Electrophysiological Predictors and Indicators of Contingency Management Treatment Response
Phase: NA
Conditions: Cocaine Use Disorder
Sponsor: VA Office of Research and Development

IRBNet #1617313 Protocol Version 1.5 
 
 
 
NCT03799341 
IRBNet #1617313 (ProSPECT #00002689)  
Electrophysiological Predictors and Indicators of Contingency Management  
Treatment Response 
Funding Agency: VA ORD 
Principal Investigator: Stuart Steinhauer, PhD1 
 
 
Version Date:  06-02-25 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 Dr. Steinhauer is the custodial PI following departure of the original PI (Dr. Sarah 
Forster) from VA Service. 

IRBNet #1617313 Protocol Version 1.5 
NOTE:  This is the protocol document approved by the VA Pittsburgh Healthcare System Institutional 
Review Board.  Formatting of this document reflects the original protocol management system 
(ProSPECT) in which the submission was developed.  
 
Study Identification Information 
1.0 * Study Name: 
Electrophysiological Predictors and Indicators of Contingency Management Treatment Response   
2.0  
* Brief Description (using layman's terms) - 500 words or less: 
Electrophysiological methods, including event-related potential and functional connectivity approaches, 
have potential to clarify mechanisms of substance use treatment response and characterize individual 
differences therein. Veterans are disproportionately affected by disorders of addiction, of which cocaine 
use disorder (CUD) is particularly problematic due to high relapse rates and the absence of approved 
pharmacotherapy options. Behavioral interventions for CUD have therefore become an important focus 
and Contingency Management (CM) has emerged as the best-supported approach. CM involves 
reinforcing cocaine abstinence (established through objective testing) with reliable, short-term reward, 
such as chances to win prizes (i.e., Prize-Based CM or PBCM). Given robust empirical support, 
nationwide dissemination of PBCM has been supported by a VHA initiative since 2011. However, PBCM 
response rates are variable and long-term benefits are limited – problems magnified by the cost of 
implementation with respect to staffing and prizes. Measurement-based approaches to PBCM 
implementation have promise to improve the effectiveness and efficiency of CM programming but have 
not yet been investigated within the VA or considered in relation to promising neuromarkers. 
Importantly, two versions of PBCM are already utilized at VA sites and may differentially benefit 
individuals with distinct neurocognitive profiles. Specifically, VA PBCM programs employ either abstract 
(voucher prize) or concrete (tangible prize) incentives, the latter of which may more effectively 
incentivize abstinence in Veterans with poor future-oriented thinking and planning ability. While 
selection between existing PBCM variants currently reflects practical considerations only, pretreatment 
neurocognitive functioning could meaningfully and realistically inform clinical decision-making in this 
regard. A sample of healthy controls will also be recruited for evaluation and serve as a comparison 
group to evaluate the differences between the treatment-seeking CUD sample and the healthy veteran 
sample. 
This project aims to advance measurement-based implementation of CM by testing a novel 
neurocognitive model with immediate implications for the use of abstract versus concrete PBCM 
incentives within the VA. Specifically, the future-minded decision-making (FMDM) model posits that CM 
scaffolds future-oriented goal representation and self-control to support abstinence during in the 
moment use-related decision-making. For individuals with greater FMDM impairment, concrete, readily-
accessible incentives may be more effective than abstract voucher-based rewards (which require future-
oriented thinking and planning to acquire value). To test this model, neurocognitive substrates of FMDM 
will be examined as predictors of differential treatment response in voucher (VoucherPBCM) versus 
tangible prize (TangiblePBCM) versions of PBCM. Veterans with CUD will be allocated to VoucherPBCM 
or TangiblePBCM, and followed for a 12-week treatment interval. Pre- and post-treatment 

IRBNet #1617313 Protocol Version 1.5 
electroencephalography (EEG) and cognitive-behavioral assessments will be used to measure FMDM-
related constructs (working memory, self-control, future-oriented decision-making, future reward 
representation) and related neuromarkers. These measures will be investigated as predictors of 
differential treatment response in VoucherPBCM versus TangiblePBCM, as well as maintenance of gains 
during a post-treatment follow-up period. Change in FMDM-related neural and cognitive measures over 
the course of treatment will also be evaluated for evidence of neuroadaptation (e.g., changes in 
functional connectivity) and enhancement of FMDM function through PBCM. Taken together, results of 
the current research project will represent a first step toward precision implementation of CM within 
the VA. 
 3.0 * Is this research study a Greater than Minimal Risk Clinical Trial?    Yes No  
 4.0 * Is this study a Greater than Minimal Risk Comparative Effectiveness research?   Yes No   
5.0 * Principal Investigator: 
Stuart Steinhauer, PhD (custodial PI) 
 
    
View: 1.0 Study Identification Information  
 Study Identification Information (Continued) 
1.0  
* Do you certify that all research staff administering informed consent are knowledgeable about the 
study? 
yes  
   
2.0  
* To the best of your knowledge do you, or any member of your research staff, have any potential, 
actual or perceived conflict of interest of a professional or personal nature that may affect any aspect of 
the research, including, but not limited to, the review and/or conduct of this study? 
  Yes No 
 
If yes, provide a description, including name of study team member with conflict: 
Dr. Steinhauer is a member of IRB1 and IRB2.  
  
3.0 * Qualifications of the Investigators: 
Stuart Steinhauer, PhD., VA Mentor/Principal Investigator (2.4 cal mos, GS 14/9, 5/8th VA). 

IRBNet #1617313 Protocol Version 1.5 
Dr. Steinhauer is a VAPHS Research Health Scientist and Adjunct Research Associate Professor of 
Psychiatry at the University of Pittsburgh. He additionally serves as the Director of the Biometrics 
Research Program at VAPHS and the University of Pittsburgh, Department of Psychiatry, including the 
Biometrics Research Laboratory at VAPHS where the proposed work will take place. Dr. Steinhauer is a 
renowned expert on psychophysiology with over three decades of VA research and mentorship 
experience and will serve as Dr. Forster’s primary mentor on the proposed work. Dr. Steinhauer has 
overseen Dr. Forster’s training throughout the award period and provided regular guidance on 
implementation of all planned research activities, as well as quality assessment, management, and 
analysis of all resulting data.  As Dr. Forster has recently transitioned to a non-VA position, Dr. 
Steinhauer will assume the role of PI for the remainder of the award period.  Recruitment for the study 
has already concluded, so remaining activities to be overseen by Dr. Steinhauer will center around final 
data collection, data analysis, and study closure. 
Sarah Forster, PhD., VA Mentee/Co-Investigator, (2.4 cal mos, GS 11/1, 2/8th VA). Dr. Forster has 
directly overseen all aspects of the proposed research and received specialized career development 
training throughout the funding period. Her responsibilities with respect to the current research have 
included oversight of all participant recruitment, participant enrollment and retention, administration of 
research assessments, intervention delivery, data collection and management, data analysis, and 
dissemination of findings. She was also responsible for hiring, training, and direct supervision of all 
research personnel. Dr. Forster has previously committed 75% effort on the current project and 25% 
effort in clinical activities through the Behavioral Health Service Line at VA Pittsburgh Healthcare 
System. Dr. Forster is a licensed clinical psychologist and has over fourteen years of relevant research 
experience. Dr. Forster has recently transitioned to a non-VA position and will no longer be able to serve 
as PI for the remainder of the award period, but will continue on as a Co-I. 
 
View: 1.2 VA Involvement  
 VA Involvement 
1.0  
Does the proposed research involve any of the following?: 
  Name  
X VA Funding  
X  VA Personnel Funded Effort  
X  VA Patients or their Private Health Information  
     Other VA Resources: Central IRB  
X   Other VA Resources: VA Equipment  
X   Other VA Resources: VA Property (Including space leased to, or used by VA)  
X    Other VA Resources: VA Databases  
None of the Above apply to this research  
    
View: 1.3 Study Funding Information  

IRBNet #1617313 Protocol Version 1.5 
Study Funding Information 
 
1.0  
* Funding Sources: 
Funding Source (Other) Code  
 
Clinical Science R&D  (9050):  VA Career Development Award 
Veterans Research Foundation of Pittsburgh (VRFP):Gerald Goldstein Early Career Mental Health 
Research Award 
  
2.0  
Upload Grant Application, if applicable (If NIH, VA, voluntary agency, must upload): 
Name Modified Date  
CDA Required Sections 9/27/2018 11:03 AM  
Forster CDA Research Plan 7/11/2019 2:41 PM  
Goldstein Award 1/7/2021 11:21 AM  
    
View: 1.4 Resources  
 1.0   
* Do you currently have adequate resources (e.g., staff, physical space, information technology, etc.) to 
protect the safety of participants, staff, and the confidentiality of subjects’ data during the conduct of 
this study?  
  Yes No 
If yes, include a listing of the VAPHS resources that will be used for this study and are necessary to 
protect participants.  
Dr. Steinhauer is the Director of the Biometrics Research Program and has provided Dr. Forster with 150 
sq ft of laboratory space at the Research Office Building of the VAPHS University Drive Campus in order 
to conduct the current project. This lab space has been outfitted with equipment for the acquisition and 
analysis of electroencephalographic (EEG), pupillometry, and cognitive-behavioral (e.g., response time 
and accuracy) data, as well as presentation of experimental stimuli such as images and sounds. Updated 
equipment has additionally been purchased using funds from the current award. A larger laboratory 
space  (~300 sq ft) is also available for our use and equipment may be migrated to this location, when 
necessary. Drs. Forster and Steinhauer also have office space and access to Dell workstations at the 
Research Office Building that can be used for data management and miscellaneous study duties. Also 
available at the Research Office Building are several interview/treatment rooms that may be used for 
the informed consent process, as well as collection of self-report and interview data and administration 
of treatment and check-in sessions, as needed. Facilities are also available for the acquisition, testing, 

IRBNet #1617313 Protocol Version 1.5 
and disposal of urine and saliva specimens that will be acquired to screen for recent substance use. Our 
budget includes funds for personal protective equipment and related supplies involved in the safe 
handling and disposal of urine and saliva specimens.  
Contingency Management (CM) is offered through the Center for the Treatment of Addictive Disorders 
at VA Pittsburgh Healthcare System. Dr. Forster has served as the local implementation coordinator for 
CM in consultation with the VHA National CM Implementation team and head of this effort, Dr. Dominic 
DePhilippis of the Philadelphia CESATE. Office and storage space in Building 29 will be available for 
treatment delivery and necessary supplies for CM delivery are available or will be purchased with study 
funds. The team leader of CTAD and VISN 4 SUD Lead, Dr. Leigh Gemmell, has provided a letter of 
support for the proposed work (see Section 15: Miscellaneous Documents). It is further noted that 
investigators will have access to the study population through recruitment mechanism described in the 
protocol and feasibility of recruitment has already been demonstrated in a separate pilot project 
(Pro1787). A letter of support has been provided by the Behavioral Health service line. 
If no, please describe the resources that will be needed and explain how the resources will be obtained 
before the study is initiated: 
 
2.0  * VAPHS requires that either the PI or co-PI have a physical presence at VAPHS. Please describe the 
role the PI and/or co-PI have at VAPHS with respect to clinical responsibilities or in relation to other 
research activities. 
The original PI (Forster) was an 8/8 Research Health Science Specialist at VAPHS from 1/2019-10/2023.  
The current PI (Steinhauer) maintained a 5/8 Research Health Science Specialist position at VAPHS 
throughout the remainder of the active award period.  Both Drs. Steinhauer and Forster continue to 
maintain a physical presence at VAPHS, where Dr. Steinhauer maintains his position as Director of the 
Biometrics Research Program and Dr. Forster maintains a Without Compensation (WOC) appointment.  
3.0  * Will off-site ancillary service facilities (e.g., radiology services, central labs, non VA space, etc) be 
used for this study? 
  Yes No  
If yes, please provide the location and a brief description of the project activities to be conducted at the 
off-site ancillary facilities: 
  
4.0  * Will a firm be contracted to obtain consent from subjects, collect private individually identifiable 
information from human subjects, or be involved in activities that would institutionally engage the firm 
in human subjects’ research?  
  Yes No  
 
If yes, please provide a description of the contracted service(s): 
* Please specify the IRB that has oversight of the firm's activity(ies): 

IRBNet #1617313 Protocol Version 1.5 
 
Name of Site / Institution IRB Approval Document FWA Number  
There are no items to display  
 
5.0 Collaborations 
Please list any non-VAPHS institutions or individuals (i.e. co-authors, mentors, etc.) that you will 
collaborate with and describe their specific role in the research: 
The following individuals will serve as collaborators and will not have access to data. Drs. Dickey and 
Siegle may view results of the study in aggregate form. Other collaborators will provide consultation and 
training without access to study data in aggregate or non-aggregate form. 
Michael Walsh Dickey, PhD., VA Co-Mentor (0.6 cal mos, GS 13/7, 5/8th VA). Dr. Dickey is a VAPHS 
Geriatric Research, Education, and Clinical Center Research Scientist at VAPHS, as well as an Associate 
Professor of Psychology and Communication Science and Disorders at the University of Pittsburgh. Dr. 
Dickey will oversee Dr. Forster’s training in the area of neuroadaptive processes underlying cognitive 
recovery, as well as application of this knowledge to develop future directions of the proposed work. He 
will also work with Dr. Forster to conduct exploratory longitudinal analyses using mixed effects modeling 
to evaluate interrelationships between multivariate treatment outcomes (e.g., neurocognitive recovery 
vis-à-vis changes in substance use over time). 
Greg Siegle, PhD., Non-VA Mentor. Dr. Siegle is an Associate Professor of Psychology and Psychiatry at 
the University of Pittsburgh with expertise in EEG, functional connectivity analysis, neuropredictive 
analytics, and longitudinal analysis of biological signals. He will oversee Dr. Forster’s training in these 
areas and will additionally assist Dr. Forster in setting up new lab equipment and optimizing data quality. 
Dr. Siegle will provide guidance on implementation of functional connectivity analyses and will work 
with Dr. Forster to improve the translational potential of predictive modeling aims, as well as future 
directions of the proposed work. 
Dominick DePhilippis, PhD., Contingency Management Consultant. Dr. DePhilippis is the Education 
Coordinator for the Center of Excellence in Substance Addiction Treatment and Education (CESATE) at 
the Corporal Michael J. Crescenz VA Medical Center and Director of the VHA Contingency Management 
Sustainability Incentive Program. Dr. DePhilippis will provide consultation on clinical implementation of 
Contingency Management at VA Pittsburgh Healthcare system to ensure high-fidelity delivery of the 
intervention in the proposed work. 
William Cohen, PhD., Machine Learning Consultant. Dr. Cohen is a Director of Research & Engineering at 
Google AI. He will provide consultation on the machine learning research and training aims of the 
proposed work. Specifically, Dr. Cohen will work with Dr. Forster to develop predictive models based on 
prospective clinical outcome data from the proposed work using Classification and Regression Tress, 
Random Forests, and Tabu Regression methods. 
William Hetrick, PhD., Functional Connectivity Consultant. Dr. Hetrick is a professor in the Department of 
Psychological and Brain Sciences at Indiana University and also serves as chair of this department. Dr. 

IRBNet #1617313 Protocol Version 1.5 
Hetrick will host Dr. Forster at the Clinical and Cognitive Neuroscience Center at Indiana University to 
conduct week-long hands-on training sessions in functional connectivity analysis. 
Dae-Jin Kim, PhD., Functional Connectivity Consultant. Dr. Kim is a research scientist in the 
Computational Cognitive Neuroscience Laboratory and Clinical and Cognitive Neuroscience Center at 
Indiana University. He will train Dr. Forster on computation of the synchronization likelihood metric of 
functional connectivity which will be utilized to quantify coordination of EEG brain signals across 
electrode sites. 
Olaf Sporns, PhD., Functional Connectivity Consultant. Dr. Sporns is a distinguished professor in the 
Department of Psychological and Brain Sciences at Indiana University, as well as the director of the 
Computational Cognitive Neuroscience Laboratory at that institution. Dr. Sporns will train Dr. Forster on 
graph theoretic analysis of EEG data in order to achieve exploratory aims of the proposed work. 
    
5.1  
If this is not Multi-Site Research, please upload the appropriate written agreement(s) here: 
 
Name  
There are no items to display  
     
View: 1.5 Project Information  
 1.0   
Does the project involve any of the following (check all that apply): 
Biological Hazards (including human biological specimens)  X 
Chemicals  X 
Ionizing radiation or use of radioactive materials   
Drug, Biological, or Nutritional (e.g. herbal or dietary) Supplement  
   
2.0   
Project Focus (check if applicable): 
Traumatic Brain Injury (TBI)  
Post Traumatic/Post Deployment Stress Disorder (PTSD/PDSD)  
Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF)  
 
3.0   
KEYWORDS 

IRBNet #1617313 Protocol Version 1.5 
Please provide a minimum of 3, maximum of 6 keywords.  Please use MeSH terms. 
* Behavior, Addictive 
* Electroencephalography 
* Decision Making 
Reinforcement (Psychology)  
Clinical Decision-Making  
Self-Control  
 
4.0 * Please describe the type of study: 
The proposed work will utilize a prospective Phase III clinical trial design to identify patient-level 
predictors of treatment outcome in TangiblePBCM versus VoucherPBCM (Specific Aim 1) and evaluate 
longitudinal recovery of FMDM function in TangiblePBCM and VoucherPBCM in order to clarify 
mechanisms of CM treatment response (Specific Aim 2). This Class III study will employ stratified 
random assignment into one of two subgroups: (1) 12 weeks of TangiblePBCM (n = 70) or(2) 12 weeks of 
VoucherPBCM (n = 70),. As CM is an adjunctive treatment option, it is noted that patients in both CM 
groups will also experience TAU during the CM treatment interval (i.e., PBCM = PBCM + TAU). CM 
recipients will additionally be followed for 6 months post treatment. Importantly, the proposed design 
enables evaluation of CM outcome predictors within a total sample of 140 CM recipients – both with 
respect to initial treatment response and longer term (6 month post-treatment outcomes Participants 
will receive a Baseline Assessment prior to the initial 12 Week Treatment interval (TangiblePBCM or 
VoucherPBCM), as well as a Follow-up Assessment at the conclusion of this period. Data from Baseline 
and Follow-up Assessments will enable longitudinal analysis of treatment-related change in EEG and 
cognitive-behavioral measures in TangiblePBCM and VoucherPBCM. For all CM recipients, CM treatment 
data (i.e., attendance, urinalysis results, prize outcomes) will be monitored throughout the 12 Week 
treatment interval. Substance use during the treatment interval will additionally be monitored for all 
participants (i.e., CM) through weekly self-report measures and urine-based drug tests; outpatient 
treatment engagement will be quantified on the basis of chart review. For CM recipients, treatment 
engagement and self-reported substance use will additionally be followed on a monthly basis for 6 
months post-treatment. This design therefore provides for quantification of CM treatment response and 
long-term outcomes for both TangiblePBCM and VoucherPBCM subgroups. Pre-treatment predictors of 
CM treatment response and long-term outcomes can therefore be evaluated for all CM recipients (n = 
140) by including treatment condition (TangiblePBCM versus VoucherPBCM) as an explanatory variable 
to parse condition-specific predictors.   
A sample of healthy controls, who either do not have a history of substance use treatment or have been 
in recovery for ≥1 year, will also be recruited as a comparison group.  
  

