Conditions: Smoking
Keywords: medication tolerability
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 36
Healthy volunteers: yes

Brief summary:
This study will focus on enhancing future smoking cessation treatment effectiveness by piloting a potentially more powerful combination of three FDA-approved pharmacotherapies: varenicline plus combination of two types of nicotine replacement therapy (NRT) treatment (nicotine lozenge and nicotine patch). Data from this pilot study will help inform the design of future studies that would use this combination treatment as a cessation tool within the chronic care arsenal of treatments.

Detailed description:
Recent research suggests that a new combination therapy may be especially effective in increasing long-term abstinence from smoking. A key purpose of the proposed study is to examine what types of tolerability concerns, if any, emerge from the simultaneous use of three FDA-approved cessation medications (varenicline, nicotine patch, and nicotine lozenge) and the timing of those events, in order to better assess how the use of this combination of tobacco cessation medicines can be most effectively and safely delivered and monitored. Study participants will take the three medications for 12 weeks in a manner consistent with labeling. Adverse events will be assessed at all study visits.

Arms:
arm 1: varenicline, nicotine patch and nicotine lozenge for 12 weeks

Interventions: intervention 1: Varenicline intervention 2: Nicotine Transdermal Patch intervention 3: Nicotine Mini
Intervention descriptions: intervention 1: Standard FDA approved 12 weeks of treatment with Varenicline intervention 2: Standard FDA approved 12 weeks of treatment with Nicotine Transdermal Patch intervention 3: Standard FDA approved 12 weeks of treatment with Nicotine Mini-Lozenge

Protocol document:
Prot_SAP_001.pdf: 
1 
 
UW‐CTRI Triple Medication Smoking Cessation Study 
 
NCT02681510 
 
Date of Document (IRB Approval Date): 1/19/2016 
 


2 
 
A. Study overview  
The primary aim of Transforming the Treatment of Tobacco Use in Health Care: Seizing the Potential of 
the Electronic Health Record to Deliver Comprehensive Chronic Care Treatment for Smoking is to 
overcome barriers to effective treatment of smokers in the primary care setting.  One of the major 
obstacles identified is the lack of treatment effectiveness. We believe that this lack of effectiveness is 
largely due to two factors.  First, most treatments delivered in the healthcare setting are isolated 
applications of a single type of cessation treatment. Optimal chronic care for tobacco dependence 
requires multiple types of interventions that collectively target the different phase of quitting, are 
sustained over time, and are adaptive. A second factor contributing to the lack of treatment 
effectiveness is that translational science is not yet sufficiently powerful so as to make the most 
effective smoking interventions appropriate for, and effective in, real world healthcare contexts. The 
proposed R35 research is intended to address this deficit by developing and applying innovative, 
efficient, and powerful research methods to translate efficacious treatments into clinical use. 
This study, the second in a series of studies being implemented as part of this NCI grant (R35CA197573), 
will focus on the treatment effectiveness obstacle by piloting a potentially more powerful combination 
of two of the most effective pharmacotherapies: varenicline plus combination nicotine replacement 
therapy (NRT) treatment.  Data from this pilot study will help inform the design of future studies that 
would use this combination treatment as a cessation tool within the chronic care arsenal of treatments. 
B. The rationale for combining varenicline and combination NRT 
Smoking cessation medication is clearly effective, but there is room for substantial improvement.  For 
instance, meta‐analyses conducted for the 2008 PHS Guideline1 showed that, generally, about three‐
quarters of smokers fail to achieve long‐term abstinence when using FDA‐approved smoking cessation 
pharmacotherapies. In fact, this level of effectiveness often declines in real world use (where smokers 
may be less motivated, adherent, and receive less counseling). Thus, despite effectiveness and high 
potential reach, evidence based smoking medications fail to help most smokers who use them achieve 
long‐term abstinence.  
Recent research suggests that a new combination therapy may be especially effective in increasing long‐
term abstinence from smoking. A study by Koegenlenberg et al. published in the Journal of the American 
Medical Association, showed that varenicline combined with the nicotine patch produced a remarkably 
high 6‐month, 7‐day point prevalence abstinence rate: i.e., 65.1% in the multiple imputation (MI) 
analyses, and 44% in the traditional intent‐to‐treat analyses2. These rates were about 15‐20 percentage 
points higher than those produced by varenicline alone (V: 46.7 and 28.8%, respectively for the MI and 
intent‐to‐treat analyses). The multiple imputation results are remarkable because it is so rare for a 
readily translatable smoking treatment to produce long‐term abstinence in a clear majority of users. If 
this finding were replicated, this combination pharmacotherapy approach could become widely used 
and drive higher rates of smoking treatment delivery in healthcare.   
Combinations of FDA‐approved therapies have shown to have a reasonable safety profile.  UW‐CTRI has 
used combination NRT in multiple studies.  In the most recent study for which a complete dataset is 
available, combination NRT (patch + lozenge) was evaluated in a sample of 1,086 participants.  
Commonly reported adverse events included itching or hives (18%), nausea (15%), and vivid dreams 
(13.4%) in the combination NRT group (n=421).  Of note, among participants receiving the nicotine patch 


