Clinical trial NCT03720899
Conditions: Smoking Cessation Nicotine Dependence
Sponsor: University of Alabama at Birmingham
Start date: 2019-03-21; Completion date: 2021-03-03
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To examine the feasibility, acceptability, and preliminary impact of using NicoBloc compared to nicotine lozenges

Detailed description:
Smoking remains the leading cause of preventable death in the U.S. with approximately 18% of the population continuing to smoke. However, smoking is concentrated in disadvantaged populations where the prevalence of smoking may be as high as 70-80 %. Participants will receive a sampling experience (use of nicotine lozenges or NicoBloc during sessions) with counseling focused around their experience of using these interventions, including side effects and smoking cessation expectancies.

Arms: arm 1: NicoBloc participants will be provided with NicoBloc to use during counseling sessions and will test smoking their conventional cigarette with NicoBloc. arm 2: Participants who receive nicotine lozenge will use the lozenge in session and will discuss the effects of using the lozenge in session.
Interventions: intervention 1: NicoBloc intervention 2: Nicotine Lozenge
Intervention descriptions: intervention 1: For Session 1, participants will use one drop of NicoBloc (which will block 33% of tar and nicotine) on their conventional cigarette and then will smoke this cigarette in session. Following smoking, they will discuss the effects of the NicoBloc on their withdrawal, cravings, and overall enjoyment of their cigarette. To bolster their in vivo NicoBloc experience, participants will be provided with NicoBloc to use between sessions to acclimate to the NicoBloc and to make practice quit attempts (PQAs). Sessions 2 and 3 are similar to Session 1 except they will use more NicoBloc product during the session and will be instructed to use the product between sessions. intervention 2: Participants who receive nicotine lozenge (mini lozenge) will be given either a 2 or 4 mg lozenge to use in session, depending on how soon they smoke after waking. If a participant smokes within 30 minutes of waking, they start with the 4 mg lozenge; more than 30 minutes, they start with the 2 mg lozenge. They will be given lozenges between sessions to make PQAs.

Protocol documents:
ICF_005.pdf: 
A Pilot Trial Comparing NicoBloc to Nicotine Lozenges: 
Initial Acceptability and Feasibility Trial
3/27/2019
NTC:300001370


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CONSENT FORM
TITLE OF RESEARCH:  A Pilot Trial Comparing NicoBloc to Nicotine Lozenges: Initial 
Acceptability and Feasibility Trial
IRB PROTOCOL:
300001370
INVESTIGATOR:
Karen Cropsey, Psy.D.
SPONSOR:
Department of Psychiatry and Behavioral Neurobiology
Supported by:
NicoBloc, plc
Purpose of the Research
You are invited to participate in a research study conducted by Karen Cropsey, Psy.D. that will 
compare the effects of two different interventions, nicotine lozenges or NicoBloc, in reduction or 
cessation of smoking. Richard Shelton, MD, will provide medical supervision. This study is 16 
weeks in duration. You are being asked to participate in this study because you are a current 
smoker. Both of the interventions used are available over-the-counter and without prescription. 
This study will enroll 50 participants from the Birmingham community.
Explanation of Procedures
This is a study designed to see if counseling plus nicotine lozenges or NicoBloc will be effective 
in quitting smoking. The counseling is focused around your experience of using these smoking 
cessation interventions, including how the use of them may help you quit smoking, side effects, 
and smoking cessation expectancies. If you are eligible to be in the study, you will be 
randomized (like the flip of a coin) into one of two groups.  If you are in the NicoBloc group you 
will use one drop of NicoBloc (which will block 33% of tar and nicotine) on your conventional 
cigarette and then will smoke this cigarette during Session 1. If you are in the nicotine lozenge 
group, you will be given either a 2 or 4mg lozenge to use in session, depending on how soon you 
smoke upon awakening. You will try the NicoBloc or the nicotine lozenge during your 
counseling session and talk about it. Things discussed will include your expectations of the 
method to reduce or stop smoking, how it may help, and side effects.  You will be asked to fill 
out forms about your smoking behavior, demographics, medical information, and a sheet that 
requires you to provide your contact information as well as two other individuals that we can 
contact about you. This contact sheet will be updated at every visit. Some of the questionnaires 
will be repeated at every visit and others will be repeated less frequently. See the chart below for 
details. If you are a woman of child bearing potential you will be asked to give a urine 
sample to test for pregnancy. At each visit you will have a carbon monoxide (CO) test where 
you will blow into a machine (like an alcohol breathalyzer), which will tell us how much CO is 
in your lungs as a result of smoking. We are asking you to attend a baseline visit, four weekly 
intervention sessions and three follow-up appointments. You are being asked to go as long as 
you can without  smoking the day of your study sessions. 
UAB IRB
Approved
01-Dec-2019
until
03-Sep-2020


