Assessing the Use of Electronic Cigarettes (E-cigarettes) as a Harm Reduction Strategy
Phase: NA
Conditions: Tobacco Use Disorder, Smoking
Sponsor: NYU Langone Health

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Research Protocol 
 
PURPOSE OF THE STUDY 
Electronic nicotine delivery devices often referred to as e-cigarettes, are battery-powered devices that 
deliver vaporized nicotine when inhaled. Corresponding with the growth in media attention, marketing 
and promotion, awareness and use of e-cigarettes has increased dramatically.  A large proportion of 
those using e-cigarettes use them to reduce the number of cigarettes they are smoking or to help them 
quit. Use of an e-cigarette by smokers unwilling or unable to stop smoking completely might be a good 
approach to reducing cigarette consumption as the e-cigarette imitates some behavioral aspects of 
cigarette smoking and contains nicotine. Moreover, the few existing studies on the effect of e-cigarettes 
on tobacco withdrawal and craving suggest promising potential to assist smokers in coping with 
smoking urges and decreasing cigarette use. The purpose of this study is to examine the feasibility of 
using e-cigarettes as a method for harm reduction and the effects of providing e-cigarettes (or placebo 
e-cigarettes) on smoking outcomes.  
 
 
BACKGROUND 
Most smokers want to quit and have made multiple quit attempts but the majority fail due to their 
dependence on nicotine and behavioral cues that reinforce their smoking behavior (Buckhalter 2005). 
Nicotine replacement therapy (NRT) is one of the most cost-effective treatments available to smokers 
who want to quit, but fewer than 20% of people quitting with NRT patch are abstinent at 12 months 
(Ronckers 2005, Stead 2012). This may be due to the fact that the NRT patch does not replace the 
behavioral ritual associated with cigarette use, nor deliver nicotine as rapidly as cigarettes (Le Houezec 
2003, Walker 2011). It has been hypothesized that e-cigarettes could be a more effective way to help 
people reduce the harm of smoking through reductions in number of cigarettes smoked per day or to 
quit smoking completely by addressing both nicotine and behavioral dependence (Bullen 2010). A 
related question is the extent to which any quitting assistance provided by e-cigarettes might be 
attributable simply to the behavioral replacement they provide (Caponnetto 2011). This is relevant 
because some e-cigarettes are available with cartridges containing as little as 0mg of nicotine. 
 
E-cigarette use appears to be growing and highest among young adults 18-24 years. A study 
conducted in Hawaii found that smokers who used e-cigarettes to try to quit were younger and had 
been smoking for fewer years than those who had not. Notably, the most recent analysis of trends in 
smoking in the US found that between 2005-2010 young adults had the lowest quit rates compared to 
other adult age groups (CDC 2014). These findings suggest a rationale for focusing on the young adult 
population in studying the potential use of e-cigarettes as a harm reduction strategy. There are an 
estimated 2.5 million e-cigarette users in the US with sales of $300 million a year (McCauley 2012). 
Many of these users are turning to e-cigarettes as a way to reduce or stop smoking. More research is 
needed to assess the effect of e-cigarette use on withdrawal symptoms, and its association with 
smoking reduction and abstinence.  
 
The rationale for this harm reduction pilot study is based upon prior work demonstrating that pre-
cessation nicotine replacement therapy (NRT) has been shown to increase the odds of reducing 
consumption of cigarettes per day (CPD by 50% or more compared to placebo) (Stead 2010). This prior 
work is especially noteworthy because smokers not interested in quitting made significant reductions in 
their smoking and maintained these reductions over time. Concern that pre-cessation NRT use will 
result in fewer quit attempts and impede cessation has not been supported by the literature. Among 19 
relevant studies, none showed that pre-cessation NRT undermined future cessation. On the contrary it 

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appears that pre-cessation NRT is associated with smoking reduction which in turn increases the 
probability of future cessation (Hughes 2006). 
 