3 
 
alone (n=241), rates of vivid dreams and itching or hives were higher (17.5% and 23.1%, respectively), 
while rates of nausea were lower (8.7%), than in the combination NRT group.  Participants in the same 
study who received varenicline alone (N=424) most often reported adverse events of nausea (30.4%), 
vivid dreams (24.6%), and insomnia (23.6%).  There were two serious adverse events reported in this 
study: angioedema resulting in hospitalization (adjudicated as an allergic reaction to varenicline), and a 
stroke (adjudicated as possibly related to NRT use).  Because there was some overlap in adverse 
events between those using combination NRT and those using varenicline, one might anticipate 
synergistic or additive effects.  However, in the Koegelenberg et al. (2014) study, participants assigned 
to varenicline and nicotine patch differed significantly from participants assigned to varenicline and 
placebo patch only in their report of “any skin reactions” (14.4% vs. 7.8%, p=.03).  Frequently reported 
adverse events for varenicline and nicotine patch included nausea (27.3%), insomnia (19.9%), and 
abnormal dreams (4.6%) – all at rates lower than reported in the UW‐CTRI study using varenicline alone.  
This study also reported a total of seven serious adverse events.  One was adjudicated as possibly 
related to study medication (pregnancy with trisomy 21 and associated congenital heart defects).  One 
anembryonic pregnancy was adjudicated as unrelated; the other five SAEs were adjudicated as 
unrelated and not specified.  The results from the Ebbert et al. (2009)3 report (the only other peer‐
reviewed publication reporting safety data for varenicline combined with NRT) are more difficult to 
interpret.  This was a retrospective report of patients who had enrolled in a residential tobacco 
treatment program (rather than volunteer research participants); patients were not randomly assigned 
to treatment regimens, and were not in their typical environments.  Of the 104 patients using 
varenicline and nicotine patch in this report 71% used an average nicotine patch dose of 32 mg/day (vs. 
21 mg/day in the UW‐CTRI and 15 mg/day in the Koegelenberg et al. studies).  Up to 32% of the Ebbert 
et al. sample used two or three NRT products in addition to nicotine patch plus varenicline.  As with the 
previous two samples, the most common adverse events reported with varenicline and NRT were 
insomnia (14%), nausea (13%), and vivid/disturbing dreams (12%).    
A key purpose of the proposed study is to examine what types of tolerability concerns, if any, emerge 
and the timing of those events, in order to better assess how the use of this combination of tobacco 
cessation medicines can be most effectively delivered and monitored. 
C. Detailed study protocol 
Participants (n=40) will be recruited via Facebook ads contextually tagged to appear only to adults in the 
Madison, WI, area who have “liked” or posted about smoking.  Those who click the ad will be taken to a 
Web page containing a brief description of the study and the opportunity to provide their contact 
information if they would like to learn more about the study. 
Those persons who provide contact information will be called by study staff and provided with a more 
detailed description of what study participation would involve (time, risks, benefits, etc.).  They will also 
be given an opportunity to ask questions.  If they remain interested based on the description, study staff 
will proceed to assess inclusion/exclusion criteria for potential participants by way of a structured 
computer‐assisted telephone interview.  Participants who meet criteria will be invited to schedule an 
initial study visit.  Those who do not meet criteria will be asked if they would like information about 
other smoking cessation treatment resources; if so, they will be given contact information for the 
Wisconsin Tobacco QuitLine. 


