tDCS and Cognitive Training Intervention for Chronic Smokers With Schizophrenia
Phase: NA
Conditions: Transcranial Direct Current Stimulation, Smoking, Cigarette, Schizophrenia
Sponsor: University of Pittsburgh

 
Study Protocol  
 
 
Official Title: tDCS and cognitive training intervention for chronic smokers 
with schizophrenia (TACTICSS) 
  
 
 
ClinicalTrials.gov ID (NCT number): NCT03588728 
 
 
 
Protocol Date: 12/12/2018 
 
 

Scientific Background 
 
Individuals with severe mental illnesses consume 35-44% of all cigarettes in the U.S., well 
above their representation in the population.1 This disproportionate level of smoking and limited access 
to cessation treatment has led to exceptionally high tobacco-related mortality and morbidity rates 
among smokers with schizophrenia.2 Of those who attempt cessation, relapse rates are much higher 
than found in the general population of smokers.3  Recent literature suggests that this discrepancy may 
be related to deficits in cognitive processes mediated by the prefrontal cortex (PFC). Specifically, 
impaired executive function and working memory have been directly linked to cessation failure among 
smokers with schizophrenia4,5, and low cognitive control of impulsivity is strongly correlated with time to 
relapse in the general population.6,7 Moreover, schizophrenia is associated with persistent cognitive 
deficits, often linked to abnormal interaction among various brain regions, particularly right inferior 
frontal gyrus (IFG) and ventral striatum, making it difficult to cope with prepotent stimuli (e.g., smoking-
related cues).4,5 Unfortunately, pharmacologic cessation treatments (e.g., Chantix, Wellbutrin) are only 
modestly effective in helping smokers with schizophrenia quit.8–11 To better assist this subset of highly 
vulnerable smokers achieve abstinence, development of new cessation adjuncts are needed. One 
promising route is the development of techniques that not only target underlying mechanisms that 
maintain smoking, but also specifically improve cognitive control. 
Cognitive enhancement therapy increases cognitive performance in schizophrenia patients, 
particularly when working memory, processing speed, executive function, and social cognition are 
targeted.12 Standard protocols are intensive, taking 18 months to complete, making standard therapy a 
sub-optimal candidate for smoking cessation. However, the Cognitive Remediation (CR) component of 
cognitive enhancement therapy focuses specifically on cognitive training and is less intensive and 
lengthy. When combined with another cognition enhancement method, namely Transcranial Direct 
Current Stimulation (tDCS), CR may provide a robust and time efficient method of improving cognitive 
control among patients with schizophrenia. tDCS studies in our lab and others have demonstrated clear 
enhancement of attention, working memory, and risk aversion using this technique13–17; as well as 
reductions in craving and amount of smoking. These findings, combined with knowledge of identified 
cognitive deficits in schizophrenia and the relationship between cognitive function and smoking 
cessation failure, suggest the potential of CR + tDCS to target cognitive deficits and smoking-related 
reactivity among smokers with schizophrenia. Specifically, we hypothesize that CR + tDCS will 
enhance cognitive control, reduce cue-induced craving and attenuate attentional bias (reaction time 
and ERPs) to smoking stimuli. Further, we will examine if these changes are associated with reductions 
in actual smoking behavior; and, we will explore the potential of CR + tDCS to increase quit intention 
and confidence in quitting among smokers with schizophrenia. Our specific aims are as follows: 
Study Objectives 
 