IRBNet #1617313 Protocol Version 1.5 
5.0 * Will any of the research being conducted as a part of this study be used to fulfill academic 
requirements (e.g., master’s thesis, dissertation, or other academic program requirements necessary to 
obtain a degree/certification, etc.)?   Yes No   
    
View: 1.6 (CR) Study Locations  
Study Locations 
 
1.0  
* Please add the local sites where this study will be conducted: 
 
  Location  
View VAPHS University Drive Division    
 If Other, Please Specify: 
      
View: 1.6.1 (CR) Multi-Site Study  
1.6.1 Multi-Site Study 
1.0 * Is this a multi-site study: 
  Yes No     
View: 1.7 Section Chief and Service Line VP approvals  
Please upload the approval of the Section Chief, if applicable and the Service Line VP. 
 
1.0  * Institutional Approval Document: 
PART I (0.04)       
View: 2 Study Objectives & Design  
Study Summary 
 
1.0 Funding End Date: 
1/1/2024   
2.0   

IRBNet #1617313 Protocol Version 1.5 
* Abstract.  Please provide a brief description of the study. 
Electrophysiological methods, including event-related potential and functional connectivity approaches, 
have potential to clarify mechanisms of substance use treatment response and characterize individual 
differences therein. Veterans are disproportionately affected by disorders of addiction, of which cocaine 
use disorder (CUD) is particularly problematic due to high relapse rates and the absence of approved 
pharmacotherapy options. Behavioral interventions for CUD have therefore become an important focus 
and Contingency Management (CM) has emerged as the best-supported approach. CM involves 
reinforcing cocaine abstinence (established through objective testing) with reliable, short-term reward, 
such as chances to win prizes (i.e., Prize-Based CM or PBCM). Given robust empirical support, 
nationwide dissemination of PBCM has been supported by a VHA initiative since 2011. However, PBCM 
response rates are variable and long-term benefits are limited – problems magnified by the cost of 
implementation with respect to staffing and prizes. Measurement-based approaches to PBCM 
implementation have promise to improve the effectiveness and efficiency of CM programming but have 
not yet been investigated within the VA or considered in relation to promising neuromarkers. 
Importantly, two versions of PBCM are already utilized at VA sites and may differentially benefit 
individuals with distinct neurocognitive profiles. Specifically, VA PBCM programs employ either abstract 
(voucher prize) or concrete (tangible prize) incentives, the latter of which may more effectively 
incentivize abstinence in Veterans with poor future-oriented thinking and planning ability. While 
selection between existing PBCM variants currently reflects practical considerations only, pretreatment 
neurocognitive functioning could meaningfully and realistically inform clinical decision-making in this 
regard. 
 This project aims to advance measurement-based implementation of CM by testing a novel 
neurocognitive model with immediate implications for the use of abstract versus concrete PBCM 
incentives within the VA. Specifically, the future-minded decision-making (FMDM) model posits that CM 
scaffolds future-oriented goal representation and self-control to support abstinence during in the 
moment use-related decision-making. For individuals with greater FMDM impairment, concrete, readily-
accessible incentives may be more effective than abstract voucher-based rewards (which require future-
oriented thinking and planning to acquire value). To test this model, neurocognitive substrates of FMDM 
will be examined as predictors of differential treatment response in voucher (VoucherPBCM) versus 
tangible prize (TangiblePBCM) versions of PBCM. Veterans with CUD will be allocated to VoucherPBCM 
or TangiblePBCM conditions and followed for a 12-week treatment interval. Pre- and post-treatment 
electroencephalography (EEG) and cognitive-behavioral assessments will be used to measure FMDM-
related constructs (working memory, self-control, future-oriented decision-making, future reward 
representation) and related neuromarkers. These measures will be investigated as predictors of 
differential treatment response in VoucherPBCM versus TangiblePBCM, as well as maintenance of gains 
during a post-treatment follow-up period. Change in FMDM-related neural and cognitive measures over 
the course of treatment will also be evaluated for evidence of neuroadaptation (e.g., changes in 
functional connectivity) and enhancement of FMDM function through PBCM. Taken together, results of 
the current research project will represent a first step toward precision implementation of CM within 
the VA. A sample of healthy controls will also be recruited as a comparison group.   
3.0 * Describe the study objectives. Please include primary aim and hypothesis, if applicable any 
secondary aims and hypotheses.  

IRBNet #1617313 Protocol Version 1.5 
 
Veterans are disproportionately affected by addictive disorders [1,2] and these conditions increase the 
likelihood of homelessness, hospitalization, incarceration, and premature death [3-5]. Rising rates have 
further been reported amongst returning OEF/OIF/OND service members – with nearly one in five 
diagnosed with a drug use disorder [6]. Cocaine use disorder (CUD) is prevalent [7] and has been 
associated with poorer treatment outcomes in other high-priority mental health conditions affecting 
Veterans (e.g., opioid use disorder and PTSD) [8-12], with which CUD frequently co-occurs. 
Unfortunately, the absence of approved pharmacotherapy options for CUD makes treatment 
engagement and relapse prevention particularly challenging. In order to improve CUD treatment 
options, in 2011 the VHA announced the national rollout of Contingency Management (CM) [13,14] – an 
empirically-supported behavioral intervention offering incentives (e.g., opportunities to win prizes) for 
negative urine drug screens to reinforce abstinence over a 12-week period. However, while the evidence 
base for CM is strong, individual responses to CM are variable [15] and long-term outcomes remain poor 
[16]. Improving the effectiveness of VA CM programming would achieve sweeping benefits for Veterans 
but demands clarification of mechanisms and predictors underlying CM treatment response. In 
particular, this knowledge will enable measurement-based adaptation of CM treatment parameters to 
better meet individual patient needs. This approach has already demonstrated promise [17] and is 
poised for rapid translation into clinical settings – although previous work has focused on customizing 
the magnitude and probability of CM reinforcement and this may engender ethical and pragmatic 
barriers to implementation. Fortunately, a recently proposed future-minded decision-making (FMDM) 
account of CM [18,19] highlights additional reinforcement parameters (e.g., tangibility of future reward), 
as well as cognitive components of the intervention that may be more suitable for measurement-based 
adaptation. According to the FMDM account, CM fosters representation of recovery-related goals in 
working memory (e.g., future abstinence-contingent reward) to potentiate inhibitory control during in 
the moment use-related decision-making. Critically, individuals with more profound FMDM deficits may 
require stronger scaffolding of future reward representation – for example, by providing concrete rather 
than abstract monetary incentives. This may have immediate implications for CM implementation 
throughout the VA, wherein a prize-based, intermittent reinforcement version of CM (PBCM) is used 
with either voucher-based (VoucherPBCM) or tangible object-based (TangiblePBCM) incentives. The 
FMDM model additionally suggests that CM may actively remediate the cognitive abilities underlying 
FMDM and strengthening this mechanism of action may further enhance and prolong benefits. 
Treatment-related neuroadaptation in the context of CM may therefore clarify new opportunities for 
customization and augmentation of existing programming, but has not yet been well-characterized.  
The proposed work will test key predictions of the FMDM account of CM with implications for (1) 
improved treatment effectiveness and (2) targeted treatment delivery. Individuals with CUD (n=140) will 
be recruited upon engagement with outpatient substance use services and assigned to 12 weeks of 
TangiblePBCM (n=70) or VoucherPBCM (n=70). Participants in all conditions will complete EEG and 
cognitive-behavioral assessments of core FMDM constructs (i.e., goal-informed cognitive control 
processes, executive working memory, episodic future thinking, and reward anticipation) before and 
after the 12 week treatment interval. Self-report measures of other clinically-relevant indicators (e.g., 
addiction propensity and severity, motivation, self-efficacy) will also be evaluated and outcomes 
(treatment engagement, subjective and objective measures of substance use) will additionally be 

IRBNet #1617313 Protocol Version 1.5 
followed throughout the 12 week treatment interval and for 6 months post-treatment in both CM 
groups. Aims and hypotheses are as follows:   
 
Specific Aim 1: Evaluate the utility of EEG and cognitive-behavioral measures of FMDM as predictors of 
differential treatment outcomes in TangiblePBCM versus VoucherPBCM. 
         Hypothesis 1a. FMDM-related measures will predict differential outcomes in TangiblePBCM relative 
to VoucherPBCM, with more FMDM-impaired individuals demonstrating improved treatment response 
in the former relative to the latter.  
         Hypothesis 1b. Inclusion of predictors from the FMDM account will significantly improve 
performance of predictive models forecasting short- and long-term outcomes in CM and inclusion of 
these predictors will be robust to model-based constraints favoring variables with lower measurement 
costs. 
Specific Aim 2: Evaluate treatment-related change in EEG and cognitive-behavioral correlates of FMDM-
related cognitive functioning during CM.   
         Hypothesis 2a. Individuals who reliably engage in TangiblePBCM and VoucherPBCM will 
demonstrate greater treatment-related change in functional connectivity networks underlying goal-
informed cognitive control processes, as well as behavioral measures of working memory and future-
oriented decision-making, relative to individuals who demonstrate poor PBCM adherence. 
         Exploratory Sub-Aim. Longitudinal change in FMDM-related measures will be investigated in 
relation to patterns of abstinence during PBCM and will reflect distinct treatment response trajectories. 
4.0 * Provide a summary of the background of the study, and explain how this research will contribute 
to existing knowledge.  Describe previous studies that provides a basis to show that the proposed 
research can be carried out without undue risk to human subjects.   
Background 
Veterans are disproportionately affected by substance use disorders [1,2] – placing those who have 
served at an increased risk of homelessness, hospitalization, incarceration, and preventable death [3-5].  
Taken together, costs associated with substance use-related healthcare, loss of productivity, and 
criminality amount to an annual economic burden of 510 billion dollars in the U.S. [20] – largely due to 
the chronic, relapsing timecourse of addiction. Indeed, over half of Veterans with substance use 
disorders will have a use-related inpatient hospitalization within one year of treatment [21]. Rising rates 
of substance use have further been noted amongst OEF/OIF/OND service members, with an estimated 
5-18% of OEF/OIF veterans meeting past year criteria for a drug use disorder [6,22]. Overall, the 
prevalence and chronicity of addictive disorders amongst Veterans translates into a high demand for 
substance use treatment within the VA, amounting to an estimated cost of 350 million dollars each year 
– 60% of which supports specialty outpatient care [23].  
While the increasing frequency of opioid use disorders amongst Veterans [24] has demanded national 
attention in recent years, cocaine addiction has been prevalent and problematic for decades, with a 
relapse rate higher than most illicit drugs [25,26]. Cocaine use disorder (CUD) additionally complicates 

IRBNet #1617313 Protocol Version 1.5 
treatment of common psychiatric and substance use comorbidities in Veterans – predicting poorer 
outcomes in individuals with post-traumatic stress disorder, schizophrenia, opioid use disorder, and 
traumatic brain injury [8-12]. Unfortunately, while effective treatment of CUD is a clear priority for VHA, 
the absence of FDA-approved pharmacotherapy options for cocaine users has made successful 
treatment engagement and relapse prevention particularly challenging. Without medications to support 
abstinence, providers have increasingly embraced specialized behavioral interventions for CUD; of 
which, Contingency Management (CM) has emerged as the frontline, empirically-supported treatment 
option (when used as an adjunct to treatment-as-usual (TAU) outpatient care). 
In line with VA’s commitment to make ‘gold standard’ substance use treatment accessible to all 
Veterans, VHA announced an initiative supporting nationwide dissemination of CM in 2011 [13,14]. CM 
is a manualized behavioral intervention that offers incentives (e.g., prize vouchers) for negative drug 
screens to reinforce abstinence over a time-limited treatment interval. CM has accumulated substantial 
empirical support over the past 25 years and has been consistently associated with reduced use and 
improved treatment retention in individuals with CUD [16,27-30], as well as other substance use 
disorders [16,29,31-33]. Despite these favorable results, however, CM has been underutilized due to 
insufficient and/or unreliable funding. To address this, VA has specifically adopted a prize-based variant 
of CM [13,14] which utilizes a lower-cost reinforcement schedule with comparable effectiveness [34] to 
improve widespread access. Even so, long-term sustainability of CM within the VA remains uncertain 
and will be bolstered by increased efficiency and effectiveness of CM programming. There are currently 
two primary considerations with respect to this goal: (1) modifying CM to enhance and sustain benefits 
and (2) targeting CM in a manner informed by patient needs. 
While CM is currently the best-supported treatment for CUD, treatment response is variable [15] and 
long-term outcomes remain poor [16]. Indeed, a recent meta-analysis of prize-based CM studies 
identified a medium end-of-treatment effect size but no appreciable benefit at 6 months post-treatment 
[16]. Low response rates (~40%) have also been reported [35] and current evidence suggests over half of 
CM responders may achieve similar outcomes in TAU [15,17]. Of note, recent work in Veterans has 
failed to demonstrate a significant effect of CM relative to TAU for treatment of stimulant use disorders 
[36], providing an imperative to improve the effectiveness of VA CM programming, specifically. 
Importantly, previous efforts to improve CM effectiveness have highlighted opportunities to adapt CM 
treatment parameters in response to individual difference factors. Both increased magnitude [15] and 
probability [37] of contingent reward, for example, have been demonstrated to increase cocaine 
abstinence in CM and may be specifically indicated in patients with greater CUD severity [17]. Previous 
experimental manipulations of CM reflect the intervention’s theoretical foundation in operant 
conditioning – whereby the probability, timing, and magnitude of a reinforcer determines its potential 
to drive behavior change. These early models of CM conceptualize substance use as a conditioned 
response to drug-related positive reinforcement (and associated cues) that can be systematically shaped 
by environmental contingencies. Abstinence-contingent alternative reinforcement introduced by CM 
therefore works to (1) increase the frequency of abstinence-consistent behaviors and (2) decrease use-
related behaviors due to opportunity costs (i.e., loss of alternative reinforcement) associated with drug-
taking. Basic tenets of this account are robustly supported within the scientific literature and have 
framed a preponderance of CM research to date. This alternative reinforcement model of CM may, 
however, overlook more subtle cognitive components of the intervention that are both necessary to its 
effectiveness and relevant to optimization and personalization of CM treatment parameters. Consistent 

IRBNet #1617313 Protocol Version 1.5 
with the alternative reinforcement account, preclinical research supports dramatic devaluation of drug 
reward when a concrete, non-drug option is made available [38]. Early CM intervention research in 
humans similarly utilized choice contexts wherein abstinence-contingent alternatives were accessible 
during use-related decision-making [39]. In practice, however, alternative rewards offered in CM are not 
immediately available; rather, they occur at some delay (e.g., hours to days after use-related decision-
making). Recent critiques have highlighted this aspect of CM, suggesting that the potency of alternative 
reinforcement in CM depends – not only on the magnitude and probability of future reward – but also 
on its robust mental representation at the time of decisions to use or abstain [18]. Beyond simple 
behavioral shaping, CM may therefore be understood to remediate the pathological imbalance between 
executive and impulsive decision systems underlying CUD by supporting pursuit of delayed (recovery-
related) reward over use [19]. Specifically, CM increases the proximity and concreteness of recovery-
related reward – factors known to enhance subjective valuation [40]. As these factors have been 
implicated in CM effectiveness [18], individual differences in future reward valuation provide a 
promising new opportunity for adaptive intervention delivery. Indeed, poorer outcomes were recently 
demonstrated in association with steeper devaluation of future reward in low magnitude but not high 
magnitude reinforcement versions of CM [41]. In sum, existing evidence suggests that alternative 
reinforcement mechanisms of CM are complimented by processes underlying the representation and 
valuation of future reward. Accordingly, a novel future-minded decision-making (FMDM) model of CM 
was recently proposed [18,19] to advance scientific inquiry into, heretofore overlooked, cognitive 
components of this important intervention. The FMDM model views the overall structure of CM as a 
scaffold for recovery-oriented goal setting and goal-oriented decision-making. Specifically, by presenting 
reliable, short-term reward to reinforce abstinence, CM provides frequent opportunities for mental 
representation of delayed reward and related contingencies. CM can therefore be understood to engage 
executive working memory processes related to goal maintenance, as well as episodic future thinking – 
which involves mental simulation of future events. Through these processes, positive outcomes of 
abstinence can be robustly represented at the time of use-related decision-making and abstinence goals 
can be more readily accessed to capacitate proactive and reactive control of behavior. 
Preliminary Studies 
Multimodal Prognostic Assessment of Contingency Management Treatment Outcomes, 2016-present.   I 
received a VISN 4 MIRECC pilot grant to collect preliminary data in support of the current research. This 
pilot has three objectives: (1) establish feasibility of the proposed design with respect to participant 
recruitment and retention, (2) optimize parameters of behavioral paradigms for repeated-measures 
data collection, and (3) evaluate preliminary predictive utility of key FMDM-related measures (ERN, N2, 
change in delay discounting with inclusion of personally-meaningful future event tags, and working 
memory function). Data collection was initiated in May, 2017 and concluded in May, 2019; data analysis 
is ongoing.  
Implications/Relevance to Current Project:  Our preliminary data demonstrate feasibility of key 
assessments proposed for use in the current project (i.e., a Parametric Conflict flankers task, modified 
delay discounting task, and the Brown-Peterson/Auditory Consonant Trigrams test of working memory), 
as well as successful recruitment and retention of CUD patients. There have been no significant adverse 
events related to study participation to date. 