 
 
METHODS 
Primary research questions:  
1) Is it feasible to recruit and retain young adult smokers in a pilot trial testing whether e-cigarette use 
can reduce the number of cigarettes smoked per day (CPD)?  
2) To what extent do smokers reduce CPD when using e-cigarettes to displace cigarette use?  
3) Are there differences in rates of reduction between two interventions arms (4.5% vs. 0 mg (placebo) 
e-cigarettes)?  
 
Study Aims 
AIM 1: To evaluate the feasibility of recruiting and retaining young adult smokers in a harm reduction 
study using e-cigarettes to displace cigarette use;  
AIM 2: To assess daily patterns of e-cigarette use (including dual use of combustible cigarettes), 
product satisfaction, and nicotine cravings with use of 4.5% vs 0 mg (placebo) e-cigarette; and 
AIM 3: To compare the effect of nicotine e-cigarettes (4.5%) vs placebo e-cigarettes on smoking 
reduction at 1, 3 and 12 weeks post baseline assessment. 
 
Study design 
This pilot study will be a two-arm, randomized controlled trial. We will randomize 50 participants into 
each intervention arm. Participants will be recruited through advertisements placed in Craigslist and 
other social media as well as flyers placement in NYU venues and street distribution with contact 
details for how to get in touch with a Research Assistant. The randomization sequence will be prepared 
by the study statistician. Participants will be randomized to one of the two arms: e-cigarettes with 
nicotine cartridges or e-cigarettes with placebo cartridges (0mg). Participants and research assistants 
will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in 
appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing 
cartridges.  
 
Figure 1. Study design 
 
 
 
 
 
Study participants 
Inclusion criteria: ages 21-35 (must present proof of age), daily smoker, smokes at least 10 cigarettes a 
day (verified by a CO level of 8 ppm or above), interested in reducing CPDs, able to provide consent, 
uses a cell phone and is willing/ able to receive and respond to daily text messages regarding his/her 
cigarette use and e-cigarette use on his/her cell phone, and willing to use an e-cigarette for 3 weeks. 
 
Exclusion criteria: Pregnant and/or breastfeeding (self-reported), current use of smoking cessation 
medications (including other forms of NRT, bupropion, or varenicline), enrolled in a smoking cessation 
program or another cessation trial. Other exclusion criteria include use of an e-cigarette in the past 14 
days, use of any other tobacco products (pipe, cigar, cigarillos, snuff, chewing tobacco, or 
hookah/shisha) in the past 30 days, an Alcohol Use Disorders Identification Test (AUDIT C) score of >7 
Recruit 100 
4.5% e-cig 
0 mg e-cig 
Assessments 
At 1, 3 and 12 wks 
Randomize 
Baseline 
assessment 

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for men and >5 for women, a Drug Abuse Screening Test-10 (DAST) score of >5. Potential participants 
will also be excluded if they report having a history of asthma or other airways disease and heart 
disease. 
 
Study Procedures 
Potential participants will be screened for eligibility by telephone. Eligible participants will be invited to 
give informed consent and complete the baseline assessment in person at the first study visit. During 
this assessment, we will ask participants to practice using the e-cigarette and give them instructions to 
return with their used e-cigarettes at their next study visit.  We will also train participates to use the text 
messaging system during the baseline visit.  For the training, we will establish an interactive texting 
protocol that introduces participants to the messaging process and trains them how to respond. After 
being enrolled in the SMS program a sample of questions will be text messaged to the participants and 
responses will be solicited to establish an understanding of how data collection works. This protocol is 
based on Dr. Furberg’s current research. (Furberg 2012, Harris 2013) The interactions will be fully 
automated and cover: 1) welcome to the intervention, 2) some example questions with practice 
answering them, and 3) information on how to contact project staff for additional support.   
 
