Cigarette Harm Reduction With Electronic Cigarette Use
Phase: NA
Conditions: Nicotine Dependence, Tobacco Toxicity, Nicotine Dependence, Cigarettes, Cardiovascular Risk Factor, Nicotine Withdrawal
Sponsor: University of California, San Francisco

 
 PAGE 1 OF 14 
 
 
 
 
Cigarette Harm Reduction 
with Electronic Cigarette Use 
 
UCSF IRB #: 17-23142 
 
Clinical Trials.gov #: NCT03473483 
 
November 30, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 PAGE 2 OF 14 
 
 
 
 
 
NAME: 
DOB: 
MRN#: 
 
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO 
CONSENT TO PARTICIPATE IN A RESEARCH STUDY 
 
Study Title: “Cigarette Harm Reduction with Electronic Cigarette Use” 
 
This is a research study about nicotine exposure and safety of electronic cigarettes.  The study 
researcher, Dr. Neal Benowitz, MD from the University of California, San Francisco 
Department of Medicine, is conducting this study and the Clinical Research Coordinator will 
explain this study to you. 
 
Research studies include only people who choose to take part.  Please take your time to make 
your decision about participating, and discuss your decision with your family or friends if you 
wish.  If you have any questions, you may ask the researchers. 
 
You are being asked to take part in this study because you are a healthy smoker who smokes at 
least 10 cigarettes every day and has had experience using an electronic cigarette (e-cigarette) 
device. 
 
Why is this study being done? 
 
The purpose of this study is to learn more about nicotine exposure and safety of e-cigarettes, 
assessing key pharmacological factors associated with the potential addictiveness and health 
effects of these products. 
 
Standardized Research E-Cigarettes (SREC), provided by the National Institutes of Health, will 
be used in this study and are considered experimental by the Food and Drug Administration and 
cannot be used outside of research studies.  
 
This study is funded by the National Institutes of Health (NIH). 
 
How many people will take part in this study? 
 
About 20 people will take part in this study at UCSF.   
 
What is the SREC E-cigarette?  

 
 PAGE 3 OF 14 
The Standardized Research E-Cigarette, or SREC, was developed by the National Institute of 
Drug Abuse (part of the NIH) to help researchers assess uncertainties in electronic nicotine 
delivery devices. You will be provided a handout that describes the SREC device, including its 
tank and battery characteristics, description of its use, and the composition of the e-liquid 
ingredients. The SREC devices are considered experimental by the Food and Drug 
Administration and cannot be used outside of research studies. The SREC device is currently 
only available in non-menthol, tobacco flavor, so you must be willing to use this flavor for the 
duration of the study.  
What will happen if I take part in this research study? 
If you agree, the following procedures will occur: 
Screening Visit: This is an approximately 2 hour screening visit to see if you want to be in the 
study, and to see if you meet the qualifications to be in the study. You will first read this consent 
and ask any questions you wish. After reading the consent, you must sign it to continue the 
screening visit in order to be considered for participation in the study.  
The following happens at this screening visit: 
 Forms: You will be asked to fill out forms to provide information about yourself 
(including age, racial/ethnic background, medical and social history, use of prescription 
and over-the counter medications, and the use of tobacco, alcohol, caffeine, and 
recreational drugs). In addition, there are several forms specifically about your smoking 
behavior, history, and dependence on nicotine. 
 Physical Data: Your height, weight, heart rate, and blood pressure will be collected. 
 Saliva Sample: You will be asked to give a saliva sample for laboratory tests to confirm 
that you are a smoker.  
 Expired Carbon Monoxide (Expired CO): You will be asked to breathe into a machine 
that records how much carbon monoxide is present in your lungs, in order to confirm 
your smoking status. If the testing indicates that you are not a smoker, you will be 
considered ineligible and dismissed without payment. 
 Urine Sample: A sample of your urine will be collected for: 
o Drug Testing 
 If the results are positive for substances other than marijuana or prescribed 
drugs, you will not be eligible to participate in the study. You will be 
dismissed without compensation, and your urine will be discarded. 
However, if you would like to rescreen for the study at a later time (within 
30 days), we will give you the option to schedule another screening visit. 
Results must be negative at that time for you to receive compensation for 
the visit and continue in the study if otherwise eligible. 
 If the results are positive for marijuana, you may be continued to be 
evaluated for eligibility.  
 If the results are positive for prescribed drugs, you may be continued to be 
evaluated for eligibility. 
o Pregnancy Testing (if applicable) 