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At the baseline visit (Session 0) you will be asked to complete several commonly used 
questionnaires. You will have a CO test and a urine drug screen. If you are a woman of child 
bearing potential you will be asked to give a urine sample to test for pregnancy. You will be 
asked to go as long as you can without smoking on the day of your Session 1. Each session 
will begin with the completion of several self-report measures and you will have a CO test.
NicoBloc Group
At Session 1 (Week 1), you will use one drop of NicoBloc (which will block 33% of tar and 
nicotine) on your conventional cigarette and then will smoke this cigarette in session. Following 
smoking, you will discuss the effects of the NicoBloc on your withdrawal, cravings, and overall 
enjoyment of their cigarette. To bolster your NicoBloc experience, you will be provided with 
NicoBloc to use between sessions to get used to the NicoBloc and to make practice quit attempts.
Sessions 2 and 3 are similar to Session 1 except you will use more NicoBloc product during the 
session and will be instructed to use the product between sessions. For example, in in session 2, 
you will use 2 drops on their cigarettes (which blocks about 66% of tar and nicotine) and then 
smoke. Similarly, in Session 3 you will use 3 drops of NicoBloc which is equivalent to blocking 
99% of the tar and nicotine exposure from a cigarette. You will discuss your experiences and 
expectancies for NicoBloc to help you quit.
At Session 4 you will discuss your experiences using NicoBloc and will set a quit date prior to 
your 8 week visit. 
You will return at 8 and 12 weeks at which time the intervention will be complete.
A final one month follow-up at Week 16 will examine how well you did without the NicoBloc. 
Nicotine Lozenge Group
At Session 1, participants who receive nicotine lozenge (mini lozenge) will be given either a 2 or 
4 mg lozenge to use in session, depending on how soon you smoke after waking. If you smoke 
within 30 minutes of waking, you will start with the 4 mg lozenge; more than 30 minutes, you 
will start with the 2 mg lozenge. Similar to NicoBloc, you will use the lozenge in session and 
will discuss the effects of using the lozenge in session. 
Sessions 2 and 3 are similar to Session 1. You will be given lozenges between sessions and will 
be instructed to use the product between sessions.
At Session 4, you will discuss your experiences using the lozenges and will set a quit date prior 
to your 8 week visit. 
All Sessions, after the four week intervention, you will be given an additional 8 weeks of 
medication (NicoBloc or Lozenge) in four week allotments to use for a sustained quit attempt. 