Aim 1: Examine the effectiveness of CR + tDCS to improve behavioral and neurophysiological 
measures of cognitive control among smokers with schizophrenia.  Using a 2 X 2 factorial design 
(n=20 per group) we will examine main and interactive effects of CR and tDCS on multiple measures of 
cognitive control.  Hypothesis:  Combined CR + tDCS will result in greater improvement in MATRICS 
measures of cognitive control, as well as continuous performance task (CPT) relative to the other 
groups (CR + sham tDCS, AC + tDCS, AC + sham tDCS). 
Aim 2: Determine the effectiveness of CR + tDCS to attenuate reactivity to smoking stimuli 
among smokers with schizophrenia. Hypothesis:  CR + tDCS will lead to greater reductions in cue-
induced craving, and improved reaction time and ERP measures of attentional bias relative to the other 
groups (CR + sham tDCS, AC + tDCS, AC + sham tDCS).  
Aim 3:  Examine if cognitive control enhancement (Aim 1) and/or changes in reactivity to 
smoking-related stimuli (Aim 2) predict reductions in measures of actual smoking behavior. 
Hypothesis: Enhanced cognitive control and attenuation of reactivity to smoking stimuli will be directly 

related to reductions in smoking topography (i.e., Latency to light, puff volume, and number of puffs) 
within the CR + tDCS group.  
Secondary Aim:  To inform future clinical research, we will also explore whether changes in 
cognitive control and smoking reactivity measures are associated with changes in quit intention and 
confidence in quitting from baseline assessment to end of study by training condition.   
Study design and methods 
Using a 2 x 2 design we examined CR (CR, active control [AC]) X tDCS (active, sham) to enhance 
cognitive control, reduce cue-induced craving, and attenuate attentional bias measures of reaction time 
and ERPs to smoking stimuli; and, we determined the impact of these changes on smoking behavior 
and intent to quit and confidence in quitting among daily smokers with schizophrenia. Participants were 
assigned to active (2.0 mA) CR + tDCS, CR + sham (0.1 mA) tDCS, active control (AC) + active tDCS, 
or AC + sham tDCS, each with anode electrode placement over the right inferior frontal gyrus (IFG) and 
cathode electrode placement over the left bicep. Similar to our previous studies participants received 30 
minutes of either active or sham tDCS during each visit, starting at the beginning of the CR training. AC 
consisted of a self-paced knowledge- and vocabulary-based task in which participants were given 
sequential multiple-choice questions about factual information at a 6th-grade level. Participants 
underwent consecutive CR + tDCS sessions, 5 days a week, for 2 weeks. Cognitive control, cue-
induced craving and attentional bias (reaction time & ERPs), as well as smoking topography were 
assessed during Week1 baseline testing and Assessment Week 4.  
Procedures and protocol 
Eligible participants will be invited to the Clinical Neurophysiology Research Lab for informed consent 
and further screening, including CO, Smoking and Medical history, PANSS18, Intention to quit19, 
Confidence in quitting,20 and hearing/vision testing to screen for sensory problems that may affect 
cognitive and/or EEG testing. After initial screening on Day 1, participants will be randomized. 
Randomization for the 4 groups will be stratified by current typical or atypical antipsychotic medication 
to control for the potential interaction of tDCS with medication class. A randomization assignment list 
will be generated for each category using a permuted 4 block design. Dropouts will be replaced. 
Participants will then be scheduled for two baseline testing sessions, completed the same week as 
initial screening. The first will utilize the MATRICS Clinical Consensus Battery (MCCB) for baseline 
testing of cognitive measures. Participants will perform form A of the MCCB at baseline, which includes 
composite scores for attention, processing speed, working memory, and reasoning/problem solving. 
Participants will also complete behavioral tests of cognitive control, cue reactivity and attentional bias 
during this visit. Participants will then complete a baseline EEG testing session on a separate visit in 
the same week. Electrophysiological measures of cognitive control will be examined using the 'AX'-type 
Continuous Performance Task (AX-CPT)21,22. Cue-induced craving and smoking topography will be 
assessed with a pictorial cue reactivity paradigm,23 and attentional bias will be measured using a 
modified stroop task.24 Following baseline testing (Week1), participants will return 5 days (M-F) for the 
next 2 weeks for cognitive training with CR / tDCS and will receive the same tDCS condition in each 
visit. In week 4, participants will perform follow-up testing using form B of the MCCB, behavioral tests of 
cognitive control, cue-reactivity, and attentional bias on the first day, and EEG testing on the second.  
Interventions.  
Cognitive Remediation (CR). CR incorporates a subset of components from Cognitive 
Enhancement Therapy found to have early benefits on the cognitive deficits of particular interest to the 
proposed studies and can be conducted more time-efficiently to achieve our specific goals. This 
abbreviated CR involves 20 hours of neurocognitive training using attention and processing speed 
training software developed by Ben-Yishay and colleagues.25 Deficits in Attention are addressed with 
exercises used to enhance vigilance and rapid decision making, inhibit irrelevant stimuli, and shift 
attention between auditory and visual modalities. These exercises facilitate reaction time in a temporal 
mode using auditory cues (The Attention Reaction Conditioner), spatial focusing with visual cues (the 