4 
 
Inclusion/Exclusion Criteria 
Inclusion criteria will be: age >17 years; >=5 cigarettes/day for the previous 6 months; alveolar CO 
>= 6 ppm; able to read, write and speak English; planning to remain in the intervention catchment area 
for at least 4 months; not currently taking bupropion or varenicline; if the participant is currently using 
NRT, s/he agrees to use only study medication for the duration of the study; free of medical 
contraindications to NRT and varenicline; and, if participant is a woman of childbearing potential, using 
an approved method of birth control during treatment.  Exclusion criteria will be: current diagnosis 
of/treatment for psychosis or bipolar disorder; suicidal ideation within the past 12 months; any history 
of suicide attempts; significant hepatic or renal impairment; history of significant allergic reactions to 
varenicline or any type of NRT in the past; use of any investigational drugs in the previous 30 days. 
At the initial study visit, potential participants will review a Powerpoint presentation with a study staff 
member providing detailed information about study procedures, time commitment, risks, and benefits.  
They will also be given the IRB‐approved Informed Consent Document and allowed to take as much time 
as they like to read it (including the option to take it home and return at a later date).  They will be given 
the opportunity during both the presentation and reading of the ICD to ask questions.  If they choose to 
provide written informed consent for study participation, staff will reconfirm all inclusion/exclusion 
criteria, including a CO breath test.  Upon reconfirmation of study eligibility, participants will be asked to 
complete the surveys  about nicotine dependence and withdrawal, smoking history and use of 
noncombustible tobacco products (see Assessment schedule below) . 
Each participant will be evaluated medically by a study physician, based upon inclusion/exclusion 
criteria, baseline assessments, and physical examination, as to their fitness for combination therapy.  If a 
participant is determined to be medically appropriate, they will be provided with the following 
medication regimen: 
1.  Varenicline 0.5 mg once daily for three days; followed by 0.5 mg twice daily for four days; 
followed by 1 mg twice daily for 11 weeks. 
2. Transdermal Nicotine 21 mg for eight weeks (starting on the Target Quit Date); followed by 
transdermal nicotine 14 mg for two weeks; followed by transdermal nicotine 7 mg for two 
weeks (Note: for participants smoking 5‐9 cigarettes/day at baseline, the regimen will be 14 
mg/day for 10 weeks followed by 7 mg/day for 2 weeks). 
3. Nicotine mini lozenges (2 mg) to be used as needed for relief of withdrawal and craving, for 12 
weeks starting on the Target Quit Date.  Participants will be urged to use at least four mini 
lozenges per day, but no more than 20 per day.     
All medicines will be provided in FDA‐approved dosing in the manufacturer’s original packaging.  
Precautions related to taking the medication will be reviewed by a study physician. 
In addition to the medication regimen, all participants will be provided with a single individual smoking 
cessation counseling provided by Dr. Fiore and trained research staff, as per the United States Public 
Health Service Clinical Practice Guideline: Treating Tobacco Use and Dependence.  Participants will also 
be asked to access a Web‐based cessation support program (www.smokefree.gov).  Target Quit Date 
(TQD) for all participants will be set for eight days from initiation of medication to allow for normal up‐
titration of varenicline.  


5 
 
 
 
