Examining Persistence in Smokers With Schizophrenia
Phase: NA
Conditions: Smoking Cessation, Schizophrenia, Schizo Affective Disorder
Sponsor: Rutgers, The State University of New Jersey

Examining Persistence in Smokers with Schizophrenia 
Marc L. Steinberg, Ph.D. 
 
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Title of Project:  
Examining Persistence in Smokers with Schizophrenia 
 
 
 
Principal Investigators: 
Marc L. Steinberg, Ph.D.   
 
 
 
Funding Source(s): 
National Institute on Drug Abuse (NIDA) 
 
1. Purpose/Specific Aims 
This study will modify our existing 8-session, individual counseling treatment manual 
(“Persistence Targeted Smoking Cessation (PTSC)”) to make it more feasible for treating 
smokers with schizophrenia. We will also test the ability of our new treatment, “Persistence 
Targeted Smoking Cessation in Schizophrenia (PTSC-S)” to increase task persistence in 
smokers with schizophrenia. 
  
 1.1 Objectives  
We will demonstrate that our new treatment “Persistence Targeted Smoking Cessation in 
Schizophrenia (PTSC-S)” is feasible for treating smokers with schizophrenia and that it 
increases their task persistence.  
 
 1.2 Hypotheses  
1. We hypothesize that that at least 80% of participants will rate the intervention as “easy to 
understand” and “helpful” on a post-intervention exit interview questionnaire. 
2. We hypothesize that smokers with schizophrenia receiving our PTSC-S intervention will 
demonstrate cognitive and behavioral increases in task persistence from baseline to 
follow-up. 
 
2. Background and Significance 
We propose to modify a theory-based smoking cessation intervention (called Persistence-
targeted smoking cessation; PTSC) to make it more feasible for treating smokers with 
schizophrenia. We will include 8 weekly individual counseling sessions and use of the 
nicotine patch for 10 weeks.  We will provide counseling sessions and nicotine patches free 
of charge to research participants. We will test the feasibility of the intervention and its 
ability to influence persistence (measured as described in the table in section 4.2).  We hope 
to develop a feasible psychosocial treatment for use in a later randomized controlled trial. 
  
Summary of Proposed Project in Lay Terms and Scientific Terms: 
This study is a non-randomized trial of a new psychosocial treatment for smoking cessation 
(for smokers with schizophrenia) that is based on cognitive behavioral therapy for smoking 
cessation – a commonly used approach.  Participants will receive free weekly counseling (8-
weeks) and free nicotine patches (10-weeks).  They will complete assessment measures 

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commonly used in smoking cessation studies.  We hope to show that this treatment is feasible 
in this small pilot study before comparing it to a more established treatment in a future RCT. 
 
3. Research Design and Methods 
We will conduct an open trial (N=26) of our 8-session, weekly, individual treatment, 
(Persistence Targeted Smoking Cessation for Schizophrenia (PTSC-S)). The purpose of this 
open trial will be to “begin to demonstrate that the intervention alters the targeted mechanism 
(thus providing an initial proof of principle).” We will measure task persistence via 
behavioral and cognitive measures administered in counterbalanced order at baseline, after 
session 3, and at one- and three-months post-quit date. By assessing task persistence at 
multiple follow-up points, we will be able to examine how many sessions are required to 
produce an effect (i.e., effect of treatment “dose”).  
 
A trained research assistant (who will receive weekly and as-needed supervision from the 
principal investigator) will pre-screen potential participants on the phone, followed by 
obtaining informed consent and administering the baseline assessment battery (see 
Assessment Measures table below). We will divide the baseline assessment battery into two 
sessions to minimize participant fatigue. Each baseline assessment session will last 
approximately 90 minutess. We will then provide free, weekly individual counseling sessions 
for 8 weeks and 10-weeks’ worth of the nicotine transdermal patch (an FDA-approved 
smoking cessation product available over the counter). All sessions will be audio recorded 
for treatment integrity and supervision. 
 