Zero Accuracy Conditioner), and temporal vigilance with auditory and visual cues (Time Estimates). 
Our experience with over 200 patients with schizophrenia reveals that they successfully progress 
through these training exercises over the 20 hours of training. For the active control (AC) condition, 
participants will complete a self-paced knowledge- and vocabulary-based task of the same duration as 
CR to equate time spent on task, while omitting the cognitive control training aspect that is central to 
CR.  
Transcranial Direct Current Stimulation (tDCS). tDCS is a low-cost, portable method that is 
well-tolerated by participants. The polarity of the current and the location of stimulating electrodes is an 
important factor that influences its effects on neural activity, with positive polarization (anodal) at the 
scalp inducing excitation of the underlying cortex, and negative polarization (cathodal) at the scalp 
resulting in the opposite effect.26–28 Functionally, cathodal tDCS suppresses while anodal stimulation 
facilitates cortical excitability.29 Modeling studies suggest that layer IV and V pyramidal cells are most 
affected by tDCS.30 In PFC, these cells receive direct and indirect regulatory signals from the striatal 
dopaminergic system, and striatal modulation of prefrontal pyramidal cells has been linked to cognitive 
control.31 We believe right inferior frontal gyrus to be the prime candidate for cognitive control 
enhancement with tDCS, given recent published results showing that greater activation in the right IFG 
during a standard Stroop task, but not striatum, was associated with greater reduction in cotinine 
levels.32,33 Participants across the 4 conditions will be assigned to a group involving either active (2.0 
mA) or sham (0.1 mA) tDCS, with anode electrode placement over the right IFG and cathode electrode 
placement over the left bicep. tDCS will be administered the first thirty minutes of each of the 10 2-hour 
CR sessions. During tDCS, patients will be monitored for possible negative side effects.  
Measures.  
Cognitive Control: 
MATRICS Clinical Consensus Battery (MCCB). An abbreviated MCCB will be completed 
before and after CR + tDCS. Subscales include: Attention: The Continuous Performance Test (CPT), 
the Continuous Performance Test—Identical Pairs (CPT-IP), and the A-X Continuous Performance 
Test (AX-CPT). Working memory: N-Back digit sequencing from the BACS, Spatial span from the 
Wechsler Memory Scale, 3rd ed. (WMS-III), Letter-number sequencing from the WAIS-III, Spatial 
delayed response task. Reasoning/problem solving: Block design from the WAIS-III, Tower of London 
from the BACS, Mazes and Categories from the Neuropsychological Assessment Battery, Penn 
Conditional Exclusion Test, Sorting test from the Delis-Kaplan Executive Functioning Scale. To reduce 
practice effects, two forms are available for most measures.   
The Continuous Performance Test (CPT) is a go/no-go task requiring continuously 
responding to frequent stimuli, and witholding response to a rare target stimulus. EEG will be recorded 
this task. The AX-CPT also requires maintaining stimulus items in temporary memory store (respond to 
the letter ‘X’ only when it follows the letter ‘A’). The AX-CPT can measure proactive cognitive control of 
response inhibition. Additionally, a negative ERP, a contingent negative variation (CNV), and a 
reduction in beta-band oscilations compared to baseline (event-related desynchronization (ERD)), 
occur between the alerting stimulus (“A”) and target stimulus (“X”). Both are blunted in schizophrenia 
patients34 and this proactive control deficit may be part of problematic cognitive coordination in 
schizophrenia35.  
Smoking-related reactivity.  
Attentional Bias (Reaction time and ERPs) Participants will be seated in front of a computer 
with a four-button color response box. Four-word lists (two neutral and two smoking-related) of 15 
words each, will be presented in a random order with no repeat. For each trial, a cross appears in the 
center of the screen for 500ms followed by one word from the list in one of the four colors. Participants 
respond by pressing the color button that matches the color in which the word appears. Reaction time 
to respond to each word is recorded within the nearest ms. These procedures are similar to those used 

