Clinical trial NCT03416621
Conditions: Tobacco Use Cessation
Keywords: Light Smoker
Sponsor: Duke University
Start date: 2018-05-17; Completion date: 2020-02-29
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of an intervention to promote smoking cessation among light smokers.

Detailed description:
The three-arm randomized controlled trial compares Arm 1) standard smoking cessation plus support text messages, 2) enhanced cue exposure treatment (lab-based + interactive SMS texting) + D-cycloserine placebo, Arm 3)will include a combination of cognitive behavioral cessation counseling, enhanced cue exposure treatment (lab-based + interactive SMS texting) and a cognitive-enhancing drug - D-cycloserine. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an inperson follow-up visit.

Arms: arm 1: Standard smoking cessation plus support text messages arm 2: enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo arm 3: enhanced cue exposure treatment (lab-based + interactive SMS texting) + active DCS. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.
Interventions: intervention 1: Cognitive behavioral cessation counseling intervention 2: Counseling and placebo drug intervention intervention 3: Counseling and active drug intervention
Intervention descriptions: intervention 1: Standard smoking cessation plus support text messages intervention 2: Enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo intervention 3: Enhanced cue exposure treatment (lab-based + interactive SMS texting)+ active DCS. In addition to an in-person, screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.

Protocol documents:
Prot_SAP_003.pdf: 
Page 1 of 9 
 
Document Cover Page 
 
Official Title of the Study: Project Q Pilot: Smoking Cessation for Light Smokers 
NCT Number: NCT03416621 
Date IRB Approved: 1/17/2020 
 
 


Page 2 of 9 
 
Project Q Pilot  
 
PURPOSE OF THE STUDY 
The purpose of this pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of an 
intervention to promote smoking cessation among light daily and intermittent smokers. The 
intervention will include a combination of cognitive-behavioral cessation counseling and cue exposure 
treatment. This pilot study aims to test tailored intervention strategies for light smokers. We will use 
data from this pilot as preliminary data for a P01 grant application we will resubmit to the National 
Cancer Institute in January 2020. 
 
BACKGROUND & SIGNIFICANCE 
Light daily and intermittent smokers (smoking ≤10 cigarettes per day or on some days) now represent 
almost half of all people who smoke; yet, smoking even a few cigarettes a day or even on some days 
increases morbidity and mortality1. Despite this, light smokers continue to be excluded from most 
cessation trials. Further, exclusion of light smokers from cessation trials contributes to health disparities 
as many light smokers are African American or Latinx, who suffer more from smoking-related diseases 
than Whites. Thus, researchers have been attempting to design interventions to help light smokers quit 
with some but limited success2-6. We argue that we do not understand enough about why light smokers 
have a different pattern, and therefore, cannot find effective ways to help them quit. Also, there are 
subgroups of light smokers. Some light smokers have always smoked 10 or fewer cigarettes a day (i.e., 
native light smokers) whereas others were formerly heavier smokers but now are light smokers (i.e., 
converted light smokers)7. To date, most researchers have designed interventions for light smokers that 
mimic those found effective for moderate to heavy smokers. These interventions have been based on 
the two-factor model for smoking behavior8, addressing both nicotine dependence and situational and 
environmental responses to cues to smoke. Thus, the interventions included pharmacological agents 
that principally attenuate nicotine withdrawal effects or make nicotine less rewarding and behavioral 
and cognitive components that teach coping skills to overcoming urges in response to cues as well as 
increasing self-efficacy, outcome expectations, and problem-solving skills. However, these interventions 
have had limited success with light smokers. Different approaches might be necessary to help light 
smokers quit.  
 
This pilot will build upon the hypothesis that while nicotine dependence may still play a role in light 
smoking, situational and environmental cues primarily drive light smoking. Thus, focusing on cue 
reactivity rather than just addressing nicotine dependence might be more effective at promoting 
cessation among light smokers. The behavioral aspect of cognitive-behavioral treatments might be more 
important for light smokers.  
 
Thus, effective cessation programs for light smokers need to incorporate traditional cognitive strategies 
that promote self-regulation, behavioral learning strategies to optimize the ability to unlearn smoking 
cues, and elements to increase motivation, decrease barriers, increase self-efficacy and improve 
outcome expectations.  
 
In this small, randomized controlled pilot trial, we will test the feasibility, acceptability, and preliminary 
efficacy of a combination of cognitive behavioral cessation counseling and cue exposure treatment, a 
cue driven treatment that has been found effective in the treatment of substance use. Further, we will 
extend cue exposure therapy beyond the clinic or laboratory by using interactive texting to help light 
smokers transfer their newly learned cue extinction skills into their natural environment. Interactive 


Page 3 of 9 
 
texting will include both self-monitoring and extinction of cue extinction skills.  Interactive texting for 
real-time data collection will include participants taking photographs of cues they identify as salient and 
triggering of their desire to smoke as well as texting when they smoke and their craving levels. We will 
incorporate the participants own photographs into their tailored cue exposure treatment conducted in 
the clinic  
 
Specific Aims 
Aim 1:   To assess the feasibility of an enhanced cue exposure therapy intervention.  This aim will 
specifically address the number of participants recruited and the number of participants who complete 
all study visits. 
 
Aim 2: To evaluate and compare the acceptability of cue exposure therapy compared to standard 
smoking cessation counseling and support text messages as measured by participants’ ratings of the 
usefulness of the intervention.   
 