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Thus, both groups will receive the medication for 12 weeks total to make a quit attempt. All 
participants will continue to receive medication and monitoring for side effects, regardless of 
their medication adherence. Study visits occur at baseline (Week 0), intervention Weeks 1-4, 
You will return at 8 and 12 weeks at which time the intervention will be complete.
A final one month follow-up at Week 16 will examine how well you did without the nicotine 
lozenges.
Note: BL=Baseline Assessment; S=session; WK=week; 1All participants will complete these surveys twice (at the beginning and end of session) during 
sessions 1-8. 
Study Assessment 
Schedule
BL
Post-Randomization Assessment Schedule
Measures or
Procedures
 compensation)
Day
0
($10)
WK1
S1
($20)
WK2
S2
($20)
WK3
S3
($20)
WK4
S4
($20)
WK8
($40)
WK12
 ($40)
WK16
1 MO 
F/U
($40)
Screening Questionnaire
X
Demographics
X
Urine Drug Screen
X
Urine Pregnancy Test (if female)
X
X
X
Smoking History
X
X
X
X
X
Treatment Expectancies
X
X
X
X
X
X
X
X
Weekly Smoking Behavior
X
X
X
X
X
X
X
X
Tobacco Use Calendar Weekly
X
X
X
X
X
X
X
X
NRT 
Lozenge 
Use 
Calendar 
Weekly
X
X
X
X
NicoBloc Use Calendar Weekly
X
X
X
X
PSS – 10 Item Questionnaire
X
X
X
X
X
X
X
X
Stanford 
Expectancies 
for 
Treatment Scale
X
X
X
X
X
Belief 
and 
Attitudes 
about 
Medication Scale
X
X
X
X
X
TAA  Questionnaire
X
X
X
X
X
X
X
X
SAQ  Questionnaire
X
X
X
X
ARME  Questionnaire
X
X
X
X
X
X
X
X
ANL  Questionnaire
X
X
X
X
X
X
X
X
ANB Questionnaire
X
X
X
X
X
X
X
X
CFS  Questionnaire
X
X
X
X
FTND  Questionnaire
X
X
X
X
WISDM  Questionnaire
X
X
X
X
QSU  Questionnaire
X
X1
X1
X1
X1
X1
X
X
MNWS  Questionnaire
X
X1
X1
X1
X1
X1
X
X
TSS  Questionnaire
X
X
CEQ  Questionnaire
X
X
Side Effects
X
X
X
X
X
Carbon Monoxide (CO)
X
X
X
X
X
X
X
X
Intervention Adherence
R
A
N
D
O
M
I
Z
A
T
I
O
N
X
X
X
X
X
X
Alliance Questionnaire
X
Alliance Questionnaire Therapist
X
Adverse Events
X
X
X
X
X
Serious Adverse Events
X
X
X
X
X


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Risks and Discomforts
You may have some side effects from taking the nicotine lozenge. The side effects occur in 
about 10% of the population who receive the medications. The side effects are generally mild 
and well-tolerated. The NRT products that we are using are available over-the-counter without a 
prescription and have been on the market for years without serious problems. 
The most common side effects are dry mouth, agitation, insomnia, headache, nausea, 
constipation, weight loss, and tremor. Most of these side effects disappear within a couple of 
weeks of starting the medication. There are no known side effects associated with the use of 
NicoBloc. 
Quitting smoking is also associated with withdrawal symptoms including feeling sad or 
depressed mood, increased appetite or weight gain, difficulty concentrating, irritability, 
insomnia, restlessness, anxiety, decreased heart rate, and cravings. Please inform the physician or 
study staff if you experience any of these side effects. Under rare circumstances, if symptoms are 
severe, please visit your nearest emergency room or dial 911 and stop taking the lozenges. If this 
should occur, please contact the study doctor after you have been treated. 
As with other interventions with a behavioral/psychological component, some participants may 
be uncomfortable answering personal questions on questionnaires or talking about personal 
information during an intervention session.
There is also the risk of loss of confidentiality. Every effort will be made to minimize this risk.
You will be assigned to a group by chance, which may prove to be less effective or to have more 
side effects than the other study group or alternatives.
Information for Women of Childbearing Potential and/or Men Capable of Fathering a 
Child
We do not know if the NRT product will affect mother’s milk or an unborn fetus. Therefore, 
breast-feeding and pregnant women are not allowed to take part in the study. If you are pregnant 
or become pregnant, there may be risks to the embryo or fetus that are unknown at this time. 
Women who can become pregnant must take a pregnancy test before the start of the study. 
Women will be screened monthly for pregnancy using a urine pregnancy test. If you become 
pregnant during the trial you will be taken off the study medication. Results of all pregnancy 
tests will be provided to you on site immediately. 
You should not father a child while on this study as the treatment may indirectly affect an unborn 
child. If you are sexually active and are at risk of causing a pregnancy, you and your female 
partner(s) must use a method to avoid pregnancy that works well or you must not have sex.
Unless you cannot have children because of surgery or other medical reasons, you must agree to 
use an effective form of birth control while taking the study drug. Effective birth control includes 