After the baseline assessment participants, will be asked to track their smoking behavior for three days 
prior to beginning to reduce. We will prompt participants to report cigarette use with a text message 
reminder 4 times a day at 4 hour intervals (e.g., how many cigarettes have you smoked in the past 4 
hours). The first text message inquiry of the day will ask participants to report any cigarettes smoked 
since the last text message prompt. This is meant to capture any overnight cigarette or e-cigarette use. 
The time of day for delivering text messages will be tailored to the participant’s schedule of waking and 
sleeping.  
 
After tracking their cigarette use, all participants will receive a 20-30 minute behavioral counseling 
consultation with a trained tobacco counselor. The counseling session will be scheduled at the baseline 
visit.  Counselors will review each participant’s smoking pattern from the three days of tracking and 
offer tailored behavioral and environmental change strategies including specific smoking reduction 
strategy options, such as eliminating cigarettes at work, in the home, or least favorite or most favorite 
cigarettes of the day, carrying only those cigarettes needed for that day, dropping cigarettes associated 
with less intense triggers first, avoiding smoking triggers, using oral or manual replacements, and other 
strategies to manage urges. Since there is inadequate evidence that any one of these strategies was 
more effective than another, participants will be encouraged to choose those that are most appealing. 
Goal setting, and barriers identification will be used to help participants improve confidence in their 
ability to reduce the number of cigarettes they smoked (Josephs 2008).  
 
In Summary, the baseline visit includes 1) completion of baseline survey, 2) registering subject on text 
messaging program, 3) have subject practice using the text message program, 4) proactive using e-
cigarette 5) make appointment for counseling session and for returning to pick up e-cigarettes. 
 
Participants will be encouraged to reduce the number of cigarettes smoked daily to at least 50% of the 
total number of cigarettes smoked per day at baseline.  This level was selected a priori as a clinically 
significant measure of reduction and to be a substantial enough reduction to address partial 
compensatory smoking (Glasgow 2009). Participants will be encouraged to substitute the use of the e-
cigarettes for each cigarette they eliminate in order to reduce nicotine withdrawal symptoms. 
 
After the counseling session, they will return to 227 east 30th street to pick up their supply of disposable 
electronic cigarettes to last one week. They will be reimbursed for travel expenses.  At the end of week 

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1 of ecig use, they will be asked to return to replenish the e-cigarettes for another 2 weeks and to 
complete a second in-person assessment. The final study visit will be 3 weeks post starting e-
cigarettes. We will conduct in depth interviews with a random sample of 10 participants in each 
intervention arm at the week 1 and 3 study visits. The first visit will focus on a process evaluation of the 
data collection experience and satisfaction with e-cigarette use while Week 3 interviews will focus on 
gaining more in-depth understanding of their experience (ease of use, satisfaction) with the product 
over time, e-cigarette related outcome expectancies and norms and explore intentions to quit and/or 
continuing dual use of cigarettes and e-cigarettes.  
Figure 2. Assessments and intervention period 
 
 
 
 
 
Data collection and Measures  
Baseline assessments: Demographic information: age, race/ethnicity, gender, years of education, 
employment, income; Smoking history:  number of cigarettes smoked per day, number of years as 
regular smoker; use of other tobacco products or e-cigarettes, number of previous attempts in the past 
12 months; Other smoking related information: self-rated importance and confidence to reduce and to 
quit, intention/readiness to quit using the readiness ladder, risk perceptions about e-cigarettes and 
combustible cigarettes, social norms related to using cigarettes and e-cigarettes, an assessment of 
urges to smoke using the QSU-Brief survey, other household members smoking at home; and the  
Behavioral factors in smoking dependence scale (Glover 2005). We will also measure carbon monoxide 
and collect saliva for cotinine measurement at baseline and study visit 3. 
 