Aim 3: To compare the preliminary efficacy of an enhanced cue exposure therapy compared to standard 
smoking cessation and support messages in light smokers as measured by a) self-report 7-day point 
prevalence abstinence from smoking and b) biochemically validated smoking cessation.  
 
DESIGN & PROCEDURES 
Design 
The two-arm trial compares Arm 1) standard smoking cessation counseling and 2) enhanced cue 
exposure treatment. For all arms, we will conduct a phone screening, provide smoking cessation 
counseling, and an in-person follow-up visit. The primary outcome will be feasibility and acceptability. 
The secondary outcome will be biochemically-validated cessation 1-week post-intervention.  
 
Consent Process 
Study staff will call people who express interest in the study and conduct a phone screening. Those 
eligible will be asked to come in-person to consent and complete the baseline visit. Study staff will meet 
potential participants to obtain informed consent.  
Data Collection Methods 
For all arms:  
The baseline survey will include questions about demographics, smoking factors, and household 
information. The follow-up surveys will include some of the same questions as the baseline as well as 
process questions to assess helpfulness of the messages and participants’ fidelity to the intervention 
protocol. The primary outcome will be assessed using seven-day point prevalence abstinence (e.g., Have 
you smoked any cigarettes in the past 7 days?) and biochemically validated through saliva analysis.  
 
Saliva samples: Saliva samples from participants at baseline and follow-up will be used to biochemically 
validate the participant’s smoking status. NicAlert strips will be used to measure the cotinine levels in 
the saliva at baseline and follow-up.   
 
Text-message real-time data collection: We will ask participants in Arm 2 to text study staff every time 
they smoke and every time they have a strong urge to smoke for four consecutive days. The system will 
ask participants to rate their level of craving (1-10) and stress (1-10) via text. We will also ask 
participants in Arm 2 to take and text several photos of the situation in which they smoked/had the urge 
to smoke. Additionally, we will ask all participants to text the system every time they feel like smoking or 


Page 4 of 9 
 
have an urge to smoke between Visits 2 and the follow-up visit. The system will ask the same questions 
about craving and stress but participants will not be asked to text a photo. For Arm 2 participants, the 
system will reply with a supportive message to encourage the participant not to smoke along with the 
questions.  Participants will be instructed not to text while driving and only to text when it is safe to do 
so. 
 
Cue exposure therapy measures: Participants will sit in front of a computer screen while the screen 
shows a PowerPoint presentation composed of a repeating set of images.  Each set will include 
standardized smoking images and images that have been shown to make people who smoke want to 
smoke.  These images will be from the International Affective Picture System (IAPS), a database of 
images designed to provide a standardized set of pictures for studying emotion and attention.  Also, we 
plan to use 4-6 of the smoking images that participants have sent themselves. We will only show 
participants their images, not images taken by other participants. Additionally, participants will also be 
exposed to in vivo cues by following instructions to touch/hold/smell smoking paraphernalia, including 
cigarettes, ashtrays, and lighters.    
 
A participant can miss completing any time point/study visit and it is not considered a protocol 
deviation.   
 
STUDY INTERVENTIONS 
Randomization 
We will randomize participants into one of two arms: Arm 1) standard smoking cessation counseling 
and2) enhanced cue exposure treatment.  The randomization will be automated and drawn from a 
random number generated list programmed onto the laptops. We will stratify randomization on the 
number of cigarettes per day and native /converted smoking status.  
 
Intervention and Control Activities 
Study staff will meet with all enrolled participants to conduct standard smoking cessation counseling 
(Visit 1: Baseline). At Visit 1, all participants will receive standard smoking cessation counseling, be asked 
to select a quit date. All participants will receive detailed instructions on how to collect real-time data on 
their smoking habits and craving levels. Arm 2 participants will be asked to identify smoking cues that 
they will photograph and also will receive detailed instructions on how to take and send pictures. 
Participants will select 4 consecutive days for collecting real-time data.  
 
After Visit 1, participants in Arm 2 will text the study phone number every time they smoke for 4 
consecutive days. The system will text questions related to the smoking encounter to the participant. 
Arm 2 participants will text a photo of the context in which they smoked. These photos will be used in 
in-person cue exposure therapy.  
 
Visit 2 
Arm 1 and 2 participants: 
 At Visit 2, all participants will meet in person with study staff to receive tobacco cessation counseling. 
All participants will complete a brief smoking assessment.  Study staff will conduct smoking cessation 
counseling for both arms.  The system will text the participant to collect data about the cue and the 
outcome.  Questions include if the participant smoked or not, craving level, and stress level. Participants 
are instructed to continue to text the system up to the follow-up visit (approximately 4 weeks total). 
 
 


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Visit 2:  
Arm 2 participants only: 
Study staff will review a summary of their real-time smoking data and then explain the process for cue 
exposure therapy. Participants will first complete a brief assessment including a questionnaire of 
smoking urges (QSU) (10 items), Minnesota Nicotine Withdrawal Scale (MNWS) (10 items), and the 
Positive and Negative Affective Schedule (PANAS) (20 items). Study staff will then explain the process for 
cue exposure therapy.  
 
Participants will sit in a room lit with a table lamp.  They will sit in a comfortable chair in front of a 
computer screen to watch the presentation.   The presentation will include repeating blocks of images.  
The image blocks include a mixture of standard photos and the individual’s photos. After each block, the 
participants will see a slide instructing them to uncover a tray located in front of them that contains 
cigarettes, ashtray and lighter.   They will be instructed to touch/hold/smell smoking paraphernalia on 
the tray.  After approximately 2 minutes, they will be instructed to cover the tray.   
 