IRBNet #1617313 Protocol Version 1.5 
5.0  * Describe the overall significance of the research in terms of the problem to be studied and 
potential findings, as well as its relevance to the care of veterans, the VAPHS, and the VHA: 
While previous efforts to enhance CM effectiveness have primarily focused on the magnitude and 
probability of reward, the FMDM model suggests additional promising avenues to enhance benefits and 
adapt treatment delivery to patient needs. For example, while the lower cost, prize-based version of CM 
(PBCM) disseminated by VHA necessarily involves uncertain future reward, PBCM has traditionally (and 
purposefully) utilized tangible reinforcement (i.e., desired material objects displayed within a prize 
cabinet) rather than monetary incentives to foster concrete representation of future reward. While this 
“tangible prize” version of CM (TangiblePBCM) has been most widely studied, it is currently used at only 
~20% of VA CM sites; rather, the majority of VA CM sites (~80%) use Canteen vouchers to improve 
convenience and expand prize options. Although matched to traditional TangiblePBCM with respect to 
reward probability and magnitude, this “voucher prize” version of CM (VoucherPBCM) entails more 
abstract reward representation that may fail to successfully incentivize abstinence in patients with 
limited future thinking capacity. Indeed, such patients may fail to convert voucher winnings into tangible 
prizes – a pattern of behavior that has previously been associated with poorer outcomes in voucher-
based programs [42]. Currently, VA sites offering TangiblePBCM primarily do so for practical reasons 
(e.g., a local VA canteen is not available for voucher redemption) but individual difference factors may 
also strategically inform selection of TangiblePBCM versus VoucherPBCM on a patient-by-patient or site-
to-site basis. 
Previous work has demonstrated that adapting CM reinforcement schedules based on patient features 
has potential to improve overall outcomes while keeping program costs low [17,41]. Specifically, 
providing higher magnitude reinforcement to patients with a poorer prognosis in CM (e.g., patients who 
test positive for cocaine at treatment outset or exhibit steeper discounting of future reward) may 
improve the likelihood of successful treatment response in these individuals. Clinical translation of such 
findings is, however, impeded by ethical considerations regarding healthcare equity, transparency, and 
patient preference when the probability and/or magnitude of reward differs between treatment 
options. Importantly, the FMDM model of CM, highlights new possibilities for personalized treatment 
adaptation – such as strategically varying the concreteness of future reward – that may be more readily 
translatable in light of these ethical issues. Identifying patient-level predictors of differential treatment 
response in TangiblePBCM versus VoucherPBCM, for example, could directly inform CM implementation 
and may, in fact, improve overall treatment response by matching patients to an appropriate level of 
future reward abstraction based on FMDM ability. Chronic cocaine users present with varying degrees of 
impairment across FMDM-related cognitive domains including working memory, attentional control, 
and decision-making and such deficits have been associated with poor treatment adherence and 
retention in CUD patients [43,44]. It is plausible that individuals with more pronounced FMDM deficits 
differentially benefit from TangiblePBCM because concrete delayed reward better supports inhibition of 
immediate reward preferences [40]. Patients with superior FMDM ability, by contrast, may be better 
equipped to utilize abstract rewards offered in VoucherPBCM, which may further provide more 
advanced opportunities to plan and simulate future reward outcomes. 
Previous work has already highlighted the potential predictive utility of FMDM-related constructs – 
identifying improved CM outcomes in individuals with better working memory performance [45] and 
higher valuation of delayed reward [41]. However, no previous work has studied such predictors in the 
context of FMDM-informed treatment variants with immediate translational potential within the VA. As 

IRBNet #1617313 Protocol Version 1.5 
previously indicated, both VoucherPBCM and TangiblePBCM are already utilized in VA substance use 
clinics but selection of one variant over the other is currently driven by practical considerations alone. 
The proposed work will determine if a measurement-based approach to implementation of 
VoucherPBCM versus TangiblePBCM is indicated and will specifically evaluate the potential of FMDM-
aligned neural and cognitive markers to guide clinical decision-making. Actionable consequences of the 
proposed work are summarized in Table 1; additional alternative outcomes (e.g., evidence of differential 
treatment response in VoucherPBCM versus TangiblePBCM by CUD severity) are not detailed but may 
also inform delivery of CM within the VA. 
Table 1. Relevance of potential empirical observations to PBCM implementation within VA. 
 
Beyond adaptive implementation of existing CM variants, the FMDM model highlights novel pathways to 
achieve enhanced and sustained benefits of CM. Specifically, the FMDM model suggests CM actively 
remediates cognitive abilities underlying future-minded decision-making and, by extension, the 
response rate and long-term outcomes of CM can be improved by strengthening this mechanism of 
action. For example, while it is already recommended that patients describe desired prize items during 
each CM session [46], explicit practice with planning and mental simulation of future events has not yet 
been incorporated into CM protocols. Similarly, working memory training may also serve to complement 
and extend the benefits of CM [47] and has already been demonstrated to improve valuation of delayed 
rewards in stimulant users [48], consistent with stronger reward representation. Because FMDM readily 
generalizes to life contexts outside of treatment, greater emphasis on developing this ensemble of 
cognitive functions during and after CM may also be key to unlocking long-term benefits of the 
intervention. However, predictions of the FMDM model regarding neurocognitive recovery during CM 
remain to be tested. Only one study to date has addressed CM-related changes in neural and cognitive 
processes – demonstrating recovery of anticipatory reward signaling in thalamus, precuneus, and 
midbrain in CUDs, consistent with improved delayed reward representation [49]. Establishing recovery 
of additional FMDM-related cognitive functions (e.g., executive working memory, episodic future 
 
Finding from the Proposed Research 
Recommendation 
Hypothesis 
Patients with greater FMDM impairment (as indexed by 
neurocognitive markers) will demonstrate improved 
treatment outcomes in TangiblePBCM relative to 
VoucherPBCM. 
TangiblePBCM is recommended 
for patients with greater FMDM 
impairment. 
Patients with less FMDM impairment (as indexed by 
neurocognitive markers) will demonstrate improved 
treatment outcomes in VoucherPBCM relative to 
TangiblePBCM. 
VoucherPBCM is recommended 
for patients with less FMDM 
impairment. 
Alternative Outcomes 
Treatment outcomes are comparable in TangiblePBCM and 
VoucherPBCM, regardless of level of FMDM impairment. 
TangiblePBCM and 
VoucherPBCM are equally 
appropriate for all patients. 
Treatment outcomes are improved in TangiblePBCM 
relative to VoucherPBCM, regardless of level of FMDM 
impairment. 
TangiblePBCM is recommended 
for all patients. 
Treatment outcomes are improved in VoucherPBCM relative 
to TangiblePBCM, regardless of level of FMDM impairment. 
VoucherPBCM is recommended 
for all patients. 

IRBNet #1617313 Protocol Version 1.5 
thinking, and inhibitory control) through CM would thus clarify important neural mechanisms of action 
with strong potential for future development. 
In sum, the FMDM model of CM has important implications for personalized treatment delivery and may 
also reveal novel opportunities to enhance the short- and long-term effectiveness of the intervention. 
However, key predictions of the model remain to be tested. The current CDA aims to address this 
knowledge gap by (1) evaluating individual differences in FMDM function as predictors of treatment 
response in CM variants utilizing concrete (TangiblePBCM) versus abstract (VoucherPBCM) future 
rewards and (2) examining longitudinal change in neural and cognitive processes underlying putative 
FMDM-based mechanisms of CM. Ultimately, this line of research aims to improve VA CM programming 
by clarifying both how and for whom existing versions of PBCM are effective. In particular, 
understanding the role of FMDM in patient-level outcomes could immediately inform treatment 
recommendations within VA clinics (wherein both VoucherPBCM and TangiblePBCM are already used). 
The proposed research may additionally highlight new opportunities to improve CM and aftercare 
programming through enhanced emphasis on FMDM skill development, maintenance, and 
generalization. Furthermore, by elucidating neural adaptation within FMDM-related brain networks 
during CM such mechanisms may be more directly targeted through cognitive training, neurofeedback, 
or noninvasive brain stimulation in subsequent research. 
  
6.0  
Please upload any additional documents: 
Name Version  
There are no items to display  
  
   
View: 2.1 Required Reviews  
Required Reviews 
 
1.0  
Type of Submission: 
New study  
If this is a 'New Paper Conversion' please include the MIRB Number: 
Please upload a letter certifying that you have made no modifications or amendments in converting this 
research study from paper to electronic: 
  

IRBNet #1617313 Protocol Version 1.5 
2.0 * Requested Review Type: 
 
 Name  
 
 Exempt  
 Expedited X 
 Full IRB Review  
 Not Human Subject Research  
 
3.0     
  
Please check which of the following Service Lines/Departments/Entities will be impacted or used in the 
conduct of this study 
Upload Letter of Support 
  
 Clinical Support     
 Medical Specialty:  Medical Service Line LOS (0.01)    
 Investigational Drug Service     
 Imaging     
 Community Based Care     
 Patient Care Services     
 Behavioral Health:  BH Service Line LOS (0.01)    
 Primary Care     
 Surgical Specialty     
 Critical Care     
 Clinical Trials Center     
 Regulatory Coordinator Support Core  
 Clinical Coordinator  
 Support Core  
 Ancillary Support Core   
Data Support Core 
Research Registry 
Registry Number: 
Other     
If Other, please specify: 
     
View: 2.1.1 Expedited Qualification  

IRBNet #1617313 Protocol Version 1.5 
  
REQUEST FOR EXPEDITED REVIEW  
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the 
research are not greater in and of themselves than those ordinarily encountered in daily life or during 
the performance of routine physical or psychological examinations or tests. 
AND  
Identification of the subjects and/or their responses would not reasonably place them at risk of criminal 
or civil liability or be damaging to the subject’s financial standing, employability, insurability, reputation, 
or be stigmatizing, or reasonable and appropriate protections will be implemented so that risks related 
to invasion of privacy and breach of confidentiality are minimal. 
 
1.0   
* Please certify that ALL of the following are true: 
Case  
Research presents no more than MINIMAL RISK to subjects (considering physical, psychological, social, 
legal and economic risk)  
Identification of the subjects and/or their responses WOULD NOT reasonably place them at risk of 
criminal or civil liability or be damaging to the subject’s financial standing, employability, insurability, 
reputation, or be stigmatizing, OR reasonable and appropriate protections will be implemented so that 
risks related to invasion of privacy and breach of confidentiality are minimal.  
The research is not classified.  
The research involves only procedures listed in one or more of the categories listed in Section 2.  
 
2.0 If you check any of the items below, the study is qualified for EXPEDITED review status under federal 
guidelines.  
 
* Select all that apply: 
 
  Description  
1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met:  
 
(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not 
required. 
 
(b) Research on medical devices for which an investigational device application (21 CFR 812) is not 
required OR the medical device is cleared/approved for marketing and the medical device is being used 
in accordance with its cleared/approved labeling.   

IRBNet #1617313 Protocol Version 1.5 
 
   
 2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: 
 
(a) From healthy, non-pregnant adults who weigh at least 110 pounds. [not to exceed 550 ml in an 8 
week period and collection may not occur more frequently than 2 times per week; or 
 
(b) From other adults and children, considering the age, weight and health of the subjects, the collection 
procedure, the amount of blood to be collected: The amount drawn may not exceed the lesser of 50 ml 
or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.   
 
   
 3. Prospective collection of biological specimens for research purposes by non-invasive means. 
 Examples: 
 
(a) hair and nail clippings in a nondisfiguring manner; 
 
(b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; 
 
(c) permanent teeth if routine patient care indicates a need for extraction; 
 
(d) excreta and external secretions (including sweat); 
 
(e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or 
wax or by applying a dilute citric solution to the tongue; 
 
(f) placenta removed at delivery; 
 
(g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; 
 
(h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more 
invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance 
with accepted prophylactic techniques; 
 
(i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; 
 
(j) sputum collected after saline mist nebulization.  
 
 4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) 
routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where 
medical devices are used, they must be cleared/approved for marketing. (Studies intended to evaluate 
the safety and effectiveness of the medical devices are not generally eligible for expedited review, 
including studies of cleared medical devices for new indications)   

IRBNet #1617313 Protocol Version 1.5 
   
 5. This research involves materials (data, documents, records, or specimens) that have been collected 
for any purpose including previous research or will be collected solely for nonresearch purposes (such as 
medical treatment or diagnosis).  
   
 6. This research involves the collection of data from voice, video, digital, or image recordings made for 
research purposes.  
 
7. This research will be performed on individual or group characteristics or behavior (including, but not 
limited to, research on perception, cognition, motivation, identity, language, communication, cultural 
beliefs or practices, and social behavior) or will employ a survey, interview, oral history, focus group, 
program evaluation, human factors evaluation, or quality assurance methodologies.   
 
View: 3 Research Design  
  
Methods & Procedures  
 
1.0    
* Does this research study involve any of the following:  
Deception  
Interview/Focus Groups  
Use of Drug, biological, or nutritional (e.g., herbal or dietary) supplement (investigational or FDA 
approved)?  
Use of medical devices  
Prospective Analysis of Specimens  
Banking of Specimens-Data  
Retrospective use of specimens  
Audio/Video Recordings or Photographs   
Honest Broker or other similar service  
None of the Above  
    

IRBNet #1617313 Protocol Version 1.5 
View: 3.2 Interview-Focus Groups  
Interview-Focus Groups 
1.0  
* Attach copies of any scripts and/or questions that will be used to guide the interviews/groups: 
Name Version  
 
Addiction Severity Index Lite 0.01  
CM Qualitative Interview 0.01  
MINI for Psychotic Disorders Studies 7.0.2 0.01  
Positive-Neutral Future Events Interview Instructions 0.02  
Timeline Follow-back Calendar Template: Alcohol 0.01  
Timeline Follow-back Calendar Template: Other Drugs 0.01  
Timeline Follow-Back Calendar Template: Cocaine 0.01  
Timeline Follow-Back Instructions: Baseline 0.01  
Timeline Follow-Back Instructions: Check-In/FU 0.01  
 
2.0  * Please describe the Study Team qualifications (for example, special training): 
Study interviews will either be directly administered by Dr. Forster or by research staff trained by Dr. 
Forster. Dr. Forster is a licensed clinical psychologist with extensive training and experience in the 
administration of structured and semi-structured diagnostic interviews in both research and clinical 
settings. Dr. Forster has previous experience administering the Structured Clinical Interview for DSM-IV 
(which requires similar knowledge and skills to administer as the M.I.N.I. 7.0.2), Addiction Severity 
Index, and Timeline Follow-Back procedure. In addition, instructions for the Positive-Neutral Future 
Events Interview were developed by Dr. Forster based on experience soliciting similar information 
through unscripted interviews during her pilot project (Pro1787). A series of qualitative interview 
questions were also developed by Dr. Forster based on her experiences working with Veterans in 
Contingency Management in both clinical and research contexts.   
    
View: 3.4 Use of Medical Devices  
Medical Devices 
1.0  
* Specify all devices used on this study: 

IRBNet #1617313 Protocol Version 1.5 
Device Name Manufacturer Use of Device IDE Number(if Applicable) Device Brochure Description of Use 
Risk Level Determined by Sponsor  
acti32Champ EEG Acquisition System Brain Products GmbH Investigational Device Not Yet Approved for 
use   actiCHamp Manual(0.01) This is a nonmedical device that will be used for the acquisition of 
electroencephalography (EEG) data in accordance with manufacturer operating standards. This device is 
non-invasive and will only be used to monitor naturally-occurring biological signals and processes in 
vivo. The actiCHamp is intended to be used for research applications only and is not sold, designed or 
intended to be used as medical devices as defined in EU Directive 93/42/EEC, nor is it intended to be 
used for other medical applications such as diagnosis or treatment of disease. The actiCHamp hardware 
has been tested and certified as per the relevant EMC and electrical safety standards. A non-medical CE 
certificate is available on request. This equipment was reviewed and approved for purchase by the 
VAPHS Bio Medical Review committee on 5/9/2019. Non-Significant Risk  
GT3XP-BTLE 4GB Activity Monitor Actigraph, LLC FDA Approved Device used in approved manner n/a 
Actigraph Brochure(0.01) GOLDSTEIN SUBSTUDY ONLY: This device will be used in accordance with 
manufacturer instructions. The device tracks physical activity, sleep, and heartrate data (logged from a 
linked Polar H7 device). ActiGraph activity monitors are FDA 510(k) cleared and ActiGraph is ISO-
13485:2016 certified. Non-Significant Risk  
ISCAN model RK406 Infra-red Pupillometer ISCAN FDA Approved Device used in approved manner n/a 
ISCAN Website(0.01) This is a Class I medical device that will be used in an approved manner to monitor 
eye movement, pupil dimensions, and blinks during the EEG procedure. This device is non-invasive and 
will only be used to monitor naturally-occurring biological signals and processes in vivo. Non-Significant 
Risk  
Polar H7 Polar FDA Approved Device used in approved manner n/a Polar H7 Info Sheet(0.01) GOLDSTEIN 
SUBSTUDY ONLY: This device will be worn around the chest to remotely measure heart rate. These data 
are transmitted via Bluetooth to the linked ActiGraph device for storage. Polar fitness monitors have 
been provided FDA 510(k) clearance. The Polar H7 is currently marketed as a commercial device and will 
not be used to diagnose, treat, or prevent a medical condition. Non-Significant Risk  
   
2.0 * Describe your plan for storage and control of devices: 
The BrainVision acti32Champ EEG acquisition system and ISCAN Pupillometer will be stored in the 
VAPHS Biometrics Laboratory in consultation with Dr. Steinhauer - a leading expert in electrophysiology 
and pupillometry. Equipment will be routinely tested and data monitored in order to ensure safe and 
effective operation.  
Activity and heart rate monitors will be stored in accordance with manufacturer instructions and will be 
cleaned and sterilized between each use.   
    
View: 3.5 Prospective Analysis of Specimens  
Prospective Analysis of Specimens 

IRBNet #1617313 Protocol Version 1.5 
1.0 * Please provide a description of samples to be collected: 
Samples Collected in the Context of Baseline, Check-In, and Follow-Up Study Visits (*No Direct 
Identifiers*): 
Urine and/or oral saliva specimens will be collected/tested at baseline using commercially-available drug 
test kits and specimen containers. We will also collect and test urine and/or oral saliva at the time of the 
follow-up EEG assessment. In addition, urine specimens may also be collected and tested using 
commercially-available drug test kits at check-in appointments if the participant is not actively involved 
in CM and/or has missed recent CM visits. However, it is noted that collection of such supplemental 
urine specimens at check-in timepoints would not apply if (1) lab-based urinalysis for substance use has 
recently been completed for clinical or research purposes, (2) the participant refuses, or (3) the 
participant is not available or able to provide a specimen. All urine and oral saliva specimens collected 
for testing with commercially-available drug test kits in the context of these described research activities 
will be marked with indirect identifiers only and will be disposed of immediately after testing. 
 