Questionnaires that are commonly used in tobacco dependence treatment studies will be used 
in the current study. Women of childbearing age will take a pregnancy test to rule out 
pregnancy. Carbon monoxide (CO) levels (also commonly collected in tobacco dependence 
treatment studies) will be assessed with a carbon monoxide monitor and CO reading in parts 
per million (ppm) will be recorded.  The carbon monoxide monitor used will be the Bedfont 
Scientific Ltd. Micro+ Smokerlyzer. The Micro+ Smokerlyzer is a hand-held, battery 
powered instrument which uses electrochemical technology to sample the gas and a 
microprocessor to convert the output from the sensor to a carbon monoxide (CO) 
concentration. The result and menus are displayed on a color LCD and an accompanying 
buzzer sounds in response to the CO level. The instrument is controlled using a touch screen 
operation and has a USB link to a computer to download readings. 
  
The Micro+ uses a breath sampling D-Piece with integrated bacterial and viral filter and a 
one-way valve designed to maximize infection control. Each patient uses a fresh mouthpiece 
for each breath sample. The D-Piece may be reused or replaced as required.  
 
The patient is asked to hold their breath for a 15 second countdown. This is displayed on the 
screen of the device. At the end of the breath hold, the patient blows gently into the Micro+ 
expiring as much of the breath in their lungs as possible. The reading on the device shall rise 
until the peak reading is held on the display. 
 
A research assistant will provide instructions on how to use the CO monitor and will record 
the results at baseline and followup appointments. A research therapist will do so during the 
8 counseling sessions. The study PI is accountable for the device. 
 
 
3.1. Duration of Study 

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Participants will be active in the study for approximately 4 months.  We anticipate 
completing data collection activities within 24 months. 
 
3.2 Study Sites 
Participants will be daily smokers primarily from central New Jersey. Participants will attend 
treatment at our Addiction Psychiatry office at 317 George St., Suite 105, New Brunswick, 
NJ. We will also recruit participants from several University Behavioral Health Care 
(UBHC) locations, including: New Brunswick, Piscataway, Monmouth Junction, and Edison. 
If it proves more convenient for participants to receive counseling at UBHC locations, we 
will provide services in those locations instead of at our George Street office. 
 
3.3 Sample Size Justification  
26 participants will be enrolled.  
 
We will enroll 26 smokers from the local area.  We will collect demographic data that will 
allow us to compare this sample to the general population of smokers.  This is a non-
randomized, pilot, feasibility study so a power analysis is not applicable to this study design.  
 
3.4 Subject Selection  
3.4.1 Inclusion Criteria  
• Must be between 18 – 64 years old 
• Must indicate commitment to quitting smoking in the next 30 days 
• 
Must smoke at least 5 cigarettes (including those labeled “little cigars”) per day for 
past 6-months 
• Expired breath carbon monoxide (CO) > 5 to ensure daily cigarette use 
• Must score < 8 (or <7 for women) on the Alcohol Use Disorders Identification Test  
• Must score less than 3 on the 6-month Drug Abuse Screening Test-10 
• Must provide a negative urine drug screen for cannabis, cocaine, or opiates (Note: 
Participants with a positive screen for opiates may participate with proof of 
prescription for opiates.) 
• Must have a diagnosis of Schizophrenia or Schizoaffective Disorder on SCID-I 
• Psychiatric illness must be stable, as indicated by no hospitalizations in previous 8 
weeks, and a stable psychotropic medication regimen including a stable antipsychotic 
dose for 8 weeks 
• Must have a working phone (for feasibility of follow-up and for ability to receive 
optional SMS text messages) 
 
3.4.2 Exclusion Criteria 
• Must not be currently receiving tobacco dependence treatment counseling 
• Must not currently be taking varenicline (Chantix), 
• Must not be taking bupropion (Zyban/Wellbutrin) to quit smoking 
• Must not be taking any nicotine preparations (gum, lozenge, patch, spray, inhaler) 
daily over the last 10 days 
• Must not report myocardial infarction in the past year, unstable angina pectoris, , or 
significant cardiac arrhythmia (including atrial fibrillation) in the past 90 days. 
• Must not be pregnant, breastfeeding, or planning on becoming pregnant in the next 
4-months. Women who can become pregnant may be included if using effective 
birth control 

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• Must not have pending legal matters with potential to result in jail time 
• Must not be planning on moving outside local area in next 3-months 
 
Participants answering “yes” to any item on the “Nicotine Patch Contraindications Form” 
will meet with an Addiction Psychiatrist for follow-up and approval for the study. The 
Addiction Psychiatrist will document this assessment in signed progress notes. 
 
