Clinical trial NCT03897439
Conditions: Smoking Cessation
Sponsor: University of Kansas Medical Center
Start date: 2019-05-01; Completion date: 2022-01-30
Enrollment: 392 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Improving cessation outcomes for African American smokers through the use of novel, empirically-based strategies is a national health priority. In the vast majority of smoking cessation studies and in clinical practice, when smokers are provided a medication to help them quit, they are expected to continue that medication regardless of how well it is working. This study will assess whether African Americans smokers respond better if they continue with a single treatment or if their treatment is changed when that treatment is not working.

Detailed description:
The objective of this study is to examine the efficacy of optimized (OPT) versus enhanced usual care (UC) treatment for smoking cessation. African American smokers randomized to OPT (n=196) will receive high intensity smoking cessation counseling, nicotine patch (NP), and up to two pharmacotherapy optimizations \[varenicline (VAR), bupropion (BUP) plus NP, \] based on verified smoking status at Weeks 2 and 6. African American smokers randomized to enhanced UC (n=196) will receive the same high intensity counseling and NP with no optimizations in pharmacotherapy. Pharmacotherapy and counseling in both groups will last for 18 weeks with long-term follow-up through Week 26. The primary outcome is biochemically-verified smoking status at Week 12.

Arms: arm 1: 196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch. arm 2: 196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.
Interventions: intervention 1: Nicotine patch intervention 2: Varenicline Tartrate intervention 3: Bupropion
Intervention descriptions: intervention 1: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment. intervention 2: VAR will be dispensed 0.5 mg once daily on Days 1-3, 0.5 mg twice daily on Days 4-7, and 1 mg twice daily from Day 8 through the end of treatment. intervention 3: BUP will be dispensed 150 mg once daily on Days 0-3 and then 150 mg twice daily from Day 4 through optimization or the end of treatment.

Protocol documents:
Prot_SAP_000.pdf: 
 
 
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NCT03897439    
 
Title: Individualizing Pharmacotherapy: A novel optimization strategy 
to increase smoking cessation in the African American community 
 
Date: 3/23/2020 


 
 
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RESEARCH PROTOCOL INVOLVING HUMAN SUBJECTS  
TEMPLATE WITH GUIDANCE 
 
Version date: March 23, 2020 
Principal Investigator: Nicole Nollen 
Study Title: Individualizing Pharmacotherapy: A novel optimization strategy to increase smoking 
cessation in the African American community 
Co- Investigator(s): Lisa Sanderson Cox, Edward Ellerbeck, Matthew Mayo 
 
I. 
Purpose, Background and Rationale 
A. Aims and Hypotheses  
 
African American (AA) smokers, who bear a disproportionate share of tobacco-related mortality, 
are poorly served by the one-shot tobacco treatment approaches that dominate research and 
clinical practice. Smoking cessation pharmacotherapy is effective for AA smokers but in general 
they achieve significantly lower absolute quit rates compared to non-AAs. A closer examination 
pinpoints early abstinence as an important but overlooked target for pre-emptive intervention. 
Abstinence rates within the first 4 weeks of treatment are 14%-36% for AA smokers compared to 
34%-65% for non-AA smokers in studies testing the same pharmacotherapies. The low rate of 
early treatment efficacy in AA smokers is important because 75% of smokers who do not quit 
within 4 weeks of the target quit day (TQD) fail to achieve abstinence at the end of treatment and 
nearly all fail to achieve abstinence at later time points. Studies conducted among non-AA 
smokers have found that switching or augmenting pharmacotherapy for initial non-responders 
results in higher rates of abstinence. These studies examined the effects of altering 
pharmacotherapy only once after the TQD, yet in the treatment of other chronic diseases (e.g., 
diabetes, hypertension) it is common for providers to alter pharmacotherapy several times in 
order to achieve desired outcomes. Hence, for AA smokers there is a critical need to understand 
the effects of pharmacotherapy optimization to achieve early, and then sustained, abstinence. 
Moreover, for the field of tobacco treatment as a whole, there is further need to extend 
pharmacotherapy research to examine the effects of multiple medication alterations on early 
abstinence and long-term cessation. 
 
The long-term goal of our research is to improve tobacco dependence treatment outcomes for AA 
smokers by identifying promising interventions. The objective of this project is to examine the 
efficacy of optimized (OPt) versus enhanced usual care (UC) treatment for smoking cessation. 
Optimization interventions have been widely used in other disciplines but are relatively new to 
tobacco dependence research. Given that tobacco dependence is a chronic, relapsing disorder 
characterized by multiple failed quit attempts, the high degree of heterogeneity in treatment 
response, and the absence of new pharmacotherapy advances, the best opportunities to improve 
tobacco treatment for AA smokers lie in the use of novel methodologies that explore how to 
optimize treatment through providing smoking cessation counseling while altering the timing, 
sequencing, or combining of existing pharmacotherapies to maximize efficacy. Consequently, AA 
smokers randomized to opt (n=196) will receive high intensity smoking cessation counseling, 
nicotine patch (NP), and up to two pharmacotherapy optimizations [bupropion (BUP), varenicline 
(VAR)] based on verified smoking status at Weeks 2 and 6. AA smokers randomized to enhanced 
UC (n=196) will receive the same high intensity counseling and NP with no optimizations in 


 
 
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pharmacotherapy. The central hypothesis is that OPT will result in significantly higher 
abstinence rates relative to UC. 
Our specific aims are: 
1) Evaluate the short- and long-term efficacy of optimized pharmacotherapy for smoking 
cessation in AA smokers. Hypothesis 1: Participants randomized to OPT will have significantly 
higher biochemically-verified abstinence at Week 12 (primary endpoint) than participants 
randomized to UC. Hypothesis 2: Participants randomized to OPT will have significantly higher 
biochemically-verified abstinence at two follow-ups, Week 18 and Week 26, than participants 
randomized to UC. 
2)  (Mediators/Moderators): Identify mediators and moderators of the relationship 
between treatment (OPT, UC) and verified abstinence at week 12. Hypothesis 3. 
Treatment engagement (medication use, counseling attendance), experience of side effects, and 
change in withdrawal, craving, reinforcing effects of nicotine, positive and negative affect, and 
self-efficacy to refrain from smoking will mediate the relationship between treatment and 
abstinence. Hypothesis 4. Gender, age, socioeconomic status (SES), nicotine exposure, menthol, 
and nicotine dependence will moderate the relationship between treatment and abstinence.   
3) (Process): Describe the response profile for each optimization pathway (OPT only). 
There are 4 pharmacotherapy pathways that participants in OPT will potentially follow. We will 
describe the process of optimization including the proportion that 1) follow each OPT pathway, 
2) re-initiate pharmacotherapy following changes in medication, 3) set new TQDs following 
changes in medication, and 4) demonstrate verified abstinence. We will also describe changes, 
by pathway, in responses that are predictive of treatment success/failure including withdrawal, 
craving, reinforcing effects of nicotine, quitting self-efficacy, positive/negative affect, and post-
optimization medication use.  
 
B. Background and Significance 
 
African American (AA) smokers disproportionately impacted by tobacco. Tobacco remains 
the leading cause of preventable morbidity and mortality in the United States, accounting for 
more than 480,000 total deaths and more than 34% of all cancer death annually.1 Although AA 
smoke fewer days per month, fewer cigarettes per day (CPD), and are less likely to be heavy 
smokers than Whites, they bear a disproportionate share of tobacco-attributable morbidity and 
mortality.2 AA are at higher risk for nearly all smoking-related chronic diseases compared to 
Whites, have twice the rate of premature death attributable to cardiovascular disease, the highest 
incidence rates for all cancers combined, and higher overall cancer mortality rates compared to 
other racial/ethnic groups.3,4 With regard to smoking-attributable lung cancer, specifically, AAs 
have a striking 43-55% higher relative risk compared to Whites with this difference being most 
pronounced at lower levels of daily cigarette consumption.5 
AA smokers are less likely than White smokers to quit or respond to treatment. Quitting 
smoking is the single most important change a smoker can make to improve health,6 yet AA are 
less likely to quit relative to non-AA despite being lighter smokers (< 10 cigarettes per day; CPD) 
and making more attempts.7 According to 2015 national prevalence data, AA smokers are 16% 
more likely than White smokers to make a quit attempt in the past year but 31% less likely to 
achieve abstinence lasting > 6 months.7 Differences persist in clinical trials where access and 
utilization of care are equalized.8-12  
 These findings have led to a misperception that smoking cessation pharmacotherapies are not 
efficacious for AA smokers. To the contrary, cessation pharmacotherapies have been found to be 
superior to placebo in RCTs conducted exclusively with AA smokers13-15 and meta-analytic and 
review articles have consistently documented the efficacy of smoking cessation medications for AA 
smokers.16-18 Based on the sum of evidence, Clinical Practice Guidelines for Treating Tobacco 
Dependence unequivocally recommend a combination of smoking cessation counseling and any one 
of the seven first-line medications - nicotine gum, nicotine patch (NP), lozenge, inhaler, nasal spray, 


 
 
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bupropion SR (BUP), and varenicline (VAR) - to optimize cessation for all smokers, including African 
Americans.6 The guidelines are also clear in the need for studies to improve cessation outcomes in 
racial/ethnic minority smokers. Our research team is one of a few in the U.S. with a line of research 
dedicated to improving tobacco dependence treatment for AA smokers. Our research spans two 
decades and includes 5 NIH-funded pharmacotherapy trials of NP,13 gum,19 BUP,14,15 and VAR12 for 
AA smokers. While we have documented the efficacy of pharmacotherapy for AA smokers,13-15 we 
have also noted a common theme in our work, and others,8-11 specifically, that quit rates for AA 
smokers are lower than those found for non-racial/ethnic minority smokers on comparable therapies 
in the literature. Optimizing response to cessation therapy among AA smokers using an empirically-
supported and novel adaptive treatment approach is the focus of this application. All participants will 
receive individualized, intensive smoking cessation counseling that has been developed in 
collaboration with an AA community advisory board and AA smokers over the past 15 years and has 
been found to be more effective than other counseling approaches with the target population.19,20 
 