in a past modified-stroop test with smokers.24 We will also examine EEG correlates of smoking 
reactivity. In past studies, smokers have increased electrophysiological responses to smoking 
compared to neutral images, such that their N200 and P300 ERPs are larger in response to smoking 
stimuli. We will assess this response before and after CR + tDCS to examine neural correlates of 
attentional bias related to increased N200 and P300 in smokers. 
Cue-Induced craving and smoking topography. Participants’ reactivity to smoking-related 
cues will also be assessed at Baseline and Week 4 Assessments. To equate time to last cigarette, 
participants will light a cigarette and smoke as much or as little as they like prior to each the testing 
session. Cue reactivity testing is computer automated. Following a practice trial, the participant will be 
viewed by the experimenter on a monitor outside of the subject room to verify compliance with 
instructions (sit back, focus on pictures, and fill out ratings), which appear on the screen. Four angles of 
each pictorial cue will be presented for 4 smoking and 4 nonsmoking picture trials with self-report 
ratings in between. Each cue trial will end with a computer prompt for subjects to complete post-trial 
craving ratings on a 0-100 scale (4-item Questionnaire on Smoking Urges)36 After the ratings are filled 
out for the last cue-reactivity trial, a screen will appear informing subjects that when the pictures return 
they may smoke as much or as little as they like. They will then complete a 10-minute ad lib smoking / 
cue-viewing period during which all smoking will occur through a CReSS cigarette holder, allowing for 
topographical assessment of latency to light, puff volume, and number of puffs.  
 
Eligibility Criteria  
Inclusion Criteria: 
1. Between the ages of 18 & 65. 
2. Currently meets DSM-5 criteria for Schizophrenia, Schizoaffective Disorder, Schizophreniform 
Disorder, or Delusional Disorder.  
3. Ability to provide written informed consent 
4. Smoke ≥ 7 cigarettes per day  
5. Expired breath CO ≥ 10 ppm at screening 
6. Stable medication regimen for ≥ 4 weeks (If on more than one psychotropic medication, main 
antipsychotic will be considered for stability) 
Exclusion Criteria: 
1. Epilepsy or Current Seizure Disorder 
2. Alcohol or Substance Dependence past 3 months (caffeine allowed, nicotine is part of inclusion 
criteria). 
3. Pregnant or lactating 
4. Psychiatric hospitalization in past 3 months 
5. Suicidal and/or aggressive behavior past 3 months 
6. Implanted cardiac or brain medical devices 
 
Data Analysis 
Prior to hypothesis testing, descriptive statistics and graphic displays will identify outliers and 
missing data and guide the use of transformations and appropriate tests. Correlation and 
principal component analysis will identify any outcomes reflecting the same underlying 
construct, and representative measures will be selected if necessary. We will use 2x2 ANOVA 
to assess the effects of tDCS (vs sham) and CR (vs AC) on pre-post change scores for all 
dependent variables. Should baseline differences be identified, post-training scores will be 
used as dependent variables, and baseline (pre-training) scores will be included as covariates 
in the analysis.  