 
 PAGE 4 OF 14 
 If the results are positive for pregnancy, you will not be eligible to 
participate in the study. You will be compensated for the screening visit 
and your urine will be discarded. 
If the screening exam shows that you can be in the main part of the study and you choose to 
continue, this is what will happen next: 
Orientation Visit: Once your smoking status is confirmed from the screening visit saliva 
sample, if eligible, you will be asked to come back to the UCSF Tobacco Research Center for an 
Orientation Visit.  
At this visit, we will prepare you for Study Week #1. 
 We will ask you not to use any marijuana or other recreational drugs from today 
until the study is completed.  
 A computer generated program will assign you to start Week 1 in one of three 
possible groups; e-cigarette only, tobacco cigarette only, or both e-cigarettes 
and tobacco cigarettes. 
 We will purchase your normally used tobacco cigarette products and/or provide you 
with the Standardized Research E-Cigarettes (SREC e-cig).  
 You will use whichever product you are assigned for 4 days at home (aka: outpatient 
days) before you are admitted to the research ward.  
 You will be given a study diary (smartphone app or paper) to track your product use (e.g., 
volume of e-liquid used and tobacco cigarettes smoked per day) and will record each 
evening an assessment of urges to smoke and nicotine withdrawal symptoms experienced 
throughout the day. You will also be asked to return all electronic cigarette products and 
tobacco cigarette butts so that we may assess the amount of nicotine consumed and 
tobacco burned.  
 Urine Collection: A sample of your urine will be collected and tested for nicotine 
breakdown by-products.  
 
Study Weeks 1, 2 & 3 Outpatient (aka: at home) Procedures: 
You will be able to use either your e-cigarette only, tobacco cigarette only, or both e-
cigarettes and tobacco cigarettes as you wish (aka: ad lib) for 4 days (Thursday-Sunday 
night).  
 During your e-cigarette outpatient days, you will be given only the SREC e-
cig device & cartridges.  
 During your tobacco cigarette outpatient days, you will be given only your 
usual amount of tobacco cigarettes.  
 During your dual use outpatient days, you will be given less than your usual 
amount of tobacco cigarettes plus the SREC e-cig device & cartridges.  
 
We will ask that you use only the provided product(s) during these outpatient days and that you 
keep track of your product usage with the study diary given to you at Orientation. You will be 
asked to abstain from smoking and vaping the night before your admission to the hospital, 
starting at 10:00pm. You must complete your diaries and send to the study coordinator via text 
or email at the end of each outpatient day.  

 
 PAGE 5 OF 14 
 
All inpatient, hospital study procedures will follow the 4 outpatient days, starting on Monday 
morning and ending Thursday morning. You may begin on any of the three groups: e-cigarette 
only, tobacco cigarette only, or both e-cigarettes and tobacco cigarettes. 
 
Inpatient Study Week SREC E-Cig (3 days): You will be admitted to the ZSFG Clinical & 
Translational Science Institute (CTSI) clinical research site (CRS) as an inpatient for 3 24-hour 
days. 
 
During the admission, you will have a pregnancy test (if female), medical history and 
physical examination conducted by the Study Physician or a Nurse Practitioner. This is required 
for all hospital admissions and these documents will become part of your permanent ZSFG 
medical record. If you wish, the results of your physical examination will be shared with you by 
the health care provider.  
 
On Hospital Day 1 (Monday), the following will occur: 
 You will be asked to arrive at the research ward at 7am to begin your inpatient study 
days. You will be given a light breakfast and, if you normally drink caffeinated 
beverages, you will be allowed a cup of your usual beverage (e.g., coffee or tea). 
 We will test your Expired CO again (the same test done at Screening visit) and a urine 
sample will be collected to make sure you were only using the products assigned to you 
and that you have abstained from smoking and vaping since 10pm last night. 
 At approximately 8am, a plastic catheter (thin flexible tube) will be inserted into a vein 
on one of your forearms (this will be used to withdraw multiple blood samples and will 
be kept in place for about 10 hours). 
 At approximately 9:00am, you will be asked to vape the SREC device in a standardized 
manner and to take puffs only at times signaled by the voice recorder.  
 You will not be allowed to vape again until 4 hours later, at which time you will be given 
the SREC e-cig device and allowed to vape it in your usual way.  
 Blood samples, about one-two teaspoons each, will be withdrawn just before vaping, and 
during the 4-hour abstinence period at 2, 5, 15, 30, 45, 60, 90, 120, 180, and 240 minutes 
after vaping. 
 Heart rate will be collected at baseline, 5, 10, 15, 30, 45, 60, 90, 120, 180, and 240 
minutes after vaping.  
 You will be asked to fill out several Questionnaires about your vaping experience before 
and after using the product and during the 4 hours when you are not vaping.  
 