Why early treatment response? A closer look at the 
NIH-funded clinical trials conducted by our group 
illuminates early abstinence as an important, but 
overlooked, target for improving tobacco dependence 
treatment outcomes for AA smokers. Acknowledging the 
limitations of comparisons across studies, Table 1 shows 
biochemically-verified abstinence rates within the first 4 
weeks of treatment for AA smokers in 4 out of 5 of our 
RCTs (early abstinence was not captured in our nicotine 
patch RCT13) and those achieved in major RCTs of the 
same therapies, which were conducted among 
predominately White smokers. As can be seen, 34-65% of non-AA smokers achieved early 
abstinence compared to 14-36% of AA smokers. Because efforts in AA have achieved moderate 
rates of early abstinence relative to non-minority smokers, concerted efforts are needed during this 
phase to improve short- and, subsequently, long-term treatment outcomes for AA smokers.  
Early abstinence strongly predicts long-term treatment efficacy. Success within the first 4 
weeks of initiating pharmacotherapy predicts long-term abstinence. Among those on NP who smoke 
within 2 weeks after beginning NP therapy, 66%-70% fail to achieve abstinence at the EOT (wks 6-
10 depending on the study).25-27 Among those on BUP, the combination of BUP + NP, or NP alone, 
only 7%-19% of those who smoked within 3 weeks of initiating pharmacotherapy were abstinent at 
the EOT compared to abstinence rates of 40%-67% for the entire sample.26,28 Conversely, these 
same studies have found that 71%-80% of participants who responded (i.e., achieved abstinence) 
during the first 4 weeks of medication remained abstinent at the EOT.25-27 We have found a similar 
pattern in our own work with AA. Among early responders (i.e., abstinent at Weeks 1 or 3), 78%-
92% remain abstinent at the EOT and, of these, 54%-77% maintained long-term abstinence.12,14,15 
These data demonstrate the solid scientific premise that: 1) participants who do not achieve 
abstinence within 4 weeks of initiating medication are unlikely to achieve abstinence later; and 2) 
participants who do achieve early abstinence are likely to maintain abstinence through treatment 
and follow-up. Together, these findings support our scientific approach of continuing early 
responders on their existing pharmacotherapy but modifying pharmacotherapy for those not 
responding.  
Lack of focus on early treatment non-responders is a missed opportunity. Many studies 
have focused on improving tobacco dependence treatment outcomes by preventing the return to 
smoking among responders. These relapse prevention studies assume a period of 
response/cessation and have had mixed success.29 By comparison, few studies have focused on 
non-responders. If the majority of early treatment responders remain abstinent at the end of 
treatment and follow-up, focusing on this sub-group to the exclusion of treatment non-responders, 
Table 1. Biochemically-confirmed abstinence rates within 
the first 4 weeks of treatment in RCTs among AA smokers 
and non-AA, predominately White smokersa 
 
 Abstinence for 
AA  
Abstinence for non-
AA smokers 
VAR 
14% at Week 412  
42%-48% at Week 
421,22  
BUPb 
22% at Week 315  
60% at Week 423  
BUPc 
36% at Week 114 
31% at Week 314 
65% at Week 223  
60% at Week 423  
Nicotine gum 
23% at Week 119 
34% at Week 424  
aCessation not reported by race in these studies, therefore, the 
rates presented are for the total sample (79%-93% W); bAA light 
smokers (1-10 CPD); cAA heavy smokers (10+ CPD) 


 
 
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who under the current treatment paradigm have a very low likelihood of achieving later abstinence, 
is a missed opportunity.   
Lack of focus on non-responders is partly due to predominant use of study designs that do not allow 
for treatment adaptation.30,31 A typical smoking cessation RCT randomizes participants at the start 
of treatment and, while response to treatment is often monitored, re-assignment based on response 
rarely occurs. In addition, success in a standard cessation RCT is based on distal endpoints (e.g., 
Wk 26), with little attention paid to early endpoints (i.e., 2-4 weeks after treatment initiation) that 
are known to strongly predict long-term outcomes. Augmenting, switching, or stepping up 
treatment for non-responders could improve outcome but has rarely been explored within tobacco 
dependence research.30,31   
 
C. 
Rationale 
Scientific premise:  Why an optimized therapy approach? Nicotine dependence is a chronic 
relapsing disorder characterized by multiple failed quit attempts.1 The cyclical process of quitting 
smoking and the high level of between- and within-subject variability to treatment calls for a 
flexible treatment approach, yet typical cessation studies randomize participants at the start of 
treatment and rarely re-assign treatment based on response. To the contrary, optimization 
strategies that alter the type, dose, duration, frequency, and/or amount of treatment at critical, 
pre-defined decision points32 are common place within other chronic diseases.32-36 In hypertension 
and diabetes, for example, clinical trial protocols routinely incorporate modifications in 
pharmacotherapy based on blood pressure and glycemic response, respectively, and the success 
of adaptations have subsequently been incorporated into clinical practice recommendations. 37,38 
 
A growing body of cessation intervention studies have used an optimized therapy design, 
finding that optimization ‘rescues’ smokers who show poor initial response.39-43 Of most relevance 
to the current study is the study by Rose et al. (2013) that assessed response to NP after 1 week 
of pre-cessation therapy and 1 week after the targeted quit date (TQD).41 Responders at each 
time point remained on the NP, while non-responders were switched to either continuation of NP 
(control condition), ‘rescue’ treatment with BUP + NP, or ‘rescue’ treatment with VAR. Primary 
findings were that: 1) non-responders who were switched to BUP + NP or VAR had abstinence 
rates at the end of treatment and at 6 month follow-up that were ~10% higher than non-
responders who remained on NP and 2) continuing the NP was highly effective among early 
responders. Another optimization study by Laude et al. (2017) treated smokers with 10 weeks of 
NP + BUP. At 10 weeks, responders either stopped medication completely or stayed on NP + BUP 
through week 26, while non-responders received VAR through week 26.44 Week 26 cessation 
among week 10 responders was high (60% no meds, 60% NP + BUP) but also notable is that, 
among non-responders, late treatment optimization to VAR led to week 26 abstinence rates of 
17% (up from 0% abstinence rates at week 10).  
 
 
Non-intervention studies have also confirmed the benefit of optimization of smoking 
cessation medications. In a prospective cohort intervention study of 795 smokers using smoking 
cessation medications across multiple quit attempts, participants were classified as (1) early users 
(used medications for initial, but not subsequent quit attempts; (2) later users (used medications 
for subsequent, but not initial quit attempt); (3) repeaters (same medications used for each quit 
attempt); and (4) switchers (different medication used for each quit attempt).45 Switchers had 
significantly higher week 4 abstinence rates relative to all other groups (28.5% versus 12.4%-
20.0%) and, interestingly, the better quit rates among switchers (versus repeaters) was not 
accounted for by progression to a better cessation medication. Rather, the act of switching drove 
better success in quitting regardless of the medications smokers were switching to/from, 
providing solid scientific premise for our approach of switching versus extending (i.e., repeating) 
pharmacotherapy in non-responders. 
 
The above studies support the strong scientific premise for an optimized approach to tobacco 
dependence treatment. Notably, 70-91% of participants in the above studies have been White 
smokers.39-43 AAs have different smoking patterns and behaviors, including a preference for 


 
 
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menthol cigarettes, fewer CPD, and different preferences for and responses to pharmacotherapy, 
including differences in nicotine and pharmacotherapy metobolims.12,15,19,46-48  Therefore, the 
selection and sequence of smoking cessation medications 
 
II. 
Research Plan and Design 
 
A. Study Objectives 
 
The objective of this study is to examine the efficacy of optimized (OPT) versus enhanced usual 
care (UC) treatment for smoking cessation.  AA smokers randomized to OPT (n=196) will 
receive high intensity smoking cessation counseling, nicotine patch (NP), and up to two 
pharmacotherapy optimizations [bupropion (BUP), varenicline (VAR)] based on verified smoking 
status at Weeks 2 and 6. AA smokers randomized to enhanced UC (n=196) will receive the 
same high intensity counseling and NP with no optimizations in pharmacotherapy. 
 
B. Study Type and Design 
 
The proposed study is a randomized adaptive treatment trial for smoking cessation in 392 AA 
smokers. Participants randomized to OPT (n=196) will receive smoking cessation counseling, 
nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified 
smoking status at Weeks 2 and 6. Participants randomized to UC (n=196) will receive the same 
smoking cessation counseling and NP; pharmacotherapy in this group will not be optimized. 
Pharmacotherapy and counseling in both groups will last for 18 weeks with long-term follow-up 
through Week 26. The primary outcome is biochemically-verified smoking status at Week 12.  
 
 
C. Sample size, statistical methods, and power calculation 
392 eligible AA smokers will be randomized.  We will use a 1:1 fashion to either OPT or 
enhanced UC. Randomization will be stratified based on to ensure an equal proportion of male 
and female smokers in OPT and UC. Randomization will be determined by computer-generated 
random numbers. Randomization assignments will be placed in sealed envelopes with sequential 
study ID numbers. After baseline data collection has been completed, the research assistant will 
select the sequential study ID number to determine the randomization assignment.  
 
The primary endpoint is urine anatabine and anabasine-verified 7-day point prevalence 
abstinence at Wk 12. While CO is used for adaptation decision making, the more robust 
anatabine/anabasine are being used for biochemical verification of study endpoints, with the 
recommended cut-off of 2 ng/ml to differentiate smokers from non-smokers.60 These tobacco 
alkaloids are the gold standard for confirming abstinence when participants are on NRT and 
cotinine measurements are invalid because detectable levels of cotinine could reflect NRT use or 
smoking.60 We expect an 18% cessation rate at Wk 12 in the UC group and a 32% cessation 
rate in the OPT group. This difference in cessation is consistent with an adaptive trial which 
found that 10% of smokers who failed on one therapy and were switched to another early in 
treatment were rescued after one adaption.35 Given two optimizations in the current study, we 
expect that ~15% of smokers will be rescued at Week 12 in OPT relative to UC. Using the chi-
square test, along with 18% and 32% cessation rates, 196 participants in each group will give 
us 90% power to detect this difference with a type I error rate of 5%. 
 
 
 
 
 
D. Subject Criteria (See Vulnerable Populations appendix, if applicable) 
 


 
 
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Participants will be AA adults over the age of 18 who smoked cigarettes daily at enrollment and 
have smoked at this rate for > 6 months. The study will be open to both men and women. We 
have chosen to focus on AAs only because their unique smoking profile places them at greater 
risk for tobacco-related disease and death.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion criteria 
Inclusion criteria are displayed in the adjoining table.  Participants must smoke 5-30 CPD to be 
consistent with packaging guidelines for NP and minimize possible confounds in treatment 
response based on extreme light (1-4 CPD) or heavy (31+ CPD) smoking. The majority of AAs 
smoke 5-10 CPD and, combined, our CPD eligibility criteria encompasses ~85% of AA smokers.   
 
Exclusion criteria 
 
Exclusion criteria are also displayed in the adjoining table.  Exclusion criteria are consistent with 
contra-indications for NP, BUP, and VAR. 13,14,86-93. Non-daily smokers and those who have used 
non-cigarette tobacco products in the past 30 days (e.g., cigars, cigarillos) will be excluded 
because NP, BUP, and VAR have not been tested in these subgroups. 
 
Withdrawal/Termination Criteria  
There are no expected circumstances in which the subject’s participation will be terminated by 
the investigator. 
 
Clarify whether a study subject may participate in another research study while 
participating in this research study 
Subjects are not able to participate in another smoking cessation research study while they are 
enrolled in the current study.  
 
