given the special nature of low income smokers, a criticism of this approach may be that this intervention 
should first be tested in a “general” population of smokers to examine initial effects before being tailored to a 
specialty population such as low income smokers. However, testing this approach with low income and 
disadvantaged smokers targets the population with the lowest rates of medication adherence who are the least 
likely to use NRT during quit attempts and the most likely to hold negative perceptions of NRT, all the proposed 
targets of this intervention. Thus, testing an adherence intervention in this population provides a smoking 
cessation intervention that is specifically responsive to the needs of this population. If we first tested this 
intervention among general/middle-upper income population of smokers who already have good rates of NRT 
adherence, we may not detect differences between our groups in NRT adherence or changes in NRT 
perceptions due to a ceiling effect. Further, smoking is now concentrated in low income and other 
disadvantaged smokers76 (e.g., substance users, mentally ill, incarcerated, etc.) and few interventions have 
been developed to help these smokers, likely due to this “trickle-down science” mentality of first testing all 
interventions with general, non-disadvantaged smokers. Given that low income smokers now represent the 
“new majority” of smokers76, testing smoking cessation interventions first in a general population of smokers 
who are at least middle income with no substance use or mental illness actually makes these interventions less 
“real world” and unable to generalize to the actual population of smokers present today. Second, a related 
criticism may be that our intervention is not intensive enough to bring about changes in such a difficult to treat 
smoker. This is an issue that we constantly struggle with and an argument can be made on both sides of this 
issue. Interventions that are very intensive in terms of time and resources are unlikely to be implemented in 
busy clinical or low resource settings; while interventions that are brief may not have the desired impact. We 
selected an intervention that is brief and simple enough to implement in busy settings by non-therapist 
providers but still intensive and targeted to bring about change. Third, we are comparing two different 


behavioral interventions that primarily differ on the mode of delivery and product selection of NRT, making it 
more challenging to find an effect. However, we feel that having an active control group which delivers a best 
practices intervention will more fully test the premise that this approach is superior for increasing adherence in 
this disadvantaged population. Obviously, comparing our active intervention to a no treatment or inferior control 
group would maximize our ability to find a significant difference between our groups, but it would not answer 
the question of superiority of this approach for this population. It is analogous in medication development to the 
developing of another SSRI medication to treat depression versus developing a new class of medications. We 
were most interested in determining if this approach could be a “new class” behavioral approach for smoking 
adherence that is superior to current best practices. Finally, other concerns that may be raised center around 
our ability to obtain the necessary sample of participants or other methodological choices. We have 
demonstrated experience with recruiting similar samples of smokers as proposed in this application and have 
been able to maintain excellent retention in our studies with challenging populations. We have been conducting 
research with disadvantaged populations for over 15 years and have made the best choices we could, realizing 
that alternative methods could also be considered and debated.  
The proposed intervention has several important strengths. First, the intervention is fairly 
straightforward, and if successful, could be implemented within low resource settings with minimal training or 
expertise needed by the interventionist. In fact, we are using non-therapists for this intervention to underscore 
the translation of this intervention in low resource settings. Second, the intervention is also very novel and 
expands from more traditional psychoeducational interventions as a mode for increasing adherence (which has 
limited results, at best) to a more experiential model similar to previous NRT sampling interventions that 
expose motivated and non-motivated smokers to NRT as a mechanism for increasing medication adherence 
and ultimately cessation. Low income smokers have lower health literacy and hold negative perceptions of 
medications. Importantly, they also appear to have limited experience with using such medications during 
smoking cessation. Providing an intervention that provides experience with the medication in a controlled, 
supervised session (in which negative experiences can be contained and reframed in real time) may be an 
important strategy to increase NRT adherence, particularly in this population. Allowing participants the 
opportunity to then select their preferred short acting NRT is believed to maximize abstinence self-efficacy, 
motivation, and engagement in the quit process. Third, few smoking cessation interventions have been 
developed for low income smokers and the proposed study represents the next logical step in developing an 
effective intervention to help these smokers increase adherence and attain abstinence. To our knowledge, no 
medication adherence studies have been developed or conducted with a low income population, despite the 
fact that low income populations hold negative NRT perceptions and have the lowest medication adherence 
and use during quit attempts.  Fourth, low income and other disadvantaged groups of smokers now represent 
the majority of the population who are current smokers and suffer from disproportionate disease burden. 
Despite this fact, interventions continue to be developed that target general smokers and exclude these 
disadvantaged smokers from clinical trials. However, developing effective smoking cessation interventions with 
this population has the potential to reduce health disparities to significantly improve health and reduce death 
and disease in this underserved population. Finally, this proposal is led by an experienced PI as well as a team 
of investigators who have worked together over the years. Thus, the ability to implement and complete this 
important study within the three year proposed timeframe is assured. See study timeline below. 
 
Timeline: Month 1 we will hire/train staff; Months 2-6 we will enroll 10 participants and begin the pre-pilot 
intervention. We will make any changes to the intervention during Month 7. During Months 8-30 we will recruit 
and complete follow-up of our participants. Months 31-33 will be for completing follow-up appointments, data 
cleaning, and data analysis. Months 34-36 will be for completing data analysis and disseminating results. 
 
Impact. Development of a novel, experiential intervention that can be delivered by non-therapists to increase 
NRT adherence through improved NRT expectancies, perceptions and self-efficacy would be a significant 
advancement in smoking cessation for low income smokers. Increasing medication adherence is believed to 
be the single most important factor for reducing racial disparities in smoking cessation and disease outcomes. 
Developing an intervention to increase NRT adherence is critical to increase smoking abstinence in low 
income, disadvantaged smokers. This project represents an important first step in developing an effective 
intervention to improve NRT adherence that could be widely adopted and disseminated by non-therapists in 
low resource settings. 

Prot_001.pdf: 
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.