After completing the cue exposure treatment (CET), the study staff will review how they can apply these 
processes outside the lab setting when the participant faces a cue to smoke over the next month. Each 
image viewed in the CET presentation will have a simple logo with words in the bottom right-hand 
corner.  This image will be used as a retrieval cue to remind participants of the CET experience when in 
the real-world setting. Participants will be instructed to text the team anytime they feel an urge to 
smoke and need support to not smoke at that moment.  The system will send the retrieval cue along 
with a supportive message.   
 
Visit 3 
Arm 1 and 2 participants: 
After approximately one week, all participants will return for Visit 3. The procedures will be the same as 
Visit 2, completing the brief smoking assessment and standard smoking cessation counseling. Visit 3 is 
the last counseling session for Arm 1 participants. 
 
Arm 2 participants: 
Participants will also complete cue exposure therapy.  This process repeats so participants will come in 
on a weekly basis for a total of 4 treatment visits (Visits 2, 3, 4, and 5) and will complete the same 
process as described for Visit 2.  
 
Follow-up 
For the final visit, participants from all arms will return to the Tobacco Cessation Lab to complete the 
follow-up assessment. This will occur one week after Visit 5 and one week after Visit 4, respectively. 
They will complete a questionnaire and we will assess abstinence via 7-day point prevalence. 
Participants will provide a saliva sample to biochemically validate their smoking status based on their 
cotinine levels. At the follow-up visits, we will ask participants if we can contact them after to ask for 
feedback on the pilot study. If they agree, we will call them or meet them in person to ask for their 
input.  
 
Participants may also be asked at the time of visits to be audio-recorded for data or quality assurance 
purposes.  They can refuse to be audio-recorded and can still participate in the study.  
 
 
SELECTION OF SUBJECTS 


Page 6 of 9 
 
Eligibility 
For all arms:  
Adults will be eligible to participate if they meet the following criteria:  
• 
Age: ≥18 
• 
Able to read and understand English 
• 
Cognitively able to provide informed consent   
• 
Daily smoker 
• 
Smoke 1-10 cigs/day on average for the last year  
• 
Express a desire to quit smoking in the next 30 days 
• 
Access to a cell phone that can send and receive SMS text messages and take and send pictures 
Exclusion criteria for all arms: 
• 
Use (within the past 30 days) of: 
o Psychiatric medications including antidepressants (MAOIs, St. John’s Wort), lithium, 
antipsychotics, or any other medications that are known to affect smoking cessation 
(e.g. clonidine); 
• 
Current use of:  
o Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine patch, nicotine replacement 
therapy or any other smoking cessation aid; 
• 
Current participation in another smoking study at our Center or another research facility; 
• 
Participated in Duke Smoking Cessation Program in the last year  
 
SUBJECT RECRUITMENT & COMPENSATION 
Screening and Recruitment  
We will recruit participants into this low-risk study through Duke Center for Smoking Cessation, 
Facebook, flyers in public locations, DukeList, Duke Primary Care clinics through the Primary Care 
Research Consortium, and Durham Public Housing. 
Staff will conduct the study in Hock Plaza. When participants call to express interest in a research study, 
staff will screen them for the study.  
At participating clinics in Durham, Wake, Orange, and Chatham counties, with a HIPAA Waiver of 
Authorization, DHTS will conduct a DEDUCE query to identify potentially eligible patients.  We will send 
patients who report tobacco use of “Light tobacco smoker” and/or “Current everyday smoker” “Smokes 
some days” a letter from their provider informing them of the study and asking them to call a study 
phone number if they prefer not to be contacted about study participation. If an email address is 
accessible for these patients, we may also attempt to email them these documents. We will call or text 
people who do not call to refuse to screen them for eligibility and set up a screening visit.  
 
The Center for Smoking Cessation and the Nursing School will post Facebook ads through their Facebook 
accounts. The Facebook ad includes a link to a Qualtrics survey that asks the participant for their contact 
information. El Centro Hispano staff will refer light smokers to the Qualtrics link as well. Study staff will 
call those interested people who complete the Qualtrics survey to assess eligibility. The eligibility 
screening will: confirm a patient’s age, smoking status, interest in quitting smoking, use of other tobacco 
products, pregnancy status, breastfeeding status, and history of serious adverse reaction to cycloserine 
in the past.  
 
Participants can receive up to $150 to complete all aspects of the study. Participants will receive $50 for 
completion of surveys at Visit 1 and $100 at the follow-up visit. Participants will not receive 


Page 7 of 9 
 
compensation for Visits 2, 3, 4 or 5 as these are intervention visits and we want the motivation to quit 
smoking to be intrinsic rather than extrinsic. Providing monetary compensation during these 
intervention sessions can interfere with this.  
 
RISK/BENEFIT ASSESSMENT 
Potential risks of study participation include breach of confidentiality with regard to identifiable 
personal information. Some of the questions participants will be asked might make them feel 
uncomfortable. All participants may refuse to answer any of the questions and may stop their 
participation in this study at any time.  All of this is outlined in the written consent form the patient signs 
at the time of enrollment into the study.  
 
Quitting smoking may cause nicotine withdrawal that may lead to headaches, irritability, weight gain, 
difficulty concentrating, poor sleep, increased appetite, anxious or depressed mood, and craving for 
cigarettes. Risks associated with drawing blood from the arm include momentary discomfort and/or 
bruising.  Infection, excess bleeding, clotting, or fainting are also possible, although very unlikely.  
 