Samples Collected in the Context of Treatment (CM; *Direct Identifiers*): 
During the 12 week treatment interval, patients will be subject to routine urinalysis (twice weekly). 
Urine specimens will be collected (and may be witnessed, if necessary) by nursing staff at the Center for 
Treatment of Addictive Disorders (CTAD) or research staff at the Research Office Building and tested for 
cocaine (and possibly other substances) by the CM therapist using a point-of-care diptest in order to 
provide the patient with immediate results for the purpose of determining CM prize draws. 
Confirmatory urinalysis will subsequently be conducted to verify point-of-care results. Urine specimens 
will therefore be forwarded to VAPHS laboratory staff for processing. For this reason, urine specimens 
collected in the routine clinical course of CM will be marked with direct identifiers prior to submission to 
the lab. However, it is noted that all urine collection/testing procedures to be conducted within the 
context of CM parallel those already used in routine clinical (i.e., non-research) administration of CM 
and other substance use treatment programming at VAPHS. It is additionally noted that participants may 
always decline to provide observed urines for lab-based processing and may alternately elect to provide 
urine specimens (not marked with direct identifiers) for kit-based testing by research personnel, as 
described above.   
2.0 * Please describe the tests or analyses to be performed on the study specimens: 
Both oral saliva and urine specimens will be tested with commercially-available test kits that 
automatically screen for specific substances of abuse and provide results within seconds to minutes. 
Commercially-available test kits generally involve exposure of specimens to a specially designed test 
card that visually changes to register the result (similar to a drug store pregnancy test). A subset of urine 
specimens (i.e., urines collected for treatment purposes and marked with direct identifiers) will 
additionally be subject to confirmatory urinalysis at the VAPHS onsite laboratory by laboratory staff. 
Details of laboratory-based testing can be provided upon request.   
3.0  
* Sample Collection Method: 

IRBNet #1617313 Protocol Version 1.5 
 Samples to be obtained will be limited to amounts routinely collected during a clinical procedure. This 
includes samples normally taken by Pathology for diagnostic purposes.  
 Samples will consist of additional material taken during a clinical procedure  
 Samples will be obtained via a separate collection procedure done solely for the purposes of this 
research  
4.0  
* Please indicate how the specimens will be identified at the time they are forwarded for use in this 
research:  
DIRECT IDENTIFERS will be included with the specimens  
INDIRECT IDENTIFIERS (codes,links) will be noted on specimens  
If multiple selections have been made, please describe why: 
As described above, specimens collected in the context of routine CM care during the 12 week 
treatment interval will be identified with direct identifiers because these samples will be subject to lab-
based processing and urinalysis. With respect to these specimens, the "Samples to be obtained will be 
limited to amounts routinely collected during a clinical procedure," and will be collected in the context 
of the patient's routine clinical care. 
Specimens collected for the purpose of objectively verifying recent abstinence for research purposes will 
not be marked with direct identifiers and will be tested and immediately disposed of by research staff. 
While these samples will also "be limited to amounts routinely collected during a clinical procedure" 
they will be collected solely for the purposes of research. We will therefore take additional steps to 
protect patient confidentiality with respect to these samples: (1) eliminating direct patient identifiers 
from the specimen collection procedure, (2) immediately disposing of samples following testing, and (3) 
utilizing only indirect identifiers (subject ID code) when recording test results.   
5.0 * Will the analysis to be done on the samples possibly result in any genetic information related to 
the subject's (or his/her relatives') health or susceptibility to a disease or condition currently or in the 
future? 
  Yes No 
If yes will patients have access to this information? 
  Yes No 
   
6.0   
* Will the analysis to be done on the samples involve whole genome sequencing? 
  Yes No 
 

IRBNet #1617313 Protocol Version 1.5 
If Yes, for research compliant with the 2018 Requirements, if the research involves whole genome 
sequencing (sequencing of a human germline or somatic specimen with the intent to generate the 
genome or exome sequence of that specimen), there must be a statement indicating that the research 
will or might include whole genome sequencing in the consent. 
 
7.0  * Please list where processing of these specimens will occur: 
Collection/processing of specimens will occur in clinical areas of Buildings 29 and 30. Specifically, 
samples collected for research purposes in Building 30 will be collected/processed in the following 
locations: GA124, GA112, GA110, and Building 30 Lobby restrooms. These locations include a patient 
restroom in the clinical trials center on the group floor of the Research Office Building, as well as two 
exam rooms available on the ground floor of the Research Office Building. Samples collected as part of 
clinical care through the Center for Treatment of Addictive Disorders (CTAD) will either be collected by 
nursing staff in one of several patient restrooms used for clinical urine collection in Building 29 or by 
research staff in Building 30 locations listed above. For patients assigned to Contingency Management, 
these samples will then be subject to point-of-care testing in a designated clinical area/treatment room 
within Building 29 or a comparable space in Building 30. Samples collected during the treatment interval 
will typically be marked with direct identifiers and forwarded to the onsite laboratory facility for 
additional processing and confirmatory drug-alcohol urinalysis. 
Plan for Destruction/Disposal of Specimens. Urine and oral saliva specimens collected for research 
purposes (indirect identifiers only) will be disposed of by study personnel immediately after testing. 
Following use, oral saliva test kits will be disposed of in red, biomedical waste containers. Similarly, used 
urine dip tests and urine specimen containers will be disposed of in red, biomedical waster containers 
after any remaining urine has been poured into a toilet and flushed down the drain. Urine specimens 
collected in the context of clinical care (direct identifiers) will be disposed of by VAPHS laboratory 
personnel after processing, using standard procedures approved by the medical facility for the 
destruction of urine specimens and specimen containers with direct patient identifiers.    
    
View: 4 Research study methods  
 
Research Study Methods  
Describe all study related procedures following enrollment of a subject in this study. 
 
Please see Section 6 for where the study team defines when a subject will be considered enrolled in the 
study. 
1.0   
* Research Procedures/Interventions: 

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Informed Consent and Screening Visit. The initial study visit will involve review of the informed consent 
document and discussion of any participation-related concerns. During the informed consent process, 
participants will be informed of drug and alcohol testing conducted at the time of the Baseline 
Assessment and that a minimum of 72 hours of abstinence from cocaine and other illicit substances is 
required prior to participation in baseline testing. After written informed consent has been obtained, 
the participant will be enrolled in the study. A brief cognitive screening tool (the Saint Louis University 
Mental Status (SLUMS) or Mini Montreal Cognitive Assessment (MoCA)) will be administered to 
determine eligibility for participation in all subsequent study procedures. However, it is noted that we 
will routinely conduct cognitive screening via the Mini MoCA as part of our initial (typically telephone-
based) eligibility assessment in order to reduce burden on participants who are deemed ineligible based 
on this criterion.  In this way, individuals who will not meet our full eligibility criteria will be more 
efficiently screened out with less time invested.  For this reason, cognitive screening will only occur at 
the Consent and Screening Visit if not already completed.  Evaluation of psychiatric and substance use 
history will follow for all individuals who pass cognitive screening.  Participants may also be asked to 
complete a Demographic Information form and Contact Information form during this visit and may 
additionally be provided with self-report questionnaires, which they may choose to complete in the time 
between the Screening Visit and Baseline Assessment. It is further noted that this session may be 
remotely conducted to reduce burden/risks to participants.  In such cases, assessments will be 
completed via telephone of video call (using locally approved technologies) and, when necessary, forms 
will be transmitted via mail, email, or warm handoff (e.g., during a clinical interaction with one of the 
Veteran's providers). 
Diagnostic Interviews and Neuropsychological Screening. The investigator or a trained research assistant 
will administer the Mini International Neuropsychiatric Interview (MINI) 7.0.2 (specifically, the version 
for studies including patients with psychotic illnesses), Saint Louis University Mental Status (SLUMS) or 
Mini Montreal Cognitive Assessment (Mini MoCA) exam, and Addiction Severity Index-Lite (ASI-Lite) to 
all study participants. The investigator has extensive experience administering the SCID - a semi-
structured interview similar to the MINI - in research and clinical contexts and has received training on 
this instrument under the direction of one of the authors (Michael First, MD). The investigator also has 
sufficient experience with the SLUMS and ASI from previous research and clinical training. The MINI will 
be used to identify comorbid psychiatric and substance use diagnoses, as well as CUD severity. The 
SLUMS or Mini MoCA will be administered to screen for moderate-to-severe cognitive impairment.  
Previously undiagnosed conditions identified through administration of the MINI or SLUMS/MoCA that 
may be relevant to the Veteran's ongoing care will be shared with the Veteran’s mental health 
treatment coordinator. The participant will be made aware of this policy during the informed consent 
process. Participants determined to be eligible following participation in diagnostic interview and 
neuropsychological screening procedures will be scheduled for a Baseline Assessment.  It is possible that 
the Informed Consent and Screening Visit and the Baseline Testing Visit could occur on the same day if 
scheduling these visits for separate days would be problematic for the participant. 
▪ MINI International Neuropsychiatric Interview for Psychotic Disorders Studies (Version 7.0.2): The MINI 
is a semi-structured clinical interview based on DSM-5 diagnostic criteria. Module J (Substance Use 
Disorders) will always be administered in full. A screening tool will be used to identify symptoms 
relevant to other diagnostic categories and additional modules will be administered, as needed, to limit 
the total time burden. Veterans identified as having additional, immediate assessment or treatment 

IRBNet #1617313 Protocol Version 1.5 
needs will be escorted to the VAPHS Behavioral Health walk-in clinic or Emergency Department (if 
determined to pose an imminent risk of harm to self or others). Diagnostic evaluation using the MINI will 
enable determination of CUD severity and effective characterization of psychiatric and substance use 
comorbidities. 
▪ Addiction Severity Index-Lite (ASI-Lite): The ASI-Lite is a semi-structured interview used to quantify 
problem severity related to alcohol and drug use, as well as functioning in five domains impacted by 
addictive disorders:  medical status, legal status, psychiatric status, family/social status, and 
employment/financial support. The ASI is commonly used to quantify overall severity of addictive 
disorders – a factor which must be considered when evaluating individual differences in substance use 
treatment response. 
▪ Cognitive Screening via One of the Following Tools (if not conducted during initial eligibility 
assessment): 
                  ▪ Saint Louis University Mental Status (SLUMS): The SLUMS is a brief cognitive screening tool, 
used to identify impairment across eight domains: working memory, concentration, attention, 
orientation, semantic fluency, visuospatial ability, executive function, and short-term recall. A cutoff of 
20 is suggested to identify dementia and serious cognitive impairment; individuals scoring ≤20 will be 
excluded from further participation. 
                 ▪ Mini Montreal Cognitive Assessment (MoCA): The mini version of the MoCA is brief cognitive 
screening tool that can be used as an alternative to the SLUMS for remotely conducted (i.e., via 
telephone or video call-based) cognitive screening.  A cutoff of 10 is suggested to identify dementia and 
serious cognitive impairment; individuals scoring ≤10 will be excluded from further participation. 
 
Baseline Assessment. The Baseline Assessment session for CM veterans and healthy controls could 
include the following components: 
Substance Use Assessment:  Recent substance use will be evaluated through self-report and objective 
testing.  
▪ Breathalyzer and Oral Saliva Drug Testing: Participants will be required to pass breathalyzer (BAC = 
0.000%), as well as urine and/or oral saliva drug screens (negative for all common illicit substances, 
excluding marijuana) in order to participate in baseline testing. Such testing is necessary to establish 
that participants are not acutely intoxicated at the time of EEG and cognitive-behavioral assessments, 
which may compromise the validity and reliability of these measures. We will offer oral saliva testing as 
an option because this method has an earlier and more proximal detection window than urine-based 
testing (sensitive to use immediately prior to testing and during the preceding 72 hours). Consequently, 
it will be possible to include CUD participants with relatively short durations of cocaine abstinence prior 
to baseline testing. Participants will be informed of drug and alcohol testing procedures at the screening 
visit and asked to abstain from drug use for 72 hours prior to testing. While this requirement will 
necessarily exclude individuals who are unable to abstain for 72 hours, such individuals would generally 
not be recommended for CM programming (VA CM implementation consultants suggest 3-4 days of 
demonstrated abstinence prior to initiating a CM referral). Consequently, this requirement should not 
prevent us from achieving a representative sample of cocaine users for whom CM is indicated.  Due to 

IRBNet #1617313 Protocol Version 1.5 
the requirement that participants pass initial drug-alcohol screening, individuals with anticipated or 
observed difficulty achieving initial abstinence may elect to schedule one or more optional pre-CM 
testing sessions with study personnel in preparation for the Baseline session. 
▪Timeline Follow-Back (TLFB) Procedure:  During the timeline follow-back, participants will be asked to 
describe drug and alcohol use during the past month, including type, frequency, and quantity. Typical 
patterns of pre-treatment drug and alcohol use may also be evaluated if a recent change in use has 
preceded the testing session (for example, patient completed residential treatment during the past 
month). 
EEG Procedure:  Participants will complete two computerized behavioral tasks while EEG is recorded 
from the surface of the scalp using a commercially-available EEG recording system.  A baseline (resting) 
acquisition may also precede task-related data acquisition, as is typical for EEG recording procedures. 
▪ Concrete-Abstract Incentive Delay Task:  In order to evaluate differences in alpha suppression during 
anticipation of concrete/tangible versus abstract/monetary reward, EEG will be recorded while 
participants perform a modified Monetary Incentive Delay task with voucher- and tangible-prize reward 
cues. Previous work has demonstrated that reward cues associated with more concrete or primary 
rewards result in greater alpha suppression during anticipation [50], as well greater recruitment of brain 
areas associated with self-referential and prospective processing [51] when compared with monetary 
reward cues. A paradigm previously used to examine anticipatory brain responses to monetary versus 
food rewards [51] will be adapted for use with voucher and tangible prize rewards. Trials will begin with 
a cue indicating reward magnitude (i.e., no reward, low reward, high reward), followed by a delay and 
target stimulus (requiring a manual response). Another delay will precede presentation of feedback 
based on response accuracy and reward magnitude. Consistent with previous work [51], reward 
feedback will consist of images depicting either monetary prizes (vouchers) or prize baskets with 
tangible items (e.g. snacks, clothing, household goods). Participants will be informed that they will not 
receive total prize winnings but that a percentage of total winnings will be awarded following the task (a 
strategy the PI has successfully used in previous work); the value of this prize bonus will generally be 
between $15-25.  Participants may additionally choose to have this bonus paid out as part of their 
standard participant compensation for the session or select one or more prize cabinet prizes of 
matching value. 
▪ Parametric Conflict Flankers Task:  As previously described, FMDM requires robust goal representation 
to inform effective proactive and reactive modulation of cognitive control. In order to assess control-
related processes, a modified Eriksen Flankers paradigm will be used to measure transient theta 
frequency synchronization of brain signals recorded at ACC and lPFC electrode sites, as well as ERN and 
conflict N2 components of response- and stimulus-locked event-related potentials, respectively. In this 
modified version of the task, trial-to-trial response conflict will be parametrically manipulated through 
different levels of flanker-target incongruity (i.e., Congruent, Incongruent-Low, Incongruent-Medium, 
and Incongruent-High). The Parametric Conflict Flanker task has previously been validated in healthy 
controls [52] and in individuals with nicotine use disorder [53]. The deadline for response production will 
be adjusted on a subject-by-subject basis to ensure an appropriate number of erroneous responses and 
to establish a similar level of task difficulty across participants and over time. 
Cognitive-Behavioral Testing: Additional FMDM constructs will be measured using cognitive tasks.  

IRBNet #1617313 Protocol Version 1.5 
▪ Personalized Delay Discounting Task:  Participants will be interviewed about upcoming positive and 
neutral life events (e.g., birthdays, holidays, vacations), occurring at latencies ranging from one week to 
one year from the testing date. Events will be rated with respect to personal relevance, valence, and 
arousal and a subset of events with similar ratings will be selected for use in a personalized version of 
the delay discounting task. Following previously described procedures [54], participants will complete a 
series of delay discounting trials with and without inclusion of event tags referencing personally-
meaningful future events from the interview. Blocked presentation of trials in each condition allows for 
characterization of standard delay discounting behavior (i.e., without event tags) as well as discounting 
in the context of episodic future thinking (with event tags). The difference in delay discounting slopes 
estimated for each condition (i.e., ∆ ln(k)) will be used as a measure of future-minded decision-making. 
Specifically, greater reduction in discounting slope with inclusion of event tags signifies greater 
engagement of episodic future thinking, thus increasing valuation of future reward. Upon completion of 
the task, participants will also be asked to rate the vividness and frequency of spontaneously-evoked 
mental imagery associated with each event tag. 
▪ Modified Brown-Peterson/Auditory Consonant Trigrams Test:  A version of the Brown-
Peterson/Auditory Consonant Trigrams test will be used to assess executive working memory. In this 
test, participants will be required to maintain letter sequences in working memory while performing a 
distractor task (serial subtraction by threes). Participants will either be asked to immediately recall 
letters or recall them following a delay.  On delay trials, participants will be provided with a letter 
sequence and starting number and will count backwards by three, out loud, for the duration of the delay 
period; the letter sequence will then be recalled. This complex-span test is used to index maintenance 
and decay of working memory contents of direct relevance to the strength of goal maintenance. Of 
note, low scores on this task have previously been associated with increased externalizing 
psychopathology and discounting of future reward [55] but the paradigm has not yet been studied in 
CUDs receiving CM. 
Self-report Questionnaires:  Participants will also complete measures of craving (Drug Craving 
Questionnaire, Alcohol Craving Questionnaire) [56], sensation seeking (Sensation Seeking Scale) [57], 
avoidance and inflexibility in response to cocaine triggers (Avoidance and Inflexibility Scale) [58], 
motivation for change (Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)) [59], 
previous cocaine relapse experiences (Time to Relapse Questinnaire) [60], sensitivity to reward and 
punishment (Sensitivity to Punishment/Sensitivity to Reward Questionnaire-20 (SPSRQ-20)) [61], 
subjective experience of retrospective and prospective memory proficiency (Prospective-Retrospective 
Memory Questionnaire) [62], self efficacy (Drug Taking Confidence Questionnaire) [63], future 
mindednesss (Consideration of Future Consequences Scale) [64], nicotine dependence (Fagerstrom Test 
for Nicotine Dependence) [65], and adverse experiences  in childhood (Adverse Childhood Experiences 
questionnaire) [66]. These instruments were chosen to measure clinically-relevant factors in substance 
use treatment (e.g., motivation, craving, and impulsivity), as well as factors previously associated with 
CM treatment outcomes specifically (avoidance-inflexibility) [58]. In order to assess the motivational 
salience of potential CM incentives, participants will also be asked to complete a Prize Preference and 
Interest Survey (currently in development, awaiting information on product inventory from VA Canteen 
Services), wherein interest in/preference for potential tangible and voucher prizes will be rated on a 
likert-type scale. For participants assigned to TangiblePBCM, this information may also be used to 
populate the prize cabinet with preferred items.   