 
 
 
References 
1. 
Lasser K, Boyd J, Woolhandler S, Himmelstein DU, McCormick D, Bor DH. Smoking and mental 
illness: A population-based prevalence study. JAMA. 2000;284(20):2606-2610. 
doi:10.1001/jama.284.20.2606 
2. 
Williams JM, Steinberg ML, Griffiths KG, Cooperman N. Smokers With Behavioral Health 
Comorbidity Should Be Designated a Tobacco Use Disparity Group. Am J Public Health. 
2013;103(9):1549-1555. doi:10.2105/AJPH.2013.301232 
3. 
Evins AE. Nicotine dependence in schizophrenia: prevalence, mechanisms, and implications for 
treatment. Psychiatr Times. 2008;25(3):55-55. 
4. 
Tidey JW, Rohsenow DJ, Kaplan GB, Swift RM. Subjective and Physiological Responses to 
Smoking Cues in Smokers with Schizophrenia. Nicotine Tob Res. 2005;7(3):421-429. 
doi:10.1080/14622200500125724 
5. 
AhnAllen CG, Tidey JW. Personalized smoking environment cue reactivity in smokers with 
schizophrenia and controls: A pilot study. Psychiatry Res. 2011;188(2):286–288. 
6. 
Mitchell SH. Measures of impulsivity in cigarette smokers and non-smokers. 
Psychopharmacology (Berl). 1999;146(4):455-464. doi:10.1007/PL00005491 
7. 
Sheffer C, MacKillop J, McGeary J, et al. Delay Discounting, Locus of Control, and Cognitive 
Impulsiveness Independently Predict Tobacco Dependence Treatment Outcomes in a Highly 
Dependent, Lower Socioeconomic Group of Smokers. Am J Addict. 2012;21(3):221-232. 
doi:10.1111/j.1521-0391.2012.00224.x 
8. 
Evins AE, Cather C, Deckersbach T, et al. A double-blind placebo-controlled trial of bupropion 
sustained-release for smoking cessation in schizophrenia. J Clin Psychopharmacol. 
2005;25(3):218-225. 
9. 
Ziedonis D, Hitsman B, Beckham JC, et al. Tobacco use and cessation in psychiatric disorders: 
National Institute of Mental Health report. Nicotine Tob Res. 2008;10(12):1691–1715. 
10. 
George TP, Ziedonis DM, Feingold A, et al. Nicotine Transdermal Patch and Atypical 
Antipsychotic Medications for Smoking Cessation in Schizophrenia. Am J Psychiatry. 
2000;157(11):1835-1842. doi:10.1176/appi.ajp.157.11.1835 
11. 
George TP, Vessicchio JC, Termine A, et al. A placebo controlled trial of bupropion for smoking 
cessation in schizophrenia. Biol Psychiatry. 2002;52(1):53–61. 
12. 
Hogarty GE, Flesher S, Ulrich R, et al. Cognitive enhancement therapy for schizophrenia: Effects 
of a 2-year randomized trial on cognition and behavior. Arch Gen Psychiatry. 2004;61(9):866-
876. doi:10.1001/archpsyc.61.9.866 