E.  Specific methods and techniques used throughout the study       
 
Laboratory tests 
Not more than 20 ml of urine will be collected four times throughout the study.  At Week 0 the 
urine will be used for the analysis of total nicotine equivalents (TNE) and other chemicals found 
in cigarettes.  At Wks 12, 18 and 26 the urine samples will provide biochemical verification of 
cessation (via urine anabasine and anatabine, with the recommended cut-off of 2 ng/ml to 
Eligibility Criteria 
Inclusion Criteria 
Exclusion Criteria 
• Non-Hispanic African 
American  
• ≥ 18 years of age 
• Smoke 5-30 CPD 
• Daily cigarette smoker  
• Smoked at current rate for > 
6 months 
• Verified smoker (CO > 5 
ppm) 
• Functioning telephone 
• Interested in quitting 
smoking 
• Willing to take NP, VAR , 
and/or BUP+NP for 18 
weeks and complete all study 
visits  
• Use of non-cigarette tobacco products in past 30 days 
• Medical contraindications to NP, BUP, or VAR: unstable cardiac condition 
(e.g., unstable angina or AMI) cardiac event, or stroke in the past 4 weeks; renal 
impairment; medications contraindicted; history of clinically significant allergic 
reactions;  history of epilepsy, seizure, head trauma, psychosis, bipolar disorder, 
eating disorder; unstable panic disorder or depression; active suicidal ideation; 
treatment for alcohol or drug dependence in the past year 
• Use of pharmacotherapy in the month prior to enrollment  
• Pregnant, contemplating getting pregnant, or breastfeeding 
• Unstable housing (e.g., street, shelter) 
• Plans to move from KC during the treatment and follow-up phase 
• Another household member enrolled in the study 


 
 
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Path B1 
Path B2 
Path B3 
Path B4 
Wk 0 
RANDOM. 
Wk 2 
OPT 1 
Wk 26 
Final 
Follow Up 
Wk 12  
Primary Outcome 
Wk 18  
EOT 
Wk 6 OPT 
2 
RANDOMIZED 
Figure 1. Optimization of Pharmacotherapy Study Flow Diagram 
aNP = nicotine patch 
b,c At each time point, response (R) defined as a CO LTE 5 ppm and non-response (NR) to defined as a CO GT 5 ppm 
Response (R)b 
stay on NP 
VAR 
Non-Response (NR)c 
switch to VAR 
R
 
stay on VAR 
Path A 
NPa 
Enhanced UC, n=196 
NR: BUP+NP 
BUP+NP 
NP 
NP 
NP 
NP
NP
a
R
 
stay on NP 
NP
NP
OPT, n=196 
NR
 
switch to VAR 
VAR 
VAR 
VAR 
BUP+NP 
Wk 1 
1ST TQD 
Wk 3 
2ND TQD 
Wk 7 
3RD TQD 
differentiate smokers from non-smokers).   Not more than 20ml of saliva will be collected at 
Week 0 for genetic analysis.  The DNA anaylsis will be used for research to understand nicotine 
metabolism genotype and phenotype.  Melanin will be assessed at Wk 0 using a skin 
reflectometer. 
Study Procedures:  
Intervention 
All eligible participants who provide written informed consent and complete the baseline survey 
will be randomized in a 1:1 fashion to either OPT or UC. 
 
Optimization Overview. The optimization flow diagram is displayed in Figure 1. Both groups will 
receive 18 weeks of pharmacotherapy according to standard dosing guidelines 6,49 but the type of 
pharmacotherapy will vary depending on group assignment and response. Path A is participants 
randomized to enhanced UC who will receive 18 weeks of NP (Wks 0-18). Path B1 is OPT 
participants who respond to NP (CO LTE 5 ppm) at each optimization time point and, therefore, 
remain on NP for 18 weeks (Wks 0-18). B2 is OPT participants who respond to NP at Wk 2 but 
who demonstrate non-response to NP at Wk 6 (CO GT 5 ppm) and are switched to VAR. 
Participants in this group will receive 6 weeks of NP (Wks 0-6) and 12 weeks of VAR (Wks 6-18). 
B3 is OPT participants who were switched to VAR at Wk 2 after non-response to NP and who 
demonstrate 
response to VAR at 
Wk 6. Participants 
in this group will 
receive 2 weeks of 
NP (Wks 0-2) and 
16 weeks of VAR 
(Wks 2-18). B4 is 
OPT participants 
who were switched 
to VAR at Wk 2 
and BUP +NP at 
Wk 6. Participants 
in this group will 
receive 2 weeks of 
NP (Wks 0-2), 4 
weeks of VAR (Wks 
2-6), and 12 weeks 
of BUP +NP (Wks 
6-18).  
 
Use of study medication will be under the supervision of Drs. Nollen (PI), Ellerbeck (Co-I and 
Kansas study physician), and Salzman (Co-I and Missouri study physician). Participants will be 
prompted to discuss side effects at each in-person visit and given the study phone number to 
report adverse events at interim time points. NIH guidelines for reporting serious adverse events 
(SAEs) will be followed. Any problems needing medical attention will be referred to Drs. Ellerbeck 
or Salzman who will carry a study pager and have served in this role in previous RCTs. Medication 
will be discontinued or reduced following a SAE or in the event of AEs judged by the clinical team 
to warrant discontinuation or reduction. In our previous RCTs with these medications only 3% of 
participants required discontinuation and 1% required reduction.  
 
NP (OPT, UC). To maximize efficacy, all participants will receive the 24-hour 21 mg NP for 18 
weeks. NP therapy will start at Week 0, with the 1st TQD occurring at Week 1.  
 


 
 
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VAR (OPT). VAR will be dispensed 0.5 mg once daily on Days 1-3, 0.5 mg twice daily on Days 4-
7, and 1 mg twice daily from Day 8 through the EOT. The new (2nd TQD will be Day 8 of VAR. 
Treatment with VAR has been approved for up to 26 weeks, with the standard course of treatment 
being 12 weeks.50 Non-responders in the current study will receive VAR for 4 weeks (Path B4), 12 
weeks (B2), or 16 weeks (B3).   
 
BUP (OPT). BUP will be dispensed 150 mg once daily on Days 0-3 and then 150 mg twice daily 
from Day 4 through optimization or the EOT. The new (3rd) TQD will be Day 8 of BUP. Treatment 
with BUP has been approved for up to 12 months, with the standard course of treatment being 12 
weeks.50 Non-responders in the current study will use BUP +NP for 12 weeks (Path B4).  
 
Counseling (OPT, UC). Both groups will receive 7 sessions of patient-centered solution-focused 
counseling for smoking cessation.6 The counseling protocol is evidence-based,6,51,52 individualized 
and culturally-specific, has been developed by our team over the last 20 years in collaboration 
with an AA community advisory board and former AA study participants,20 and has been found to 
be superior for AA smokers in head-to-head comparisons with other counseling approaches (i.e., 
motivational interviewing, brief advice).19,53 The goal of counseling is to increase knowledge 
(including information particularly relevant to AA), develop skills (including behavioral and 
cognitive strategies) based on individual needs, and provide intra-treatment social support. Skills 
include medication management and adherence, coping responses to address withdrawal/craving 
and lapses, strategies to address smoking triggers, reduce cue-smoking contingencies, and 
increase self-efficacy to promote abstinence and support a smoke-free lifestyle. Our approach is 
intentionally flexible to match the needs of each participant over the course of behavior change. 
Counseling goes hand-in-hand with a 30-page culturally-targeted Kick It at Swope Quit Smoking 
Guide, used in previous KIS trials. For the purposes of rapport and continuity of care, participants 
will meet with the same counselor each session. Counseling will be delivered by our experienced 
staff who are certified tobacco treatment specialists, have extensive experience treating AA 
smokers within clinical trials, and are active members of the community. Dr. Cox (co-I), a licensed 
clinical psychologist, will be responsible for counselor training and supervision. Time points for 
counseling have been selected to correspond with ongoing CO monitoring of smoking 
status/response to treatment (Wks 0, 2, 6, 12) and one week following optimization/assessment 
time points, which will coincide with TQDs (Wk 1 for all, and Wk 3, 7 for non-responders in both 
groups). 
 
Procedures and Methods 
 
An overview of major study events is provided in the adjoining table. 
 
Initial Screening. The initial screen will review inclusion/exclusion criteria. Those eligible will 
be scheduled to complete final eligibility screening within 14 days. All ineligible smokers will be 
referred to local resources. 
 
Final Screening and Enrollment (Wk 0). Final eligibility screening will be conducted in 
person and will consist of a pregnancy test on women of childbearing age and obtaining 
informed consent.  
 
Counseling Visits (Wks 0, 1, 2, 3, 6, 7, 12). Counseling sessions, each lasting approximately 
20 minutes, will be completed in person at Wks 0, 2, 6, 12 and by telephone at Wks 1, 3, 7. The 
number of sessions is consistent with our previous studies where we have achieved visit 
completion rates of ~ 80%.12,14,15,19 
 


 
 
KUMC – HRPP- 03/23/2023 
 
Page 10 of 24
 
 
 
 
Response/Non-Response to Pharmacotherapy (Wk 2, 6). Exhaled air carbon monoxide 
(CO) is an immediate, non-
invasive method of 
biochemically verifying smoking 
status. At Wk 2 and 6, all 
participants will breathe into a 
Micro-3 Smokerlyzer (Bedfont 
Scientific) for the purpose of 
determining abstinence. All 
participants will be informed of 
their CO level and it will be 
used to frame counseling 
discussions around smoking 
status/quitting. OPT 
participants with CO LTE 5 ppm 
will be considered ‘responders’ 
and will continue on their 
existing pharmacotherapy. 
Those with CO GT 5 ppm will 
be considered ‘non-responders’ 
and will be switched to the next 
pharmacotherapy per Figure 1.  
 
 
Medication Dispensing (Wk 
0, 2, 6, 12). Medication will be 
dispensed at Wk 0 (baseline) 
and Wk 2, 6, 12 in the quantity 
needed to get participants to 
the next 
assessment/optimization time 
point. This approach has resulted in 88% attendance at medication dispensing visits in our 
previous studies. Participants will be asked to return unused medication to ensure (a) that OPT 
participants take only the medication corresponding with the current stage of treatment and (b) 
that OPT and UC participants on NP receive a supply that corresponds with their current dosing 
needs. Those who do not attend medication dispensing visits will be mailed enough of their 
current medication to get them to the next dispensing time point. Participants must be eligible 
for NP, BUP, and VAR as a condition of eligibility; however, prior to switching, we will reassess 
medical eligibility in OPT non-responders. Given the short time frame between visits and careful 
upfront screening, we expect that very few non-responders will be medically ineligible for 
switching. Those who are will either receive the next therapy for which they are eligible (BUP, 
VAR) or, if medically ineligible for either switch, stay on their existing pharmacotherapy.   
 
COVID-19 Remote Visits.  
Beginning March 23, 2020 and for the duration of the “COVID-19 Stay at Home Order’ all face-
to-face encounters will be temporarily terminated.  All previous in-person assessments will be 
completed over the phone.  Urine samples will be either mailed in or left outside for pickup by 
study staff as determined by location and abilities of the study participant.  Medication will be 
dispensed similarly; either by mail or dropped at the study participant’s home. Instructions and 
counseling sessions will be completed by phone and/or facetime. Because enrollment activities 
cannot be completed remotely, study enrollment will be temporarily suspended.   
When the ‘Stay at Home Order’ is lifted or COVID-19 precautions are no longer deemed 
necessary, the original study protocol will go into effect.  
 
 Overview of Major Study Events and Measures 
 
 
 
Screen 
Enroll 
 
 
 
 
 
Primary 
Endpoint 
EOT 
Follow-
Up 
 
WEEKS 
-2* 
0 
1* 
2 
3* 
6 
7* 
12 
18 
26 
Screening 
X 
X 
 
 
 
 
 
 
 
 
Intervention 
 
 
Counseling 
 
X 
X 
X 
X 
X 
X 
X 
 
 
Medication Dispensing 
 
X 
 
X 
 
X 
 
X 
 
 
Smoking Abstinence 
 
 
CO  
 
X 
 
X 
 
X 
 
 
 
 
Urine for TNE & 
Anabasine/Anatabine  
 
X 
 
 
 
 
 
X 
X 
X 
Saliva 
 
X 
 
 
 
 
 
 
 
 
Mediators 
Withdrawal  
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Craving  
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Reinf effects of nicotine  
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Pos & Neg Affect 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Self-efficacy 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Side effects 
 
 
X 
X 
X 
X 
X 
X 
X 
 
Medication use 
 
 
X 
X 
X 
X 
X 
X 
X 
 
Counseling completion 
 
X 
X 
X 
X 
X 
X 
X 
 
 
Moderators (all assessed at baseline) 
See measures 
 
X 
 
 
 
 
 
 
 
 
Process Measures (OPT only) 
# down each OPT path 
 
 
 
 
 
 
 
X 
 
 
# reinitiating medication 
 
 
 
 
X 
 
X 
 
 
 
# setting new TQD 
 
 
 
 
X 
 
X 
 
 
 
Verified abstinence 
 
 
 
 
 
 
 
X 
X 
X 
Change in withdrawal, 
craving, reinf effects of 
nicotine, affect, and self-
efficacy post-optimiz. 
 