On Hospital Day 2 (Tuesday), the following will occur: 
 You will be able to vape the SREC e-cig device as you wish from 8am to 12am midnight.  
 The time of each SREC puff will be recorded using your smartphone diary application or 
paper log and SREC devices will be collected at the end of the day to determine product 
usage. 
 You will wear a 24-hour ambulatory blood pressure and heart rate recorder for 
cardiovascular monitoring which will take a reading approximately every 30 minutes. 
 You will be asked to fill out several Questionnaires. 
 At 3pm we will ask you to stop vaping for 15 minutes, and we will collect a saliva 
sample (about half-1 teaspoon) at 3:15pm.  

 
 PAGE 6 OF 14 
 There will also be 24-hour urine collections. 
 
On Hospital Day 3 (Wednesday), the following will occur: 
 In the morning, an intravenous catheter (same as Day #1) will be placed for blood 
collections every four hours from 8am to midnight, and at 8am the next day (Thursday).  
 You will continue to be able to vape the SREC e-cig device as you wish. 
 The time of each SREC puff will be recorded using your smartphone diary application or 
paper log and all SREC devices will be collected at the end of the day to determine 
product usage. 
 You will be asked to fill out several Questionnaires.  
 There will also be 24-hour urine collections. 
 
You will be discharged from the hospital at approximately 9-10am Thursday morning.  
 
Inpatient Study Week Tobacco Cigarettes (3 days):  
This week will follow the same structure as the SREC week mentioned above, but instead you 
will be using your usual tobacco cigarettes. The following differences will occur:  
 The morning of Hospital Day 1, you will be asked to smoke your tobacco cigarette in a 
standardized manner: 1 puff every 30 seconds until cigarette is complete.  
 You will be given your usual amount of tobacco cigarettes for the remaining hospital 
days. 
 You will complete your diary data for your tobacco cigarette use.  
 You will collect all of your cigarette butts. 
 
Inpatient Study Week Both SREC & Tobacco Cigarettes (3 days):  
This week will be the same structure as the SREC only & Tobacco Cigarette only weeks, except 
for the following differences:  
 
On Hospital Days 1, 2 & 3 (Monday, Tuesday & Wednesday), the following will occur: 
 At approximately 8am, you will be asked to smoke your first tobacco cigarette.  
 You will be asked to smoke again at regular intervals throughout the day. 
 You will be given less than of your normal tobacco cigarette amount.  
 You will be given the SREC device to vape ad lib.  
 The time of each cigarette or SREC puff will be recorded using your smartphone diary 
application or paper log and all cigarette butts and SREC devices will be collected at the 
end of the day to determine product usage. 
 
Study Schedule: The order of weeks will be rotated across participants. 
Study Week: SREC E-Cig Only  
Day 1 
Day 2 
Day 3 
Day 4 
Day 5 
Hospital Day 1  
Day 6 
Hospital Day 2 
Day 7 
Hospital Day 3 
Thurs 
Fri 
Sat 
Sun 
MONDAY 
TUESDAY 
WEDNESDAY 
< ---------- At Home -----------> 
< ------------------------------ Hospital -----------------------------> 

 
 PAGE 7 OF 14 
SREC E-cig use only  
  
Daily Diaries  
 
Emailing or texting Diaries to 
the Study Coordinator end of 
day  
Expired CO test 
and urine sample 
 
Standardized 
Vaping Session 
 
4-hr abstinence 
and blood draws 
  
Followed by free 
use ad lib  
Vaping ad lib  
  
24-hr BP/HR 
monitoring 
 
Saliva collection 
  
24-hr urine 
collection 
Vaping ad lib 
  
Blood draws 
throughout 24-hours  
  
24-hr urine collection 
 
Discharge: Thursday 
morning after final 
blood draw 
 
Study Week: Tobacco Cigarette Only  
Day 1 
Day 2 
Day 3 
Day 4 
Day 5 
Hospital Day 1 
Day 6 
Hospital Day 2 
Day 7 
Hospital Day 3 
Thurs 
Fri 
Sat 
Sun 
MONDAY 
TUESDAY 
WEDNESDAY 
< ---------- At Home -----------> 
< ------------------------------ Hospital -----------------------------> 
Tobacco Cigarette use only 
 