There may be a direct medical benefit to the participants as they might quit smoking. They also might 
find the intervention to be helpful. What we learn from the participants in the study will help us develop 
a P01 grant application being re-submitted to the National Cancer Institute in January 2020. 
 
COSTS TO THE SUBJECT 
There will be no additional costs to the participant as a result of being in this study. 
 
DATA ANALYSIS & STATISTICAL CONSIDERATIONS 
The purpose of this study is to evaluate the feasibility, acceptability, and preliminary efficacy of an 
intervention to promote smoking cessation among light smokers. The intervention arms will be 
compared using descriptive statistics. Results from these analyses will be used to prepare a P01 grant 
application.  
 
Statistical Analysis of Feasibility Aim 1:  For this feasibility aim, the two arms will be combined. We have 
two feasibility metrics. We will consider the intervention feasible if we enroll 6 light smokers per month 
and 75% complete at least 2 study visits.  
 
Statistical Analysis of Aim 2: For this acceptability aim, we will ask participants in all arms how useful 
the intervention was (1=“Not at all useful” to 5=“Extremely useful”), whether the intervention will 
change their smoking (1=“Will not change at all” to 5=“Will change a lot”), and whether they would 
recommend the program to a friend (1=“Definitely would not recommend” to 5=“Definitely would 
recommend”).  For the intervention to be deemed acceptable, 75% of participants in Arm 2 would have 
to rate each item a “4” or a “5.” Note that this decision rule has nothing to do with the efficacy of the 
control arm. The percentage of participants endorsing “1”, “2”, “3”, “4”, and “5” on each of the three 
Likert-scaled items will be calculated and compared between arms. This comparison will be used to 
detect any unexpected, gross difference between arms.  For example, if arm median on “how useful was 
the intervention?” were “2” and “5”, this result would be considered both unexpected and noteworthy 
regardless of which arm did better.   
 
Statistical Analysis of Aims 3 and 4: This aim will compare the arms on the efficacy of the intervention. 
We’ll start by calculating an estimated prevalence (with 95% confidence interval) for the binary measure 
of point prevalence, with the confidence interval based on the standard formula for the standard error 


Page 8 of 9 
 
or a binomial proportion. We’re interested in all 3 pairwise comparisons between the groups, 
recognizing that only the comparison between groups 1 and 2 is randomized.  Each of the comparisons 
would be based on a chi-square or Fisher’s exact test as appropriate.  Because this is a pilot study, which 
is not intended to be a definitive assessment of efficacy all 3 comparisons, we would use a cut-off value 
of p=0.05 for declaring statistical significance.  
 
DATA & SAFETY MONITORING 
The quality of data collection will be enhanced through extensive training of all personnel involved in 
data collection. Quality control checks will include feedback on protocol fidelity, interpersonal skills, and 
data entry and cleaning.  
 
We will monitor participant safety by maintaining ongoing contact with staff and convening weekly 
meetings between the investigators and the project team. The study field staff will be trained and 
provided with a written protocol that instructs them to contact the Project Coordinator if any reportable 
AE occurs. The Project Coordinator will follow-up with participants within 48 hours to ensure that the 
event has been resolved and document actions. All non-reportable AEs will be reported to the Principal 
investigator at regular meetings and the IRB via annual reports.  
 
PRIVACY, DATA STORAGE & CONFIDENTIALITY  
Prior to any physical screening procedures, we will inform participants in their consent forms of the data 
storage and confidentiality safeguards, which are practiced according to current HIPAA regulations.  
Study records that identify participants will be kept confidential as required by law. Blood and urine 
specimens will be sent to LabCorp for processing.  Name, date of birth, and gender will be included with 
each specimen.  Except when required by law, participants will not be identified by name, social security 
number, address, telephone number, or any other direct personal identifier in study records disclosed 
outside of Duke University Health System (DUHS) (except to LabCorp). For records disclosed outside of 
DUHS, participants will be assigned a unique code number. The key to the code will be kept in a locked 
file in the PI’s office separate from the locked file where the study records are stored. 
 
People Designs, a Durham-based consulting and development firm, will manage the texting system. 
Texting data will be housed on a web-accessible interface behind the Duke firewall so that study staff 
can access the participant texts and data is stored securely. Only People Designs staff listed on the 
Outside Key Personnel list will have access to the system and text-based data.  
 
Data will be collected by staff both in person and on the telephone.  All participants will be assigned a 
code number that is the sole identifier on all study data forms. Survey data will be collected on paper-
and-pencil surveys and entered into computers via a password protected REDCap form on a secure 
network server. Participants may also complete the surveys directly into REDCap. Study staff may enter 
data directly into REDCap during the interviewer-administered surveys. Access will only be granted to 
study staff who need to access the data. Staff will store active participant files in personal locking file 
cabinets. Access to this file will be limited to study personnel. 
 