 
 
X 
X 
X 
X 
X 
 
 
Descriptive Measures (all assessed at baseline) 
See measures 
 
X 
 
 
 
 
 
 
 
 
Visit Length (in minutes) 
30 
120 
45 
60 
45 
60 
45 
120 
45 
45 
*phone visit; all other visits are in-person 


 
 
KUMC – HRPP- 03/23/2023 
 
Page 11 of 24
 
 
 
 
Retention. Retention is enhanced by having participants meet with the same counselor each 
time. We have also developed a system of reminders and compensation for participant efforts 
that have resulted in impressive retention rates in our previous clinical trials. Reminders. Five 
days prior to each visit a reminder postcard, email, and/or text noting the scheduled 
appointment date and time will be sent. Participants will also be called, texted, or emailed 
(based on preference) up to 6 times to remind them of their upcoming visit. A detailed tracking 
database, with an automated reminder system, will notify counselors of when to send reminder 
messages. Compensation. Participants will be given a $30 gift card at Wks 0, 2, 6 and 12, a 
$20 gift card at Wk 18, a $40 gift card at Wk26, and a $10 gift card at Wks 1, 3, 7 as 
compensation for their time/travel.  Participants may receive an additional $20 at Wks 2, 6, 12 
and 18 for returning their unused medication.   
 
Clearly indicate which procedures, tests, visits, etc., are parts of usual standard 
therapy and which are performed solely for research purposes.  
 
All tests, procedures, and visits are being performed solely for research purposes and are not 
billable to insurance companies. 
 
Describe the fate of any body component (blood, CSF, bone marrow, etc.) used in the 
study, emphasizing confidentiality of labeling of the sample and the sample’s 
destruction or storage.  
 
Samples will be labeled only with a unique study identification number and only members of Dr. 
Nollen and Reed’s team will have access to the samples. Samples will be disposed of one month 
after the final report is sent out to the Principal Investigator, unless participants agree to have 
their urine stored for future testing. 
 
 
F. Risk/benefit assessment 
 
Physical risk 
Risks for participating are primarily those associated with the use of pharmacotherapy. Common 
side effects occurring in >5 % of patients is summarized below for each medication. To address 
these concerns, participants will receive written information and information from their counselor 
about how to manage any of these symptoms.  Risks will be minimized by our extensive exclusion 
criteria which encompass contraindications for NP, VAR, and BUP.   
 
Nicotine Patch: 
 
 
• 
Sweating  
• 
Redness or swelling at the patch 
site  
• 
Irritability  
• 
Problems sleeping or vivid 
dreams 
• 
Headache  
• 
Dizziness  
 
• 
Nausea or vomiting  
• 
Abnormal heartbeat or rhythm  
• 
Diarrhea Nervousness or 
restlessness  
• 
Difficulty breathing  
• 
Tiredness 
 
 
 
Bupropion and Varenicline Risks: 


 
 
KUMC – HRPP- 03/23/2023 
 
Page 12 of 24
 
 
 
 
 


 
KUMC – HRPP- 03/12/2015 
 
Page 13 of 24
 
 
 
• 
Nausea 
• 
Sleep problems (trouble sleeping or vivid, unusual or strange dreams) 
• 
Headache 
• 
Constipation 
• 
Gas 
• 
Dry mouth 
• 
Dizziness 
• 
Disturbance in attention 
• 
Fatigue 
• 
Skin changes (dry skin or acne) 
Psychological risk 
Risks for participants in both treatment arms (OPT, UC) also include those associated with the 
inconvenience of participation including answering surveys, providing blood and urine, and 
participating in follow-up visits and assessments. To minimize the inconveniences associated with 
study participation we will review all data collection instruments and study procedures to minimize 
the number of items in our instruments and improve the accessibility and convenience of our study 
procedures.  We anticipate using several methods to enhance convenience to participants, including 
offering study visits in the evening and on weekends and offering patients a choice of where they will 
be seen (KUMC or Swope). Another risk is feeling pressured to be in the study, which we will track in 
order to monitor and will report this as an adverse event.   
 
Social risk 
None 
 
Economic risk 
None 
 
Potential benefit of participating in the study 
There are also no direct benefits to participating in this study except that researchers hope that the 
information from this research study may be useful in improving treatment for AA smokers. 
G. Location where study will be performed:  
The study will take place at Swope Health Central, 3801 Blue Parkway, in Kansas, Missouri or at the 
KUMC CRU in Fairway, Kansas based on the preference of each participant.  All data will be directly 
entered into an electronic data capture system (i.e., RedCap or CRIS), therefore minimizing the use 
of paper records.  If paper records are generated, they will be stored in locked file cabinets at 
Swope.  Only study staff will have access to the locked records at Swope and the secure online 
electronic data capture system.   
 
H. Collaboration (with another institution, if applicable): Gary Salzman, M.D. will serve as a co-
investigator and the PI of the subcontract to Truman Medical Center (TMC). TMC is one of the 
largest provider of safety net medical care for uninsured and under-insured patients in the Kansas 
City metropolitan are.  Dr. Salzman is the Chief of Respiratory and Critical Care at TMC whose 
patient population is 40% African American.  Dr. Salzman will lead recruitment efforts of TMC 
patients.  He will participate in weekly team meetings and review documents as needed.  KUMC will 
serve as the lead IRB. 
 
I. Single IRB Review for a Multi-site study (if applicable):  N/A 
 
J. Community-Based Participatory Research (if applicable): N/A 
 


 
KUMC – HRPP- 03/12/2015 
 
Page 14 of 24
 
 
 
K. Personnel who will conduct the study, including: 
Indicate, by title, who will be present during study procedure(s) 
Personnel on the project include:  Nikki L. Nollen (PI), Lisa Cox (co-I), Ed Ellerbeck (co-I and 
study physician), Allen Greiner (co-I and Study physician), Matt Mayo (co-I, lead biostatistician), 
Tricia Snow (project director), Lexi Brown (senior research analyst), Genevieve Casey (research 
assistant), Brian Hernandez (research assistant),  Terri Tapp (research assistant), and Michael 
Arnold (GRA). 
 
1. Primary responsibility for the following activities, for example:  
a. Determining eligibility: Ed Ellerbeck, Allen Greiner, Nikki Nollen, Tricia Snow, , 
Brian Hernandez, Terri Tapp, Michael Arnold 
 
b. Obtaining informed consent: Tricia Snow, , Brian Hernandez, Terri Tapp, Michael 
Arnold 
 
c. Providing on-going information to the study sponsor and the IRB: Nikki Nollen, 
Tricia Snow 
 
d. Maintaining participant's research records: Tricia Snow,  Brian Hernandez, Terri 
Tapp, Lexi Brown, Dinesh Mudaranthakam, Matt Mayo 
 
e. Completing physical examination: Not applicable 
f. 
Taking vital signs, height, weight: Height and weight will be the only vital 
signs taken.  They  will be performed by Tricia Snow,  Brian Hernandez, Terri 
Tapp 
 
g. Drawing / collecting laboratory specimens: Tricia Snow,  Brian Hernandez, Terri 
Tapp 
 
h. Performing / conducting tests, procedures, interventions, questionnaires: Tricia 
Snow, Brian Hernandez, Terri Tapp 
 
i. 
Completing study data forms: Tricia Snow, Brian Hernandez, Terri Tapp,  Lexi 
Brown, Michael Arnold 
 
j. 
Managing study database: Matt Mayo, Lexi Brown, Dinesh Mudaranthakam, Tricia 
Snow 
 
L. Assessment of Subject Safety and Development of a Data and Safety Monitoring Plan 
 
The current study involves three FDA-approved smoking cessation medications -- nicotine patch (NP), 
bupropion (BUP), and varenicline (VAR). These medications do not require an investigational new drug 
application and are being used in accordance with cleared/approved labeling.  Specifically, nicotine 
patch is available over-the-counter without a prescription and is approved for long-term use. 
Participants in the current study will use the nicotine patch for up to 18 weeks or for a shorter duration 
if it is determined that the nicotine patch is not working for them. Bupropion (BUP) and varenicline 
(VAR) both require a prescription. Participants will receive clearance from a physician to use these 
products before being enrolled and will be under the medical supervision of a physician during the 
course of the study. Treatment with VAR has been approved for up to 24 weeks, with the standard 
course of treatment being 12 weeks.50 Participants in the current study will receive VAR for 4 weeks, 12 
weeks, or 16 weeks.  The shorter course of treatment (i.e., 4 weeks) will only occur if VARis not working 
for the participant (i.e., they are not quit and/or are experiencing substantial nicotine-related withdrawal 
or craving and medication-related adverse events).  These are standard instances in which the use of 
VAR would be terminated.  Treatment with BUP has been approved for up to 12 months, with the 
standard course of treatment lasting from 6 – 12 weeks.50 Participants in the current study will use BUP 


 
KUMC – HRPP- 03/12/2015 
 
Page 15 of 24
 
 
 
for 12 weeks.  The black box warning for both BUP and VAR has been removed 
(https://www.fda.gov/Drugs/DrugSafety/ucm532221.htm) due to evidence that these medications do not 
increase neuropsychiatric harm relative to placebo; this is true in individuals with and without a mental 
health diagnosis.54   
 
This study does not involve more than minimal risk. We will protect participants and minimize risks by 
using the strict exclusion criteria and careful monitoring of adverse events (AEs). AEs will be tracked 
during regularly scheduled provider visits or through spontaneous reports made by participants. Drs. 
Ellerbeck, Salzman (or the treating provider) and Nollen will be made aware of unexpected or serious 
AEs within 24 hours of the first report by participants; all other AEs will be reviewed weekly by Dr. 
Nollen and discussed at regular meetings with Dr. Ellerbeck. SAEs will be reported to the KUMC IRB, 
FDA, and NIDA within 24 hours of first awareness of the event. Unexpected adverse events that are 
related to the study medication will be reported to KUMC IRB, FDA, and NIDA within 5 working days of 
first awareness of the event if the event is not serious fatal and within 24 hours of first awareness if the 
event is serious. Unexpected adverse events that are unrelated to the study medication will be reported 
to the KUMC HSC during yearly routine event reporting. IRB actions taken in this study will be reported 
to NIDA.  Drs. Ellerbeck or Salzman (or the treating provider) will determine relatedness for each 
reported AE. SAEs will be defined as any event experienced by a study subject while on the study 
medication that is fatal, life-threatening (subject was at risk of death from the event as it occurred), 
disabling or incapacitating, requires inpatient hospitalization or prolongs a current hospitalization, is a 
congenital anomaly in the offspring of a subject who received the study medication, or required 
intervention to prevent permanent impairment or damage.  
 