Follow‐Up 
All participants will be followed over the 13 week course of treatment with structured assessment of 
safety, tolerability, treatment adherence, smoking, use of noncombustible nicotine, and treatment 
satisfaction.  Participants will be contacted by a study physician during the week following their TQD to 
perform an AE assessment.  This AE assessment screens for critical indicators of potential risks related to 
study medication, including cardiac problems and suicide ideation.  Should any questions on the 
screener be endorsed as unresolved symptoms, a study physician will contact the participant to further 
discuss the symptoms, study medication use and other related personal or medical information.  All 
other assessments (including additional AE assessments) will be weekly telephone calls conducted by 
study staff utilizing structured instruments shown in the Assessment Table below (MN Withdrawal Scale, 
noncombustible use assessment, timeline follow‐back and adverse event assessment), with reports of 
adverse events being followed to resolution.  Attribution of AE relatedness to study treatment will be 
made by Dr. Fiore.  All AE assessments indicating unresolved symptoms which may be related to study 
medication will be assessed to determine any dosage adjustment (modification of dose or 
discontinuation of a medication.) Any Serious Adverse Events requiring reporting will be reported during 
mandated timeframes to the UW Health Sciences IRB and the National Cancer Institute (study sponsor).   
Follow‐up assessments will be conducted by telephone on a weekly basis, starting on the TQD and for 
four weeks thereafter (the period during which adverse events are most likely to emerge), then every 
two weeks for the following eight weeks.  In addition to the structured assessment, study staff will also 
use a timeline follow‐back procedure to track and smoking and noncombustible nicotine use on a daily 
basis during the treatment period, as these may influence treatment tolerability and efficacy 
assessments.  Table 1 presents the study assessment schedule.  In addition to the formal study 
assessments, participants will be able to initiate contact with study staff if they have questions/concerns 
regarding their treatment.  Study staff will review follow‐up data on a weekly basis.  UW‐CTRI’s standing 
Data Safety and Monitoring Board will review overall study data after the first 5 participants have 
completed their first week post‐quit; after the first 20 participants have reached that milestone; and at 
the completion of the study.  [The DSMB comprises Drs. James Cleary, Burke Richmond, and James 
Sosman, all of whom are independent of the pilot study.] 
Analytic plan 
This is an exploratory study of the tolerability and feasibility of combining varenicline with combination 
NRT.  There is no comparison group, so no inferential statistical tests are proposed.  Data regarding 
safety will be summarized in descriptive tables based on the adverse event organ system and reported 
frequency.  Should any Serious Adverse Events occur, they will be captured in a narrative manner, 
including the PI’s assessment of relatedness to study medication.  Participant‐reported outcomes 
related to treatment acceptance and impact on withdrawal will be summarized and reported tabularly 
with mean and standard deviation for each item.  Number of participants discontinuing any medication 
will also be summarized across the sample. 


6 
 
Given that no inferential statistical tests will be performed for this single‐group, open‐label, descriptive 
pilot study, it is not appropriate to provide a statistical power analysis.  The sample size of 40 was 
selected to provide demographic diversity in terms of gender, socioeconomic status, and smoking 
history variables, as well as providing robust estimates of the incidence of possible adverse events 
related to the combination pharmacotherapy. 
Data collection and security 
Confidentiality of participant data and information will be accomplished by using participant numbers as 
unique identifiers, allowing us to keep participant data separate from identifying information. Data 
generated through study participant and data obtained on medical history from participants will be 
stored in secure databases under protections and procedures consistent with the guidelines and 
regulations of the UW School of Medicine and Public Health (UW‐SMPH). Outside access is available only 
via an encrypted connection to the Department of Medicine Citrix server located at the UW Clinical 
Science Center in Madison. The servers at the University of Wisconsin Center for Tobacco Research and 
Intervention (UW‐CTRI) Madison office are physically secured in a locked room. Data backups are 
created nightly and stored in a locked safe. Significant safeguards have been implemented to protect 
data including virus and adware protection, firewall, access controls and encryption when appropriate 
such as wireless and remote access. All UW‐CTRI staff members have completed HIPAA/human subjects 
training and are aware of the sensitivity of study‐related data. The UW SMPH has developed school‐
wide data security policies and procedures and these were implemented in 2009. UW‐CTRI data security 
policies and procedures conform to those of the SMPH. UW‐CTRI will use an enterprise‐level database 
that supports audit trails such as access, change logging, and more sophisticated access control for 
managing and tracking user access privileges.   No publications or presentations resulting from this 
research program will contain any identifying information about individual participants.  All data 
including phone screen and study participant data will be prepared for analysis by eliminating all HIPAA 
identifiers and, within 9 months following the time the primary analysis, the study database will be 
archived and the study will be closed to IRB.   Only the de‐identified data set will be available for any 
future use, either by UW Investigators or others who may request data in accord with NIH guidelines. 
Payment/retention plan 
Participants will be compensated $50 for attending the single in‐person visit and $10 for their time for 
completion of each telephone follow‐up assessment following their initial visit, for a potential total 
reimbursement of $140.  All study medication and the initial assessments and smoking cessation 
counseling will be provided at no cost to participants. 
 