Daily Diary 
 
Emailing or texting Diaries to 
the Study Coordinator end of 
day 
Expired CO test 
and urine sample 
 
Standardized 
Smoking Session 
 
4-hr abstinence 
and blood draws 
  
Followed by Free 
use ad lib 
Smoking ad lib 
  
24-hr BP/HR 
monitoring 
  
Saliva collection 
 
24-hr urine 
collection 
Smoking ad lib 
  
Blood draws 
throughout 24-hours  
  
24-hr urine collection 
 
Discharge: Thursday 
morning after final 
blood draw 
 
 
 
Study Week: Both SREC E-cig & Tobacco Cigarettes 
Day 1 
Day 2 
Day 3 
Day 4 
Day 5 
Hospital Day 1 
Day 6 
Hospital Day 2 
Day 7 
Hospital Day 3 
Thurs 
Fri 
Sat 
Sun 
MONDAY 
TUESDAY 
WEDNESDAY 
< ---------- At Home -----------> 
< ------------------------------ Hospital -----------------------------> 
Tobacco Cigarette Use  
(less than your normal 
amount) 
 
&  
 
SREC use ad lib  
 
Daily Diary 
 
Emailing or texting Diaries to 
the Study Coordinator end of 
day 
Expired CO test 
and urine sample 
 
Tobacco Cigarette 
Use (less than 
your normal 
amount) 
 
& SREC use ad lib  
 
 
Tobacco 
Cigarette Use  
(less than your 
normal amount) 
& SREC use ad 
lib  
 
Saliva collection 
  
24-hr CV 
monitoring 
  
24-hr urine 
collection 
Tobacco Cigarette Use  
(less than your normal 
amount) 
& SREC use ad lib  
 
Blood draws 
throughout 24-hours  
  
24-hr urine collection 
 
Discharge: Thursday 
morning after final 
blood draw 
Study locations: The Screening and Orientation Visits will take place at the UCSF 
Tobacco Research Center (3130 20th Street, Suite 308) and the Inpatient Study Days will 
take place at the CTSI-CRS (5B Research Ward) at Zuckerberg San Francisco General 
Hospital (1001 Potrero Avenue, 5th floor). 

 
 PAGE 8 OF 14 
How long will I be in the study? 
Participation in the study will consist of a screening visit (1-2 hours), Orientation visit (1-2 
hours), 12 outpatient days, 9 inpatient days for a total of 23 days.  
Throughout the study 
We will keep in touch with you via your cell or home phone through calls or texts. Some of the 
things we may contact you about are visit reminders, clarifications of any medications you are 
taking, or questions about the products you are using. You will also use email and text to send us 
your diaries to review.  
 
Can I stop being in the study? 
 
Yes.  You can decide to stop at any time. Tell the Clinical Research Coordinator, your CTSI-
CRS nurse, or the Study Physician or Nurse Practitioner if you are thinking about stopping or 
decided to stop. 
In rare cases, people are unable to give blood even if a catheter is placed correctly. If this 
happens while you are on the study, the Study Physician/Nurse Practitioner may stop you from 
continuing the study. In this case, you would be compensated for that study day and withdrawn 
from the rest of the study. 
The Clinical Research Coordinator, Study Physician or Principal Investigator, may stop you from 
taking part in this study at any time if he or she believes  
 it is in your best interest 
 if you do not follow the study rules 
 if the study is stopped 
Behavior Policy at the UCSF Tobacco Research Center: We may restrict your time here and 
withdraw your participation to ensure the health and safety of other research participants, staff, 
and visitors at our center. This may occur under the following circumstances that include, but are 
not limited to: inappropriate, abusive or threatening behavior at study visits; violation of 
smoking, drug, or alcohol policies at visits; excessive number of personal guests; and/or 
interference with the participation of other study participants. 
What side effects or risks can I expect from being in the study? 
You may have side effects while on the study. If you develop side effects, your participation in 
the study may be stopped, depending upon the severity.  
You should talk to the Clinical Research Coordinator, the Study Nurse Practitioner or the Study 
Physician about any side-effects you experience while taking part in the study. 
Risks and side effects related to the study procedures include: 