IRBNet #1617313 Protocol Version 1.5 
For healthy participants, participation in activity/heartrate monitoring activities will be described in the 
primary study consent form and participants may engage in these activities without additionally 
providing consent under Substudy 2.  
Randomization. Following baseline testing, patient participants will be randomized into TangiblePBCM 
(n = 70) and VoucherPBCM (n = 70) conditions. We will stratify on one or more of the following 
variables:  age, involvement in medication-assisted treatment for opioid use disorder (yes/no), working 
memory score from modified Brown-Peterson test (< or ≥ Veteran-specific norm), and current diagnosis 
of bipolar or psychotic illness (yes/no).  A minimization approach may additionally be employed in order 
to allow for stratification on an expanded set of potentially-relevant clinical and demographic factors. 
Working memory ability was identified as a potential focus of stratification because it is expected to 
relate to other FMDM constructs of interest and Veteran-specific norms are available for the modified 
Brown-Peterson test [67]. Participants will be informed of PBCM treatment assignment during 
scheduling of the initial CM treatment appointment.  Participants previously assigned to a TAU only 
condition will continue to be followed for check-in and follow-up procedures if agreeable to doing so.  
To maximize options for future data analysis, this may apply to individuals previously assigned to TAU 
who elect to begin standard PBCM through CTAD rather than continuing in the TAU only treatment 
condition as part of the study. 
Treatment. All participants will receive treatment-as-usual during the 12-week treatment interval, which 
will entail recommended participation in at least two outpatient group and/or individual psychotherapy 
encounters through CTAD per week; participants will additionally continue pharmacotherapy for 
substance use and/or other mental health conditions, if applicable  For participants assigned to either 
Prize-based Contingency Management (PBCM) condition, PBCM will be used and implemented in 
accordance with the VA protocol for CM, as well as guidance on PBCM, more generally. PBCM involves 
one-on-one sessions with a provider, during which a urine specimen provided by the patient is tested for 
cocaine using a point-of-care dip-test. Results of point-of-care testing are then shared with the patient 
and negative results are reinforced with draws from a fish bowl containing 500 paper slips, 250 of which 
award small, large, or jumbo prizes (remaining slips deliver words of encouragement). Patients are 
reinforced with a single prize draw for their first negative specimen; an additional prize draw is added 
for each consecutive negative result (up to 8 prize draws per session). Abstinence-contingent prize 
draws are reset to one upon either a positive test result or missed appointment. The proposed work will 
systematically evaluate two variants of PBCM used within the VA (detailed below) which will be 
administered twice weekly during 15-20 minute sessions over a 12 week period. The probability of each 
reward magnitude will be the same in both treatment conditions. Specifically, 41.8% of paper slips will 
award a small prize, 8% will award a large prize, and 0.2% will award a jumbo prize. During the active 
treatment period, CM treatment data (i.e., attendance, urinalysis results, prize outcomes) will be logged 
by the CM provider, and may also be followed through chart review.  Participants will additionally be 
asked to provide regular updates regarding any changes in their housing status or medications (including 
changes in dosing schedule and/or clinic privileges for patients in medication-assisted treatment) and 
participation in non-VA substance use treatment (e.g., 12-step meetings in the community).  Under 
unusual circumstances in which a Veteran’s prolonged absence from in-person treatment is unavoidable 
(e.g., due to illness or travel) one or more CM sessions may be conducted via VVC using oral fluid testing 
(i.e., methods already reviewed and approved under Substudy 1). 

IRBNet #1617313 Protocol Version 1.5 
▪ TangiblePBCM: For participants assigned to TangiblePBCM, prize draws resulting in one or more small, 
large, or jumbo wins will result in access to a prize cabinet stocked with small (approximately $0.75-
$1.25 in value), medium (approximately $3-$5 in value), large (approximately $20-25 in value), and 
jumbo (approximately $75-$100in value) incentive items. Medium incentive items are included for 
selection in the event that a patient draws several small prize slips on the same day and are considered 
equivalent to 4-5 small prizes. Selection of specific prize items will be informed by patient preference 
and items will be restocked regularly. The prize cabinet will be open during TangiblePBCM sessions such 
that prize items are readily visible. Selection of prizes, maintenance of the prize cabinet, and policies 
regarding prize redemption will follow guidance on administration of TangiblePBCM within the context 
of research protocols [68]. 
▪ VoucherPBCM: For participants assigned to VoucherPBCM, prize draws resulting in one or more small, 
large, or jumbo wins will be reinforced with VA Canteen vouchers in the specified incentive range. 
Participants in this condition may additionally be asked to provide information on voucher redemption 
using a self-report or clinician/researcher-administered CM Voucher Survey. 
Weekly Check-In Appointments (12 Weeks). Participant outcomes (outpatient treatment engagement, % 
cocaine-negative urines, self-reported days of use) will be followed throughout the 12 week treatment 
interval; during this period the timeline follow-back procedure will be administered by phone or in-
person on an approximately weekly basis. During the treatment interval, the timeline follow-back 
procedure will always be administered such that the beginning of the assessment interview corresponds 
with the last occurrence of the timeline follow-back procedure.  In this way we will endeavor to collect 
self-reported substance use data for the full 12 week treatment interval.  This effectively means that 
one or more missed check-in appointments may be administered at the time of the next check-in 
attended, if needed. Outpatient substance use treatment engagement and urinalysis results will be 
monitored through review of participant medical records.  Participants will additionally be asked to 
provide regular updates regarding any changes in their housing status or medications (including changes 
in dosing schedule and/or clinic privileges for patients in medication-assisted treatment) and 
participation in non-VA substance use treatment (e.g., 12-step meetings in the community).  For CM 
participants, this information may be gathered, in part or in full, during 1:1 CM treatment appointments.  
This information will, however, also be assessed during check-in appointments to ensure that relevant 
information is reliably tracked for all participants, regardless of current participation in CM sessions (see 
Supplemental Check-in Questions uploaded under Section 3.2).   
Follow-up Visit: A subset of procedures from the Screening/Baseline Assessment will be repeated at the 
conclusion of the 12 week treatment interval for all participants.  Procedures will generally involve 
repetition of the EEG procedure, re-administration of cognitive/cognitive-behavioral testing, and re-
administration of one or more self-report questionnaire measures.  The timeline follow-back procedure 
will generally also be completed again at the time of the follow-up visit and specific items from the 
Addiction Severity Index Lite may also be re-administered.  To optimize test-retest reliability of the 
Personalized Delay Discounting task (if applicable), we will attempt to identify a new set of personally-
relevant future event tags with similar valence, salience, and arousal to those utilized at Baseline 
Assessment through repetition of the Positive-Neutral Future Events interview at the time of the Follow-
up Visit. A-B variants of cognitive/cognitive-behavioral tests may also be employed as needed.  It is 
noted that, in some cases, the follow-up visit may occur earlier or later than 12 weeks following 
treatment initiation.  Some flexibility in the timing of the follow-up session may be necessary in order to 

IRBNet #1617313 Protocol Version 1.5 
maximize our opportunities to collect post-treatment data on as many participants as possible.  It is, for 
example, possible that a participant might conclude treatment earlier than 12 weeks due to returning to 
work or moving out of the area.  In such cases, we would invite the participant to complete the follow-
up session early.  Similarly, delays in scheduling of the follow-up session may also occur for a variety of 
reasons.  Provided that the participant is still willing to complete the follow-up session, this session may 
therefore also be scheduled to occur more than 12 weeks from the start of treatment. For healthy 
controls, a follow-up visit will also be conducted after the initial session, at a delay similar to that 
achieved within the patient sample. This session may include repetition of other measures conducted at 
baseline, which can include the repetition of the EEG procedure, cognitive-behavioral testing, and/or 
self-report questionnaires.  
Monthly Check-In Appointments (24 Weeks). CM-assigned participants will engage in research visits on 
an approximately monthly basis for 6 months following the 12 week treatment period. Timeline follow-
back data will be the primary outcome measure and will be collected by phone or in-person. We will 
also continue to monitor outpatient substance use treatment engagement and urinalysis results through 
review of participant medical records during this time period.  During the post-treatment follow-up 
interval, the timeline follow-back procedure will always be administered such that the beginning of the 
assessment interview corresponds with the last occurrence of the timeline follow-back procedure.  In 
this way we will endeavor to collect self-reported substance use data for the full 6 month post-
treatment interval.  This effectively means that one or more missed check-in appointments may be 
administered at the time of the next check-in attended, if needed. Healthy controls will not participate 
in Check-in Visits.  
If necessary, longer research visits (e.g., Screening/Consent, Baseline, Follow-up may occur over one or 
more sessions in order to support complete data collection. 
Unexpected Findings:  While EEG procedures will be conducted for research purposes only, it is possible 
that abnormal patterns of brain activity could be detected during the procedure.  While we do not 
anticipate such incidental findings due to the nature of the EEG procedure and equipment to be utilized, 
participants will be informed that such findings are possible during the consent process, as well as of our 
procedure for handling such findings should they be detected.  Specifically, participants will be informed 
that we will inform their primary care physician of any incidental findings from the EEG procedure in 
order to ensure that appropriate clinical follow-up can be initiated. It is also possible that we might 
identify new information about a participant's current mental health as a consequence of clinical 
interviews conducted in the context of the study.  For example, it is possible that we will identify that a 
participant meets criteria for a mental health condition that has not previously been documented in 
his/her medical record.  Participants will also be informed of this possibility during the consent process 
and we will ask to share any such findings with the participant's mental health treatment coordinator.  
Finally, it is possible that a participant will have a breathalyzer test result that places him/her above the 
legal limit to operate a motor vehicle (BAC ≥ 0.08).  In such cases, we will repeat the breathalyzer test to 
confirm the result and, if the second test result confirms a BAC ≥ 0.08 we will contact the VA police with 
the participant's name and location.  The VA police will then respond according to their procedure for 
handling intoxicated patients who are at risk of driving.  Participants will also be informed of this policy 
during the informed consent process and will have an opportunity to ask questions.  Participants will 
also have the opportunity to decline participation if they do not agree to any policies regarding the 
handling of incidental or unexpected findings. 

IRBNet #1617313 Protocol Version 1.5 
Appointment Reminders:   Phone outreach will generally be conducted prior to the Screening Visit, 
Baseline Assessment, and Follow-up (Post-Treatment) Visit in order to remind participants of these 
upcoming appointments and, if necessary, provide additional information (e.g., instructions for 
preparing for the appointment, directions to the Research Office Building).  Participants may also be 
provided with a written appointment reminder (see Section 8).  Weekly check-ins will generally be 
conducted during scheduled CM treatment visits but may also be conducted by phone or during a 
research visit outside the context of a CM treatment session (for example, this will be the case for 
participants assigned to treatment-as-usual).  Phone calls may therefore also be conducted, as 
necessary, to schedule and/or remind participants of upcoming check-ins.  Monthly check-ins will 
generally be conducted by phone; however, a reminder phone call may also be made prior to a 
scheduled monthly phone check-in if needed or requested by the participant. 
Retention Procedures:  Due to the nature of our study population (treatment-seeking substance users) it 
may be necessary to reschedule initial study appointments (e.g., Screening Visit, Baseline Assessment) 
due to No Shows, recent substance use, or other factors.  For example, it is not uncommon that 
motivation to engage with substance use treatment will fluctuate and patients may, for example, cancel 
or postpone initial appointments for this reason.  In order to capture a representative sample of 
treatment-seeking substance users we will make efforts to reschedule initial study appointments that 
have been cancelled or missed as long as the following conditions are met:  (1) the participant continues 
to express strong interest in study participation and (2) the participant continues to meet general 
eligibility criteria for the study.  With respect to the latter condition, a previously eligible participant 
may, for example, become ineligible prior to completing initial study appointments if he/she elects to 
begin Contingency Management treatment prior to completing these appointments. However, as stated 
later in this protocol, eligibility will be assessed prior to enrollment and there may be some cases in 
which the duration of abstinence exceeds that stated in our criteria such that an interested participant 
can be rescheduled for a missed initial research appointment without encouraging resumed cocaine use 
in order to continue meeting eligibility criteria.   Because participants may only begin treatment offered 
through the study after completing the Screening Visit and Baseline Assessment, individuals will be 
reminded that they can elect to pursue Contingency Management treatment outside the context of the 
study if they wish to begin treatment at an earlier timepoint than what might be possible through the 
study.  It may also be necessary to re-evaluate eligibility and repeat screening/consent (and potentially 
baseline testing) procedures for individuals who have previously engaged with the study but have not 
progressed to the point of randomization in the past.  For example, this may apply to individuals whose 
progress through the study was interrupted by the COVID-19 pandemic.  Given the longitudinal nature 
of the current project, we will also make every reasonable effort to follow-up with participants who 
have been randomized into one of the two study treatment conditions.  Importantly, participants 
assigned to Contingency Management will have access to a 12-week course of treatment, regardless of 
attendance during treatment (or continued participation in the study).  Consequently, unless a 
participant has voluntarily withdrawn (or been withdrawn) from treatment, we will make an effort to 
schedule Contingency Management appointments throughout the 12 week treatment period.  This may 
involve up to three outreach attempts (phone and/or letter) after a missed appointment.  We will follow 
a similar protocol for missed research check-ins, as well as for the Follow-Up Visit.  For missed check-in 
appointments, we will typically make up to five outreach attempts (phone and/or letter).  However, 
because our study population may have inconsistent telephone service, an additional five outreach 
attempts may be made, as needed (for example, in cases in which a participant's mobile phone service 

IRBNet #1617313 Protocol Version 1.5 
has been temporarily disabled).  This outreach protocol will also apply to scheduling and/rescheduling of 
the Follow-Up Visit.  We will additionally ask participants to provide an optional alternative contact for 
research-related communications.  Optional alternative contact information may be used to convey 
HIPAA-compliant messages to participants or to request updated contact information for a participant 
who has been difficult to contact through contact information listed in his/her chart.  Participants may 
also elect to update or rescind alternative contact information at any time.  Participants will be 
reminded that they may withdraw from the study at any time in retention-related communications (for 
example, see letters included under Section 8).  We will otherwise continue to attempt weekly or 
monthly check-ins (depending on condition assignment and study phase) on a weekly or monthly basis, 
respectively, for all actively enrolled participants.  For participants who do not respond to the previously 
described outreach effort and are approaching the end of the study interval, we will transmit a final 
outreach letter to the participant that will provide study contact information, instructions for 
withdrawal from the study, as well as the date upon which study participation will automatically 
terminate.  For participants assigned to Treatment-as-Usual, this date will be 30 days after the end of 
the 12-week treatment interval and for participants assigned to one of the two Contingency 
Management conditions, this date will be 210 days from the end of the 12-week treatment interval (i.e., 
30 days after the 6-month post-treatment timepoint). 
Chart Abstraction Procedures: Information in participant electronic health records will be reviewed and 
data from CPRS may be added to study records at several points during the study.  Prior to providing 
written informed consent, prospective participants undergoing telephone screening will be asked to 
verbally consent to review of their CPRS records by study personnel.  During screening procedures (and 
following either verbal (by phone) or written (in person) consent), information relevant to participant 
eligibility will be reviewed and documented. Eligible participants who enroll in the study will also be 
subject to additional chart abstraction procedures throughout the course of the study.  Chart 
abstraction will generally occur on an approximately weekly basis during the 12 week treatment interval 
and will primarily involve documentation of outpatient substance use/behavioral health treatment 
engagement, missed and cancelled substance use/behavioral health appointments, missed doses of 
medication-assisted treatment (if applicable), lab-based drug-alcohol urinalysis results, changes in 
medications, changes to housing or legal status, and/or any other relevant changes to psychiatric of 
medical status.  Data from Contingency Management sessions may also be reviewed for consistency 
with study tracking logs.  In addition, data on previous courses of Contingency Management participants 
may additionally be abstracted for those with prior Contingency Management treatment experience.  
Following the 12 week treatment interval, chart abstraction procedures will continue for participants 
assigned to one of the two Contingency Management treatment conditions but will occur on an 
approximately monthly basis.  Examples of forms used for Chart Abstraction thought the Dacima Clinical 
Suite are included under Section 15 (Miscellaneous Documents).  Following consent to the study, data 
on engagement with CM treatment, not delivered through the study, may also be derived from review 
of the patient’s chart.  
Use of Meal Tickets: Participants will be eligible to receive a same-day meal ticket if scheduled for >3 
hours of testing during any given visit.  In order to ensure comparable prize options for participants 
assigned to VoucherPBCM and TangiblePBCM, a meal ticket option will also be made available in the CM 
Prize Cabinet.   

IRBNet #1617313 Protocol Version 1.5 
Use of Bus Tickets: Need-based travel assistance will be made available to all participants in the form of 
single use bus tickets.   
Please upload a table of procedures if applicable. 
The study procedures table must be completed for:  
   - All Greater than Minimal Risk (GTM) studies; and  
   - All Minimal Risk studies that use Standard of Care or Usual Care/Interventions. 
Name Modified Date  
Study Procedures Table 9/1/2020 10:46 AM  
  
2.0   
* Will Usual Care Procedures/Interventions be used?" 
  Yes No 
If yes, please specify and include a description of what the usual care or expected level of care is at 
VAPHS (e.g., medications, testing, timing, etc.) for patients, similar to those individuals that meet the 
inclusion/exclusion criteria for this research study: 
A typical outpatient with Cocaine Use Disorder will be recommended to participate in group and/or 
individual psychotherapy targeting problematic substance use. Contingency Management (CM) is also 
frequently recommended for such patients. At VAPHS, CM involves twice weekly urine-based drug 
testing (point-of-care and confirmatory urinalysis) for chances to win abstinence-contingent reward. 
All participants will receive treatment-as-usual during the 12-week treatment interval, which will be 
defined as recommended participation in at least two outpatient group and/or individual psychotherapy 
encounters within CTAD per week; participants will additionally continue pharmacotherapy for 
substance use and/orother mental health conditions, if applicable. The majority of participants will also 
receive one of two different versions of CM, already used within the VA (specifically, VoucherPBCM or 
TangiblePBCM).  
 
   
2.1   
If Usual Care Procedures/Interventions will be used, who is the individual or entity responsible for 
relevant aspects of the usual care (i.e., which of the above usual care activities will the research study 
team be responsible for)?: 
The research study team will specifically be responsible for the delivery of CM within the context of the 
current study. The PI currently serves as the local implementation coordinator and primary provider of 
CM at VAPHS. She will oversee this aspect of usual care in consultation with the National CM 

IRBNet #1617313 Protocol Version 1.5 
Implementation Team, as well as other CTAD providers. CM will be delivered by one or more research 
interventionists trained by the PI and supervised in consultation with her mentor(s).   
2.2  Does the usual care at VAPHS for the condition of interest in this research study differ from national 
guidelines/recommendations (i.e. standard of care)? 
  Yes No   
If yes, please describe the differences: 
  
2.3  Are any procedures that are considered standard for this patient population performed more 
frequently than usual care? 
  Yes No   
If yes, please indicate which time points are considered usual care and which are considered research. 
 
2.4  If there is more than one standard, does VAPHS limit which one is followed (e.g. warfarin use for 
atrial fibrillation vs. one of the newer anticoagulants). 
  Yes No   
   
If yes, please explain: 
  
3.0   
* Does clinical expertise need to be enlisted? 
  Yes No 
 
If yes, please provide the provisions for enlisting the services of a clinician with appropriate expertise 
and privileges to perform duties, if the investigator is not a clinician [i.e. reviewing the data, adverse 
events, and new study findings; also making required decisions to protect the health of the subject (e.g., 
stopping the participant’s involvement in the study or determining when to notify the subject or the 
subject’s health care provider of information that may affect the health of the subject)]: 
It is possible that circumstances could present during the study that would require clinical expertise. 
While suicidal/homicidal ideation and behaviors are not a focus of the current study, it is always possible 
that an imminent threat to the safety of the self or other could be disclosed during study assessments or 
CM treatment visits. If this should occur, study activities will be discontinued and study personnel will 
respond to the mental health crisis. This may include contacting the patient's mental health provider 
and/or escorting the patient to the mental health walk-in clinic or emergency department with the 
assistance of VA police. If such symptoms are described over the phone (or during a video call), study 

IRBNet #1617313 Protocol Version 1.5 
personnel will follow the VAPHS warm-transfer protocol and/or VVC e911 protocol. This protocol is 
designed to ensure a warm transfer of the call to either the Veterans Crisis Line or local emergency 
services. Study personnel will also contact the patient's mental health provider in such cases to ensure 
appropriate follow-up. Participants will be informed of the limits of confidentiality during the informed 
consent process for the study. Significance of risk will be assessed by the PI. Dr. Forster has substantial 
experience working with individuals at elevated risk of suicide/homicide and has managed mental health 
crises in both research and clinical settings.  
During participation in study procedures, it is also possible that an incidental finding could occur. We do 
not anticipate that incidental findings are likely because we are not conducting assessments for clinical 
purposes, designed to identify new medical or psychiatric problems. For example, the EEG procedure we 
describe herein is different from that used by a neurologist and is not designed to inform diagnosis of 
brain-related disorders. However, if data collected from a participant are found to be anomalous in 
some way, we will notify the participant of this within one week and will also share the result with the 
participant's Primary Care Physician. Similarly, it is possible that we may identify a previously 
undiagnosed mental health condition during study interviews. If this should occur and the information is 
relevant to ongoing care, we will share this information with the patient's mental health treatment 
coordinator. Participants will be alerted to the protocol for handling incidental findings during the 
informed consent process. 
   