 
 
 
 
Assessment schedule 


7 
 
 
Wk ‐1 
TQD 
Wk 1 
Wk 2 
Wk 3 
Wk 4 
Wk 6 
Wk 8 
Wk 
10 
Wk 
12 
 
Visit 1 
Call 1 
Call 2 
Call 3 
Call 4 
Call 5 
Call 6 
Call 7 
Call 8 
Call 9 
Smoking History 
X 
 
 
 
 
 
 
 
 
 
Fagerstrom Test 
of Nicotine 
Dependence 
X 
 
 
 
 
 
 
 
 
 
WI Index of 
Smoking 
Dependence 
Motives 
X 
 
 
 
 
 
 
 
 
 
MN Nicotine 
Withdrawal 
Scale 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Noncombustible 
Use Assessment 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Timeline 
Follow‐Back 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Combination 
Treatment 
Assessment 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse 
Experience 
Assessment 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
References 
1. Fiore MC, Jaen CR, Baker TB, et al.  Treating Tobacco Use and Dependence: 2008 Update.  
Clinical Practice Guideline.  Rockville, MD: US Department of Health and Human Services.  Public 
Health Service.  May 2008. 
2. Koegelenberg C. F. N., Bateman E. D.,  van Zyl‐Smit R. N.,  Bruning A.,  O’Brien J. A.,  Smith C.,  
Abdool‐Gaffar M. S., Emanuel S., Esterhuizen T. M., Irusen E. M.  Efficacy of varenicline 
combined with nicotine replacement therapy vs varenicline alone for smoking cessation: a 
randomized clinical trial.  Journal of the American Medical Association, 2014;312(2):155‐161. 
doi:10.1001/jama.2014.7195 
3. Ebbert JO, Burke MV, Hays JT, Hurt RD. Combination treatment with varenicline and nicotine 
replacement therapy. Nicotine & Tobacco Research. 2009;11(5):572‐576. 

ICF_000.pdf: 
Page 1 of 7
Fiore-Cessation Project Consent Form; October 14, 2015                 
UW HS-IRB #2015-1376 
UNIVERSITY OF WISCONSIN-MADISON
Subject CONSENT to Participate in Research
And
AUTHORIZATION to Use and/or Disclose Identifiable Health Information for 
Research 
Title of the Study: 
UW Smoking Cessation Research Project 
Principal Investigator: Michael C. Fiore, MD, MPH, MBA
Phone: 608-262-8673; email: mcf@ctri.wisc.edu;
1930 Monroe St., Suite 200, Madison, WI 53711 
Study Funding:
National Cancer Institute
INVITATION 
You are invited to participate in this research study that is studying the use of a 
combination of three FDA-approved medicines for quitting smoking.  You are invited to 
take part because you are interested in quitting smoking. This is a 3 month research 
study. You will get 12 weeks of nicotine patch, nicotine lozenge and varenicline 
(Chantix).  You will also receive quit-smoking coaching.  The U.S. Public Health Service 
guideline on treatment for quitting smoking recommends both medication and coaching.  
Approximately 40 people will participate in this study. 
Your participation in this research study is completely voluntary. If you decide not to 
participate, the health care provided to you by your primary care provider will not be 
affected in any way. 
A. WHAT IS THE PURPOSE OF THIS STUDY? 
The purpose of the research is to discover whether a combination of three FDA-
approved stop smoking medicines is well-tolerated and a useful way to help people who 
want to quit smoking.
B. WHAT WILL MY PARTICIPATION INVOLVE? 
If you decide to participate in this study, you will be provided with study medicines and 
coaching and will receive medical monitoring throughout treatment.  You will be asked 
to complete an initial in-person clinic visit which will last about 1 hour. This is the only in-
person visit in the study.  You will also complete 9 follow-up assessment phone calls on 
your quit day and 1, 2, 3, 4, 6, 8, 10 and 12 weeks after you quit (described below).  In 
total, your participation could take up to 3 hours over 4 months.  
IRB Approval Date: 1/19/2016              
Date IRB Approval Expires: 1/18/2017
FWA00005399     HS IRB
University of Wisconsin – Madison