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birth control pills, patch, IUD, condom, sponge, diaphragm with spermicide, or avoiding sexual 
activity that could cause you to become pregnant.
Benefits
The study interventions may help you to quit smoking. It is unknown if this intervention will 
help you abstain from smoking in the future. You may not benefit directly from taking part in 
this study. However, this study may help us better understand how to help people quit smoking 
in the future.
Alternatives
The alternative is to not participate in the study. If you do not want to be in the study you can get 
smoking cessation treatment by your primary care doctor who can prescribe medication for you 
to help you quit. There are also free quit line services to help you quit smoking and we can give 
you those phone numbers if you are interested. 
Confidentiality
Information obtained about you for this study will be kept confidential to the extent allowed by 
law. However, research information that identifies you may be shared with the UAB Institutional 
Review Board (IRB), the NIH, the FDA, and others who are responsible for ensuring compliance 
with laws and regulations related to research, including people on behalf of the Office for Human 
Research Protections (OHRP). The results of the research may be published for scientific 
purposes. However, your identity will not be given out.
Your anonymity will be protected in any research papers and presentations that result from this 
work.  
In certain instances, researchers may disclose voluntarily, without your consent, information that 
would identify you as a participant in a research project in the following cases: (1) wanting to 
harm yourself, (2) wanting to harm other people, or (3) reports of child or vulnerable adult abuse. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This website will not include information that can identify you. At most, the 
website will include a summary of the results. You can search this website at any time.
Voluntary Participation and Withdrawal
Whether or not you take part in this study is your choice. There will be no penalty if you decide 
not to be in the study. If you decide not to be in the study, you will not lose any benefits you are 
otherwise owed. You are free to withdraw from this research study at any time. Your choice to 
leave the study will not affect your relationship with this institution. 


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You may be removed from the study without your consent for the following reasons:

The study doctor thinks it is necessary for your health or safety

You have not followed study instructions

Administrative reasons require you to stop
If you are a UAB student or employee, taking part in this research is not a part of your UAB 
class work or duties.  You can refuse to enroll, or withdraw after enrolling at any time before the 
study is over, with no effect on your class standing, grades, or job at UAB. You will not be 
offered or receive any special consideration if you take part in this research.
Cost of Participation
There will be no cost to you for taking part in this study. All drugs, exams, and medical care 
related to this study will be provided to you at no cost during the 16 week study period.
If you require standard medical care, the costs of your standard medical care will be billed to you 
and/or your insurance company in the usual manner. If you want to keep taking the medication 
after our study has ended, you will be responsible for the cost of continuing the medication. 
Payment for Participation in Research
You will be paid for your participation in this study. Overall, you have the opportunity to receive 
up to $210. You will receive $10 for your baseline visit and $20 each for sessions 1 through 4.  
After session 4, you will receive $40 for week 8, 12, and 16. You will be given a Greenphire 
ClinCard, which is a reloadable gift card. In order to be paid through ClinCard we require that 
you provide your social security number (SSN). At each visit, your compensation will be loaded 
onto your card. Please allow up to 2 weeks for processing of compensation.
Payment for Research-Related Injuries
UAB and NIH have not provided for any payment if you are harmed as a result of taking part in 
this study. If such harm occurs, treatment will be provided. However, this treatment will not be 
provided free of charge.
Significant New Findings
You will be told by your doctor or the study staff if new information becomes available that 
might affect your choice to stay in the study.
Text Messaging
In the event that we cannot reach you by phone, we use text messages for appointment 
reminders, if you miss an appointment, and/or if we need to reach you concerning the study. 
We will not include any of your personal health information in these text messages, and the 


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messages will state they are from the UAB research study. Please indicate below if you agree 
to receive text messages regarding the study.
_____ Yes, I agree to receive text messages concerning this study.
_____ No, I do not agree to receive text messages concerning this study.