4.0   
Please upload any surveys, questionnaires, and data collection forms. 
  Document Description Version Number  
View ACQ(0.01)   0.01  
View ACT Version A(0.01)   0.01  
View ACT Version B(0.01)   0.01  
View Adverse Childhood Experiences(0.01)   0.01  
View AIS(0.01)   0.01  
View BL / FU Session Notes (0.01)   0.01  
View CFCS(0.01)   0.01  
View CM Fidelity Assessment(0.01)   0.01  
View CM Prize Reminder Slip(0.01)   0.01  
View CM Session Flowchart(0.03)   0.03  
View CM Tracking Form Wks 11-12 Fri Start(0.01)   0.01  
View CM Tracking Form Wks 11-12 Tues Start(0.04)   0.04  
View CM Tracking Form Wks 1-2 Fri Start(0.01)   0.01  
View CM Tracking Form Wks 1-2 Tues Start(0.05)   0.05  
View CM Tracking Form Wks 3-4 Fri Start(0.01)   0.01  
View CM Tracking Form Wks 3-4 Tues Start(0.04)   0.04  
View CM Tracking Form Wks 5-6 Fri Start(0.01)   0.01  
View CM Tracking Form Wks 5-6 Tues Start(0.04)   0.04  
View CM Tracking Form Wks 7-8 Fri Start(0.01)   0.01  

IRBNet #1617313 Protocol Version 1.5 
View CM Tracking Form Wks 7-8 Tues Start(0.04)   0.04  
View CM Tracking Form Wks 9-10 Fri Start(0.01)   0.01  
View CM Tracking Form Wks 9-10 Tues Start(0.04)   0.04  
View DCQ(0.02)   0.02  
View Demographic Info Form(0.02)   0.02  
View DTCQ (To Be Purchased)(0.01)   0.01  
View Fagerstrom(0.01)   0.01  
View List of Emotions(0.01)   0.01  
View Mini_MoCA(0.01)   0.01  
View POC Test Results(0.01)   0.01  
View PPIS(0.02)   0.02  
View PRMQ(0.01)   0.01  
View SLUMS(0.01)   0.01  
View SOCRATES(0.01)   0.01  
View SPSRQ(0.01)   0.01  
View SSS(0.01)   0.01  
View TRQ(0.01)   0.01  
    
View: 4.1 Research study methods: analysis Plan   
1.0  * Please describe the analysis plan for the study (it is acceptable to refer to the sponsor/multi-site 
protocol for section if applicable): 
Data Analytic Plan. 
EEG Data Preprocessing.  Data from both incentive delay and flankers tasks will be visually inspected and 
band-pass filtered using parameters specific to each analysis. Data will subsequently be corrected for 
ocular, movement, and (if applicable) line noise artifact, using independent components analysis or 
possibly other methods. If necessary, bad channels will be replaced with interpolated data. Data from 
each task will be segmented into event-locked epochs.  Epochs with significant residual artifact will be 
rejected and a current source density transformation may be applied to improve spatial resolution, prior 
to analysis, if deemed necessary. Alpha suppression will be computed for the pre-feedback reward 
anticipation interval in the Incentive Delay task by computing event-related spectral power in the alpha 
band (8-12 Hz), relative to a pre-response baseline interval. Differential alpha suppression to high 
magnitude tangible versus voucher prizes will be quantified at occipital sites (O1, Oz, O2) within the 
1500 ms time window preceding feedback. For the Flankers task, ERN and conflict N2 amplitudes will be 
determined as follows. For response-locked event-related potentials, the negative peak amplitude of the 
difference wave computed for error vs. correct responses at sites FCz and/and Cz will be used as the 
measure of ERN amplitude. The sum of differences in stimulus-locked N2 amplitude between congruent 
vs. intermediate incongruity conditions and congruent vs. high incongruity conditions will be used to 
quantify parametric modulation of conflict N2 by differential control demands. For functional 
connectivity analyses, data will be bandpass filtered into targeted frequency bands (e.g., delta, theta, 
alpha, beta, and gamma). Theta frequency synchronization between ACC electrode sites (e.g., Cz, FCz) 
and lPFC electrode sites (e.g., F3, F4, F5, F6) will specifically be evaluated for error vs. correct and 
congruent vs. incongruent trials using synchronization likelihood or a similar approach. Exploratory 

IRBNet #1617313 Protocol Version 1.5 
network level analyses may also be conducted for event-locked epochs from both Incentive Delay and 
Flankers tasks.  In addition, based on exploratory findings from our pilot effort (Pro1787) we may 
additionally conduct exploratory analyses of our brief pre-task baseline (resting-state) EEG recordings 
including quantification of eyeblink rate and related metrics from EOG and EEG and channels. 
Cognitive-Behavioral Data Preprocessing. In the Personalized Delay Discounting task, switch points will 
be determined for each participant based on decision outcomes for trials in each condition (with 
personally-relevant event tags, without personally-relevant event tags) and latency. Switch points 
represent the monetary amount at which a switch from immediate preference to delayed preference (or 
vice versa) takes place, suggesting similar subjective valuation of immediate and delayed amounts in 
that context. Next, a hyperbolic discounting model will be fit to switch point data on an individual 
subject basis to determine the discounting slope parameter, k. The difference in the natural log of k for 
event tag versus standard (no event tag) discounting conditions will subsequently be computed for each 
subject as an index of self-controlled decision-making in the context of episodic future thinking. No 
preprocessing is necessary to compute Brown-Peterson test scores; the total score (sum of all correct 
responses) will be used as the primary index of performance. 
Pupillometry Data Preprocessing. Pupillometry data may also be acquired during participant 
engagement with computerized experimental paradigms and/or pre-task baseline EEG recordings.  
These data will be pre-preprocessed utilizing standard methods under the direction of co-investigator, 
Dr. Steinhauer, in preparation for additional exploratory analyses. 
Power Analysis and Sample Size. In analyses of baseline predictors of treatment response in CM 
recipients (estimated n = 119-140) and long-term (i.e., six month) outcomes (estimated n = 105-140), 
using the statistical rule of thumb of needing 10 observation per predictor, our originally projected 
sample size would provide adequate power to include 10-14 variables in regression-based analyses. 
Random Forest methods are further supported for an expanded set of variables, as this highly flexible 
and powerful approach has been validated in “wide datasets,” wherein the number of predictors 
exceeds the number of observations. With the anticipated enrollment of 140 participants, there will 
additionally be adequate power (β = 0.20, alpha = 0.05) to detect an effect size of f = 0.12 for the 
treatment adherence (adherent, non-adherent) X time (baseline, follow-up) interaction, supporting 
planned comparison of treatment-related change in neural and cognitive-behavioral measures between 
PBCM adherent and non-adherent Veterans. Assuming 15% attrition, the estimate of the detectable 
effect size for the treatment X time interaction for a total sample size of 119 is f = 0.13. The anticipated 
effect size of treatment-related change in synchronization likelihood between ACC-lPFC electrode sites is 
not known. However, previous work has established a medium-to-large effect size for treatment-related 
change in the ERN and N2 (in association with cognitive training).[74,75]  
 
It was necessary to revise our original analytic plan to accommodate a smaller sample size than that 
originally projected. Recruitment under the current protocol was initially delayed due to institutional 
barriers that prevented timely acquisition of our EEG system. While recruitment was promptly initiated 
after our equipment was finally received, approximately three months later, all research activities were 
suspended due to risks posed by the COVID-19 pandemic. Due to the collection of EEG data and the 
nature of the interventions under study (e.g., need to be in the physical presence of the prize cabinet to 
potentially benefit from the increased psychological proximity of reward), it was not possible to convert 
the current protocol to be conducted fully remotely during the pandemic.  A series of administrative 

IRBNet #1617313 Protocol Version 1.5 
holds on research activities therefore effectively suspended enrollment for approximately one year.  
After research activities could be safely resumed, the COVID-19 pandemic also continued to negatively 
impact recruitment as the majority of outpatient substance use treatment services continued to be 
offered remotely throughout the remainder of our active enrollment period.  This resulted in reduced 
foot traffic through clinic areas, making it more difficult to connect with potentially eligible participants. 
While a variety of new recruitment methods were introduced, our final sample size was much smaller 
than originally projected. 
 
To address limitations related to the ratio of observations to predictors in the context of our reduced 
sample size, we revised our predictive analytic approach (Specific Aim 1) to prioritize model stability and 
interpretability, while framing results as more preliminary in nature. With respect to Aim 1, a revised 
sample size of ~50 participants was identified as sufficient to support investigation of up to five 
candidate predictors: e.g., two EEG-derived metrics, one clinical measure, one neurocognitive measure, 
and treatment condition. Recent simulation-based work (Austin & Steyerberg, 2015) further suggests 
that as few as two participants per predictor may be adequate, supporting investigation of the original 
candidate set even within the reduced sample. Two consulting biostatisticians endorsed this revised 
approach and further recommended modeling repeated binary outcomes over the course of CM 
treatment to improve power. In line with this recommendation, we modeled 24 repeated binary 
outcomes per participant, yielding up to 24 x n observations across n participants. However, recognizing 
that the effective number of independent events remains tied to the number of participants rather than 
the number of observations, we adopted a two-stage variable selection process to reduce the risk of 
overfitting. In the first stage, we screened predictors using single-predictor longitudinal logistic 
regression models, identifying those with theoretically plausible associations with the outcome. This 
process narrowed our total number of candidate predictors. In the second stage, we applied stepwise 
forward selection guided by the Akaike Information Criterion (AIC) to construct a parsimonious, 
interpretable multivariate model. To further assess model robustness and generalizability, we evaluated 
predictive performance using leave-one-out cross-validation (LOOCV).   
 
Implications of our reduced sample size were also considered for Specific Aim 2, which involves 
longitudinal analysis of change in key neurocognitive metrics with adherence and abstinence as 
potential covariates. Based on guidance from statistical consultants, a sensitivity analysis indicated that 
a total sample size of 36 participants with both pre- and post-treatment data would provide adequate 
power to detect small to medium effect sizes (f = 0.17–0.30). This revised projection reflects the 
practical constraints of the available sample while maintaining sufficient power for detecting meaningful 
change over time in the context of repeated measures analysis. As an alternative analytic strategy, a 
median split approach to adherence and abstinence may be considered if data suggest that 
dichotomization would enhance interpretability or improve model stability in the context of limited 
sample size. While treating these variables as continuous covariates is generally preferred due to 
increased power and retention of variance, a binary approach may be appropriate in cases of non-linear 
relationships, bimodal distributions, or when simplifying the model structure offers clear interpretive 
advantages. 
Specific Aim 1. Evaluate the utility of EEG and cognitive-behavioral measures of FMDM as predictors of 
differential treatment outcomes in TangiblePBCM versus VoucherPBCM. A significant interaction 
between CM treatment condition (i.e., TangiblePBCM versus VoucherPBCM) and neurocognitive indices 

IRBNet #1617313 Protocol Version 1.5 
of FMDM function (i.e., EEG and cognitive-behavioral measures) is hypothesized. Specifically, individuals 
demonstrating greater FMDM impairment (poorer working memory function, less reduction in delay 
discounting with inclusion of future event tags, and reduced EEG/ERP signaling to abstract future reward 
and control demands) will achieve better outcomes in Tangible PBCM, relative to VoucherPBCM 
(Hypothesis 1a).  In models including PBCM treatment condition as a factor, inclusion of EEG and 
cognitive-behavioral predictors is expected to significantly reduce prediction error with respect to both 
PBCM treatment response and long-term outcomes. Differential alpha suppression in response to 
tangible prize versus voucher prize rewards, in particular, will assay engagement by different types of 
future reward utilized in TangiblePBCM and VoucherPBCM. Consequently, differential alpha suppression 
is expected to be an especially robust predictor of outcomes in existing PBCM variants.  It is further 
hypothesized that this candidate neuromarker will be selected for inclusion in a readily translatable 
predictive model – even when incorporating resource constraints that penalize predictors derived from 
more costly procedures (e.g., EEG incurring a greater cost-based penalty than self-report measures; 
Hypothesis 1b).  
The proposed design affords measurement of all candidate predictors prior to initiation of PBCM, as well 
as monitoring of both CM treatment response and long-term outcomes for all CM recipients. Predictive 
models of CM treatment response and long-term outcomes will be developed separately, with the 
caveat that our revised final sample size may not support the latter. Candidate predictors will include 
pretreatment FMDM-related EEG (concrete versus abstract alpha suppression, ERN amplitude, 
parametric N2 amplitude effect) and cognitive-behavioral measures (Brown-Peterson score, ∆ln(k)), as 
well as clinical indicators (e.g., craving severity, past month cocaine use, number of previous treatment 
episodes) ) and self-report scores. In order to examine the interaction between candidate predictors and 
CM reward parameters, PBCM condition (TangiblePBCM versus VoucherPBCM) will also be considered 
as an explanatory variable in predictive models.  
I will receive focused training in predictive modeling, with an emphasis on recursive partitioning 
machine learning methods: classification and regression trees (CART) and random forests (RF). Our 
original analytic plan proposed that regression trees would be grown to examine the predictive 
structure of explanatory variables (including PBCM treatment condition) with respect to the following 
continuous outcomes: (1) % cocaine-negative urines during CM, (2) % CM sessions attended, (3) % days 
of any self-reported substance use during CM, and (4) % days of self-reported stimulant use during the 6 
months following CM. CART involves partitioning observations into more homogenous subgroups with 
respect to the outcome of interest by identifying cut points along predictor variables. For each CART, 
cost-complexity pruning would be conducted using five-fold cross validation to limit overfitting. A 
Random Forest (RF) approach would subsequently be implemented with each set of predictors and 
outcomes to objectively evaluate the relative importance of each predictor and optimize overall model 
performance. RF involves growing an ensemble of decision trees based on bootstrapped samples of 
observations and predictors to increase tree diversity. This method includes internal cross-validation 
using out-of-bag error rates (based on observations not included in the bootstrap sample) to limit 
overfitting during model training and performs well without excessive tuning of model parameters. 
Taken together these data mining approaches would provide deep insight into interrelationships 
between predictors and outcomes of interest and could also be further examined through aa resource-
constrained Tabu search procedure to develop multiple regression models forecasting treatment 
response (% cocaine-negative urines) in each PBCM variant, while penalizing individual predictors based 

IRBNet #1617313 Protocol Version 1.5 
on measurement cost.103 Resource-constrained Tabu search has not previously been used to analyze 
the predictive utility of neuromarkers in view of the increased cost of measuring these signals but is 
ideally suited to this issue in measurement-based care. In our revised approach, we employed 
longitudinal logistic regression as described above and specifically examined outcomes on a per session 
basis, with provision of a cocaine-negative specimen at the session being considered a successful 
outcome and cocaine-positive or missing specimens considered unsuccessful. This revised approach 
enables more efficient use of the available data by capturing the full trajectory of participant responses 
over time through repeated measures modeling, rather than relying on a single aggregated outcome. 
Missing Data Strategies: Recursive partitioning approaches (CART, RF) flexibly handle missing data for 
candidate predictors through several heuristic and/or interpolation based approaches. Missing data 
handling for TABU search is not yet well-characterized but works well, provided that missing data is 
randomly distributed and relatively rare. Expecting a 15% rate of attrition, usable substance use 
outcome data is anticipated for a minimal sample size of n = 119 CM recipients. Additional outcome 
variables will be derived from chart review (e.g., treatment engagement, urinalysis results), providing 
additional options for quantifying outcomes, not contingent on participation in study check-in 
appointments. Importantly, all methods specified above can be used with binary outcomes (i.e., CM-
completer versus CM-non-completer). Consequently, while efforts will be made to collect detailed 
outcome data on each participant (and this appears feasible on the basis of my ongoing pilot project), 
primary predictive modeling aims can be accomplished under circumstances of high attrition and data 
loss. Our revised analytic approach has also been configured to be resilient to missingness through 
handling missing specimens as unsuccessful outcomes using an intent-to-treat approach.  Where 
necessary (e.g., for treatment trajectories impacted by the pandemic), a Bayesian logistic regression 
model can also be used to impute missing values based on observed patterns to estimate likely values 
for unobserved responses.  
Specific Aim 2. Evaluate longitudinal change in cognitive-behavioral and EEG-based indices of FMDM 
during CM. Engagement in PBCM will be associated with differential enhancement of control-related 
theta synchronization between ACC and lPFC during high conflict events in the Parametric Conflict 
Flankers task, relative to PBCM nonadherence and will also foster greater improvement in working 
memory and episodic future thinking effects on delay discounting (Hypothesis 2a). Individual differences 
in treatment response trajectory during CM will also be explored as a factor in neuroadaptive change 
during treatment (Exploratory Sub-Aim). 
Increased functional connectivity within control-related brain networks in conjunction with CM would 
reflect important mechanisms of neural recovery facilitated by this intervention. I will receive training in 
functional connectivity analysis of EEG data, which may include a series of learning experiences guided 
by my co-mentor, Dr. Siegle, and consultants, Drs. Hetrick, Kim, and Sporns. Most importantly, I will 
receive training in synchronization likelihood, a nonlinear approach to estimating functional connectivity 
which measures statistical dependencies in dynamic time series and can thus characterize both linear 
and nonlinear interdependencies in EEG data. This technique may be applied to evaluate 
synchronization strength between pairs of electrodes and within frequency bands, based on a priori 
hypotheses, although more traditional functional connectivity measures may also be utilized. 
Specifically, theta frequency synchronization between ACC and lPFC electrode sites will be computed to 
quantify transient network dynamics related to control modulation. Treatment-related change in 