Page 2 of 7
Fiore-Cessation Project Consent Form; October 14, 2015                 
The in-person clinic visit will include the following:

We will ask you to fill out a questionnaire that will include information about your 
smoking (when and how often you smoke), how dependent you are on nicotine, 
your mood states, basic demographic information (age, gender) and social 
support.

You will take a breath test that measures carbon monoxide in your lungs, which 
helps measure how much you smoke. After inhaling deeply and holding your 
breath for 15 seconds, you will breathe out into a disposable tube that will be 
placed over a sensor.

We will collect information about your height and weight.

We will also help you set a target quit date.
Study treatments:
In this study, we are testing the use of 3 medications all designed to help smokers 
quit smoking, plus smoking cessation coaching.  The use of the 3 medicines 
together is experimental. The treatments would be provided to you at no cost.     
The treatment includes 12 weeks of the nicotine patch, nicotine lozenge and 
varenicline (Chantix) and an in-person coaching session that would happen 
today. 
Study assessments:

We will ask you to complete 9, 5-10 minute follow-up assessment phone calls on 
your quit day and at Weeks 1, 2, 3, 4, 6, 8, 10 and 12 after the quit day.  At each 
of these calls you will be asked to answer on smoking status, use of alcohol or 
other tobacco products, nicotine withdrawal symptoms, mood, stress, social 
support, and medication use and safety. 
We will also collect the following information about you: 
Name, address, phone number and information about your smoking and other 
tobacco use, height, weight, carbon monoxide level, and study medication use. 
C. ARE THERE ANY BENEFITS TO ME? 
All participants will receive evidence-based treatment that includes FDA-approved 
medicines and quit-smoking coaching.  Both quit-smoking coaching and the medicines 
have been shown to help smokers quit.  We don’t know if being in this study will make it 
easier for you to quit smoking, but it may.  In addition, the information you provide 
during the study will help us learn how to help other people quit smoking. 
D. WILL I BE PAID FOR MY PARTICIPATION? 
You will receive up to $140 for participating in this study.  You will receive $50 for 
completing the initial clinic visit, and $10 for completing each of the 9 assessment calls.  
IRB Approval Date: 1/19/2016              
Date IRB Approval Expires: 1/18/2017
FWA00005399     HS IRB
University of Wisconsin – Madison


Page 3 of 7
Fiore-Cessation Project Consent Form; October 14, 2015                 
E. ARE THERE ANY SIDE EFFECTS OR RISKS TO ME? 
1. The most common side effects to the nicotine patch are a skin rash, insomnia, and 
vivid dreams. In rare cases, a more severe allergic reaction may occur involving hives 
(raised, itchy areas of skin), difficulty breathing, and swelling of the face, lips, tongue, or 
throat. If you have symptoms of a severe allergic reaction, get emergency care right 
away. 
2. The most common side effects of the nicotine mini-lozenge include heartburn, 
nausea, hiccups, and sore throat. It is also possible that you may get too much nicotine 
(nicotine overdose) and feel symptoms of nausea, vomiting, dizziness, diarrhea, 
weakness, and rapid heartbeat.  
3. While using the mini-lozenge and patch together, mild or moderate nicotine overdose 
symptoms can occur.  These usually resolve by lowering the patch and mini-lozenge 
doses.  In cases of severe symptoms of nicotine overdose, the patch and mini-lozenge 
should be discontinued and you should contact your doctor and notify study staff.  
4. The most likely side effects associated with varenicline are nausea and sleep disruption. It is 
also important to note that some individuals may experience worsening of psychiatric conditions 
or symptoms such as anger, agitation, depression, or suicidal thoughts. Varenicline may be 
associated with a small, increased risk of certain heart problems in people with heart and blood 
vessel disease or, in rare cases, a serious skin rash. Study staff will be checking your symptoms 
at every call. You should contact your doctor and notify study staff immediately if you 
experience any significant emotional, skin rash or heart-related symptoms.
5. Tolerability of the use of varenicline with nicotine patch and/or lozenge is not certain. 
Another risk to taking part in the study is that your study information could be known to 
someone who is not involved in performing or monitoring this study. 
F. HOW WILL MY PRIVACY BE PROTECTED AND WHO WILL USE MY HEALTH 
INFORMATION? 
Your information will be entered directly into a password-protected computer and 
encrypted. Information will then be stored on a secure server in a locked room. Paper 
documents will be stored in locked filing cabinets in locked rooms and shredded when 
no longer needed. 
The information collected from you during this study will be used by the researchers and 
research staff of the UW-Madison and its affiliates (the University of Wisconsin Hospital 
and Clinics and the University of Wisconsin Medical Foundation) for this study. It may 
also be shared with others at the UW-Madison and outside the UW-Madison. 
Others at UW-Madison and its affiliates who may need to use your health 
information in the course of this research: 
• UW-Madison regulatory and research oversight boards and offices
• Accounting and billing personnel at the UW-Madison 
Others outside of UW-Madison and its affiliates who may receive your health 
information in the course of this research: 
IRB Approval Date: 1/19/2016              
Date IRB Approval Expires: 1/18/2017
FWA00005399     HS IRB
University of Wisconsin – Madison