Justification of exclusion of any sub-segment of the population:  Children will not be 
included in the study because young children are unlikely to be daily smokers and the 
nicotine patch (which will be used in this study) is not currently FDA approved for children. 
All participants must be at least 18 years old to participate in this study. 
 
4. Study Variables 
 
 
4.1 Independent Variables or Interventions  
We will provide 8-weeks of free counseling to participants. Study therapists will utilize the 
“Persistence-Targeted Smoking Cessation-Schizophrenia (PTSC-S)” manual developed by 
Dr. Steinberg, which is based on cognitive behavioral therapy.  PTSC-S is an 8-session, 
individual, smoking cessation counseling strategy that focuses heavily on using cognitive 
behavioral therapy targeted at disputing automatic thoughts that may reduce task persistence 
for smokers with schizophrenia.  While disputing automatic thoughts will be the focus of 
each session, skill building and support will also be included.  Participants will be asked to 
complete homework assignments between sessions – including keeping a daily thought 
record to monitor automatic thoughts that may put them at risk for smoking.  A daily 
thought record is a commonly used cognitive behavioral therapy homework assignment in 
which participants practice identifying and evaluating their thoughts.  Participants will also 
track their daily cigarette use and nicotine patch use for homework.  Participants will use 
commonly used, established measures to provide brief assessment information at the end of 
each session (i.e., nicotine dependence, tobacco use, nicotine lozenge use, nicotine craving, 
and nicotine withdrawal). 
 
4.1.1 Drug or Device Interventions  
We will give participants a 10-week supply of the nicotine transdermal patch (an FDA-
approved, over-the-counter medication) to be used starting on their Quit Date.  
Although the nicotine patch is commercially available without a doctor’s prescription, 
Co-I Dr. Jill Williams (an addiction psychiatrist) will provide medical monitoring 
during this study. Consistent with the product insert, participants will be instructed to 
use one nicotine patch daily, and to apply it upon awakening at about the same time 
each day. Subjects will be instructed to vary the site of application of the patch daily to 
minimize any skin irritation. They will use the 21mg patch for the first 8-weeks, then 2-
weeks of the 14mg patch.  
 
 
 
 
 
 
 
 

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4.2 Dependent Variables or Outcome Measures 
Assessment measures: See table below 
 
*Wisconsin Smoking Withdrawal Scale will be administered before sessions 4 through 8 
 
4.4 Risks of Harm  
There is a risk of discomfort associated with nicotine withdrawal for patients who are 
quitting smoking. The nicotine patch (an FDA-approved medication) is well tolerated; 
however there are potential side effects that may arise when using the patch. Each patient 
will discuss these side effects with their therapist. If questions arise as a result of the patch, 
Concept 
Measure 
B/L 
 
Weekly 
QD 
Session 
8 
3-mo. 
Post 
QD 
DEMOGRAPHICS 
Smoking History & Demographics Questionnaire (includes National 
Health and Nutrition Examination Survey (NHANES) items) 
X 
 
 
 
 
TOBACCO USE  
Fagerström Test for Nicotine Dependence (Heatherton et al., 1991) 
X 
 
 
 
 
Timeline Followback (TLFB; Sobell & Sobell, 2000) 
 
X 
X 
X 
X 
Current Tobacco Use – $ spent, menthol use, night-time smoking 
X 
 
 
 
 
Expired Breath Carbon Monoxide (CO) 
X 
X 
X 
X 
X 
Brief WISDM 
X 
 
 
 
 
NRT USE 
Self-reported use of patch – including visual inspection of patch  
 
X 
X 
X 
X 
NRT side effects 
 
X 
X 
X 
X 
Nicotine patch contraindications form 
X 
 
 
 
 
CRAVING AND 
WITHDRAWAL 
Wisconsin Smoking Withdrawal Scale (Welsch et al., 1999)  
X 
 
X* 
X 
 
X 
 
MOTIVATION TO 
QUIT SMOKING 
ICT – Change Measure (includes self-efficacy) (Miller & Johnson, 
2008) 
X 
 