Follow-up assessment study visits: At 1 and 3 weeks, we will assess withdrawal symptoms using the 
Minnesota Nicotine Withdrawal Scale (MNWS), e-cigarette use, cigarette use, quit attempts, and 
reduction in number of cigarettes used/day. Using Atkinson’s treatment satisfaction scale, we will 
assess side effects associated with using the e-cigarette, convenience of use, perceived effectiveness, 
and global satisfaction with the product (Atkinson 2004).  At the final study visit (week 3) we will also 
assess changes in baseline readiness to quit, intention to quit, norms related to smoking and using e-
cigarettes, confidence in quitting and changes in intention to quit. At 12 weeks post starting e-cigarettes 
we will conduct follow up telephone surveys to assess current e-cigarette and cigarette use. 
 
At each follow up assessment, RAs will complete a checklist for all of the activities including, 
completing surveys, and providing e-cigarettes. Note that we will schedule visits up to 4 times. If the 
subject misses all of those visits he/she will be considered lost to follow up. We will also attempt to 
contact subjects up to 10 times at different hours of the day and via text message to schedule or 
reschedule appointment to increase retention rates. 
 
Table 1.  In person survey assessments 
Measures  
Screener Baseline 
Wk 1 
Wk 3 
Wk 12 
telephone 
Socio demographics 
     X 
 
 
 
 
Smoking history and nicotine dependence 
 
X 
 
 
 
Other tobacco products and marijuana use 
 
X 
 
 
 
Readiness to quit 
 
X 
 
X 
 
Visit 1 
Baseline 
assessment 
Track 
smoking 3 
days via SMS 
Telephone 
counseling 
Study Visit 3 
(end of wk 3 
 e-cigarette 
Study visit 
(end of wk 1 
e-cigarette 
use  
Start e-
cigarettes 
and track 
use via SMS 
12 wk 
telephone 
follow up 

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Importance and confidence in quitting  
 
X 
 
X 
 
Smoking urges for traditional cigarettes (QSU-Brief) 
 
X 
 
X 
 
Self-efficacy questionnaire (SEQ12) 
 
X 
 
X 
 
Secondhand home policy and other smokers at home 
 
X 
 
X 
 
Risk perception (e-cigarettes)  
 
X 
 
 
 
Social norms  
 
X 
 
X 
 
History of E-cigarette use  
 
X 
 
X 
 
Health status 
 
X 
 
 
 
Behavioral dependence scale 
 
X 
 
X 
 
Current E-cigarettes use 
 
X 
 
 
 
Treatment satisfaction scale (Side effects, Effectiveness,  
convenience related to e-cigarettes) 
 
 
X 
X 
X 
Minnesota Nicotine Withdrawal Scale 
 
 
X 
X 
 
Current cigarette use 
1. Someday, every day, not at all  
2. Number per day on days smoke (Self-report and CO and  
       saliva validated abstinence  
 