 
 


Page 9 of 9 
 
References  
1. 
Jamal A, King BA, Neff LJ, Whitmill J, Babb SD, Graffunder CM. Current Cigarette Smoking Among 
Adults - United States, 2005-2015. MMWR Morbidity and mortality weekly report. 
2016;65(44):1205-1211. 
2. 
Ahluwalia JS, Okuyemi K, Nollen N, et al. The effects of nicotine gum and counseling among 
African American light smokers: a 2 x 2 factorial design. Addiction (Abingdon, England). 
2006;101(6):883-891. 
3. 
Cox LS, Nollen NL, Mayo MS, et al. Bupropion for smoking cessation in African American light 
smokers: a randomized controlled trial. Journal of the National Cancer Institute. 
2012;104(4):290-298. 
4. 
Cabriales JA, Cooper TV, Salgado-Garcia F, Naylor N, Gonzalez E. A randomized trial of a brief 
smoking cessation intervention in a light and intermittent Hispanic sample. Experimental and 
clinical psychopharmacology. 2012;20(5):410-419. 
5. 
Gariti P, Lynch K, Alterman A, Kampman K, Xie H, Varillo K. Comparing smoking treatment 
programs for lighter smokers with and without a history of heavier smoking. Journal of 
substance abuse treatment. 2009;37(3):247-255. 
6. 
de Dios MA, Anderson BJ, Stanton C, Audet DA, Stein M. Project Impact: a pharmacotherapy 
pilot trial investigating the abstinence and treatment adherence of Latino light smokers. Journal 
of substance abuse treatment. 2012;43(3):322-330. 
7. 
Pollak KI, Fish LJ, Lyna P, Peterson BL, Swamy GK, Levine MD. Predictors of pregnant quitters' 
intention to return to smoking postpartum. Nicotine & tobacco research : official journal of the 
Society for Research on Nicotine and Tobacco. 2015;17(6):742-745. 
8. 
Shiffman S, Dunbar MS, Ferguson SG. Stimulus control in intermittent and daily smokers. 
Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors. 
2015;29(4):847-855. 
9. 
Rodrigues H, Figueira I, Lopes A, et al. Does D-cycloserine enhance exposure therapy for anxiety 
disorders in humans? A meta-analysis. PLoS One. 2014;9(7):e93519. 
10. 
Ashare RL, Schmidt HD. Optimizing treatments for nicotine dependence by increasing cognitive 
performance during withdrawal. Expert opinion on drug discovery. 2014;9(6):579-594. 
11. 
Santa Ana EJ, Rounsaville BJ, Frankforter TL, et al. D-Cycloserine attenuates reactivity to smoking 
cues in nicotine dependent smokers: a pilot investigation. Drug and alcohol dependence. 
2009;104(3):220-227. 
12. 
Nesic J, Duka T, Rusted JM, Jackson A. A role for glutamate in subjective response to smoking 
and its action on inhibitory control. Psychopharmacology (Berl). 2011;216(1):29-42. 
 
 

ICF_002.pdf: 
Consent Cover Page 
 
Official Title of the Study: Project Q Pilot: Smoking Cessation for Light Smokers  
NCT Number: NCT03416621  
Date IRB Approved: 1/17/2020 


ent to Participate in a Research Study 
Cons
 
 
 
Form 
M0345 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
You are being asked to take part in this research study because you smoke between one to ten cigarettes 
every day. Research studies are voluntary and include only people who choose to take part. Please read 
this consent form carefully and take your time making your decision. As study staff discusses this 
consent form with you, please ask him/her to explain any words or information that you do not clearly 
understand. We encourage you to talk with your family and friends before you decide to take part in this 
research study. The nature of the study, risks, inconveniences, discomforts, and other important 
information about the study are listed below. 
 
Please tell study staff if you are taking part in another research study. 
 
Dr. Kathryn Pollak will conduct the study and it is funded by Duke Cancer Institute. Portions of Dr. 
Kathryn Pollak’s research team’s salaries will be paid by this grant. 
 
WHY IS THIS STUDY BEING DONE? 
The purpose of this study is to test whether people find a new program helpful as they attempt to quit 
smoking. The study includes counseling and texting about your smoking and cravings to smoke. 
 
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY? 
Approximately 30 people will complete this study at Duke. 
 
WHAT IS INVOLVED IN THE STUDY? 
If you agree to be in this study, you will be asked to sign and date this consent form. To make sure the 
study is right for you, you will be asked to answer 
 Questions on the following: how often you smoke, use of other tobacco products, depression, 
anxiety, drug and alcohol use, willingness to attend all study visits. 
 
Depending on the results of the questions, you may not be eligible for the study. 
 
 
DUHS IRB 
IRB NUMBER: Pro00089760 
IRB REFERENCE DATE: 01/17/2020 
IRB EXPIRATION DATE: 02/01/2021 
 
 
Page 1 of 7 
Subject Initials  
 
DUKE UNIVERSITY HEALTH SYSTEM 
Project Q Pilot 
If you are interested in learning more about this study, please continue reading below. 
CONCISE SUMMARY 
This is a research study to test whether people who smoke less than 10 cigarettes per day find a new 
program helpful as they attempt to quit smoking. A possible benefit from being in this study is 
quitting smoking. 
 
Participants have a 1 in 2 chance of receiving the more intensive counseling. One group will receive 
support through text messages to stop smoking and counseling. The second group will receive text 
messaging support, counseling and studies in the lab to examine what cues trigger smoking. 
Depending on the group, participants will be asked to come to Duke up to 6 times and also use their 
phones to text the study staff. Participants will be in the study for about 4-6 weeks total. 


ent to Participate in a Research Study 
Cons
 
 
 
Form 
M0345 
DUKE UNIVERSITY HEALTH SYSTEM 
 
Project Q Pilot 
Enrollment and randomization: If you sign the consent and pass screening criteria, you may be in the 
study. If you are in the study, we will assign you (like flipping a coin) to one of two groups. 
 