X 
X 
 
Quitting Fatigue 
 
 
X 
X 
X 
Commitment to Quitting Smoking Scale (CQSS) 
X 
 
X 
X 
 
ANHEDONIA 
Temporal Experience of Pleasure Scale (Gard et al., 2006)  
X 
 
X 
X 
X 
Snaith - Hamilton Pleasure Scale (Snaith et al., 1995)  
X 
 
X 
X 
X 
Tripartite Pleasure Inventory (Leventhal, 2010) 
X 
 
X 
X 
X 
 
 
 
 
 
 
 
TASK 
PERSISTENCE 
Mirror Tracing 
X 
 
X 
X 
X 
Breath-holding 
X 
 
X 
X 
X 
Temperament and Character Inventory—Persistence Scale (TCI-P) 
X 
 
X 
X 
X 
2-item Task Persistence Measure 
X 
 
X 
X 
X 
Distress Tolerance Scale (DTS) 
X 
 
X 
X 
X 
Sustained Divided Attention Task 
X 
 
X 
X 
X 
Thoughts About Smoking Questionnaire 
X 
 
X 
X 
X 
Daily Habits Questionnaire 
X 
 
 
 
 
SUBSTANCE USE 
/ MENTAL 
HEALTH ISSUES 
Alcohol Use Disorders Identification Test (AUDIT; Babor et al., 
2001) 
X 
 
 
 
 
6-month Drug Abuse Screening Test – 10 (DAST-10; Skinner, 1982) 
X 
 
 
 
 
Urine drug screen (for cannabis, cocaine, opiates) 
X 
 
 
 
 
SCID-RV for DSM 5 - Modules  A, B, and C  
X 
 
 
 
 
Brief Symptom Inventory (BSI; (Derogotis, 1975) 
X 
 
 
 
 
CES-D 
X 
X 
X 
X 
X 
INTERVENTION 
INTEGRITY / 
FEASIBILITY 
Exit interview 
 
X 
X 
X 
 
Study created integrity measure 
We will confirm treatment integrity 
throughout the study 

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one of the study co-investigators is an Addiction Psychiatrist who will be available to provide 
patients with information regarding their side effects. 
 
There is a risk that participants’ confidentiality could be violated.  To reduce the risk of 
violating confidentiality, several steps will be taken.  Only IRB approved members of the 
research team will have access to the data.  The research staff collecting the data will bring 
the data to the PI within 24 hours of it being collected.  Data will only be accessed when 
coded, entered, or audited.  The PI will maintain responsibility for safe data storage.  All data 
will be stored in locked cabinets within locked rooms.  Based on these procedures, we 
anticipate that the risk to confidentiality is very low. 
 
 
HANDLING OF UNEXPECTED OR ADVERSE EVENTS 
Response to new or unexpected findings and to changes in the study environment: 
The study team will meet on a quarterly basis while participants are in the study. The team 
will monitor the study according to the guidelines specified in the study protocol and the 
operating procedures established at the initial meeting, unless the team determines during 
the course of the trial that modification of the guidelines is in the best interest of the study 
and its participants. Such a decision may be based on new information that emerges during 
the course of the study (e.g., publication of the results of a similar trial), realization of 
inappropriate initial study assumptions, or the occurrence of an unanticipated scenario. 
 
Identifying, managing, and reporting adverse events: 
There is a risk of discomfort associated with nicotine withdrawal for patients who are 
quitting smoking. The nicotine patch (an FDA-approved medication) is well tolerated; 
however there are potential side effects that may arise when using the patch. Each patient 
will discuss these side effects with their therapist. If questions arise as a result of the patch, 
one of the study co-investigators is an Addiction Psychiatrist who will be available to 
provide patients with information regarding their side effects. 
 
The research staff member who observes or is notified of a possible adverse event will 
notify the Principal Investigator within 24-hours. Events which are 1) Unexpected in terms 
of nature, severity or frequency, given the research protocol, IRB-approved informed 
consent document, product labeling and other sources of information, and given the 
characteristics of the subject population being studied, 2) Related or possibly related to 
participation in the research, and 3) Potentially place the research subjects or others at a 
greater risk of harm (including physical, psychological, economic or social harm) than was 
previously known or recognized will be reported to the IRB in a written Unanticipated 
Problems/Adverse Events In Human Subjects Research Report.  If these events are deemed 
“serious,” we will report within one week of discovery.  If not, we will report within two 
weeks of discovery.  In addition, if a death occurs within 30 days of the intervention, 
whether or not it was deemed study related, we will report within 24-hours of discovery.  
 