 
III. 
Subject Participation 
 
A. Recruitment: 
 
Participants will be recruited through clinic and community-based efforts. Flyers will be placed 
around Swope, KUMC and Truman Medical Center (TMC) for patients to take and providers will be 
asked to refer patients by providing them with the study line information. We will use the KUMC 
HERON database and the TMC electronic medical records to identify AA smokers and will ask their 
physician to send their patient a letter informing them of the study.  We will also use the Frontiers 
registry to identify AA adult smokers who have agreed to be contacted for research. We will also 
use radio, TV, bus and Facebook ads and word of mouth, as needed, to recruit participants. Finally, 
AA smokers are currently being screened for other research studies being conducted by our team 
(i.e., active studies being conducted Dr. Nollen, Ellerbeck, or Cox). Those who are found to be 
ineligible for these studies will be informed about the current study and offered the opportunity to 
be screened. Recruitment letters, advertisements, and flyers are in the process of being developed. 
They will be submitted to the IRB for approval before any participants are enrolled.   
 
B. Screening Interview/questionnaire 
 
The screening interview will take place over the phone and be conducted by a member of the study 
team. The screening questionnaire will address the general inclusion/exclusion criteria in the 
Eligibility Criteria table above. Only participants who have express interest will be screened. 
  
C. Informed consent process and timing of obtaining of consent 
 
Consent will be obtained prior to participant involvement. Individuals interested in the proposed 
study will meet the research assistant at Swope or the CRU. Each individual will be given a copy of 
the consent form and as much time as they need to review its contents. After the consent form is 
read, both the individual and the research assistant will review the consent form together and the 
potential participant will be encouraged to ask questions. Each individual will be reminded that 
participation in the study is completely voluntary and their decision to participate will not affect 


 
KUMC – HRPP- 03/12/2015 
 
Page 16 of 24
 
 
 
their current or future medical care at the treating facility. The consenting process will take place in 
a private location. 
D. Alternatives to Participation 
Alternatives to participating in the study are to quit “cold turkey” (without assistance), use other 
smoking cessation programs, purchase other NRT from their pharmacy, obtain a prescription for 
varenicline, bupropion or other smoking cessation products from their physician, or continue to 
smoke. 
 
E. Costs to Subjects 
There are no costs to subjects. All tests, procedures, and visits are being performed solely for 
research purposes and are not billable to insurance companies. 
 
F. How new information will be conveyed to the study subject and how it will be 
documented 
 
 We have plans to publish data from this study in aggregate but will not provide any individualized 
feedback to participants.   
 
G. Payment, including a prorated plan for payment 
Participants will be given a $30 electronically loaded gift card at Wks 0,2, 6 and 12, $20 gift card at 
Wk 18 and a $40 electronically loaded gift card at Wk 26 and a $10 electronically loaded gift card at 
Wks 1,3, 7 in appreciation for their time and participation. Participants may receive an additional 
$20 at Wks 2, 6, 12 and 18 for returning their unused medication.  Participants must complete the 
visit to receive the reimbursement associated with that time point. Travel costs will not be 
reimbursed.  Participants will also be given $20 for each referral who is eligible and enrolls in the 
study.  Each participant may refer up to 3 total referrals. 
 
 
H. Payment for a research-related injury 
N/A  
IV. 
Data Collection and Protection 
A. Data Management and Security 
 
Confidentiality will be maintained by assigning each participant a study identification number and 
numerically coding all data. The association of the ID-code and the participant’s name will be kept 
by Tricia Snow in a locked file cabinet. The screening questionnaire and all survey data will be 
directly entered into RedCap or CRIS and accessible only by study staff. Any paper copies of records 
will be kept in a locked filing cabinet in offices that are kept locked when unoccupied.  Only 
summaries of group data will be reported in any publications or presentations, with no identification 
of individuals.  Because identifiable information will be collected, participant privacy will be 
maintained throughout the duration of the study by adhering to the regulations set forth by the 
HIPAA Privacy Rule.  More specifically, identifiable information will not be released without written 
authorization of the participant.  Mobile devices will not be used for data collection or storage. 
Identifiable data will not be sent outside of KUMC.  
 
B. Sample / Specimen Collection 


 
KUMC – HRPP- 03/12/2015 
 
Page 17 of 24
 
 
 
No more than 20 ml of urine will be collected at Weeks 0, 12, 18, and 26. Not more than 20ml of 
saliva will be collected at Week 0 for analysis of nicotine metabolism genotype and phenotype. All 
samples  will be de-identified andlabeled with a study identification number. Samples will be stored 
at the Bioanalytical Laboratory at the Fairway Clinical Research Center under the direction of Greg 
Reed, PhD (urine), at the University of Toronto under the direction of Dr. Rachel Tyndale, PhD (urine 
and saliva), and at the University of California-San Francisco under the direction of Dr. Neal 
Benowitz, MD (urine and saliva). Samples will be accessible only to members the study team. 
Results from biomarker analyses will be de-identified and shared only with members of the research 
team. Any resulting publications will present the data in aggregate; individual participants will not 
be identified. Samples will be disposed of one month after the final report is sent out to the Principal 
Investigator, unless participants agree to have their urine stored for future testing. For participants 
who agree to future testing, samples will be stored indefinitely.  
 
C. Tissue Banking Considerations 
 
For participants who agree to future testing, samples will be stored indefinitely. New markers of 
nicotine and carcinogen exposure and genetic differences in nicotine metabolism are being 
discovered and the stored biological samples would be used for analysis of these new markers.  All 
samples stored for future biomarker analyses will be de-identified and accessible only to members 
of the study team. Results from these analyses will be de-identified and shared only with members 
of the research team. Any resulting publications will present the data in aggregate; individual 
participants will not be identified.    
 
D. Procedures to protect subject confidentiality 
Confidentiality will be maintained by assigning each participant a study identification number and 
numerically coding all data.  All biological samples and survey data will be labeled with the study 
identification number and never with the participants name or other identifiable information.  The 
association of the ID-code and the participant’s name will be kept by Tricia Snow in a locked file 
cabinet and will only be accessible to members of the study team. 
 
E. Quality Assurance / Monitoring 
 
All data will be directly entered into our electronic data capture system (i.e., RedCap or CRIS) that 
contains edit checks to control the quality and completeness of data entry. Completeness of data 
entry will be automatically verified before each assessment is completed. The electronic data 
capture system is behind the KUMC secure firewall with role-based access that is HIPAA and human 
subjects compliant. There are no plans for ongoing third-party monitoring. 
 
V. 
Data Analysis and Reporting 
A. Statistical and Data Analysis 
See II.C. above (Sample Size, Statistical Methods, and Power Calculations) 
 
B. Outcome 
See II.C. above (Sample Size, Statistical Methods, and Power Calculations) 
 
C. Study results to participants  


 
KUMC – HRPP- 03/12/2015 
 
Page 18 of 24
 
 
 
Study results will not be shared with participants. 
 
D. Publication Plan 
We plan to publish results in appropriate tobacco journals – e.g., JAMA, JNCI, Journal of General 
Internal Medicine, Addiction, Annals of Behavioral Medicine, Nicotine & Tobacco Research, Cancer 
Epidemiology, Biomarkers, & Prevention.  
 
VI. 
Bibliography / References / Literature Cited  
 
1. 
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Society;2017. 
2. 
Cunningham TJ, Croft JB, Liu Y, Lu H, Eke PI, Giles WH. Vital Signs: Racial Disparities in Age-Specific Mortality 
Among Blacks or African Americans - United States, 1999-2015. MMWR Morb. Mortal. Wkly. Rep. 2017;66(17):444-
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3. 
Haiman CA, Stram DO, Wilkens LR, et al. Ethnic and racial differences in the smoking-related risk of lung cancer. N. 
Engl. J. Med. 2006;354(4):333-342. 
4. 
Ahluwalia JS, McNagny SE, Clark WS. Smoking cessation among inner-city African Americans using the nicotine 
transdermal patch. J. Gen. Intern. Med. 1998;13(1):1-8. 
5. 
Ahluwalia JS, Harris KJ, Catley D, Okuyemi KS, Mayo MS. Sustained-release bupropion for smoking cessation in 
African Americans: a randomized controlled trial. JAMA. 2002;288(4):468-474. 
6. 
Cox LS, Okuyemi K, Choi WS, Ahluwalia JS. A Review of Tobacco Use Treatments in U.S. Ethnic Minority 
Populations. Am. J. Health Promot. 2011;25(5_suppl):S11-S30. 
7. 
Cox LS, Nollen NL, Mayo MS, et al. Bupropion for smoking cessation in African American light smokers: a randomized 
controlled trial. J. Natl. Cancer Inst. 2012;104(4):290-298. 
8. 
Robles GI, Singh-Franco D, Ghin HL. A review of the efficacy of smoking-cessation pharmacotherapies in nonwhite 
populations. Clin. Ther. 2008;30(5):800-812. 
9. 
Webb MS. Treating tobacco dependence among African Americans: a meta-analytic review. Health Psychol. 
2008;27(3s):S271-282. 
10. 
Laude JR, Bailey SR, Crew E, et al. Extended treatment for cigarette smoking cessation: a randomized control trial. 
Addiction. 2017;112(8):1451-1459. 
11. 
Fiore M, Jaen C, Baker T, et al. Treating Tobacco Use and Dependence Clinical Practice Guideline: 2008 Update. 
Washington, DC: U.S. Department of Health and Human Services; 2008. 
12. 
Nollen NL, Cox LS, Yu Q, et al. A clinical trial to examine disparities in quitting between African-American and White 
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13. 
8. Pharmacologic Approaches to Glycemic Treatment. Diabetes Care. 2017;40(Supplement 1):S64-S74. 
14. 
James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: 
Report from the panel members appointed to the eighth joint national committee (jnc 8). JAMA. 2014;311(5):507-520. 
15. 
Rose JE, Behm FM. Adapting smoking cessation treatment according to initial response to precessation nicotine patch. 
Am. J. Psychiatry. 2013;170(8):860-867. 
16. 
Baker TB, Mermelstein R, Collins LM, et al. New methods for tobacco dependence treatment research. Ann. Behav. Med. 
2011;41(2):192-207. 
17. 
Kidwell KM. SMART designs in cancer research: Past, present, and future. Clin. Trials. 2014;11(4):445-456. 
18. 
U.S. Department of Health and Human Services. The Health Consequences of Smoking--50 Years of Progress. A Report 
of the Surgeon General. 2014;https://www.surgeongeneral.gov/library/reports/50-years-of-progress/. 
19. 
American Cancer Society. Cancer Facts & Figures for African Americans 2013-2014. Atlanta, GA: American Cancer 
Society; 2013. 
20. 
Babb S, Malarcher A, Schauer G, Asman K, Jamal A. Quitting Smoking Among Adults - United States, 2000-2015. 
MMWR Morb. Mortal. Wkly. Rep. 2017;65(52):1457-1464. 
21. 
Croghan IT, Hurt RD, Ebbert JO, et al. Racial differences in smoking abstinence rates in a multicenter, randomized, open-
label trial in the United States. J Public Health. 2010;18(1):59-68. 
22. 
Cropsey KL, Weaver MF, Eldridge GD, Villalobos GC, Best AM, Stitzer ML. Differential success rates in racial groups: 
results of a clinical trial of smoking cessation among female prisoners. Nicotine Tob Res. 2009;11(6):690-697. 
23. 
Gariti P, Lynch K, Alterman A, Kampman K, Xie H, Varillo K. Comparing smoking treatment programs for lighter 
smokers with and without a history of heavier smoking. J. Subst. Abuse Treat. 2009;37(3):247-255. 