We will ask you to pick a smoking quit date that is about one week after your first study visit (today). 
Also, we will ask you to attend up to six study visits (including today’s visit), each lasting about 1 to 1.5 
hours. 
 
 Study Visit 1 will occur after you sign this consent form. We will ask you to answer questions 
and give us a sample of your breath to test for a chemical called carbon monoxide, which comes 
from smoking cigarettes. We also will ask you to talk to our study staff about your smoking and 
make plans to try to quit. We will provide instructions on how to send us text messages to help 
us learn about your smoking. We will ask you to pick a quit date that is within 1-2 weeks. 
 Real time smoking data collection. (Second group only) After Study Visit 1, we will ask that 
you text us every time you smoke for 4 days. We will ask you a few questions about what is 
going on for you when you are smoking. We will also ask you to take a picture of where you are 
each time you smoke for those 4 days. 
 Study Visit 2 will occur approximately 1 week after Visit 1. We will ask you to answer a few 
questions about your smoking and provide another breath sample. We will ask you to meet with 
someone to talk about your smoking and how your attempt to quit smoking is going. 
o If you are assigned to the second group, we will go over the summary of the information 
you texted about your smoking. 
o If you are assigned to the second group, we will show you a mix of your photos and 
photos we have related to smoking, as well as other items that may remind you of 
smoking (such as cigarettes, a lighter, etc.). You will not be able to smoke while viewing 
the photos or holding these objects. We will ask you to answer questions about your 
desire to smoke afterwards. 
 Between Visit 2 and Visit 3: We will send you one or two text messages a day to help you not 
smoke. We will also ask you to text the study when you are craving a cigarette or if you smoke 
and the study will text you to help you not smoke at that time and to ask you questions about 
craving and stress level. 
 Study Visit 3 will occur approximately 1 week after Visit 2. Study Visit 3 is exactly like Study 
Visit 2. We will ask you to answer a few questions about your smoking and provide another 
breath sample. We will ask you to meet with someone to talk about your smoking and how your 
attempt to quit smoking is going. 
o If you are assigned to the second group, we will show you a mix of your photos and 
photos we have related to smoking, as well as, other physical items that may remind you 
of smoking (i.e. cigarettes, a lighter, etc.). You will not be able to smoke while viewing 
the photos or holding these objects. We will ask you to answer questions about your 
desire to smoke afterwards. 
 Between Visit 3 and Visit 4. We will send you one or two text messages a day to help you not 
smoke. If you are assigned to the second group, you will be asked to text the study when you are 
craving a cigarette or if you smoke and the study will text you to help you not smoke at that time 
and to ask you questions about craving and stress level. 
 Study Visit 4 will occur approximately1 week after Visit 3. We will ask you to answer a few 
questions about your smoking and provide another breath sample. 
DUHS IRB 
IRB NUMBER: Pro00089760 
IRB REFERENCE DATE: 01/17/2020 
IRB EXPIRATION DATE: 02/01/2021 
 
 
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Subject Initials  
 


ent to Participate in a Research Study 
Cons
 
 
 
Form 
M0345 
DUKE UNIVERSITY HEALTH SYSTEM 
 
Project Q Pilot 
o If you are assigned to the first group, this will be your last visit. In addition to the items 
listed above, you will also be asked to provide a saliva sample. 
 
o If you are assigned to the second group, we will ask you to meet with someone to talk 
about your smoking and how your attempt to quit smoking is going. We will also show 
you a mix of your photos and photos we have related to smoking, as well as, other 
physical items that may remind you of smoking (i.e. cigarettes, a lighter, etc.). You will 
not be able to smoke while viewing the photos or holding these objects. We will ask you 
to answer questions about your desire to smoke afterwards. 
 Between Visit 4 and Visit 5 (Second group only). We will send you one or two text messages a 
day to help you not smoke. If you are assigned to the second group, you will be asked to text the 
study when you are craving a cigarette or if you smoke and the study will text you to help you 
not smoke at that time and to ask you questions about craving and stress level. 
 Study Visit 5 will occur approximately1 week after Visit 4. Only those in the second group will 
attend Study Visit 4. We will ask you to answer a few questions about your smoking and provide 
another breath sample. We will ask you to meet with someone to talk about your smoking and 
how your attempt to quit smoking is going. 
o If you are assigned to the second group, we will show you a mix of your photos and 
photos we have related to smoking, as well as, other physical items that may remind you 
of smoking (i.e. cigarettes, a lighter, etc.). You will not be able to smoke while viewing 
the photos or holding these objects. We will ask you to answer questions about your 
desire to smoke afterwards. 
 Between Visit 5 and Visit 6 (Second group only). We will send you one or two text messages a 
day to help you not smoke. If you are assigned to the second group, you will be asked to text the 
study when you are craving a cigarette or if you smoke and the study will text you to help you 
not smoke at that time and to ask you questions about craving and stress level. 
 Visit 6 will occur approximately1 week after Visit 5 for those in the second group. We will ask 
you to answer a few questions about your smoking, provide another breath sample and provide a 
saliva sample. We will ask you if we can contact you to ask you for feedback on the study. If 
you agree, we will call you or meet you in-person to hear about your experience in the study. 
 
We may call or text you between visits to remind you of visits. However, please call us immediately if 
you have any questions or concerns. 
 
We may audio record some of your answers to the surveys and your counseling sessions. We will seek 
verbal permission from you to audio record your answers at the time of the surveys. The audio 
recordings will be stored electronically on a password protected, encrypted computer that will be kept in 
a locked office at Duke University. The recordings will not be shared with anyone outside of the 
research team. Once the study is complete, the audio recordings will be destroyed. You have the right to 
refuse to be audio-recorded, and it will not impact your ability to participate in this study. 
 