Any item listed on the Adverse Events Log that is deemed to be of more than mild severity 
will be discussed with the Addiction Psychiatrist within 7 days of the study appointment at 
which the research staff learned of it. The Addiction Psychiatrist will document this 
“Moderate” or “Severe” AE and the recommended action, if any, in signed progress notes. 
 
The Principal Investigator will meet with research staff to discuss the impact of participation 
upon patients. If concerns are reported, the Principal Investigator will discuss modification 
of the research procedures with the research team, and request IRB approval of proposed 

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changes (if any).  We believe that this level of monitoring is commensurate with the degree 
of risk to participants. 
 
Adverse events will be reviewed weekly at research meetings, followed by completion of a 
separate progress note inserted into the participant’s binder. Each adverse event will now 
have a space to indicate the date a progress note was made. The AE list and related progress 
notes will be on a different color paper than the rest of the chart to ensure that proper 
attention is paid. 
 
Emergency care: 
Participants will be instructed to call 911 if they experience a medical emergency and Acute 
Psychiatric Services (APS) at 855-515-5700 if they experience a psychiatric emergency. The 
research assistant will administer a depression measure at the beginning of each session. If 
there is an indication that the patient is experiencing serious depression, the therapist will 
inform the patient and communicate concerns with the PI. The patient will be counseled 
accordingly and provided with appropriate emergency contact information. 
 
4.5 Potential for Benefit 
The benefits of taking part in this study include access to high-quality, smoking 
cessation treatment based on empirically supported psychosocial approaches.  If 
participants quit smoking, they will experience health benefits; however, they may 
receive no direct benefit from taking part in this study. 
 
5.  Subject Recruitment and Enrollment Considerations 
 
5.1 Subject Recruitment 
The project will take place at our Rutgers offices in New Brunswick, NJ, located in the 
building next to a large University Behavioral Health Care outpatient clinic that serves 
more than 500 clients with a diagnosis of schizophrenia or schizoaffective disorder 
annually. We will recruit smokers from Rutgers University Behavioral Health Care, 
from private psychiatric intensive outpatient treatment providers, from the community 
via our website and local flyers, and via Rutgers listservs. Potential participants will call 
our offices for a telephone pre-screen. If potentially eligible, they will be offered a more 
in-depth in-person screening after providing informed consent. If all inclusion criteria 
are met, they will be invited to participate. This is an urban area with a large low-
income population and therefore a greater proportion of smokers than the average of 
14.8% in the state of New Jersey.  Previous studies have given us the necessary 
experience with Rutgers listservs, websites, Craigslist, and use of flyers and brochures 
to maximize recruitment. 
 
5.2 Consent Procedures 
Participants will read a consent form or will have the consent form read to them before 
signing it. A trained research assistant (who will receive weekly and as-needed 
supervision from the principal investigator) will pre-screen potential participants on the 
phone, followed by obtaining informed consent and administering the baseline 
assessment battery. Trained research staff will proactively ask participants to describe 
the research study to them in their own words to ensure that participants understand the 
consent form.  If there is any doubt of competence to consent, the individual will not be 
enrolled. 
 

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5.2 Subject Costs and Compensation 
Participants will be paid $100 through the duration of the study. They will receive $40 
at the baseline assessment ($10 for first baseline session, $30 for second baseline 
session), $10 at the Quit Date assessment, $30 at session 8, and $20 at the 3-months 
post-quit date assessment.  
 
6.   Data Handling  
As this study is primarily a feasibility study, our data analysis plan will primarily comprise 
descriptive statistics such as mean (sd) sessions attended and percent of participants reporting 
3-months post quit-date abstinence. We need to collect all of this data in order to demonstrate 
that our PTSC treatment manual is generalizable to a population of smokers with 
schizophrenia. We need to examine changes in relevant variables such as self-reported 
cigarette and medication use, withdrawal, smoking urges, and mechanisms of change in order 
to evaluate the efficacy of our treatment.  
 