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Questions
If you have any questions, concerns, or complaints about the research or a research-related injury including 
available treatments, you may contact the principal investigator Karen Cropsey, PsyD. She will be glad to 
answer any of your questions. Dr. Cropsey’s number is 205-975-7809. The study medical doctor, Richard 
Shelton, MD, may also be reached during office hours at 205-975-9295 or after hours by paging him at 205-
934-3411 for any medical questions.
If you have questions about your rights as a research participant, or concerns or complaints about the research, 
you may contact the UAB Office of the IRB (OIRB) at (205) 934-3789 or toll free at 1-855-860-3789. Regular 
hours for the OIRB are 8:00 a.m. to 5:00 p.m. CT, Monday through Friday. You may also call this number in 
the event the research staff cannot be reached or you wish to talk to someone else.
Legal Rights
You are not waiving any of your legal rights by signing this informed consent document.
Signatures
Your signature below indicates you agree to participate in this study. You will receive a copy of this signed 
consent form.
Signature of Participant
Date
Signature of Person Obtaining Consent
Date


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University of Alabama at Birmingham
AUTHORIZATION FOR USE/DISCLOSURE OF 
PROTECTED HEALTH INFORMATION (PHI) FOR RESEARCH
Participant Name:  
UAB IRB Protocol Number:  300001370
Principal Investigator: Karen Cropsey, Psy. D. 
Research Protocol: A Pilot Trial Comparing NicoBloc to 
Nicotine Lozenges: Initial Acceptability and Feasibility Trial 
Sponsor:  UAB Department of Psychiatry & Neurobiology
What is the purpose of this form?  You are being asked to sign this form so that UAB may use and release your protected health 
information for research.  Participation in research is voluntary.  If you choose to participate in the research, you must sign this form 
so that your protected health information may be used for the research.
Why do the researchers want my protected health information?  The researchers want to use your protected health information as 
part of the research protocol listed above and as described to you in the informed consent.
What protected health information do the researchers want to use?  All medical information, including but not limited to 
information and/or records of any diagnosis or treatment of disease or condition, which may include sexually transmitted diseases 
(e.g., HIV, etc.) or communicable diseases, drug/alcohol dependency, etc.; all personal identifiers, including but not limited to your 
name, social security number, medical record number, date of birth, dates of service, etc.; any past, present, and future history, 
examinations, laboratory results, imaging studies and reports and treatments of whatever kind, including but not limited to 
drug/alcohol treatment, psychiatric/psychological treatment; financial/billing information, including but not limited to copies of your 
medical bills,  and any other information related to or collected for use in the research protocol, regardless of whether the 
information was collected for research or non-research (e.g., treatment) purposes.
Who will disclose, use and/or receive my protected health information?  All Individuals/entities listed in the informed consent 
documents, including but not limited to, the physicians, nurses and staff and others performing services related to the research 
(whether at UAB or elsewhere); other operating units of UAB, HSF, UAB Highlands, Children’s of Alabama, Eye Foundation Hospital, 
and the Jefferson County Department of Health, as necessary for their operations; the IRB and its staff; the sponsor of the research 
and its employees and agents, including any CRO; and any outside regulatory agencies, such as the Food and Drug Administration, 
providing oversight or performing other legal and/or regulatory functions for which access to participant information is required.
How will my protected health information be protected once it is given to others?  Your protected health information that is given 
to the study sponsor will remain private to the extent possible, even though the study sponsor is not required to follow the federal 
privacy laws. However, once your information is given to other organizations that are not required to follow federal privacy laws, we 
cannot assure that the information will remain protected.
How long will this Authorization last?  Your authorization for the uses and disclosures described in this Authorization does not have 
an expiration date.
Can I cancel this Authorization?  You may cancel this Authorization at any time by notifying the Principal Investigator, in writing, 
referencing the research protocol and IRB Protocol Number. If you cancel this Authorization, the study doctor and staff will not use 
any new health information for research. However, researchers may continue to use the protected health information that was 
provided before you cancelled your authorization.
Can I see my protected health information?  You have a right to request to see your protected health information. However, to 
ensure the scientific integrity of the research, you will not be able to review the research information until after the research 
protocol has been completed.
Signature of participant: 
Date: 
or participant's legally authorized representative: 
Date: 
Printed Name of participant’s representative: 
Relationship to the participant: 