HOW LONG WILL I BE IN THIS STUDY? 
Your entire study participation, including follow-up, will last approximately 7 weeks. 
 
WHAT ARE THE RISKS OF THE STUDY? 
 
 
DUHS IRB 
IRB NUMBER: Pro00089760 
IRB REFERENCE DATE: 01/17/2020 
IRB EXPIRATION DATE: 02/01/2021 
 
 
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Subject Initials  
 


ent to Participate in a Research Study 
Cons
 
 
 
Form 
M0345 
DUKE UNIVERSITY HEALTH SYSTEM 
 
Project Q Pilot 
There is the potential risk of loss of confidentiality. Every effort will be made to keep your information 
confidential; however, this cannot be guaranteed. Some of the questions we will ask you as part of this 
 
study may make you feel uncomfortable. You may refuse to answer any of the questions and you may 
take a break at any time during the study. You may stop your participation in this study at any time. 
 
As a result of your participation in this study, you are at risk for the side effects described below. You 
should discuss these side effects with the study doctor or physician assistant, as well as your regular 
health care provider if you choose. 
 
Smoking Withdrawal: 
When quitting smoking you may experience some, all or none of the withdrawal symptoms: headache, 
nausea, constipation or diarrhea, decrease in heart rate and blood pressure, fatigue, drowsiness, and 
insomnia, irritability, difficulty concentrating, anxiety, depression, tobacco cravings, increased desire for 
the taste of sweets, and/or increased hunger and caloric intake leading to weight gain. 
 
ARE THERE BENEFITS TO TAKING PART IN THE STUDY? 
If you agree to take part in this study, there may be direct medical benefit to you. A possible benefit 
from participation in this study is quitting smoking. We hope that in the future the information learned 
from this study will benefit people that smoke in the future. 
 
WHAT ALTERNATIVES ARE THERE TO PARTICIPATION IN THIS STUDY? 
If you do not wish to participate in this study, there are other alternatives to treat tobacco use. You can 
talk with your doctor about prescription medicines that may help you quit (including Varenicline or 
Bupropion), or nicotine-replacement products offered outside of this study, both over-the-counter and by 
prescription. Information about these resources is available through the North Carolina Tobacco Use 
Quit line at http://www.quitnownc.org or by calling (800) 784-8669. 
 
WILL MY INFORMATION BE KEPT CONFIDENTIAL? 
Participation in research can involve some loss of privacy. We will do our best to make sure that 
information about you is kept confidential, but we cannot guarantee total confidentiality. Your personal 
information may be viewed by individuals involved in this research and may be seen by people 
including those collaborating, funding, and regulating the study. We will share only the minimum 
necessary information to conduct the research. Your personal information may also be given out if 
required by law. 
 
The texting gateway system used for delivering the text messages to and from your cell phone will store 
the phone number you use for sending and receiving messages, along with the content of the text 
messages you will receive or send. These messages will only be about your smoking. The texting system 
will be managed by People Designs in Durham, NC. Once the study is over, we will destroy all text 
messages. 
 
In addition, your records may be reviewed to meet federal or state regulations. Reviewers may include 
the Duke Cancer Institute, the Duke University Health System Institutional Review Board, and others as 
appropriate. If any of these groups review your research record, they may also need to review your 
entire medical record. 
 
DUHS IRB 
IRB NUMBER: Pro00089760 
IRB REFERENCE DATE: 01/17/2020 
IRB EXPIRATION DATE: 02/01/2021 
 
 
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Subject Initials  
 


ent to Participate in a Research Study 
Cons
 
 
 
Form 
M0345 
DUKE UNIVERSITY HEALTH SYSTEM 
 
Project Q Pilot 
 
If this information is disclosed to outside reviewers for audit purposes, it may be further disclosed by 
them and may not be covered by the federal privacy regulations. 
 
Results of tests and studies done solely for this research study and not as part of your regular care will 
not be included in your medical record. Finally, you should understand that the investigator is not 
prevented from taking steps, including reporting to authorities, to prevent serious harm to yourself or 
others. 
 
The study results will be retained in your research record for at least six years after the study is 
completed. At that time either the research information not already in your medical record may be 
destroyed or information identifying you will be removed from such study results at DUHS. Any 
research information in your medical record will be kept indefinitely. 
 
While the information and data resulting from this study may be presented at scientific meetings or 
published in a scientific journal, your name or other personal information will not be revealed. 
 
Some people or groups who receive your health information might not have to follow the same privacy 
rules. Once your information is shared outside of DUHS, we cannot guarantee that it will remain private. 
If you decide to share private information with anyone not involved in the study, the federal law 
designed to protect your health information privacy may no longer apply to the information you have 
shared. Other laws may or may not protect sharing of private health information. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
Law. This Web site will not include information that can identify you. At most, the Web site will 
include a summary of the results. You can search this Web site at any time. 
 
WHAT ARE THE COSTS TO YOU? 
There will be no additional costs to you as a result of being in this study. However, routine medical care 
you would have received whether or not you were in this study will be charged to you or your insurance 
company. You may wish to contact your insurance company to discuss this further. We will monitor 
your DUHS patient care charges to make sure that costs are directed appropriately. If you have any 
questions or concerns about appropriate billing, contact your study team coordinator so that he/she can 
help find a resolution. These tests and studies are not a part of routine care, and people who are not part 
of the study do not usually have them performed. Please ask Dr. Pollak or the study staff if you would 
like to know more about which tests and studies are being done solely for research purposes. 
 