13. 
Coffman BA, Trumbo MC, Clark VP. Enhancement of object detection with transcranial direct 
current stimulation is associated with increased attention. BMC Neurosci. 2012;13:108. 
doi:10.1186/1471-2202-13-108 
14. 
Clark VP, Coffman BA, Mayer AR, et al. TDCS guided using fMRI significantly accelerates 
learning to identify concealed objects. NeuroImage. 2012;59(1):117-128. 
doi:10.1016/j.neuroimage.2010.11.036 
15. 
Marshall L, Mölle M, Hallschmid M, Born J. Transcranial Direct Current Stimulation during Sleep 
Improves Declarative Memory. J Neurosci. 2004;24(44):9985-9992. 
doi:10.1523/JNEUROSCI.2725-04.2004 
16. 
Fecteau S, Knoch D, Fregni F, Sultani N, Boggio P, Pascual-Leone A. Diminishing Risk-Taking 
Behavior by Modulating Activity in the Prefrontal Cortex: A Direct Current Stimulation Study. J 
Neurosci. 2007;27(46):12500-12505. doi:10.1523/JNEUROSCI.3283-07.2007 
17. 
Fecteau S, Pascual-Leone A, Zald DH, et al. Activation of Prefrontal Cortex by Transcranial 
Direct Current Stimulation Reduces Appetite for Risk during Ambiguous Decision Making. J 
Neurosci. 2007;27(23):6212-6218. doi:10.1523/JNEUROSCI.0314-07.2007 
18. 
Kay SR, Flszbein A, Opfer LA. The positive and negative syndrome scale (PANSS) for 
schizophrenia. Schizophr Bull. 1987;13(2):261. 
19. 
DiClemente CC, Prochaska JO, Fairhurst SK, Velicer WF, Velasquez MM, Rossi JS. The 
process of smoking cessation: an analysis of precontemplation, contemplation, and preparation 
stages of change. J Consult Clin Psychol. 1991;59(2):295. 
20. 
Gwaltney CJ, Metrik J, Kahler CW, Shiffman S. Self-efficacy and smoking cessation: a meta-
analysis. Psychol Addict Behav J Soc Psychol Addict Behav. 2009;23(1):56-66. 
doi:10.1037/a0013529 
21. 
Barch DM, Braver TS, Nystrom L, Noll DC, Cohen JD. Activation of prefronal cortex by the 
representation and maintainance of context information. Schizophr Res. 1997;24(1):163–163. 
22. 
Carter CS, Braver TS, Barch DM, Botvinick MM, Noll D, Cohen JD. Anterior cingulate cortex, 
error detection, and the online monitoring of performance. Science. 1998;280(5364):747–749. 
23. 
Conklin CA, Vella EJ, Joyce CJ, Salkeld RP, Perkins KA, Parzynski CS. Examining the 
relationship between cue-induced craving and actual smoking. Exp Clin Psychopharmacol. 
2015;23(2):90. 
24. 
Drobes DJ, Elibero A, Evans DE. Attentional bias for smoking and affective stimuli: a Stroop task 
study. Psychol Addict Behav. 2006;20(4):490. 
25. 
Ben-Yishay Y, Piasetsky EB, Rattok J. A systematic method for ameliorating disorders in basic 
attention. Published online 1987. Accessed July 11, 2016. http://psycnet.apa.org/psycinfo/1987-
97860-008 
26. 
Bindman LJ, Lippold OCJ, Redfearn JWT. The action of brief polarizing currents on the cerebral 
cortex of the rat (1) during current flow and (2) in the production of long-lasting after-effects. J 
Physiol. 1964;172(3):369. 