Page 4 of 7
Fiore-Cessation Project Consent Form; October 14, 2015                 
• The National Cancer Institute (the study sponsor)
• Serious adverse events associated with use of the study drug will be reported to the 
FDA and the drug manufacturer
• 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.
People outside the UW-Madison and its affiliates who receive your health information 
may not be covered by privacy laws and may be able to share your health information 
with others without your permission. Usually when we share information from research 
studies with others outside the UW-Madison and its affiliates, it is not shared in a way 
that can identify an individual. 
In addition, we are required by law to take appropriate action if we learn that you are in 
danger of hurting yourself or others.  This action may involve sharing information about 
you with appropriate authorities (e.g., a police department) in order to protect your 
safety or the safety of others.
G. IS MY PERMISSION VOLUNTARY AND MAY I CHANGE MY MIND? 
Your permission is voluntary. You do not have to sign this form and you may refuse to 
do so. If you refuse to sign this form, however, you cannot take part in this research 
study. 
You may completely withdraw from the study at any time. You also may choose to 
cease participation or skip any questions that you do not feel comfortable answering.  In 
addition, the Principal Investigator can end your study participation if there are serious 
violations of the study protocol or procedures by you that put you at risk.  During your 
participation in the study, you will be informed of any new information that may affect 
your willingness to continue in the study.
IF YOU DECIDE NOT TO PARTICIPATE IN THIS STUDY OR IF YOU STOP WHILE 
THE STUDY IS UNDERWAY, ANY HEALTH CARE YOU RECEIVE FROM THE UW-
MADISON AND ITS AFFILIATES WILL NOT BE AFFECTED IN ANY WAY. 
H. ARE THERE ANY ALTERNATIVES?
You do not have to participate in this study to receive help with quitting smoking.  If you 
decide not to participate in this study, you can receive help from your primary care 
provider at your health clinic.  Also, you can receive help from the Wisconsin Tobacco 
Quit Line by calling the toll-free number 1-800-QUIT-NOW (1-800-784-8669).
I. WILL THERE BE ANY COMPENSATION FOR INJURY RESULTING FROM THIS 
RESEARCH?
IRB Approval Date: 1/19/2016              
Date IRB Approval Expires: 1/18/2017
FWA00005399     HS IRB
University of Wisconsin – Madison