WHAT ABOUT COMPENSATION? 
You will be reimbursed up to $150 for your expenses related to your participation (parking, gas, and 
time). You will receive $50 for completing Visit 1. You will be compensated $100 at your final visit 
(either Visit 4 or Visit 6 depending on which group you are in). 
 
WHAT ABOUT RESEARCH RELATED INJURIES? 
Immediate necessary medical care is available at Duke University Medical Center in the event that you 
are injured as a result of your participation in this research study. However, there is no commitment by 
 
DUHS IRB 
IRB NUMBER: Pro00089760 
IRB REFERENCE DATE: 01/17/2020 
IRB EXPIRATION DATE: 02/01/2021 
 
 
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Subject Initials  
 


ent to Participate in a Research Study 
Cons
 
 
 
Form 
M0345 
DUKE UNIVERSITY HEALTH SYSTEM 
 
Project Q Pilot 
Duke University, Duke University Health System, Inc., or your Duke physicians to provide monetary 
compensation or free medical care to you in the event of a study-related injury. 
 
 
For questions about the study or research-related injury, contact Dr. Kathryn Pollak at (919) 681-4757 or 
the study coordinator, Shayna Clancy at (919) 681-4558 during regular business hours and Dr. Pollak at 
(919) 602-2485 after hours and on weekends and holidays. You can reach Dr. James Davis, the study 
doctor, 24-hours a day at (608) 217-9405. 
 
WHAT ABOUT MY RIGHTS TO DECLINE PARTICIPATION OR WITHDRAW FROM THE 
STUDY? 
Being in this trial is voluntary. If you do not sign this consent form, you will continue to receive care, 
but not as part of this study. You may choose not to be in the study, or, if you agree to be in the study, 
you may withdraw from the study at any time. However, if you decide to stop participating in the study, 
we encourage you to talk to study staff first. If you withdraw from the study, no new data about you will 
be collected for study purposes unless the data concern an adverse event (a bad effect) related to the 
study. If such an adverse event occurs, we may need to review your entire medical record. 
 
Your decision not to participate or to withdraw from the study will not involve any penalty or loss of 
benefits to which you are entitled, and will not affect your access to health care at Duke. If you do 
decide to withdraw, we ask that you contact Dr. Pollak in writing and let her know that you are 
withdrawing from the study. Her mailing address is 2424 Erwin Road, Suite 602, Durham, NC 27705. 
 
We will tell you about new information that may affect your health, welfare, or willingness to stay in 
this study. 
 
Your doctor may decide to take you off this study if your condition gets worse, if you have serious side 
effects, or if your study doctor determines that it is no longer in your best interest to continue. The 
sponsor or regulatory agencies may stop this study at any time without your consent. Reasons why this 
might occur include difficulty in study recruitment or retention that will significantly impact the ability 
to evaluate the study endpoints or any new information becomes available during the study that 
necessitates stopping the study. If this occurs, you will be notified and your study doctor will discuss 
other options with you. 
 
Your samples and/or data may be stored and shared for future research without additional informed 
consent if identifiable private information, such as your name and medical record number, are removed. 
If your identifying information is removed from your samples or data, we will no longer be able to 
identify and destroy them. 
 
The use of your samples may result in commercial profit. You will not be compensated for the use of 
your samples other than what is described in this consent form. 
A description of this clinical trial will be available on https://clinicaltrials.gov/ as required by U.S. Law 
(ClinicalTrials.gov Identifier: NCT03416621). This Web site will not include information that can 
identify you. At most, the Web site will include a summary of the results. You can search this Web site 
at any time. 
 
 
DUHS IRB 
IRB NUMBER: Pro00089760 
IRB REFERENCE DATE: 01/17/2020 
IRB EXPIRATION DATE: 02/01/2021 
 
 
Page 6 of 7 
Subject Initials  
 


ent to Participate in a Research Study 
Cons
 
 
 
Form 
M0345 
DUKE UNIVERSITY HEALTH SYSTEM 
 
Project Q Pilot 
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS? 
For questions about the study or a research-related injury, or if you have problems, concerns, questions 
or suggestions about the research, contact Dr. Kathryn Pollak at (919) 681-4757 during regular business 
hours and Dr. Pollak at (919) 602-2485 after hours and on weekends and holidays. 
 
For questions about your rights as a research participant, or to discuss problems, concerns or suggestions 
related to the research, or to obtain information or offer input about the research, contact the Duke 
University Health System Institutional Review Board (IRB) Office at (919) 668-5111.STATEMENT 
OF CONSENT 
"The purpose of this study, procedures to be followed, risks and benefits have been explained to me. I 
have been allowed to ask questions, and my questions have been answered to my satisfaction. I have 
been told whom to contact if I have questions, to discuss problems, concerns, or suggestions related to 
the research, or to obtain information or offer input about the research. I have read this consent form and 
agree to be in this study, with the understanding that I may withdraw at any time. I have been told that I 
will be given a signed and dated copy of this consent form." 
 
 
Signature of Subject 
Date 
Time 
 
 
Signature of Person Obtaining Consent 
Date 
Time 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
DUHS IRB 
IRB NUMBER: Pro00089760 
IRB REFERENCE DATE: 01/17/2020 
IRB EXPIRATION DATE: 02/01/2021 
 
 
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