27. 
Landau WM, Bishop GH, Clare MH. Analysis of the form and distribution of evoked cortical 
potentials under the influence of polarizing currents. J Neurophysiol. 1964;27(5):788–813. 
28. 
Purpura DP, McMurtry JG. Intracellular activities and evoked potential changes during 
polarization of motor cortex. J Neurophysiol. 1965;28(1):166–185. 
29. 
Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak 
transcranial direct current stimulation. J Physiol. 2000;527(3):633–639. 
30. 
Radman T, Ramos RL, Brumberg JC, Bikson M. Role of cortical cell type and morphology in 
subthreshold and suprathreshold uniform electric field stimulation in vitro. Brain Stimulat. 
2009;2(4):215–228. 
31. 
Goldman-Rakic PS. Regional and cellular fractionation of working memory. Proc Natl Acad Sci. 
1996;93(24):13473–13480. 
32. 
Brewer JA, Worhunsky PD, Carroll KM, Rounsaville BJ, Potenza MN. Pretreatment brain 
activation during stroop task is associated with outcomes in cocaine-dependent patients. Biol 
Psychiatry. 2008;64(11):998–1004. 
33. 
Krishnan-Sarin S, Balodis IM, Kober H, et al. An exploratory pilot study of the relationship 
between neural correlates of cognitive control and reduction in cigarette use among treatment-
seeking adolescent smokers. Psychol Addict Behav. 2013;27(2):526. 
34. 
Dias EC, Bickel S, Epstein ML, Sehatpour P, Javitt DC. Abnormal task modulation of oscillatory 
neural activity in schizophrenia. Published online 2013. Accessed January 6, 2017. 
https://books.google.com/books?hl=en&lr=&id=7QB7CgAAQBAJ&oi=fnd&pg=PA209&dq=Dias,+
E.+C.,+Bickel,+S.,+Epstein,+M.+L.,+Sehatpour,+P.,+%26+Javitt,+D.+C.+&ots=21GJdfR-
j8&sig=C0lJ95oZ2mCoe-gQfcdgCmJLot8 
35. 
Phillips W, Silverstein S. Convergence of biological and psychological perspectives on cognitive 
coordination in schizophrenia. Behav Brain Sci. 2002;26(1). Accessed January 6, 2017. 
http://clin-eeglab.narod.ru/mmn/BBSCommentary.pdf 
36. 
Carter BL, Tiffany ST. The cue-availability paradigm: the effects of cigarette availability on cue 
reactivity in smokers. Exp Clin Psychopharmacol. 2001;9(2):183-190. 
 
 
 

  
University of Pittsburgh 
Institutional Review Board 
3500 Fifth Avenue 
Pittsburgh, PA 15213 
(412) 383-1480 
(412) 383-1508 (fax) 
http://www.irb.pitt.edu 
  
  
Memorandum 
  
  
To: 
Cynthia Conklin, 
From: 
Jamie Zelazny, PhD, Vice Chair 
Date: 
12/13/2018 
IRB#: 
REN18110090  / PRO17080543 
Subject: tDCS and cognitive training intervention for chronic smokers with schizophrenia 
(TACTICSS) 
 
 
The Renewal for the above referenced research study was reviewed and approved by 
the Institutional Review Board, Committee G , which met on 12/12/2018. 
Please note the following information: 
The risk level designation is Greater Than Minimal. 
Approval Date: 
12/12/2018 
Expiration Date: 
12/11/2019 
Please note that it is the investigator’s responsibility to report to the IRB any unanticipated 
problems involving risks to subjects or others [see 45 CFR 46.103(b)(5) and 21 CFR 
56.108(b)]. Refer to the IRB Policy and Procedure Manual regarding the reporting 
requirements for unanticipated problems which include, but are not limited to, adverse 
events.  If you have any questions about this process, please contact the Adverse Events 
Coordinator at 412-383-1480. 
The protocol and consent forms, along with a brief progress report must be resubmitted at 
least one month prior to the renewal date noted above as required by FWA00006790 
(University of Pittsburgh), FWA00006735 (University of Pittsburgh Medical Center), 

FWA00000600 (Children’s Hospital of Pittsburgh), FWA00003567 (Magee-Womens Health 
Corporation), FWA00003338 (University of Pittsburgh Medical Center Cancer Institute). 
Please be advised that your research study may be audited periodically by the 
University of Pittsburgh Research Conduct and Compliance Office. 
 
  
University of Pittsburgh 
Institutional Review Board 
3500 Fifth Avenue 
Ground Level 
Pittsburgh, PA 15213 
(412) 383-1480 
(412) 383-1508 (fax) 
http://www.irb.pitt.edu 
 Memorandum 
  
 
To: 
Cynthia Conklin  
From: 
IRB Office 
Date: 
6/14/2018 
IRB#: 
MOD17080543-02 / PRO17080543 
Subject: tDCS and cognitive training intervention for chronic smokers with 
schizophrenia (TACTICSS)   
 
 
The University of Pittsburgh Institutional Review Board reviewed and approved the 
requested modifications by expedited review procedure authorized under 45 CFR 46.110 and 
21 CFR 56.110. 
Modification Approval Date:   6/14/2018 
Expiration Date:                   1/30/2019 
The following documents were approved by the IRB: 
TACTICSS 