 
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24. 
Murray RP, Connett JE, Buist AS, Gerald LB, Eichenhorn MS. Experience of Black participants in the Lung Health 
Study smoking cessation intervention program. Nicotine Tob Res. 2001;3(4):375-382. 
25. 
Ahluwalia JS, Okuyemi K, Nollen N, et al. The effects of nicotine gum and counseling among African American light 
smokers: a 2 x 2 factorial design. Addiction. 2006;101(6):883-891. 
26. 
Harris KJ, Ahluwalia JS, Okuyemi KS, et al. Addressing cultural sensitivity in a smoking cessation intervention:  
Development of the Kick it at Swope project. Journal of Community Psycholoy. 2001;29(4):447-458. 
27. 
Jamal A, King BA, Neff LJ, Whitmill J, Babb SD, Graffunder CM. Current Cigarette Smoking Among Adults - United 
States, 2005-2015. MMWR Morb. Mortal. Wkly. Rep. 2016;65(44):1205-1211. 
28. 
CDC. Coverage for Tobacco Use Cessation Treatments. National Center for Chronic Disease Prevention and Health 
Promotion, Office of Smoking and Health; 2014. 
29. 
Bricker JB, Copeland W, Mull KE, et al. Single-arm trial of the second version of an acceptance & commitment therapy 
smartphone application for smoking cessation. Drug Alcohol Depend. 2017;170:37-42. 
30. 
Bricker JB, Bush T, Zbikowski SM, Mercer LD, Heffner JL. Randomized trial of telephone-delivered acceptance and 
commitment therapy versus cognitive behavioral therapy for smoking cessation: a pilot study. Nicotine Tob Res. 
2014;16(11):1446-1454. 
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Almirall D, Compton SN, Rynn MA, Walkup JT, Murphy SA. SMARTer discontinuation trial designs for developing an 
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52. 
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Not Applicable 
 
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Gonzales D, Rennard SI, Nides M, et al. Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs 
sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006;296(1):47-55. 
22. 
Jorenby DE, Hays JT, Rigotti NA, et al. Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial 
agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 
2006;296(1):56-63. 
23. 
Jorenby DE, Leischow SJ, Nides MA, et al. A controlled trial of sustained-release bupropion, a nicotine patch, or both for 
smoking cessation. N. Engl. J. Med. 1999;340(9):685-691. 
24. 
Malcolm RE, Sillett RW, Turner JA, Ball KP. The use of nicotine chewing gum as an aid to stopping smoking. 
Psychopharmacology (Berl.). 1980;70(3):295-296. 
25. 
Ferguson SG, Gitchell JG, Shiffman S, Sembower MA. Prediction of abstinence at 10 weeks based on smoking status at 2 
weeks during a quit attempt: secondary analysis of two parallel, 10-week, randomized, double-blind, placebo-controlled 
clinical trials of 21-mg nicotine patch in adult smokers. Clin. Ther. 2009;31(9):1957-1965. 
26. 
Jamerson BD, Nides M, Jorenby DE, et al. Late-term smoking cessation despite initial failure: an evaluation of bupropion 
sustained release, nicotine patch, combination therapy, and placebo. Clin. Ther. 2001;23(5):744-752. 
27. 
Kenford SL, Fiore MC, Jorenby DE, Smith SS, Wetter D, Baker TB. Predicting smoking cessation. Who will quit with 
and without the nicotine patch. JAMA. 1994;271(8):589-594. 
28. 
Jorenby  DE, Leischow  SJ, Nides  MA, et al. A Controlled Trial of Sustained-Release Bupropion, a Nicotine Patch, or 
Both for Smoking Cessation. N. Engl. J. Med. 1999;340(9):685-691. 
29. 
Hajek P, Stead LF, West R, Jarvis M, Hartmann-Boyce J, Lancaster T. Relapse prevention interventions for smoking 
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32. 
Almirall D, Nahum-Shani I, Sherwood NE, Murphy SA. Introduction to SMART designs for the development of adaptive 
interventions: with application to weight loss research. Transl. Behav. Med. 2014;4(3):260-274. 
33. 
Almirall D, Compton SN, Rynn MA, Walkup JT, Murphy SA. SMARTer discontinuation trial designs for developing an 
adaptive treatment strategy. J. Child Adolesc. Psychopharmacol. 2012;22(5):364-374. 
34. 
Dawson R, Lavori PW. Placebo-free designs for evaluating new mental health treatments: the use of adaptive treatment 
strategies. Stat. Med. 2004;23(21):3249-3262. 


 
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with smokers unwilling to quit: a factorial screening experiment. Addiction. 2016;111(1):117-128. 
40. 
Piper ME, Fiore MC, Smith SS, et al. Identifying effective intervention components for smoking cessation: a factorial 
screening experiment. Addiction. 2016;111(1):129-141. 
41. 
Rose JE, Behm FM. Adapting smoking cessation treatment according to initial response to precessation nicotine patch. 
Am. J. Psychiatry. 2013;170(8):860-867. 
42. 
Rose JE, Behm FM. Combination treatment with varenicline and bupropion in an adaptive smoking cessation paradigm. 
Am. J. Psychiatry. 2014;171(11):1199-1205. 
43. 
Schlam TR, Fiore MC, Smith SS, et al. Comparative effectiveness of intervention components for producing long-term 
abstinence from smoking: a factorial screening experiment. Addiction. 2016;111(1):142-155. 
44. 
Laude JR, Bailey SR, Crew E, et al. Extended treatment for cigarette smoking cessation: a randomized control trial. 
Addiction. 2017;112(8):1451-1459. 
45. 
Heckman BW, Cummings KM, Kasza KA, et al. Effectiveness of Switching Smoking-Cessation Medications Following 
Relapse. Am. J. Prev. Med. 2017;53(2):e63-e70. 
46. 
Caraballo RS, Yee SL, Gfroerer J, Mirza SA. Adult tobacco use among racial and ethnic groups living in the United 
States, 2002-2005. Prev. Chronic Dis. 2008;5(3):A78. 
47. 
Caraballo RS, Giovino GA, Pechacek TF, et al. Racial and ethnic differences in serum cotinine levels of cigarette 
smokers: Third National Health and Nutrition Examination Survey, 1988-1991. JAMA. 1998;280(2):135-139. 
48. 
Lynam I, Catley D, Harris KJ, Goggin K, Berkley-Patton J, Thomas J. African American smokers' intention to use 
pharmacotherapy for cessation. Am. J. Health Behav. 2012;36(5):615-627. 
49. 
Hurt RD, Ebbert JO, Hays JT, McFadden DD. Treating tobacco dependence in a medical setting. CA Cancer J. Clin. 
2009;59(5):314-326. 
50. 
Clinical Practice Guideline Treating Tobacco U, Dependence Update Panel L, Staff. A clinical practice guideline for 
treating tobacco use and dependence: 2008 update. A U.S. Public Health Service report. Am. J. Prev. Med. 
2008;35(2):158-176. 
51. 
Perkins KA, Conklin CA, Levine MD. Cognitive-behavioral therapy for smoking cessation: a practical guidebook to the 
most effective treatments. Taylor & Francis; 2008. 
52. 
Webb Hooper M, Antoni MH, Okuyemi K, Dietz NA, Resnicow K. Randomized Controlled Trial of Group-Based 
Culturally Specific Cognitive Behavioral Therapy Among African American Smokers. Nicotine Tob Res. 2017;19(3):333-
341. 
53. 
Catley D, Goggin K, Harris KJ, et al. A Randomized Trial of Motivational Interviewing: Cessation Induction Among 
Smokers With Low Desire to Quit. Am. J. Prev. Med. 2016;50(5):573-583. 
54. 
Anthenelli RM, Benowitz NL, West R, et al. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine 
patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled 
clinical trial. Lancet. 2016;387(10037):2507-2520. 
 

ICF_001.pdf: 
NCT03897439   
Title: Individualizing Pharmacotherapy: A novel optimization strategy
to increase smoking cessation in the African American community
Date: 2/3/2022


Page 1 of 12 
Study Title: Individualizing pharmacotherapy: A novel optimization strategy to increase smoking cessation in 
the African American community 
RESEARCH CONSENT FORM 
Individualizing Pharmacotherapy: A novel optimization strategy to increase smoking 
cessation in the African American community  
Sponsor: The University of Kansas Medical Center 
Investigator: Nikki Nollen, PhD 
University of Kansas Medical Center 
913-588-3784
This research study will be performed by the University of Kansas Medical Center (KUMC) and 
based at Swope Health Central, 3801 Blue Parkway in Missouri, or KUMC Clinical Research Unit 
in Fairway, KS with Dr. Nikki Nollen as the researcher. Participants will have preference of what 
site they want to use. About 392 people will be enrolled in the study. 
Why am I being asked to take part in this study? 
You are being asked to take part in this study because you are an African American (AA) smoker 
who is interested in quitting.   
Why is this study being done?   
Smoking is the leading cause of disease and death in the United States. African Americans have 
higher rates of tobacco-related disease than the general population. African Americans smoke 
fewer cigarettes per day than Whites but have a harder time quitting. We do not know why African 
Americans have a harder time quitting than Whites. By doing this study, we will examine whether 
or not changing treatment medications based on an individual’s response will help more smokers 
KUMC IRB # STUDY00142310 | Approval Period 2/4/2021 – 2/3/2022 | FWA# 00003411


Page 2 of 12 
  
Study Title: Individualizing pharmacotherapy: A novel optimization strategy to increase smoking cessation in 
the African American community 
 
 
 
quit smoking.  We also hope to identify factors that make quitting smoking harder for some African 
Americans and easier for others. Findings from this study could help researchers figure out ways 
to improve treatment and make quitting easier for African American smokers.   
 
What is being tested in this study? 
You are being invited to participate in a research study to compare how well optimized treatments 
(OPT) versus usual care (UC) treatments work for smoking cessation. Optimized treatments use 
available smoking cessation medications but switch between them if one medication is not working 
for you.  Usual care treatments provide the same smoking cessation medication for the entire 
treatment period. This study is testing whether or not changing treatment medications for those 
who are not responding to their current plan improves short and long-term quitting.   
 
How long will I be in the study? 
Your participation in this study is expected to last about 24 weeks.  After initial screening (week 0) 
you will have 18 weeks of treatment (week 1-18), and a follow-up visit 6 weeks after your last 
treatment (week 24).  You will be asked to visit the clinic 6 times over the course of the study and 
complete 3 sessions over the phone.  
 
What will I be asked to do?  
If you decide to join the study, you will be asked to read and sign this consent form before any 
study procedures take place.  
 
The study will be divided into 3 phases: 
 
Screening/Enrollment phase: In this phase eligible participants will be asked to complete 
procedures and answer survey items. 
 
Treatment phase:  In this phase you will attend smoking cessation counseling sessions with 4 
sessions at the clinic and 3 over the phone.  You will also receive your study medication, answer 
survey items and complete study procedures. 
 
End study follow-up:  Six weeks after your last counseling session and dose of medication you will 
be asked to come to the clinic for tests and respond to survey items during this phase. 
 
You will be randomized (like flipping a coin) to one of 2 groups: 
 
• Group 1:  This group will receive the nicotine patch and may receive varenicline, 
also known as Chantix, and Wellbutrin, also known as Zyban depending on response 
to the medication.  Medication will last for 18 weeks.   
• Group 2:  This group will receive the nicotine patch for 18 weeks.  
 
Both groups will receive high intensity smoking cessation counseling.   
 