X 
X 
X 
X 
 
Quit attempt (24 hour) in past week 
 
 
X 
X 
X 
Acceptability and Receptivity to txt messages 
 
 
X 
X 
X 
 
Text message assessment:  
We will send questions via text messages for a total of 24 days (3 days of baseline assessment of 
cigarette use and 21 days of dual use with e-cigarette). The first phase of data collection will include a 
three-day baseline assessment of the study participants’ usual smoking pattern. This will begin the day 
after the baseline assessment.  Participants will receive text messages approximately every 4 hours (4 
times/day). The questions will only ask about cigarette use in the previous time period, mood and 
cravings (Table 2). We will wait until the study participant responds to the first message before sending 
each follow up message. Depending on the participant’s answer to whether or not they have smoked a 
cigarette and/or E-cigarette in the previous time period, they might receive different combinations of 
questions. For example, there are 6 questions in the first message each day for the 3 day baseline 
assessment of cigarette use. However if the participant has not smoked any cigarettes in the previous 
time period, they will only receive 3 of the questions. Each question is sent to the participant only after 
the previous one receives a response.   
During the intervention stage which will last 3 weeks, we will again send text messages 4 x/day.  These 
messages will assess the following 1) number of cigarettes smoked in the previous time period, 2) use 
of e-cigarettes, 3) satisfaction with cigarettes and/or e-cigarette (“On a scale of 0-9 how pleasurable 
was the last [cigarette/E-cigarettes]?”), and 4) cravings (“On a scale from 0-9  how much do you want 
to smoke a CIGARETTE right now?”). The first text of the day will also ask how soon after waking 
participants smoked a cigarette and used an e-cigarette and if they used cigarettes, how much do they 
want to smoke fewer cigarettes than usual and how hard it would be to use E-cigs only.  Questions 
about use of e-cigarettes will include the following: 1) how many separate times in the previous time 
period did you use your e-cigarette (“time” is defined as around 5 or more puffs or 5 or more minutes of 
use), 2) On average, how many puffs did you take with each use, and 3) How many minutes ago was 
your last E-cigarette puff? We will use numerical scales because our experience has demonstrated that 
this allows for more accurate data collection.  
If subjects do not return any messages for a 24 hour period we will contact them by phone to assess if 
there is a problem with receiving the texts.  

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Table 2. Text messages and schedule 
 
Rule (based 
on answer to 
the first 
question) 
Text 
3 days baseline 
tracking cig use 
Intervention 
period 
1st  2nd 
3rd 4th 1st  2nd 
3rd 4th 
 
Since your last report: Did you smoke a cigarette and/or E-
cigarette?            [no=0; cig=1; Ecig=2; both=3] 
X 
X 
X 
X 
X 
X 
X 
X 
 
Thinking about this morning, how many minutes after waking 
did you smoke your first cigarette? (Text 9999 if you did not 
smoke any cigarettes today) 
 
 
 
X 
 
 
 
X 
 
Thinking about this morning, how many minutes after waking 
did you use your first E-cig? (Text 9999 if you did not use any 
E-cigs today) 
 
 
 
 
 
 
 
X 
 
Thinking about TODAY only: Do you want to smoke fewer 
cigarettes than usual?        [0=Not at all ; 9=Very, Very Much] 
 
 
 
 
X 
 
 
 
 
Thinking about TODAY only: How hard would it be to use E-
cigs ONLY?        [0=Not at all ; 9=Extremely] 
 
 
 
 
X 
 
 
 
If used cig 
Since your last report:  How many cigarettes did you smoked?  
X 
X 
X 
X 
X 
X 
X 
X 
If used cig 
How many minutes ago did you smoke a cigarette? [Text “0” if 
your are currently smoking] 
X 
X 
X 
X 
X 
X 
X 
X 
If used cig 
only 
On a scale of 0-9 how satisfying was your last cigarette? 
[0=Not at all – 9=Extremely Satisfying] 
X 
X 
X 
X 
X 
X 
X 
X 
If used e-cig 
Since your last report: How many separate times did you use 
an E-cigarette?  
 
 
 
 
X 
X 
X 
X 
If used e-cig 
only 
On average, how many puffs did you take with each use?   
 
 
 
 
X 
X 
X 
X 
If used e-cig 
How many minutes ago was your last E-cigarette puff? [Text 
“0” if you are currently using an E-cigarette] 
 
 
 
 
X 
X 
X 
X 
If used e-cig 
On a scale of 0-9 how satisfying was your last E-cigarette? 
[0=Not at all – 9=Extremely Satisfying]  
 
 
 
 
X 
X 
X 
X 
 
On a scale of 0-9, how much do you want to smoke a 
CIGARETTE right now?  [0=Not at all – 9=Very, Very much] 
X 
X 
X 
X 
X 
X 
X 
X 
 
Thank you for completing the survey. 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
Primary outcome: For Aim 3, the primary outcome will be reduction in CPD and we will summarize 
this data  as the proportion of participants who achieve 50% reduction in CPD at 3 weeks. Smoking 
reduction will be measured by a combination of self-report, text message data and changes in CO and 
saliva cotinine between baseline and end of treatment (3 weeks). 
 