 
 PAGE 9 OF 14 
 Venipuncture and Catheterization: A catheter (small plastic tube) will be placed in a 
vein in one forearm in order to make it easier to take the multiple blood samples. The 
catheter will remain in place for about 10 hours. There is a small risk of pain, swelling, 
bruising, or infection.   
 Blood Loss: You will lose a total of about 1 cup of blood during the entire study. This 
amount of blood loss poses no risk to healthy individuals.  
 The Study Procedures may be inconvenient and tedious (filling out forms, spending 
time in the hospital, providing specimens, etc.) and you may have trouble staying awake 
as required.  
 During abstinence, you may feel withdrawal symptoms from smoking/nicotine 
withdrawal. The symptoms can be uncomfortable but are typically of minimal risk. These 
symptoms can include anger, irritability, frustration, anxiousness, nervousness, depressed 
mood/sadness, craving for a cigarette, difficulty concentrating, increased appetite or 
hunger, weight gain, sleep problems, restlessness, difficulty concentrating, impatience, 
constipation, dizziness, coughing, dreaming or nightmares, headaches, nausea, and sore 
throat. 
 You may also feel uncomfortable when getting your blood pressure taken depending on 
the tightness of the cuff. 
 Risks of Electronic Cigarette Use:  The health effects of e-cigarettes are not known. 
While not harmless, e-cigarettes generally exposes users to fewer toxins than smoked 
tobacco products. A notice from the FDA about the safety of this product says they do 
not know whether e-cigarettes are safe for their intended use, how much nicotine or other 
potentially harmful chemicals are being inhaled during use, or if there are any benefits 
associated with using these products. Side effects may include: sore throat, burning in the 
throat, dizziness, headache, coughing, change in taste and others. Although uncommon, 
batteries in e-cigarettes have exploded and injured users or overheat and cause burns. 
Defective cartridges, tanks or devices may leak e-liquid. If this should happen, wash the 
exposed area to remove the e-liquid immediately. On rare occasions, allergic reactions 
have occurred. Let us know if you have allergies to propylene glycol or glycerin or any 
foods. The liquid in e-cigs (often called e-liquid or e-juice) can contain nicotine that can 
cause harm and possible death if the e-liquid or the refill cartridges containing e-liquid 
are swallowed.  Keep all e-liquid and cartridges away from children and pets.     
Are there benefits to taking part in the study? 
There will be no direct benefit to you from participating in this study. However you may benefit 
from the knowledge that you are contributing in a very important way to further scientific 
knowledge concerning harm reduction and health risks for tobacco and e-cigarette users.  
What other choices do I have if I do not take part in this study? 
You are free to choose not to participate in the study.  If you decide not to take part in this study, 
there will be no penalty to you.   

 
 PAGE 10 OF 14 
Will information about me be kept private? 
We will do our best to make sure that the personal information gathered for this study is kept 
private.  However, we cannot guarantee total privacy.  Your personal information may be given 
out if required by law.  If information from this study is published or presented at scientific 
meetings, your name and other personal information will not be used. 
Organizations that may look at and/or copy your research records for research, quality assurance, 
and data analysis include: Representatives of the University of California, the Study Sponsor 
(National Institutes of Health), and the Food and Drug Administration (FDA). 
Participation in research may involve a loss of privacy, but information about you will be 
handled as confidentially as possible. Two kinds of “charts” are created when you take part in 
one of our studies: 
1. A medical record at the Zuckerberg San Francisco General Hospital will be created 
because of your participation in this study.  Your consent form, hospital nursing forms, 
and some of your hospital laboratory test results will be included in this record.  
Therefore, other health care providers may see your test results and become aware of 
your participation.  Hospital regulations require that all health care providers treat 
information in medical records confidentially. The forms you fill out during your 
screening visit, many of the forms filled out during the study, the generic testing results, 
and the results of assays on the biological specimens collected on the study will not 
become part of your hospital records. 
2. We make a “research chart” specifically to hold the forms and sample testing results that 
do not appear in the ZSFG medical record. You will be given a unique study 
identification number that will be used in this research chart and on your study samples. 
This number is different from your medical record number. While the study is in process, 
we keep some identifying information in this chart so that we are able to contact you, 
process payments, etc. Once the study is completed, identifying information is removed 
from the chart and stored separately where it is only available to research personnel who 
need access to it. Charts and samples are always kept in locked rooms. We keep the link 
between your identity and your study number and your samples for several reasons. We 
may want to contact you (with your agreement) to see if you want to participate in 
additional studies. We also need to keep track of when a subject participates in more than 
one study so that certain tests are not repeated. Or you may want to contact us later on to 
ask that your samples be destroyed, and we cannot do this unless we know the link to 
your research study number. 
Will any research-related procedures be billed to me? 
No. The sponsor has agreed to pay for all procedures associated with this research study; you or 
your insurer will not be billed.  