 
 
 
KUMC IRB # STUDY00142310 | Approval Period 2/4/2021 – 2/3/2022 | FWA# 00003411


Page 3 of 12 
  
Study Title: Individualizing pharmacotherapy: A novel optimization strategy to increase smoking cessation in 
the African American community 
 
 
 
Below you will find a schedule of events listing all procedures that will occur at each study visit.   
 
Schedule of Events  
Week 0 
Week 1* 
Week 2 
 Week 3* 
 Week 6 
Week 7* 
Week 12 
Week 18 
Week 24 
 
 
 
 
 
 
 
 
 
 
Eligibility Screening 
X 
 
 
 
 
 
 
 
 
Informed Consent 
X 
 
 
 
 
 
 
 
 
Pregnancy Test 
x 
 
 
 
 
 
 
 
 
Height/Weight 
X 
 
 
 
 
 
 
 
 
Counseling Sessions 
X 
X 
X 
X 
X 
X 
X 
 
 
Surveys  
X 
X 
X 
X 
X 
X 
X 
X 
 
Receipt of study 
medication 
X 
 
X 
 
X 
 
X 
 
 
Return unused study 
medication 
 
 
X 
 
X 
 
X 
X 
 
Carbon Monoxide Test 
X 
 
X 
 
X 
 
 
 
 
Saliva Sample 
X 
 
 
 
 
 
 
 
 
Urine Sample 
X 
 
 
 
 
 
X 
X 
X 
Approximate length of 
study visit 
2 hrs 
20 mins 
1 hr 
20 mins 
1 hr 
20 mins 
1 hr 
45 mins 
30 mins 
Visits marked with an asterisk * will be conducted over the phone.  All other visits will be conducted in clinic. 
The following is a description of each test and procedure listed above: 
Pregnancy test  
If you are a woman able to have children, you will be asked to take a pregnancy test. You cannot 
participate in this study if you are pregnant. 
 
Counseling Visits 
You will participate in 15-30-minute counseling sessions to help you quit smoking. Counseling will 
be completed in person at weeks 0, 2, 6, 12 and by telephone at weeks 1, 3, 7. Counseling will be 
delivered by our experienced staff who are certified tobacco treatment specialists and have 
extensive experience treating African American smokers within clinical trials.    
 
Your counseling sessions will be audio recorded. The reason for audio recording sessions is for 
clinical purposes only. Specifically, to ensure that you are receiving the highest quality of care and 
that counseling fits your unique needs. No data will be drawn from the digital recordings. The 
digital files will be identified by a number, not your name, and will be stored on a secure server. No 
one other than the study team will have access to the recordings. Your audio recording may be 
kept for 15 years. After that, it will be destroyed. 
KUMC IRB # STUDY00142310 | Approval Period 2/4/2021 – 2/3/2022 | FWA# 00003411


Page 4 of 12 
  
Study Title: Individualizing pharmacotherapy: A novel optimization strategy to increase smoking cessation in 
the African American community 
 
 
 
 
Surveys 
You will be asked questions about yourself, for example, your age, education level, and 
employment status, your tobacco use history, how smoking and/or quitting makes you feel, and 
your experience with the quit smoking medications. There is a risk of feeling uncomfortable while 
answering some of the questions in the surveys. If you feel uncomfortable at any time you may 
skip a question or stop participating all together. 
 
Medication Dispensing  
At week 0 all participants will receive a 2-week supply of the nicotine patch. At weeks 2, 6 and 12 
participants assigned to Group 2 will receive another supply of the nicotine patch. Participants that 
are randomized to Group 1 will be assessed at weeks 2 and 6 and if are not responding to their 
current medication, as determined by study protocol, will be switched first to varenicline and then 
to bupropion and the nicotine patch, if applicable.  Participants are asked to return unused 
medication.  Those who do not attend medication dispensing visits may be mailed enough of their 
current medication to get them to the next dispensing time point. Instructions on medication use 
will be provided at each medication dispensing visit. 
 
Carbon Monoxide Test 
Exhaled air carbon monoxide (CO) is an immediate, non-invasive method of confirming smoking 
status. At screening, week 2 and week 6, participants will breathe into a carbon monoxide machine 
for the purpose of determining smoking level.    
 
Urine and Saliva Samples 
Study staff will collect about 1 ounce of urine at weeks 0, 12, 18 and 24.  At week 0, a saliva 
sample will also be collected.  Both the urine and saliva samples will be used to test for nicotine 
and other chemicals found in cigarettes.   Additionally, the saliva sample will be used for genetic 
testing.  Your entire genetic makeup will not be determined from this testing. The cells in your body 
contain deoxyribonucleic acid, or DNA for short.  DNA is passed down from your parents.  It 
carries the genes that determine how you look and how your body works.  Differences in genes 
may help explain why a particular drug is effective and safe in some people, but not in others.  
Differences in genes also may explain why some people get certain diseases, but others do not.  
Your DNA will only be used for research to understand how your body breaks down nicotine and 
chemicals from cigarettes and the quit smoking medications.   
 
 
Melanin Reading 
The melanin level in your skin will be measured. Melanin is a pigment that is found in your skin, 
hair, and eyes. This will be done using a reflectometer which is a device that shines a low intensity 
light on 3 different measurement sites on the skin. 
 
Text Messages: You can choose to sign up for emails or text messages about this study. The 
messages will remind you about your study appointments and give you other information that 
might be helpful during the study. You will pay your standard texting rate. This message service is 
optional. If you decide to receive messages when the study starts, you can still change your mind 
later.    
 
KUMC IRB # STUDY00142310 | Approval Period 2/4/2021 – 2/3/2022 | FWA# 00003411


Page 5 of 12 
  
Study Title: Individualizing pharmacotherapy: A novel optimization strategy to increase smoking cessation in 
the African American community 
 
 
 
What are the possible risks or discomforts? 
The study drugs may cause side effects or other problems. You should tell the research team 
about anything that is bothering you or any changes in your health since the last visit. The 
researchers may be able to take steps to reduce side effects. You may experience none, some, or 
all of the side effects listed below. There may be other side effects or risks that are not yet known. 
  
The common side effects listed below are those occurring in > 5% of patients. 
 
Nicotine Patch:
• Sweating  
• Redness or swelling at the patch site  
• Irritability  
• Problems sleeping or vivid dreams 
• Headache  
• Dizziness  
 
• Nausea or vomiting  
• Abnormal heartbeat or rhythm  
• Diarrhea  
• Nervousness or restlessness  
• Difficulty breathing  
• Tiredness
Zyban and Chantix Risks:  
 
• Nausea 
• Sleep problems (trouble sleeping or 
vivid, unusual or strange dreams) 
• Headache 
• Constipation 
• Gas 
• Dry mouth 
• Dizziness 
• Disturbance in attention 
• Fatigue 
• Skin changes (dry skin or acne
Rarely (less than 1%), patients who take Zyban or Chantix experience 
• Gum disease (gingivitis) 
• Restless leg syndrome, where you may feel throbbing, pulling, or creeping in the 
legs and the uncontrollable need to move your legs.   
• Ringing in the ears (tinnitus). 
 
Rare but serious side effects occur in < 5% of patients taking Zyban or Chantix and 
include: 
• Changes in mood: Some patients feel moody, angry, or have thoughts of hurting 
themselves or someone else while taking or after stopping the Zyban or Chantix. If 
you notice these changes stop taking the medication and call your doctor and your 
counselor right away. Some people with a history of depression or other mental health 
problems may notice these symptoms may worsen while taking Zyban or Chantix.  
Feeling moody, angry, and irritable are also symptoms of nicotine withdrawal that 
people notice when they cut back on cigarettes or stop smoking completely. 
• Seizures: There have been reports of seizures/convulsions in patients treated with 
varenicline or Zyban. In most cases, the seizure started within the first month of 
therapy. If you experience a seizure while on the medication, stop taking the 
medication and contact your doctor and your counselor right away. 
• Heart or blood vessel problems: If you have heart disease, taking Chantix or Zyban 
may increase your chance of certain heart-related events including a change from the 
normal heartbeat, heart attack, or heart failure. Contact your doctor and your 
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Page 6 of 12 
  
Study Title: Individualizing pharmacotherapy: A novel optimization strategy to increase smoking 
cessation in the African American community 
 
 
 
counselor right away if you experience new or worsening signs of heart disease. New 
or worsening signs might include trouble breathing, chest pain, or pain in legs when 
walking. 
• Injury: There have been reports of car accidents, near-miss accidents in traffic, or 
other accidental injuries in patients taking Zyban or Chantix. In some cases, the 
patients reported feeling tired, dizzy, loss of alertness or difficulty concentrating while 
driving. Do not drive until you know how the medication may affect you. 
 
Allergic Reaction Risks 
Some people can have serious skin reactions while taking nicotine gum, nicotine patch, 
Chantix or Zyban. Symptoms of an allergic reaction are: 
• rash 
• difficulty breathing 
• wheezing when you breathe 
• sudden drop in blood pressure (you may feel dizzy or faint) 
• swelling around the mouth, throat or eyes 
• fast pulse and/or chest tightness/pain 
• sweating 
 
If you experience any of these rare but serious symptoms or have a rash with peeling 
skin or blisters in your mouth, stop taking the study medication and get medical 
attention right away. If you feel you need immediate medical assistance you should call 
911 and you should tell the ER doctor that you are a participant in a research study. 
Please also contact the study team if you have any of these or any other side effects 
during the study.  
 
Pregnancy Risks  
The drugs used in this study might hurt an unborn child or a child who is breast-feeding. 
You cannot be in this study if you are pregnant or nursing a baby.  You cannot be in this 
study if you are trying to get pregnant.  You will have a pregnancy test before the study 
starts.  You must use birth control during the study.  The approved methods of birth 
control are:  
• abstinence 
• the consistent use of an approved oral contraceptive (birth control pill or “the pill”)  
• an intrauterine device (IUD)  
• hormonal implants 
• contraceptive injection  
• double barrier method (diaphragm with spermicidal gel or condom with 
contraceptive foam) 
 
There may be pregnancy risks that are not known yet. For this reason, you must tell the 
researcher right away if you get pregnant during the study.  There are no identified 
reproductive risks related to a male’s use of nicotine patch, bupropion or varenicline.  
KUMC IRB # STUDY00142310 | Approval Period 2/4/2021 – 2/3/2022 | FWA# 00003411


Page 7 of 12 
  
Study Title: Individualizing pharmacotherapy: A novel optimization strategy to increase smoking 
cessation in the African American community 
 
 
 
 
Are there benefits to being in this study?   
You may or may not benefit from this study. Researchers hope that the information 
from this research study may be useful in the treatment of other patients who smoke. 
 
Will it cost anything to be in the study?   
The study will pay for all study-related medical services provided during this study. 
These services include the study drug, study visits, and study-related procedures such 
as the urine, saliva, and carbon monoxide tests and counseling sessions as listed in 
this consent form. 
 
If you are assigned to receive the drug Chantix, it is being provided for the study by 
Pfizer at no cost to you. 
 
Any other medical visits and procedures you have outside of the study due to other 
standard of care treatments or other health issues are billable to you or your insurance 
through normal hospital billing practices. Standard of care means necessary for the 
care of a medical issue as determined by your doctor and not necessary for this study. 
    
Your insurance may not cover some or all of the standard care services if you are part 
of a research study. You may want to talk to your insurance company and review your 
specific benefits and coverage before deciding to participate. You will be responsible for 
normal co-pays, deductibles and non-covered services that are not the responsibility of 
the study. Some procedures require Pre-Certification from your insurance company, 
and representatives of the clinic or hospital will be helping you with that process. Pre-
Certification is not a guarantee of payment.    
 