Secondary outcomes: We will assess potential side effects associated with e-cigarette use, additional 
use of other tobacco products and/or marijuana, satisfaction with the e-cigarettes, nicotine 
urges/cravings and withdrawal symptoms. An exploratory secondary aim includes assessing 
differences in the primary and secondary outcomes between the intervention arms.  
 

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Feasibility measures include: 1) Percentage of subjects screened who are eligible and enroll, 2) 
percentage retained at 3 and 12 weeks, 3) retention across study conditions, 4) consistency in tracking 
use of e-cigarettes and cigarettes, and 5) satisfaction with e-cigarettes. 
 
Characteristics of the Research Population 
Described above under the study participants section. 
 
Number of Subjects 
We expect to enroll 100 smokers total, 50 in each arm.  
 
Gender of Subjects 
We would ensure equitable inclusion of both men and women in this study. 
 
Age of Subjects 
All subjects will be 21-35. We are particularly interested in studying the effectiveness of e-cigarettes as a harm 
reduction strategy among young adults as this is an understudied population and one that has demonstrated 
exceptionally high rates of adoption of this product. 
 
Racial and Ethnic Origin 
We will recruit across all racial and ethnic groups.  
 
Inclusion Criteria 
All subjects must be between 21-35 years old, daily smokers, smoke at least 10 cigarettes per day, interested 
in reducing CPDs, able to provide consent, use a cell phone, are willing/able to receive and respond to daily 
text messages regarding their cigarette use and e-cigarette use on their cell phone, and are willing to use an e-
cigarette for 3 weeks. 
 
Exclusion Criteria 
Subjects will be excluded if they are pregnant and/or breast feeding (self-reported), are currently using 
smoking cessation medications (including other forms of NRT, buproprion, or varenicline), are enrolled in a 
smoking cessation program or another cessation trial, have used an e-cigarette in the past 14 days, have used 
any other tobacco products (pipe, cigar, cigarillos, snuff, chewing tobacco, rolling tobacco, or hookah/shisha) in 
the past 30 days, score ≥7 (men) or ≥5 (women) on the Alcohol Use Disorders Identification Test (AUDIT-C), 
score ≥ 5 on the Drug Abuse Screening Test-10 (DAST), or report having a history of asthma, other airways 
diseases, or heart disease. 
 
Data Analysis and Data Monitoring 
 
All measures collected during study visits and by telephone at 12 weeks, will be summarized for each 
time point with standard descriptive statistics and frequency tables, as appropriate. Measures with 
significant baseline treatment group differences (assessed by analysis of variance or chi-squared as 
appropriate to the primary outcome measure) will be considered for inclusion as covariates in a 
generalized linear mixed model analysis.   
 
In terms of the EMA data, as per Shiffman (2013), analysis of the EMA data will be handled through 
several different approaches depending on the research question. For example, if we want to assess 
differences between individuals with no reference to change over time we can ask if there is a 
correlation between cravings and e-cigarette use.  Data would be collapsed over time, averaging 
craving ratings for each subject from all signal-contingent assessments in order to derive a single 

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craving score. Using simple Pearson correlation across subjects we can assess correlations between 
cravings and e-cigarette use. If we are interested in assessing how craving intensity changes with 
changes in cigarette use we would use a GEE model (Shiffman 2013). 
 