SAP_004.pdf: 
 
 
 
 
 
 
A Pilot Trial Comparing NicoBloc to Nicotine Lozenges: Initial Acceptability and Feasibility Trial 
2/2/2022 
NTC:300001370 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Data Analytic Approach 
Participant screening, baseline eligibility, baseline attendance, study eligibility, and 
retention rates throughout the study were calculated overall and per time point. Retention rates 
between groups at each time point and other dichotomized variables such as adherence were 
assessed using Chi-Square analyses. Participant demographics and baseline smoking 
characteristics were assessed, and group differences examined using measures of effect size 
(Cramer’s V and Cohen’s d). Group differences over time were analyzed using generalized 
estimating equations (GEEs) with all available data (i.e., Intent-To-Treat analyses). GEE results 
were followed-up with pairwise comparisons when applicable. Measures administered pre- and 
post-session (QSU and MNWS) were calculated as a change score and included as such in GEE 
analyses. Pre-session scores were subtracted from post session scores such that negative scores 
reflect decreases in withdrawal symptoms or smoking urges throughout the session.  For 
measures administered at two or less time points, t-tests were used to examine group differences.  
 

Prot_003.pdf: 
 
 
A Pilot Trial Comparing NicoBloc to Nicotine Lozenges: Initial Acceptability and Feasibility Trial 
3/27/2019 
NTC:300001370 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Purpose  
This pilot study will examine the feasibility, acceptability, and preliminary impact of using NicoBloc 
compared to nicotine lozenges. Forty (n=40) participants will be randomized to one of two interventions 
1) NicoBloc or 2) nicotine lozenge. All participants will complete approximately 60 minutes of baseline 
assessment to determine smoking history and characteristics prior to randomization, including previous 
experience with NRT.  
 
Analysis strategy 
Feasibility and acceptability will be measured through high study retention (70%) and recruitment 
(recruitment of all participants within 24 months) in our groups. Additional items of acceptability include 
high scores on treatment satisfaction and credibility/expectancies that are equal or higher to the 
NicoBloc group. Medication adherence is a third primary outcome with expected differences between 
our groups. Adherence is notoriously difficult to determine. Self-reported adherence is not always 
reliable, particularly during treatment studies where there is a demand characteristic to report the 
desired targeted behavior (e.g., adherence to medication). The behavioral methods described under the 
assessment section represent the best available self-report tools for determining NRT adherence (e.g., 
Timeline Follow Back (TLFB) report, returning used products and packaging). Adherence will be defined 
by self-report using the TLFB and verified through returned patches and packaging. Good adherence is 
defined by taking greater than 80% of doses of medication at each time point.  
 
 Background  
Summarize in 2-3 paragraphs past experimental and/or clinical findings leading to the design of this 
protocol. Include any relevant past or current research by the PI. For drug and device studies, 
summarize the previous results (i.e., Phase I/II or III studies).  
Smoking remains the leading cause of preventable death in the U.S. with approximately 18% of the 
population continuing to smoke. However, smoking is concentrated in disadvantaged populations where 
the prevalence of smoking may be as high as 70-80 %. Participants will receive a sampling experience 
(use of nicotine lozenges or NicoBloc during sessions) with counseling focused around their experience 
of using these interventions, including side effects and smoking cessation expectancies.  
 NicoBloc is a pink occlusion fluid supplied in 15 ml bottles. Three drops applied to a cigarette filter will 
trap up to 99% of tar and nicotine in the filter (depending upon cigarette brand). The ingredients of 
NicoBloc are: Corn Syrup (86.83%), Water (12.76%), Citric Acid (E330) – acidity regulator (0.30%), 
Sodium Benzoate (E211) – food preservative (0.05%), Potassium Sorbate (E202) – food preservative 
(0.05%), Allura Red 40 (E129) – red food colouring (0.01%). These ingredients are classified as FDA 
approved food grade ingredients. 
Procedure 
A urine drug screen and pregnancy test for females will be obtained during the screen visit. If positive, 
participants will be screen failures and will not be enrolled in the study. Specimens will not be 