 
 PAGE 11 OF 14 
Will I be paid for taking part in this study? 
In return for your time and effort, you could be compensated up to a total of $2,500 if all parts of 
the study are completed. This includes the following: 
 
o Screening Visit: $20 
o Study Week #1 (4 days Outpatient, 3 days Inpatient): $620 
 
Abstaining from smoking & vaping: $40 
o Study Week #2 (4 days Outpatient, 3 days Inpatient): $620 
 
Abstaining from smoking & vaping: $40 
o Study Week #3 (4 days Outpatient, 3 days Inpatient): $620 
 
Abstaining from smoking & vaping: $40 
o Bonus for Completion of Study: $500 
 
You will be compensated $20 for today’s Screening Visit as long as your drug test is negative 
(marijuana is okay) and the saliva lab results indicate that you are a regular user of the tobacco 
and the e-cigarette products you reported. 
 
You will be compensated $40 for abstaining from smoking & vaping before each hospital 
admission. You will need to stop smoking & vaping at 10pm Sunday night. We test this with a 
carbon monoxide reading Monday morning, and your levels must be below 8ppm.  
If our tests show that you have not abstained, you will not receive the $40. Additionally, 
all study procedures will be delayed while we wait for your levels to decrease.  
 
Below is your schedule for compensation. If you complete the entire study & you receive the 
study bonus, you will receive 4 checks and the money for abstaining from smoking & vaping in 
cash.  
 
Schedule for Compensation 
Visit 
Amount 
Processing 
Screening 
$20 
#1 Check (processed after visit)  
Study Week 1, Abstaining 
$40  
Cash  
Study Week 1, 7-days 
$620 
#2 Check (processed after discharge)   
Study Week 2, Abstaining 
$40  
Cash  
Study Week 2, 7-days 
$620 
#3 Check (processed after discharge)   
Study Week 3, Abstaining 
$40  
Cash  
Study Week 3, 7-days 
$620 
#4 Check (processed after discharge)   
Study Bonus 
$500 
With #4 Check in mail  
 
Checks will be mailed to you via the schedule above and it may take up to 4-6 weeks for you to 
receive your check. You will need to provide your home address and social security number 
to receive payment. 
 
If your payment checks are not received by the end of 6 weeks from the last day of your study 
visit for that portion of the study, please contact Ms. Patricia Winston at 415-206-8326. 
 

 
 PAGE 12 OF 14 
You should be aware that the income you receive from being in the study may need to be reported to 
the IRS on your income tax return. If you receive more than $600 in a calendar year, the income will 
be reported to the IRS and an IRS Form 1099 will be sent to you. 
 
How do I get the study bonus?  
You will receive the study bonus if you complete all parts of the study, both outpatient (at home) 
procedures and the inpatient hospital stay, and you use only the assigned products we give you. 
This includes following all study rules, accurately keeping track of your study products, 
completing your diaries, providing all samples & measurements, and attending all of your visits. 
If you are having difficulty completing any of the study activities, let your Clinical Research 
Coordinator know right away, so our team can help you. We will collect a urine sample from 
you at each hospital admission and will test it to make sure during your at-home study days that 
you only used the products we gave you.  
 
What happens if I am injured because I took part in this study? 
 
It is important that you tell the study personnel if you become sick or injured. You may directly 
tell your Study Nurse Practitioner, Ralf Burgert (415-206-8902) or the Principal Investigator, 
Neal Benowitz, MD (at 415-206-8324) if you feel that you have been injured because of taking 
part in this study. 
 