We will assess multiple aspects of intervention feasibility including the eligibility rate (the proportion of 
smokers who were eligible for trial participation), the acceptance rate (the percentage of eligible 
individuals we recruited to the study) and reasons for study ineligibility and refusal. We will compare 
retention rates in the two study arms at each study visit (weeks 1,3, and 12). We will also assess 
consistency in tracking use of e-cigarettes and cigarettes, and satisfaction with e-cigarettes (see 
measures section). We will compute frequencies and percentages for categorical outcomes and 
means, standard deviations, medians, and interquartile range for continuous outcomes. 
As part of our feasibility analysis, we will conduct qualitative interviews with 10 subjects in each arm at 
1 and 3 weeks. Interview transcripts will be analyzed with Atlas.ti. A coding manual of core and 
secondary codes will be developed by Dr. Shelley and Dr. Krebs, both experienced qualitative 
researchers. Intercoder reliability will be assessed by examining rates of disagreement. 
 
This study will be monitored by NYU School of Medicine’s (NYUSOM) IRB in accordance with NIH 
guidelines on data safety and monitoring of clinical trials 
(http://cancertrials.nci.nih.gov/clinicaltrials/conducting/dsm-guidelines/page2).   
 
Data Storage and Confidentiality 
This study represents no greater than minimal risk. All data entered into the research database will be 
protected by confidential entry codes. All participants will receive a permanent unique numerical study 
identifier (ID#), with no relationship to personally identifying information. In addition, computer records 
will be maintained in such a way that the patient’s name or other obvious identifying factors is not 
accessible in the same file or using the same code. All computer systems are protected from possible 
external access. The data collected for this study will be used strictly for the purposes states in this 
grant application and will only be available to relevant research staff at NYU. We will output de-
identified data from the research database to SAS for data analysis. Findings will be presented in 
aggregate form only with no references made to the individual patient’s data. 
 
The principal investigator will regularly monitor the Research Assistant’s work over the course of the 
study and will meet weekly with study team for quality assurance and monitoring purposes, and to 
review problems or concerns that may arise. 
 
Research Triangle Institute (RTI) will manage the text messaging system. They have extensive 
experience integrating mobile technology and behavioral research and have developed an onsite 
system to provide researchers with a gateway (Gateway Manager) for communicating via text with 
study participants. Prior to launching the system several quality assurance steps will be taken to ensure 
high quality standards are maintained throughout the implementation phase. These include: system 
verification prior to starting the study, use of a test device by RTI staff to receive a sample of outgoing 
messages during the intervention phase to monitor the health of the test gateway in real time, 
systematic and serial review of the gateway components, and contingency plans to ensure continued 
message delivery.   
Participant cell phone numbers will be entered into the RTI messaging system along with the final 
database of potential text messages. The Gateway Manager will contain no other personal identifying 
information, medical or assessment data.  

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Access to the system will be password protected, employing Extended Validation SSL certificates that 
provide 256-bit encryption. Both RTI and NYUSM will execute business associate agreements which 
stipulate RTI’s privacy guarantees.  NYUSM will have access to messages both sent and received by 
study participants for process evaluation purposes, but these will only be identified by a PIN.  Subjects 
may be at minimal risk of a breech of privacy if someone else gains access to their phone during the 
implementation phase.  Therefore, we will inform participants of this risk during recruitment and 
encourage participants to mitigate this risk by 1) not sharing their phone with others, 2) password 
protect their mobile device, 3) deleting project-related text messages after reading them, and 4) in the 
event of loss, notifying the RA  to terminate service to the device.   
RTI International is one of the world's leading research institutes, providing research and technical 
services to governments and businesses in more than 40 countries in the areas of health and 
pharmaceuticals, education and training, surveys and statistics, advanced technology, international 
development, economic and social policy, energy and the environment, and laboratory testing and 
chemical analysis. They have an extensive security system in place covering three critical areas: 
physical security (e.g. limiting data center access to data center technicians, biometric scanning for 
controlled data center access, 24/7 on-site staff providing additional protection against unauthorized 
entry) operational security (e.g., using ISO17799-based policies and procedures, which are regularly 
reviewed as part of the SAS70 Type II audit process; training all employees on documented information 
security and privacy procedures; restricting access to confidential information to authorized personnel 
only; logging and tracking systems access for auditing purposes) and system security (e.g. using 
dedicated firewall and virtual private network (VPN) services to help block unauthorized system access; 
applying data protection with managed backups).  
 