For studies being conducted in UPMC facilities, no clinical activities that are impacted by 
the modifications can be undertaken by investigators until they have received approval from 
the UPMC Fiscal Review Office. 
Please note that it is the investigator’s responsibility to report to the IRB any unanticipated 
problems involving risks to subjects or others [see 45 CFR 46.103(b)(5) and 21 CFR 
56.108(b)]. Refer to the IRB Policy and Procedure Manual regarding the reporting 
requirements for unanticipated problems which include, but are not limited to, adverse 
events. If you have any questions about this process, please contact the Adverse Events 
Coordinator at 412-383-1480. 
The protocol and consent forms, along with a brief progress report must be resubmitted at 
least one month prior to the renewal date noted above as required by FWA00006790 
(University of Pittsburgh), FWA00006735 (University of Pittsburgh Medical Center), 
FWA00000600 (Children’s Hospital of Pittsburgh), FWA00003567 (Magee-Womens Health 
Corporation), FWA00003338 (University of Pittsburgh Medical Center Cancer Institute). 
Please be advised that your research study may be audited periodically by the 
University of Pittsburgh Research Conduct and Compliance Office. 
  
University of Pittsburgh 
Institutional Review Board 
3500 Fifth Avenue 
Pittsburgh, PA 15213 
(412) 383-1480 
(412) 383-1508 (fax) 
http://www.irb.pitt.edu 
  
Memorandum 
  
  
To: 
Cynthia Conklin, PhD  
From: 
Margaret Hsieh, MD, Vice Chair 
Date: 
2/20/2018 
IRB#: 
PRO17080543  
Subject: tDCS and cognitive training intervention for chronic smokers with schizophrenia 
(TACTICSS) 

 
At its full board meeting on 1/31/2018, the University of Pittsburgh Institutional Review 
Board, Committee H, reviewed the above referenced research study and approved it pending 
minor modifications. Your responses to these comments have been reviewed and the 
research submission, in its currently modified form, adequately addresses the concerns of the 
IRB and is therefore approved.  
Please note the following information: 
The risk level designation is Greater Than Minimal Risk. 
This study is supported by the following federal grant application: 
R21DA045137 Cognitive remediation and transcranial direct current stimulation to aid 
smokers with schizophrenia 
The IRB has approved the waiver for the requirement to obtain a written informed consent 
for a screening interview. 
  
The IRB has approved the waiver for the requirement to obtain informed consent to use 
protected health information to identify potential research subjects. 
The IRB has approved the advertisement that was submitted for review as written. As a 
reminder, any changes to the advertisement other than to edit contact information requires 
IRB approval prior to distribution. 
Approval Date:    2/16/2018 
Expiration Date:  1/30/2019 
For studies being conducted in UPMC facilities, no clinical activities can be undertaken by 
investigators until they have received approval from the UPMC Fiscal Review Office. 
Please note that it is the investigator’s responsibility to report to the IRB any unanticipated 
problems involving risks to subjects or others [see 45 CFR 46.103(b)(5) and 21 CFR 
56.108(b)]. Refer to the IRB Policy and Procedure Manual regarding the reporting 
requirements for unanticipated problems which include, but are not limited to, adverse 
events.  If you have any questions about this process, please contact the Adverse Events 
Coordinator at 412-383-1480. 

The protocol and consent forms, along with a brief progress report must be resubmitted at 
least one month prior to the renewal date noted above as required by FWA00006790 
(University of Pittsburgh), FWA00006735 (University of Pittsburgh Medical Center), 
FWA00000600 (Children’s Hospital of Pittsburgh), FWA00003567 (Magee-Womens Health 
Corporation), FWA00003338 (University of Pittsburgh Medical Center Cancer Institute). 
Please be advised that your research study may be audited periodically by the 
University of Pittsburgh Research Conduct and Compliance Office.