Treatment and Compensation for Injury:  If you are injured as a result of being in 
this study, the University of California will provide necessary medical treatment.  The 
costs of the treatment may be billed to you or your insurer just like any other medical 
costs, or covered by the University of California, depending on a number of 
factors.  The University does not normally provide any other form of compensation 
for injury.  For further information about this, you may call the call the Office of the 
Institutional Review Board, at 415- 476-1814.  
What are my rights if I take part in this study? 
Taking part in this study is your choice.  You may choose either to take part or not to take part in 
the study.  If you decide to take part in this study, you may leave the study at any time.  No 
matter what decision you make, there will be no penalty to you and you will not lose any of your 
regular benefits. Leaving the study will not affect your medical care. You can still get medical 
care from our institution. 
We will tell you about new information or changes in the study that may affect your health or 
your willingness to continue in the study. 
In the case of injury resulting from this study, you do not lose any of your legal rights to seek 
payment by signing this form. 
Who can answer my questions about the study? 
You can talk to the Clinical Research Coordinator, Lisa Harms, 415-608-4864) the Project 
Manager (Natalie Nardone, PhD at 415-514-1450), the Study Nurse Practitioner, Ralf Burgert 

 
 PAGE 13 OF 14 
(415-206-8902) or the Principal Investigator (Neal Benowitz, MD at 415-206-8324) about 
questions or concerns you have about this study.  
 
For questions about your rights while taking part in this study, you may call the Office of 
the Institutional Review Board (a group of people who review the research to protect your 
rights) at 415-476-1814. 
 
A description of this clinical trial will be available on http://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 website at any time. 
 
Future Studies: The researchers in the Division of Clinical Pharmacology and Experimental 
Therapeutics at UCSF would like to know if you are interested in participating in future studies 
for which you may be eligible. By initialing this section of the form, you are giving them 
permission to keep a file of your information (name, contact information, date of birth, 
laboratory results, and completed questionnaires) and to re-contact you. You will be under no 
obligation to actually participate in any new study, and whether or not you initial this section will 
have no effect on your participation in the current study. You may withdraw permission to be re-
contacted at any time by calling the research coordinator or emailing research staff at 
tobaccocoord@ucsf.edu. 
 
I agree to allow the researchers in the Division of Clinical Pharmacology and 
Experimental Therapeutics at UCSF to keep my information on file as described 
above so that I may be re-contacted for possible participation in future nicotine 
and smoking related studies for which I may be eligible. 
 
Specimen storage: Your agreement to allow your leftover blood and urine samples to be used in 
any future research is voluntary, and if you choose not to participate it will in no way affect your 
participation in the current study. These samples may be used for other research not related to 
this study. These samples will be retained in non-identifiable form, meaning that there will be no 
information associated with the blood or urine samples that will allow anyone to know your 
identity. The samples will be stored at the Tobacco Biomarker Laboratory at ZSFG and they will 
be kept until they are used up or no longer needed. Only UCSF researchers or other academic 
institutions working in collaboration with the study investigators will be allowed access to the 
samples and data. The samples may be used in the development of tests, products, or discoveries 
that may have potential commercial value, you will not share in any financial benefits. You may 
at any time ask to have your samples withdrawn from research use by emailing research staff at 
tobaccocoord@ucsf.edu, and any identifiable samples and associated data still in their possession 
will be destroyed. Please indicate whether you are willing to allow your samples to be saved and 
used for future research by initialing one of the lines below: 
_______ Yes, The researchers may keep my blood and urine samples for future related 
research. 
_______ No, I do not want my blood and urine samples used for any research tests other 
than those needed for the main research study. 
 

 
 PAGE 14 OF 14 
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CONSENT 
 
You have been given a copy of this consent form and the Experimental Subject’s Bill of Rights 
to keep. 
 
PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to 
participate or to withdraw from the study at any time without penalty or loss of benefits to 
which you are otherwise entitled. If you are a student or employee of the University, refusal 
or withdrawal will not affect your grades or employment status.  You may be withdrawn from 
the study without your consent if the researchers believe that it is in your best interest or if 
you fail to follow study procedures (for instance, failure to keep appointments or to provide 
specimens). 
 
If you wish to participate in this study, you should sign below. In addition, you will be asked 
to sign a separate form authorizing access, use, creation or disclosure of health information 
from you. 
 
 
 
 
 
  
/  
 
 
     Date 
Participant's Signature for Consent 
Print 
 
 
 
     Date 
Person Obtaining Consent