Risk/Benefit Assessment 
 
Risk 
This is a minimal risk study. Subjects may experience side effects from using an inhaled nicotine 
product including throat irritation, nausea, headache, however these side effects are rare. Of note, 
nicotine replacement products are available over the counter because of their excellent safety profile.  
 
Protection Against Risks 
We will use standard forms to assess side effects that may be associated with nicotine replacement 
therapies (NRT) and potential adverse events at each study contact.  The PI will be on call to speak to 
the RA, if necessary, at the time of these study visits and will review all reports of side effects within 24 
hours to determine if the side effect warrants discontinuing the medication. It is important to note, that 
our extensive experience with the use of NRT in clinical trials has demonstrated that most side effects 
can be addressed with additional explanation to patients regarding proper use of the intervention and 
reminders not to smoke while using nicotine replacement therapy. We will adhere to the NYU School of 
Medicine IRB policy for reporting adverse events and we will give patients a contact number to call if 
they experience side effects.  
 
To protect against loss of confidentiality all data entered into the research database will be protected by 
confidential entry codes. Therefore there will no documents linking the patient’s name or any other 
identifying information to the study data. When we are collecting identifying data, unique identifiers 
always replace names in the research database. Locked file cabinets will be used to store materials 
with identifying information (e.g., provider consent forms). All computer systems are protected from 
possible external access. No internet access is possible with the research systems. The data collected 
for this study will be used strictly for the purposes stated in this study and will only be available to 

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relevant research staff at NYU. IRB approval will be sought to any data collection involving human 
subjects.  
 
All study participants enrolled in the pilot study may withdraw at any time. The PI will report any issues 
and/or problems identified through their ongoing review of standardized data summary reports which 
are used to monitor patient accruals, treatment, outcomes and adverse events (if any). The PI will 
regularly monitor RA’s work over the course of the study and will meet weekly with research staff for 
quality assurance and monitoring purposes, and to review problems or concerns that may arise.  
 
Potential Benefits to the Subjects 
Participants will have the potential benefit of reducing the number of cigarettes smoked. Some patients 
may individually experience no benefit. In the long term, findings from this study will contribute to filling 
gaps in our knowledge about the most effective methods for helping smokers reduce and/or quit 
tobacco use.  
 
Investigator’s Qualification & Experience 
 
Dr. Donna Shelley has considerable experience studying the implementation of tobacco use treatment 
guidelines in both medical and dental practices, and studying innovative interventions to increase 
smoking cessation among disparate populations.  
 
All study staff is required to be trained in Human Subjects and HIPAA policies and procedures and the 
handling of data to ensure the confidentiality in order to obtain Institutional Review Board (IRB) 
approval from NYU. 
 
Consent 
Trained research assistants will obtain consent. Participants will be recruited by placing a study ad on 
Craigslist or another similar venue where the research assistant’s number will be placed. If interested 
they will call the number and be assessed to see if they meet study criteria. If eligible, participants will 
be asked to come to NYU to meet with study staff. Written consent will be obtained at that first visit. 
Subjects will be asked if they understand what has been read and if they have any questions. The 
consent will be read to all subjects. The informed consent process will be ongoing dialogue between 
the prospective research participants and the RAs.  
 
Costs to the Subject and reimbursement 
The subject will incur no costs as a result of participating in the study. 
 
Payment for Participation  
Participants will be paid $20 for each in person assessment totaling $60 and $10 for the 12 week follow 
up telephone survey. They will also receive $4/day (24 days) for each of the four times they receive 
messages per day and a $1 bonus each day if they answer all of the messages. Therefore each 
participant can receive up to $190.  We propose to send 4-9 messages 4x per day (assessing not only 
use of e-cigarette and cigs but also craving and/or mood etc) for a total of 681 messages per subject.  
 
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