IRBNet #1617313 Protocol Version 1.5 
executive working memory and delay discounting behavior will also be evaluated as cognitive-behavioral 
indicators of FMDM-related function.  
Repeated measures analysis of covariance (ANCOVA) will be conducted to evaluate treatment-related 
change in the following indices of FMDM between PBCM adherent and non-adherent: (1) control-
related theta synchrony between ACC and lPFC, (2) Brown-Peterson working memory score, and (3) 
change in the episodic future thinking effect in delay discounting slopes (∆ ln(k)). A general linear model 
design will be utilized including assessment latency (baseline versus follow-up) as a within-subjects 
factor. In order to account for differences in substance use, adherence, and PBCM treatment condition, 
these factors (% days of use, % sessions attended, PBCM condition) may also be considered as 
covariates or between-subjects factors using a median split approach. Tukey’s HSD (or equivalent) will 
be used for post hoc evaluation of marginal means to clarify main and interaction effects. Adjusted 
marginal means may  be used to investigate covariates as moderators of the treatment-by-time 
interaction. Given the previously identified relationship between ACC-lPFC theta phase synchrony and 
amplitude of the ERN and conflict N2,66,67 treatment-related change in these ERPs may also be 
evaluated using the same approach. Correlations between ERN/N2 amplitudes and ACC-lPFC theta 
synchrony, as well between EEG and cognitive-behavioral measures, may also be computed for each 
timepoint to identify significant linear relationships between dependent measures.  To account for the 
constraints of a reduced sample size, we may employ alternative statistical approaches as needed—
particularly to address non-normality and other assumption violations that could compromise model 
validity. 
Additional exploratory analyses may also be conducted to investigate trajectories of recovery during 
PBCM in relation to neuroadaptive change. I will receive specialized training in multilevel modeling 
approaches to longitudinal data analysis, including use of growth mixture models to resolve latent 
subgroups exhibiting distinct patterns of longitudinal change. For participants assigned to both PBCM 
conditions, longest duration of cocaine abstinence may be computed on a weekly basis from within-
treatment urinalysis results and attendance (unexcused, missed appointments will also be considered to 
end a period of abstinence). Growth mixture modeling may subsequently be employed to evaluate intra-
individual change in the longest duration of abstinence achieved during PBCM treatment and determine 
if distinct change profiles meaningfully represent inter-individual variance. If identified, subgroups 
exhibiting distinct trajectories in PBCM may also exhibit different patterns of neural recovery within 
functional connectivity networks underlying cognitive control and reward representation. Exploratory, 
network-based analyses may therefore also be conducted (if applicable) and may generate new insights 
into neuroadaptive processes that reflect and may also support sustained abstinence in CM. Cocaine 
users have previously been demonstrated to exhibit reduced interhemispheric functional connectivity 
within the dorsal frontoparietal control network, which is thought to support goal-directed top-down 
control of attention and behavior, as well as representation and anticipation of future rewards. My 
training in functional connectivity analysis of EEG data will support exploratory analysis of network-level 
disturbances in CUD, as well as potential treatment-related change in interhemispheric functional 
connectivity within the dorsal frontoparietal control network in relation to CM. Using methods 
previously described by my consultants, Drs. Hetrick, Kim, and Sporns, I may also employ 
synchronization likelihood to identify localized functional connectivity networks that significantly differ 
between CUD subgroups exhibiting different patterns of cocaine abstinence during CM. Briefly, pairwise 
synchronization likelihood will be computed between all pairs of EEG channels for reward- and control-

IRBNet #1617313 Protocol Version 1.5 
related epochs derived from Incentive Delay and Flankers tasks, respectively. Non-parametric, network-
based statistics will subsequently be employed to identify pairings which differ significantly between 
CUD subgroups at baseline and follow-up, including potential differences in interhemispheric functional 
connectivity within the dorsal frontoparietal control network. Training offered by my consultants would 
also afford the opportunity to combine synchronization likelihood with graph theoretic approaches to 
functional connectivity analysis. Consequently, additional exploratory analyses can target differences in 
network-level properties within local (e.g., strength, local efficiency, betweenness centrality) and global 
(e.g., path length, small worldness, global efficiency) functional connectivity structures. However, it is 
noted that additional exploratory analyses can only be undertaken if the final sample size is sufficient to 
support them. 
Missing Data Strategies:  Individuals lost to follow-up will be excluded from these analyses due to 
necessary inclusion of longitudinal measures from the follow-up timepoint. It is anticipated that 
covariates of interest will be available for all individuals who complete the follow-up assessment 
session. Specifically, treatment engagement will be determined on the basis of chart review and self-
reported substance use will be evaluated on a weekly basis. For participants who miss one or more 
check-in assessment during the treatment period, the timeline follow-back procedure will be extended 
to evaluate the full period between the present and previous study contact. In my previous longitudinal 
study of substance users, I was able to collect all necessary follow-up data on 80.8% of my originally 
enrolled sample. However, it is also possible that unexpected circumstances may require imputation of 
missing data values.  In such cases imputation of missing values will leverage available within- and 
between-subjects data. 
Additional exploratory analyses and quality assessment analyses will also be conducted over the course 
of the study.  Consequently, the analysis plan outlined above will not cover all analyses that may be 
potentially undertaken with the current dataset.   Similarly, additional approaches to data preprocessing 
(filtering, data reduction, artifact rejection, etc.) that are not described above may also be applied in 
order to optimize signal quality for the purposes of proposed and exploratory analyses.  It is noted that, 
because of the nature of the current study (human subjects research, psychophysiological research), 
data points may not be reliably collected as prescribed for all participants and timepoints.  For example, 
missing data may occur if a participant chooses to discontinue study procedures during an assessment 
visit due to fatigue or external obligations.  Data loss may also occur due to equipment failure or other 
conditions results in poor quality data during psychophysiological recordings and cognitive-behavioral 
testing procedures.    
View: 5 Sub-Studies  
1.0  * Is there a sub-study or are there sub-studies associated with this study? 
There is a sub-study (or there are sub-studies) associated with this study and VAPHS is participating.   
    
View: 5.1 Sub-Studies  
1.0  * Please describe the sub-study or sub-studies: 
SUB-STUDY 1:  FEASIBILITY OF CM TREATMENT VIA TELEHEALTH TREATMENT SESSIONS 

IRBNet #1617313 Protocol Version 1.5 
Due to the current COVID-19 pandemic, it is possible that noncritical in-person outpatient visits will be 
discontinued if there is a surge in new cases in our local area.  Given the nature of the current RTC, we 
are at risk of substantial data loss if CM treatment sessions offered through the current protocol must 
be terminated (as was the case in 3/2020).  We would therefore like to conduct a sub-study to test the 
feasibility of conducting CM sessions via telehealth treatment sessions.  Specifically, we will experiment 
with methods for delivering CM via VA Video Connect sessions.  One or more Veterans will be provided 
with oral fluid point-of-care tests and will be trained on how to perform this type of objective testing 
during VVC sessions such that results can be remotely reviewed and prize draws rewarded accordingly.  
Participants in this case study will receive the standard voucher version of PBCM offered at VAPHS and 
prize vouchers will be delivered to or retrieved by Veteran following the remote session.  Participants 
will additionally be asked to provide feedback on home-based point-of-care testing, methods for 
remotely conducted CM prize draws, prize transmissal, and other related aspects of remotely-delivered 
CM treatment. As described in the Substudy consent form, a combination of remote and in-person 
treatment sessions may be offered, depending upon the unique needs of each participant and/or 
barriers to remote implementation that may present over time. 
Between 1-15 Veterans will be invited to take part in telehealth-based CM treatment sessions.  We will 
specifically make an effort to invite individuals to participate for whom in-person CM sessions are not 
preferred because (1) the Veteran is at high risk for complications from COVID-19, (2) the Veteran is 
under quarantine due to COVID-positive status or housing-related restrictions, or (3) the Veteran has 
ongoing transportation problems that make attending in-person treatment sessions more difficult.  All 
participants will be either be self-referred or clinician-referred to receive CM services and will meet 
general requirements for this type of treatment (e.g., ongoing problematic stimulant use).  Participants 
must also be willing and able to participate in telehealth services, appropriate for telehealth care, and 
able to interact and communicate through audio and visual elements of the VVC platform.  No other 
eligibility criteria will apply.  Participants in the substudy may be former (e.g., completed or withdrawn) 
participants from the primary protocol or participants determined ineligible to participate in the primary 
protocol.  Participants will not receive any compensation for participating other than prizes received in 
the course of treatment.  Aside from the use of VA-approved telehealth technology to remotely conduct 
CM treatment sessions, the CM protocol to be used in this substudy will be identical to that prescribed 
by VHA's National CM Implementation effort.  Importantly, similar adaptation of evidence-based 
treatment protocols to telehealth are (and have been) routinely conducted in the course of standard 
clinical care during the pandemic.  There are also no significant risks associated with the proposed 
telehealth-based protocol - rather, it is expected that this CM option may be lower risk for some 
Veterans.  Potential participants will be informed of this opportunity during either interactions with the 
research team regarding in interest in the primary protocol (e.g., upon screening out) or during initial 
clinical interactions upon referral to CM if barriers to in-person attendance are identified.  Participants 
will provide informed consent to participate in this substudy.  Data collected will generally be limited to 
information typically acquired in the course of standard clinical administration of CM (i.e., self-reported 
use, substance use test results, attendance, etc.).  However, we will additionally take note of any 
feedback from patients regarding the telehealth experience, as well as any technical or logistical 
problems that occur in the course of remote administration.  The goal of this substudy will be to develop 
and refine methods for remote administration of PBCM should this become necessary in the future. The 
standard CM note template will be used to document such sessions in CPRS.  All data collected for this 
substudy can be extracted from documentation of treatment sessions entered in the chart.  

IRBNet #1617313 Protocol Version 1.5 
Risks and Benefits:  With respect to Substudy 1, participants will have the opportunity to receive a 
telemedicine version of CM that is not otherwise available at our site and this may benefit Veterans for 
whom remote treatment options are indicated or preferred.  There are no significant risks associated 
with the proposed telehealth-based protocol - rather, it is expected that this CM option may be lower 
risk for some Veterans.  This substudy will combine the use of an approved "standard of care" treatment 
option with approved VA telehealth technology (e.g., VVC) and so does not significantly deviate from 
standard clinical practice.  However, due to the use of Veteran-administered oral fluid testing, this 
treatment protocol would currently only be permissible in the context of research.  Participants will be 
informed of confidentiality and privacy considerations that are unique to telehealth at the start of each 
session (for example, ensuring that the Veteran has sufficient privacy in their current environment), as is 
typical of all such clinical interactions. 
SUB-STUDY 2:  REMOTE PHYSIOLOGICAL MONITORING FOR STATE-DEPENDENT PREDICTORS OF 
CRAVING AND USE 
SUB-STUDY 2 Specific Aim: Establish feasibility of data collection using wearable sensors and identify 
promising physiological markers of stimulant craving and/or use between treatment encounters. 
In this sub-study, I will leverage the existing infrastructure of my CDA research to collect supplemental 
physiological and activity data via wearable sensors to identify potential real time markers of craving 
and use. Participants will be recruited through our established recruitment pipeline. Following 
enrollment in the parent protocol, up to 45 participants will be invited to participate in additional 
physiological and activity monitoring during the first two weeks of the 12-week treatment interval. 
Individuals who decline to participate will be asked to share specific concerns contributing to this 
decision. Those who choose to enroll will be outfitted with a wrist-worn ActiGraph wGT3X-BT wearable 
activity monitor and Bluetooth-enabled Polar H7 Heart Rate monitor. Together, these medical-grade 
wearable devices enable high resolution monitoring of heart rate (including R-R intervals), physical 
activity (including sleep/wake time and related metrics), and compliance without conveying feedback to 
the wearer. Participants will receive training on routine maintenance of wearable devices, including 
requirements for recharging/changing batteries. Feedback regarding acceptability of wearable 
monitoring, as well as problems encountered, will be recorded at the beginning and end of sub-study 
participation. Devices will be returned at the conclusion of the 2-week recording period, whereupon 
data will be downloaded and the participant will be compensated $40. Participants may additionally 
receive daily reminder calls during the 2-week recording interval to ensure that they are wearing the 
devices properly and to troubleshoot any problems that may arise.  Upon request, participants may 
receive a copy of a clinical report, generated by ActiLife software, summarizing activity and sleep data 
from the recording interval.   
Data Analytic Plan. The number of participants declining to participate in the sub-study, as well as 
feedback regarding acceptability of wearable device monitoring will be quantitively and qualitatively 
summarized.  Data collected through ActiGraph/Polar wearable devices will be reviewed, preprocessed, 
and analyzed using ActiLife software. The proportion of data rejected due to noncompliance (detected 
using ActiLife’s Wear Time Validation Tool) or poor electrocardiography (ECG) signal quality (determined 
through visual inspection) will subsequently be computed. Valid data segments will be subject to 
additional analyses investigating potential markers of high-risk states in wearable data streams. Based 
on previous work and known cardiovascular effects of stimulants, periods of elevated resting heart rate 

IRBNet #1617313 Protocol Version 1.5 
are expected to predict self-reported stimulant use and subsequent stimulant-positive urinalysis. For 
example, periods of elevated heart rate associated with cocaine craving can be distinguished from use 
events based on duration (30-40 minutes for craving versus 2 hours for use). The number and duration 
of elevated resting heart rate intervals will be investigated as potential predictors of self-reported and 
objectively verified stimulant use using a mixed effects logistic regression approach. Additional 
exploratory features extracted from ECG and activity data (e.g., heart rate variability (linked to craving in 
alcohol users), sleep efficiency (known to be impaired during early cocaine abstinence), and 
number/duration of physical activity bouts) may also be considered. These preliminary analyses will 
serve to identify promising state-dependent markers from wearable data streams for future 
investigation. Importantly, a mobile interface to be developed under a separate protocol (Pro3566) will 
support ecological momentary assessment of craving, stress, and substance use and these data will 
critically inform future efforts to distinguish physiological markers associated with high-risk for use – of 
relevance to delivery of in the moment interventions – from actual use events.    
View: 6 Study Population Summary  
Study Population Summary 
1.0 * What is the maximum number of subjects you plan to enroll at VAPHS? 
215 (Target Sample Size Primary Study = 140; an additional 1-5 Veterans may be invited to participate in 
Sub-Study 1) 
Participants in Sub-Study 2 (n = 45) will already be enrolled in the primary protocol and so are already 
included in the projected target sample.  
2.0  
* Do you plan on enrolling patients into different categories: 
  Yes No  
 If yes, please explain: 
Participants who complete Screening and Baseline testing procedures will be randomized into two 
different conditions: VoucherPBCM (n = 70) or TangiblePBCM (n = 70. Details of the two study 
conditions are provided under Section 4. Healthy controls will either have no history of substance use 
treatment or will be considered to be in long-term recovery (i.e., having achieved > 1 year of abstinence 
from cocaine and other illicit substances).  We will make an effort to match healthy controls to the 
patient sample based on age, sex, and smoking (nicotine use) status.   
3.0 If this is a multi-site study, indicate the projected total subject accrual: 
No.   
4.0  
* Please provide a justification for the sample size: 
Power Analysis and Sample Size. In analyses of baseline predictors of treatment response in CM 
recipients (estimated n = 119-140) and long-term (i.e., six month) outcomes (estimated n = 105-140), 

IRBNet #1617313 Protocol Version 1.5 
using the statistical rule of thumb of needing 10 observation per predictor, there will be adequate 
power to include 10-14 variables in regression-based analyses. Random Forest methods are further 
supported for an expanded set of variables, as this highly flexible and powerful approach has been 
validated in “wide datasets,” wherein the number of predictors exceeds the number of observations. 
With the anticipated enrollment of 140 participants, there will additionally be adequate power (β = 0.20, 
alpha = 0.05) to detect an effect size of f = 0.12 for the treatment adherence (adherent, non-adherent) X 
time (baseline, follow-up) interaction, supporting planned comparison of treatment-related change in 
neural and cognitive-behavioral measures between PBCM adherent and non-adherent subgroups. 
Assuming 15% attrition, the estimate of the detectable effect size for the treatment X time interaction 
for a total sample size of 119 is f = 0.13. The anticipated effect size of treatment-related change in 
synchronization likelihood between ACC-lPFC electrode sites is not known. However, previous work has 
established a medium-to-large effect size for treatment-related change in the ERN and N2 (in 
association with cognitive training) [69,70]. We have also proposed to compare the treatment-seeking 
CUD sample to the approximately 45 healthy controls who may be invited to participate in a comparison 
sample. Data from controls would help determine how CM-referred veterans differ from healthy 
individuals with respect to approaches to rewarding abstinence. However, it was ultimately not possible 
to enroll a sufficient healthy comparison sample at our site. In addition, due to factors that negatively 
impacted participant accrual over the course of the current study (as described elsewhere in the 
protocol) a revised analytic approach was developed to make use of a sample size that was significantly 
reduced relative to that originally projected. 
 
An additional 1-15 Veterans will be invited to participate in Substudy 1, with the goal that at least one 
individual completes a full course of treatment via telehealth. This sample size is reasonable for a case 
study and also reflects financial considerations which may impact the ongoing availability of oral fluid 
testing supplies for this purpose. 
      