distributed or stored. They will be labeled with a unique study identifier. There will be no clinical data 
associated with the specimens. They are used only to establish eligibility for the study. 
After eligibility determination and consent to participate, the baseline assessments will be administered. 
This assessment is expected to take about 60 minutes and will provide basic smoking history, smoking 
behavior, and proposed mediators and moderators such as treatment interest, expectancies for NRT 
and NicoBloc, previous use of NRT, craving, withdrawal, and side effects associated with NRT use (see 
Table 1 description) and will be repeated during the study period (see Table 2 for assessment schedule). 
At each visit the participant will have a carbon monoxide test (CO) which will determine how much CO is 
in the lungs. At the baseline visit, participants will be asked to prolong smoking as long as they can on 
the days of the study sessions. Female participants will be screened monthly for pregnancy.  
Participants will be randomized to either NicoBloc or Nicotine Lozenge and will undergo the following 
interventions. Interventionists will be undergraduate level research assistants (RAs) with degrees in 
psychology or a related field. They will be trained to follow the manual and deliver both behavioral 
interventions by the PI, although they will not have extensive tobacco training. All sessions will be audio-
taped and 20% will be coded for treatment fidelity to ensure no contamination between behavioral 
interventions. 
NicoBloc: NicoBloc participants will be provided with NicoBloc to use in each 30-minute session and will 
test smoking their conventional cigarette with NicoBloc. In session, they will discuss their experience of 
smoking their cigarette with NicoBloc at each of the sessions. For Session 1, participants will use one 
drop of NicoBloc (which will block 33% of tar and nicotine) on their conventional cigarette and then will 
smoke this cigarette in session. Following smoking, they will discuss the effects of the NicoBloc on their 
withdrawal, cravings, and overall enjoyment of their cigarette. To bolster their in vivo NicoBloc 
experience, participants will be provided with NicoBloc to use between sessions to acclimate to the 
NicoBloc and to make practice quit attempts (PQAs). Sessions 2 and 3 are similar to Session 1 except 
they will use more NicoBloc product during the session and will be instructed to use the product 
between sessions. For example, in Session 2, they will use 2 drops on their cigarettes (which blocks 
about 66% of tar and nicotine) and then smoke. Similarly, in Session 3 they will use 3 drops of NicoBloc 
which is equivalent to blocking 99% of the tar and nicotine exposure from a cigarette and then smoke. 
At Session 4 they will discuss their experiences using NicoBloc and will set a quit date prior to their 8 
week visit. Participants will return at 8 and 12 weeks (EOT) with a final one month follow-up at Week 16.  
 
Nicotine Lozenge: Participants who receive nicotine lozenge (mini lozenge) will be given either a 2 or 4 
mg lozenge to use in session, depending on how soon they smoke after waking. If a participant smokes 
within 30 minutes of waking, they start with the 4 mg lozenge; more than 30 minutes, they start with 
the 2 mg lozenge. Similar to NicoBloc, they will use the lozenge in session and will discuss the effects of 
using the lozenge in session. They will do this for all four Sessions and will be given lozenges between 
sessions to make PQAs. They will be asked to set a quit date during Session 4 similar to the NicoBloc 
participants.  
 


After the four week intervention, participants will be given an additional 8 weeks of medication 
(NicoBloc or Lozenge) in four week allotments to use for a sustained quit attempt. Thus, both groups will 
receive the medication for 12 weeks total to make a quit attempt. All participants will continue to 
receive medication and monitoring for side effects, regardless of their medication adherence. Study 
visits occur at baseline (Week 0), intervention Weeks 1-4, Week 8, Week 12 (EOT), and then a 1 month 
follow-up after medication use has ended.  
Phone numbers will be collected to send study appointment reminders, missed appointment 
notifications only or if the participant needs to be reached concerning the study.