You can still be in the study even if your insurance denies coverage for your standard of 
care treatment or if you are uninsured. The hospital has a financial assistance program 
which it makes available to all patients who qualify. If your insurance denies coverage 
and you do not qualify for the financial assistance, you will be charged for all bills that 
are not the responsibility of the study. The study staff will be able to provide more 
information to you.    
 
Will I get paid to participate in the study? 
You will receive payment for participation in this study as outlined in the table below.  
You will receive a total of $290.00 if you complete the entire study. If your participation 
in this study ends early, you will be paid only for the visits you have completed. You 
may also receive $20 for each referral who is eligible and enrolls in this study.  You may 
complete up to 3 different referrals for an additional total of $60. 
 
 
 
KUMC IRB # STUDY00142310 | Approval Period 2/4/2021 – 2/3/2022 | FWA# 00003411


Page 8 of 12 
  
Study Title: Individualizing pharmacotherapy: A novel optimization strategy to increase smoking 
cessation in the African American community 
 
 
 
Week 0 Week 1 Week 2 Week 3 Week 6 Week 7 Week 12 Week 18 Week 24 
$30.00 
$10.00 
$30.00 
$10.00 
$30.00 
$10.00 
$30.00 
$20.00 
$40.00 
 
 
$20.00* 
 
$20.00* 
 
$20.00* $20.00* 
 
*If you return your unused medication at Weeks 2, 6, 12, and 18 you will receive an 
additional $20.00 per visit.   
 
You will be given a ClinCard, which works like a debit card. After a study visit or referral 
enrolls in this study, payment will be added onto your card by computer. The money will 
be available within 1-2 business day. You can use the ClinCard at an ATM or at a store. 
No one at KUMC will know where you spent the money. You will be given one card 
during the study. If your card is lost or stolen, please call (866) 952-3795. 
 
The KUMC Research Institute will be given your name, address, social security number, 
and the title of this study to allow them to set you up in the ClinCard system. Study 
payments are taxable income. A Form 1099 will be sent to you and the Internal 
Revenue Service if your payments are $600 or more in a calendar year.  
 
Your personal information will be kept on a secure computer. It will be removed from 
the computer after the study is over and the money on the card has been used. Your 
information will not be shared with other businesses. It will be kept completely 
confidential. 
 
 
 
Will the researchers get paid for doing the study?  
The research team and the institution (KUMC Research Institute, Inc.) are not being 
paid to conduct this study. 
 
What happens if I get hurt or sick during the study?   
If you have a serious side effect or other problem during this study, you should 
immediately contact Dr. Nollen at 913-588-3784 or 816-550-5895 or Dr. Allen Greiner at 
913-515-4054.  A member of the research team will decide what type of treatment, if 
any, is best for you at that time.  
 
If you have a bodily injury as a result of participating in this study, treatment will be 
provided for you at the usual charge. Treatment may include first aid, emergency care 
and follow-up care, as needed. Claims will be submitted to your health insurance policy, 
your government program, or other third party. You will be billed for the costs that are 
not covered by the insurance. You do not give up any legal rights by signing this form. 
 
 
KUMC IRB # STUDY00142310 | Approval Period 2/4/2021 – 2/3/2022 | FWA# 00003411


Page 9 of 12 
  
Study Title: Individualizing pharmacotherapy: A novel optimization strategy to increase smoking 
cessation in the African American community 
 
 
 
If you think you have been harmed as a result of participating in research at the 
University of Kansas Medical Center (KUMC), you should contact the Director, Human 
Research Protection Program, Mail Stop #1032, University of Kansas Medical Center, 
3901 Rainbow Blvd., Kansas City, KS 66160.  Under certain conditions, Kansas state 
law or the Kansas Tort Claims Act may allow payment to persons who are injured in 
research at KUMC.      
 
Do I have to be in the study? 
Being in research is voluntary.  You can choose whether or not to participate.  Even if 
you decide not to join the study, you can still come to KUMC for services and treatment. 
  
What other choices do I have? 
You can choose not to be in the study. Instead of being in this study, you can receive 
treatment that is already available. Other available treatments include: quitting cold 
turkey, using other smoking cessation programs, purchasing nicotine gum or patches 
from the pharmacy, and obtaining a prescription for nicotine inhaler, nasal spray, 
lozenge, Zyban or Chantix from your doctor. You can have access to smoking 
cessation medications even if you are not in this study. 
 
How will my privacy be protected?  
The researchers will protect your information, as required by law. Absolute 
confidentiality cannot be guaranteed because persons outside the study team may 
need to look at your study records. Your health information is protected by a federal 
privacy law called HIPAA. By signing this consent form, you are giving permission for 
KUMC to use and share your health information.  If you decide not to sign the form, you 
cannot be in the study.   
 
 
The researchers will only use and share information that is needed for the study. To do 
the study, they will collect health information from the study activities and from your 
medical record.  Your medical records at KUMC may contain information such as name, 
address, phone, date of birth, social security number, or other identifiers. Your health 
information will be used at KUMC by Dr. Nollen, members of the research team, the 
KUMC Research Institute and officials at KUMC who oversee research, including 
members of the KUMC Human Subjects Committee and other committees and offices 
that review and monitor research studies.   
 
By signing this form, you are giving Dr. Nollen and the research team permission to 
share information about you with persons or groups outside KUMC. Your information 
may be shared with the monitoring company that inspects study data, Bioanalytical 
Laboratory at the Fairway Clinical Research Center, the laboratory that processes study 
lab samples, the University of California at San Francisco, the University of Toronto, 
Jasjit Ahluwalia, MD, MPH, MS, other business partners of the sponsor who help with 
the study, the U.S. Food and Drug Administration (FDA), and U.S. agencies that 
oversee human research (if a study audit is performed).  These groups or agencies may 
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Page 10 of 12 
  
Study Title: Individualizing pharmacotherapy: A novel optimization strategy to increase smoking 
cessation in the African American community 
 
 
 
make copies of study records for audit purposes. The purpose for using and sharing 
your information is to make sure the study is done properly.  
 
The HIPAA privacy law may not apply to everyone who receives your health 
information. Your information might not be protected by HIPAA if persons outside 
KUMC disclose it.  In some cases, there may be other laws that protect your information 
from improper use. If your study data is sent outside the U.S., HIPAA privacy 
protections may not apply; however, the sponsor is still required to keep your data 
confidential.   
 
Your permission to use and share your health information will not expire unless you 
cancel it. Any research information that is placed in your medical record will be kept 
indefinitely.   
 
While you are participating in this study, you may see and copy any study information 
that is placed in your KUMC medical record. However, some study information is kept 
only by the researcher. The records kept only by the researcher may not be available to 
you until the end of the study.   
 
The researchers may publish the results of the study. If they do, they will only discuss 
group results. Your name will not be used in any publication or presentation about the 
study.   
 
To help us protect your privacy, we have obtained a Certificate of Confidentiality from 
the National Institutes of Health. The researchers can use this Certificate to legally 
refuse to disclose information that may identify you in any federal, state, or local civil, 
criminal, administrative, legislative, or other proceedings, for example, if there is a court 
subpoena. The researchers will use the Certificate to resist any demands for 
information that would identify you, except as explained below. 
 
The Certificate cannot be used to resist a demand for information from personnel of the 
United States Government that is used for auditing or evaluation of federally funded 
projects or for information that must be disclosed in order to meet the requirements of 
the federal Food and Drug Administration (FDA). 
 
You should understand that a Certificate of Confidentiality does not prevent you or a 
member of your family from voluntarily releasing information about yourself or your 
involvement in this research. If an insurer, employer, or other person obtains your 
written consent to receive research information, then the researchers may not use the 
Certificate to withhold that information. 
 
Finally, it is important to recognize the limitations of confidentiality.  The investigator has 
a responsibility to report to the proper authorities to prevent serious harm to you or 
others and instances of abuse to children, elders, or the disabled.   
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Page 11 of 12 
  
Study Title: Individualizing pharmacotherapy: A novel optimization strategy to increase smoking 
cessation in the African American community 
 
 
 
 
Can I stop being in the study? 
You may stop being in the study at any time.  Your decision to stop will not prevent you 
from getting treatment or services at KUMC.  
 
You have the right to cancel your permission for researchers to use your health 
information. If you want to cancel your permission, please write to Dr. Nollen. The 
mailing address is Dr. Nikki Nollen, University of Kansas Medical Center, 3901 Rainbow 
Boulevard, Mail Stop 1008, Kansas City, KS 66160. If you cancel permission to use 
your health information, you will be withdrawn from the study. The researchers will stop 
collecting any additional information about you unless they need information about a 
side effect of study medication. They are permitted to use and share information that 
was gathered before they received your cancellation.   
 
Could my participation be stopped early?  
This study might be stopped, without your consent, by the investigator or by the FDA. 
Your participation also might be stopped by the investigator if it is in your best interest 
or if you do not follow the study requirements.   
 
The investigator, nor the University of Kansas Medical Center will be obligated to 
provide you with any study medication or treatment if the study is stopped early. Your 
physician will decide about future treatment, if it is needed.   
 
Who can I talk to about the study?   
Before you sign this form, Dr. Nollen or other members of the study team should 
answer all your questions. You can talk to the researchers if you have any more 
questions, suggestions, concerns or complaints after signing this form.  If you have any 
questions about your rights as a research subject, or if you want to talk with someone 
who is not involved in the study, you may call the Human Subjects Committee at (913) 
588-1240. You may also write the Human Subjects Committee at Mail Stop #1032, 
University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS 66160. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This Web site will not include information that can identify you. At 
most, the Web site will include a summary of the results. You can search this Web site 
at any time. 
 
CONSENT 
Dr. Nollen or the research team has given you information about this research study.  
They have explained what will be done and how long it will take.  They explained any 
inconvenience, discomfort or risks that may be experienced during this study.   
 
By signing this form, you say that you freely and voluntarily consent to participate in this 
research study.  You have read the information and had your questions answered.   
KUMC IRB # STUDY00142310 | Approval Period 2/4/2021 – 2/3/2022 | FWA# 00003411


Page 12 of 12 
  
Study Title: Individualizing pharmacotherapy: A novel optimization strategy to increase smoking 
cessation in the African American community 
 
 
 
You will be given a signed copy of the consent form to keep for your records. 
 
____________________________________  
 
 
Print Participant’s Name 
 
 
 
 
 
 
 
_________________________    _______ 
 
 
__________________ 
Signature of Participant 
 
   Time 
 
 
Date 
 
___________________________________ 
Print Name of Person Obtaining Consent 
 
____________________________________  
 
__________________ 
Signature of Person Obtaining Consent  
 
 
Date 
 
I want to receive visit reminders by (check one): 
 
 Email ________________________________ (your email) 
 Text message __________________________ (your cell phone number) 
 Not at all  
 
______________ 
_______________________________________________ 
(Date / Time)             (Printed Name of Participant) 
 
______________________________________________ 
(Signature of Participant) 
 
 
 
 
PERMISSION TO BE CONTACTED ABOUT FUTURE STUDIES 
I give permission to be contacted about future studies that might require more 
information:  
 
 
YES   
 
NO 
About smoking  
 
 
 
 




About any other health related issues 
 




 
__________  
_______________________________________________ 
(Date / Time)             (Signature of Participant) 
 
KUMC IRB # STUDY00142310 | Approval Period 2/4/2021 – 2/3/2022 | FWA# 00003411