Data collection: 
The majority of data will be collected through face-to-face interview.  A research assistant 
will read the questions to the participants while they read along from their own copies of the 
measures to maximize participant comprehension.  If participants are unable or unwilling to 
attend a follow-up appointment at our Rutgers RWJMS offices, a research assistant will meet 
the participant off-site, in a public location agreeable to the participant such as a local public 
library. If off-site appointments are also impossible, we will conduct telephone interviews.  
Data will be stored at the Division of Addiction Psychiatry; 317 George Street; Suite 105; 
New Brunswick, NJ 08901.  Only the IRB-approved research team will have access to the 
research data. 
 
Data entry, editing and management, including handling of data collection forms, 
different versions of data, and data storage and disposition: 
To reduce the risk of violating confidentiality, several steps will be taken.  Only IRB 
approved members of the research team will have access to the data.  The research staff 
collecting the data will bring the data to the PI within 24 hours of it being collected (data are 
collected on secure laptops and/or in file folders identified only by participant ID number). 
The research team shares the same office space at 317 George Street in New Brunswick.  
Data will only be accessed when coded, entered, or audited.  The PI will maintain 
responsibility for safe data storage.  All data will be stored in locked cabinets within locked 
rooms in the Division of Addiction Psychiatry, 317 George Street, New Brunswick, NJ. 
  
All computer files will be kept on computers requiring login and complex passwords for 
entry, and all files with identifying information will have the extra protection of a password 
to open that individual file.  The individual participant’s personal information, including 
name and contact numbers, will be kept separate from their study data and linked only by a 
study number assigned by the PI.  The master link between the study number and patient 
contact information will be destroyed once all data is collected and checked for accuracy. 
The confidential binder containing telephone screen forms will be shredded and properly 
discarded after 12 months of study completion. Participant names will not be used in any 
publications or papers derived from this study. 
 
Limitations of study: 
Because this is a pilot feasibility study, our sample size is relatively small and the 
generalizability of our findings should therefore be interpreted with caution. 

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7. Statistical Analysis 
We will review all data quarterly.  
 
To address hypothesis 1 that participants will rate the PTSC-S as “easy to understand” and 
“helpful” during a post-intervention exit interview, we will do the following: 
a) Calculate the percentage of participants who rate the intervention as “easy to 
understand” and “helpful” and test whether this percentage exceeds 80% using a one-
sample test of binomial proportion (Rosner, 2010) 
b) Explore which participant characteristics tend to be associated with positive or 
negative views of this intervention, by examining bivariate association (e.g., chi-square 
test for discrete categorical characteristics and two-sample t-test for continuous 
measurements) and logistic regression analysis 
 
 
To address hypothesis 2 that smokers with schizophrenia receiving our PTSC-S intervention 
will demonstrate cognitive and behavioral increases in task persistence (measured by mirror 
tracing, breath-holding, 2-item persistence self-report, Sustained Attention Test, and 
Thoughts About Smoking Questionnaire), we will do the following: 
a) Calculate and plot summary statistics to explore the cross-sectional and longitudinal 
distributions of persistence scores  
b) Use paired t-tests to probe for changes in task persistence from baseline to end-of-
counseling (session 8), followed by mixed model analysis with persistence scores as 
the dependent variable and time as the independent variable 
c) Construct linear contrasts to evaluate changes in persistence scores from baseline to 
end-of-counseling (session 8). If the normality assumption is violated, we will apply 
the necessary variable transformations 
 
8. Reporting Results 
 
8.1 Individual Results 
Participants will not be provided with individual study results.   
 
8.2 Aggregate Results 
Aggregate results such as average number of sessions attended, proportion of participants 
obtaining abstinence from smoking, and cigarettes smoked per day may be reported in peer 
reviewed scientific conference presentations, peer-reviewed scientific publications, or peer-
reviewed NIH grant applications. 
 
8.3 Professional Reporting 
Study results may be presented to the scientific community via peer reviewed manuscripts 
and presentations at scientific conferences.  They will also be included in peer-reviewed NIH 
grant applications. 
 
 
 
 
 
9. Bibliography 

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(1995). A scale for the assessment of hedonic tone the Snaith-Hamilton Pleasure Scale. 
British Journal of Psychiatry, 167, 99-103. PMID: 7551619 
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