Page 5 of 7
Fiore-Cessation Project Consent Form; October 14, 2015                 
In the event that you are physically injured as a result of participating in this research, 
emergency care will be available.  You will, however, be responsible for the charges for 
the emergency care.  There is no commitment to provide any compensation for 
research-related injury.  You should realize, however, that you have not released this 
institution from liability for negligence.  Please contact the investigator, (Michael C. 
Fiore, MD, MPH, MBA) at (608-262-8673) if you are injured or for further information.
J. HOW LONG WILL MY PERMISSION TO USE MY HEALTH INFORMATION LAST? 
By signing this form you are giving permission for your health information to be used by 
and shared with the individuals, companies, or institutions described in this form. Unless 
you withdraw your permission in writing to stop the use of your health information, there 
is no end date for its use for this research study. You may withdraw your permission at 
any time by writing to the person whose name is listed below: 
Michael C. Fiore, MD, MPH, MBA
UW Center for Tobacco Research and Intervention
1930 Monroe St. Suite 200. Madison, WI 53711 
Beginning on the date you withdraw your permission, no new information about you will 
be used. Any information that was shared before you withdrew your permission will 
continue to be used. If you withdraw your permission, you can no longer actively take 
part in this research study. 
K. WHO SHOULD I CONTACT IF I HAVE QUESTIONS? 
Please take as much time as you need to think over whether or not you wish to 
participate. If you have any questions about this study at any time, contact the Principal 
Investigator Michael C. Fiore, MD, MPH, MBA at 608-262-8673.
If you have any questions about your rights as a research participant or complaints 
about the research study that you could not resolve with the study team, contact the 
UWHC Patient Relations Representative at 608-263-8009 or University of Wisconsin 
Medical Foundation Patient Relations Representative at 800-552-4255 or 608-821-
4819. 
IRB Approval Date: 1/19/2016              
Date IRB Approval Expires: 1/18/2017
FWA00005399     HS IRB
University of Wisconsin – Madison


Page 6 of 7
Fiore-Cessation Project Consent Form; October 14, 2015                 
AGREEMENT TO PARTICIPATE IN THIS STUDY
AND
PERMISSION TO USE AND/OR DISCLOSE MY HEALTH INFORMATION 
I have read this consent and authorization form describing the research study 
procedures, risks, and benefits, what health information will be used, and how my health 
information will be used. I have had a chance to ask questions about the research 
study, including the use of my health information, and I have received answers to my 
questions. I agree to participate in this research study, and permit the researcher to use 
and share my health information as described above. YOU WILL RECEIVE A COPY 
OF THIS FORM AFTER SIGNING IT. 
__________________________________________
_____________
Printed Name of Participant
     Date
__________________________________________
_____________
Signature of Participant
     Date
__________________________________________
_____________
Printed Name of Person Obtaining Consent and Authorization     Date
__________________________________________
_____________
Signature of Person Obtaining Consent and Authorization
     Date
IRB Approval Date: 1/19/2016              
Date IRB Approval Expires: 1/18/2017
FWA00005399     HS IRB
University of Wisconsin – Madison


Page 7 of 7
Fiore-Cessation Project Consent Form; October 14, 2015                 
VOLUNTARY STATEMENT OF INTENT TO AVOID PREGNANCY
According to the FDA and the manufacturer of the nicotine patch and nicotine mini-
lozenge, these medications should not be used by pregnant women.  The risks of these 
medications to an unborn child are not fully known.  We ask female study participants 
who are able to get pregnant or who believe that it is possible to get pregnant to agree 
to the statement below about avoiding pregnancy while taking study medication.  
Women who have had tubal ligation (“tubes tied”) to prevent pregnancy do not have to 
sign below if the tubal ligation occurred more than a year ago and no pregnancy has 
occurred.  Woman who are menopausal and have not had a menstrual period in more 
than one year are not required to sign. Male participants are not required to sign this 
statement.
I,                                    
 (print name) agree to attempt to avoid pregnancy while I am 
taking study medication.  I will continue to employ medically acceptable means of 
contraception that have been approved by study staff.  These methods include IUD, oral 
contraceptive, implantable or injectable contraceptives, barrier methods, or abstinence. I 
will immediately contact study staff if pregnancy is suspected. I am aware that I may 
decline to sign this statement and my refusal to sign will have no effect on my further 
treatment from my primary care provider; however, I cannot participate in this research 
study.
______________________________                                    ______________
Signature of Participant
                     
      Date
IRB Approval Date: 1/19/2016              
Date IRB Approval Expires: 1/18/2017
FWA00005399     HS IRB
University of Wisconsin – Madison