View: 6.1 Study Population  
Study Population 
1.0  
* Check all that apply to describe your study population: 
  
  Study Population  
   
 Non-Veterans  
 Special Populations  X 
 Veterans  X 
 Vulnerable populations  X 
 Other  
 
2.0 * Indicate the inclusion criteria for enrollment: 

IRBNet #1617313 Protocol Version 1.5 
▪ Military Veterans, ages 18-75 
▪ DSM-5 Criteria for Cocaine Use Disorder (Mild, Moderate, or Severe) 
▪ Cocaine Use Within Past 45 Days (or past 60 days if in a controlled environment for part of this time) 
▪ Stated Goal of Cocaine Abstinence or Reduced Cocaine Use 
▪ Normal or Corrected-to-Normal Visual and Auditory Acuity (e.g., patients with glaucoma or tinnitus 
may be eligible) 
These criteria will be assessed prior to enrollment and it is noted that many participants will no longer 
meet all the above-stated criteria throughout the full study interval. For example, time since most 
recent cocaine use may exceed 45-60 days in patients who achieve and maintain abstinence during 
Contingency Management treatment and this would not be considered grounds for withdrawal from the 
study. 
Healthy controls will either have no history of substance use treatment or will be considered to be in 
long-term recovery (i.e., having achieved > 1 year of abstinence from cocaine and other illicit 
substances).  We will make an effort to match healthy controls to the patient sample based on age, sex, 
and smoking (nicotine use) status. 
For Sub-Study 1, 1-5 Veterans will be invited to take part in telehealth-based CM treatment sessions. We 
will specifically make an effort to invite individuals to participate for whom in-person CM sessions are 
not preferred because (1) the Veteran is at high risk for complications from COVID-19, (2) the Veteran is 
under quarantine due to COVID-positive status or housing-related restrictions, or (3) the Veteran has 
ongoing transportation problems that make attending in-person treatment sessions more difficult. All 
participants will be either be self-referred or clinician-referred to receive CM services and will meet 
general requirements for this type of treatment (e.g., ongoing problematic stimulant use). Participants 
must also be willing and able to participate in telehealth services, appropriate for telehealth care, and 
able to interact and communicate through audio and visual elements of the VVC platform. No exclusion 
criteria will apply. Participants in the substudy may be former (e.g., completed or withdrawn) 
participants from the primary protocol or participants determined ineligible to participate in the primary 
protocol. 
3.0 * Indicate exclusion criteria for enrollment: 
▪ History of Severe Traumatic Brain Injury, Seizure Disorder, or other Neurological Conditions resulting in 
structural and/or functional abnormalities of the brain that are expected to reduce interpretability of (or 
acquisition of generalizable knowledge from) psychophysiological datasets  
▪ Severe or Unstable Medical or Psychiatric Condition that may interfere with study participation or the 
ability to follow the intervention protocol (e.g., suicidality, untreated secondary substance use disorder, 
ongoing cancer treatment, potential for future/frequent medical hospitalization) 
▪ Pregnant or Lactating Women 
▪ Moderate-to-Severe Neurocognitive Impairment per Medical Record or SLUMS ≤ 20 or Mini MoCA ≤ 10 

IRBNet #1617313 Protocol Version 1.5 
▪ In Long-Term Residential Treatment In a Controlled Environment or Imminently Expected to Enter Such 
Treatment During the Study Interval at the time of Screening 
These criteria will be assessed prior to enrollment and it is  possible that participants will experience a 
change in one or more of these criteria over the course of the study. For example, patients may be 
admitted to residential treatment or experience a medical hospitalization (unrelated to participation) 
during the study interval. In an effort to collect full and complete longitudinal data on as many 
participants as possible, such circumstances will not necessarily result in participant withdrawal from 
the study. However, if any such change is determined to adversely impact the risk-to-benefit ratio of 
continued participation, investigator-initiated withdrawal of the participant will occur. 
It is further noted that individuals living in transitional housing will be eligible for inclusion. In addition, 
patients who are scheduled to discharge from a residential treatment program (e.g. CTAD CORE) will be 
considered eligible if they are not imminently expected to seek admission to another residential 
treatment environment upon discharge.   
Healthy controls will either have no history of substance use treatment or will be considered to be in 
long-term recovery (i.e., having achieved > 1 year of abstinence from cocaine and other illicit 
substances).  Healthy controls will be excluded if they test positive for substance use (e.g., based on 
breathalyzer test results or urine drug testing) at the time of the baseline assessment.  An effort will be 
made to achieve a healthy comparison sample that is demographically similar to the patient sample and 
it is noted that otherwise eligible individuals may be excluded in order to achieve this objective.  
4.0 If there are any age, ethnic, language, or gender-based exclusion criteria, including the exclusion of 
any pregnant or lactating women, or those of child-bearing potential, please provide justification: 
Pregnancy and/or lactation may alter event-related potentials under study herein. As it will not be 
possible to systematically evaluate the influence of pregnancy/lactation on event-related potentials in 
the current design, there is scientific justification for excluding these individuals.   
5.0 Please specify why vulnerable subjects and/or special populations will not be enrolled:  
   
6.0 With some exceptions as listed in VHA Handbook 1200.05, incompetent subjects cannot be enrolled 
in VAPHS approved research. Specify that you will not enroll incompetent subjects and the general rules 
to be used in making that determination: 
We will not enroll incompetent subjects in the current protocol. Competence to provide informed 
consent will be evaluated during the informed consent process. Those who are unable to provide 
informed consent will be excluded from the study.   
    
View: 6.2 Study Population- Vulnerable Populations  
Study Population 
1.0  
* Check all that apply to describe your study population: 

IRBNet #1617313 Protocol Version 1.5 
Children  
 Decisionally Impaired  
 Economically Disadvantaged  X 
 Educationally Disadvantaged   
 Prisoners  
   
2.0 * Describe the precautions, and any additional safeguards that will be taken to protect the rights and 
welfare of vulnerable subjects if they are to be enrolled. Also note that certain populations may feel 
pressured or be vulnerable to coercion or undue influence to participate in research. Indicate any special 
considerations that may be taken for such groups: 
We will not specifically target economically disadvantaged individuals in our recruitment efforts. 
However, it is possible that Veterans interested in participation and eligible for the current study will be 
from economically disadvantaged backgrounds.  
Several safeguards have been established to minimize the risk of coercion or undue influence and to 
protect the rights of our participants.  
Some potential participants will be informed of the study by one of their providers. This will allow 
participants to discuss concerns regarding participation with someone who is not directly affiliated with 
the study and who is oriented toward the needs of the patient rather than the study. We believe this 
will prevent patients from feeling pressured to participate in the current study. We also expect that the 
majority of potential participants will self-initiate contact with study personnel directly. In these cases 
the potential participant has already decided that he/she is interested in the study, which may offset the 
risk of coercion.  
While we will provide monetary compensation for time and travel, we believe that study payments are 
reasonable and would not be considered to be coercive. Participants will also be educated that 
"informed consent is an ongoing process" and that they can choose to stop participating at any time 
without financial penalty or loss of benefits to which the Veteran would otherwise be entitled. Before 
each procedure, a brief description will be provided, including the rationale for the procedure as well as 
what the participant can expect to experience. Participants will be provided with an opportunity to ask 
questions prior to each study procedure and will also be informed that they may decline to begin a 
procedure if they feel uncomfortable in any way. They will also be reminded throughout that they may 
choose to end participation at any time, even if this requires terminating a procedure that is already 
under way.  
    
View: 6.2.3 Economically Disadvantaged  
Economically Disadvantaged 
1.0 * Target Number of Participants: 
140   
2.0 * Please provide a justification for including these subjects: 

IRBNet #1617313 Protocol Version 1.5 
We will not specifically target economically disadvantaged individuals in our recruitment efforts. 
However, it is possible that individuals of low socioeconomic status will be identified as potential 
participants. Specifically, many patients with chronic substance use disorders are members of 
economically disadvantaged communities and substance use may also result in adverse consequences 
with respect to employment and income. Recruiting a representative sample of Veterans with substance 
use disorders is necessary to improve generalizability of the our findings and we would be unable to 
achieve a representative sample if we specifically excluded economically-disadvantaged individuals. We 
additionally note that the treatment under study (Contingency Management) has been demonstrated to 
be effective, regardless of income level [71].   
    
View: 6.3 Study Population- Special Populations  
Study Population 
 
1.0  
* Check all that apply to describe your study population: 
Employee and Student Subjects  
Investigators Clinical Population   X 
 
2.0 * Provide a justification for including these subjects: 
It is possible that a potentially eligible participant will be a member of a clinical population seen by a 
study investigator. For example, it is possible that one or more investigators will be involved with 
administration of CM or other substance use treatment services through the Behavioral Health service 
line. Dr. Forster provided clinical services through the Center for Treatment of Addictive Disorders 
during active recruitment and the majority of patients who would be eligible for this study will likely be 
receiving care through this clinic. While subjects from these populations may be at an increased risk of 
coercion, study procedures have been developed to protect against this risk and are further described 
under Section 6.3.2. Importantly, patients will regularly be informed/reminded that research is optional 
and voluntary and that they will have comparable access to Contingency Management treatment if they 
choose not to participate in the current study.    
      
View: 6.3.2 Investigators clinical population  
Investigators clinical population 
1.0 * Please indicate how you will minimize the potential for them to feel coerced to participate.  
Discuss how the potential confusion in roles will be addressed: 
It is possible that a potentially eligible participant will be a member of a clinical population seen by a 
study investigator. For example, it is possible that one or more investigators will be involved with 
administration of CM or other substance use treatment services through the Behavioral Health service 

IRBNet #1617313 Protocol Version 1.5 
line. While subjects from these populations may be at an increased risk of coercion, study procedures 
have been developed to protect against this risk. Specifically, all participants will be asked to provide 
written informed consent prior to undergoing study procedures and will have the option to voluntarily 
discontinue the study at any time. During the informed consent process, all participants will be informed 
of the following: "Your doctor may also be involved as an investigator in this research study. As both 
your doctor and a research investigator, s/he is interested both in your medical care and the conduct of 
this research study. You are under no obligation to participate in this or any other research study 
offered by your doctor. Before you agree to participate in this research study, or at any time during your 
participation in this study, you may discuss your care with another doctor who is not associated with this 
research study."  
It is noted that some participants will initially receive information about the study from a clinician who is 
not a study co-investigator and will therefore have an opportunity to discuss participation with this 
unaffiliated provider. In addition, we anticipate that the majority of potentially eligible participants will 
self-initiate contact with the study. In such cases, potentially eligible participants would not be under 
the direct clinical care of a study investigator involved with CM until after they had evaluated their 
interest in the study and determined whether or not they wished to participate. However, it is possible 
that participants under direct clinical care by a study investigator could receive information about the 
study from that investigator in some cases. If this should occur, the investigator will identify that he/she 
is involved with the study but will arrange that the screening and informed consent process could be 
conducted by other study personnel if the participant prefers. The investigator will inform potential 
participants that such arrangements have been made in order to minimize confusion about roles served 
by the investigator, as well as any perceived pressure to participate. Study personnel will always take 
care to clearly delineate clinical versus research procedures in which participants may become involved 
and will make all participants aware that research involvement is voluntary and can be discontinued at 
any time. Importantly, patients will regularly be informed/reminded that research is optional and 
voluntary and that they will have comparable access to Contingency Management treatment if they 
choose not to participate in the current study.    
View: 7 Risk/Benefit Assessment-Risks  
Risk/Benefit Assessment-Risks 
 
1.0  
* Risk classification for this study (select one). 
 Minimal Risk  X 
 Greater than Minimal Risk  
 
2.0 * Basis for making the above recommendation: 
The potential risks to subjects in the proposed research are minimal. The proposed work utilizes only 
noninvasive procedures that suggest a level of risk, comparable to that which is typically encountered in 

IRBNet #1617313 Protocol Version 1.5 
daily life or in routine physical or psychological examinations or tests. Potential risks include 1) minor 
itchiness or irritation at EEG electrode sites, 2) distress or discomfort during interview and/or self-report 
assessments, and 3) loss of confidentiality of information collected in the context of the proposed 
research. Risks are specific to involvement in proposed research procedures. Participation in this study 
will not entail any additional therapeutic risk. There are no known contraindications to Contingency 
Management. Furthermore, patients will be informed that they may withdraw from the study at any 
time without penalty and will continue to have access to Contingency Management services through 
CTAD.    
3.0 * Describe the safety precautions that will be taken to minimize risks/harms: 
Participants will be informed of potential risks during the informed consent procedure and will also be 
informed of all measures to protect against these risks (detailed below under, Protection Against Risk). 
The risks associated with the proposed research are minimal and methods in place to protect against 
these risk have already been evaluated and approved by the VAPHS Institutional Review Board in the 
context of an ongoing pilot study using procedures described in the proposed research. Consequently, 
the measures in place to protect against risks in the proposed work are expected to be adequate. The 
Contingency Management interventions used within this study are already routinely used within the VA 
and are not associated with any additional risks. Participants will, however, be asked to report any 
change in substance use, mental health symptoms, or gambling behavior that they notice during 
Contingency Management; while we have no reason to expect such changes, these symptoms will be 
monitored in order to guard against unknown risks.  
Participants will be informed of potential risks during the informed consent procedure and will also be 
told that they can discontinue the study at any time without penalty or loss of access to treatment 
services. Participants will be informed that they do not need to answer questions posed in interviews or 
on self-report questionnaires if they do not wish to. They will also be asked to report discomfort during 
the EEG procedure, such as itchiness on the scalp, around electrode sites. If discomfort or distress is 
reported during any study procedure, the participant will be asked if he/she wishes to discontinue the 
procedure. Procedures will be discontinued upon participant request at no risk of penalty. As private 
information will be collected as part of this study, there is a risk of loss of privacy and confidentiality. 
This risk will be described during the informed consent procedure. In addition, all electronic and paper 
data will be stored in an approved, secure location and will not be transmitted outside the VA. All 
possible efforts will be made to limit the inclusion of personally identifiable information on study-
related documents. Personal identifiers will not be used to label study data. Participants will be assigned 
a study ID and this coded number will be used to identify all paper and electronic files related to study 
participation. The link between the participant ID code and participant name will be maintained in a 
single file which will be password-protected and accessible by key study personnel only; this file will also 
be stored behind the VA firewall in a secure location on the VA network. The participant ID code will not 
be included on informed consent documents or other paper forms that include identifiable information 
(e.g., contact information) and will be stored separately from documents labeled with a participant ID 
code. Participants will be informed of information that may be entered in their personal medical record 
as part of clinical care administered through the study; such information may include urinalysis lab 
results and Contingency Management progress notes. Participants will also be informed that they can 
continue with the research study even if they choose to discontinue Contingency Management and/or 
do not wish to provide urines that will be subject to lab-based urinalysis. It is additionally noted that 

IRBNet #1617313 Protocol Version 1.5 
there are no known contraindications to Contingency Management. In the event that a participant 
assigned to treatment-as-usual expresses a self-assessed need to seek initiation of Contingency 
Management programming prior to conclusion of the 12 week treatment interval, the participant will be 
reminded that he/she can voluntarily withdraw from the study at any time.    
4.0  
* Provide details regarding the nature of each risk using the area provided below: 
  Risk Name  
View Activity / HR Monitoring (GOLDSTEIN SUBSTUDY ONLY)  
View Confidentiality  
View Interviews  
View EEG Recording  
View Self Report Questionnaires  
 
5.0 * Do you plan on using the research answering service:   Yes No 
 
If yes, please Upload the research answering service form: 
    
6.0 If your study involves a treatment or intervention, please upload the Patient ID Card: 
    
View: 7.1 Risk/Benefit Analysis-Potential Benefits and Alternatives  
  
Risk/Benefit Analysis-Potential Benefits and Alternatives 
Describe any potential for benefits to participants in this study: 
 
1.0 * Direct and Indirect Benefits to Subjects: 
There are no direct benefits to participants in the proposed research. However, it is noted that 
participants assigned to the TangiblePBCM condition will have access to a version of CM that (while 
already used within the VA) is not currently offered at VA Pittsburgh and may potentially benefit some 
patients more than VoucherPBCM (the version currently offered at our site). It is also possible that 
participants will learn new information about themselves through participation in study interviews, self-
report questionnaires, or other procedures. Participants will also be informed that their participation 
may help others by improving our understanding of important mechanisms of action in Contingency 
Management (as well as substance use recovery, more broadly) and may additionally clarify individual 
differences that affect how people respond to existing variants of PBCM. 

IRBNet #1617313 Protocol Version 1.5 
   
2.0 * Describe alternatives (research or non-research) that are available to subjects if they choose not to 
participate in this study: 
The alternative to participation in the current protocol is non-participation. Veterans who choose not to 
participate will continue to receive treatment-as-usual and may be eligible for other research studies.   
       
View: 8 Methods of Recruitment and Retention  
  
Recruitment Methods and Materials used for Retention 
 
1.0  
 
* Select recruitment methods used on this study: 
 Mail Campaign  X 
 Referral by independent source  X 
 Advertising such as fliers, letters, or ads (newspaper, TV, radio) X 
 Web Site   
 Research registry 
 Selected from pre-existing records  X 
 Pre-existing relationship with participants   
 Other  
If Other Methods Specify: 
Mail Campaign  
1.0 
* Please specify whether an “opt-in” or “opt-out” recruitment approach will be 
used. If an “opt-out” approach is planned, please provide a rationale for why the 
IRB should approve this approach including an assessment of the level of risk of 
this study and a description of the direct benefit of this study to all participants: 
The mail campaign targeting potential treatment recipients will utilize an "opt-out" approach 
whereby Veterans will be invited to contact the study team if interested in participation and 
notified that they may be contacted by the study team if they have not responded within a 
specific timeframe (~1 month). Phone outreach will be conducted to confirm that the 
Veteran is not interested in participating. 
 
We believe that an "opt-out" approach is justified for the current protocol for the following 
reasons: 
(1) the current study involves minimal risk 
(2) all participants stand to benefit by receiving an evidence-based treatment offered 
through the study 
(3) those most likely to benefit from treatment offered through this study (i.e., individuals 
with motivational deficits that interfere with substance use treatment engagement and/or 
achieving and maintaining cocaine abstinence) are also least likely to self-initiate contact 

IRBNet #1617313 Protocol Version 1.5 
with the study 
team after receiving a letter. 
 
As described further under #2 below, our mail campaign will involve outreach to Veterans 
identified as potentially benefitting from Contingency Management treatment.  This will 
include Veterans recently referred to Contingency Management and those recently evaluated 
for substance use treatment services who have a diagnosis of Cocaine Use Disorder.  This 
may also include Veterans who have previously participated in Contingency Management 
and those who have engaged with screening/prescreening activities but did not complete 
randomization into treatment.  In addition, Veterans identified to have recently tested 
positive for cocaine via drug-alcohol urinalysis results documented in the electronic health 
record may also receive mailings.  In such cases, Veterans known to the study team may be 
contacted directly by mail and those who are not known to the study team will initially 
receive outreach about the study through their provider but may also receive a follow-up 
mailing. 
 
In addition, our proposed recruitment method also includes several safeguards to ensure 
that patient rights are protected. First, we will send a letter indicating that patients can self-
initiate contact with the study team to express that they are either interested in or not 
interested in study participation. We will additionally specify that, if we have not heard from 
the patient by a specific date, the study team may initiate phone contact to confirm that the 
patient is not interested. Under these circumstances we will always proceed under the 
assumption that the participant does not wish to participate (i.e., they have opted out) but 
will contact them by phone to confirm that they do not wish to opt-in. We will keep a record 
of participants to whom letters have been sent (including the date specified for potential 
phone follow-up), as well as phone contact and screening records in a spreadsheet on a 
secure VA shared drive that can only be accessed by the study team. These records will be 
regularly reviewed to identify Veterans who have not self-initiated contact and are due for 
phone follow-up. Phone outreach will entail a maximum of three total outreach calls, of 
which a maximum of one voicemail will be left if the patient is not available. Letters 
notifying Veterans of potential phone outreach will be on VA letterhead and will be signed by 
Dr. Forster, who is well-known to many potential recipients as a provider within the CTAD 
clinic.  Taken together, these precautions should be sufficient to address possible discomfort 
or suspicion that could arise from a "cold call." 
 
2.0 * Specify how subjects will be identified and how study eligibility will be determined: 
Veterans will be recruited upon outpatient treatment engagement through CTAD at VAPHS. The 
following methods will be used to identify potentially-eligible Veterans with CUD: 
1) CTAD Initial Evaluations / Intake Assessments. All patients initiating treatment through CTAD (or 
beginning a new episode of care) complete an evaluation with a CTAD provider. CTAD providers will be 
encouraged to inform Veterans about the study if they meet criteria for CUD. If the Veteran is agreeable, 
the CTAD psychologist will forward his/her information to the study team for subsequent outreach. 
CTAD assessment clinic records will also be screened on a weekly basis and a mailing with study 
information will be sent to potentially eligible patients. Screening will include CTAD outpatient Initial 
Evaluations, as well as intake/screening assessments for the CTAD CORE residential program and Opioid 
Substitution Treatment Clinic (OSTC).  
Established CTAD patients who have been referred to CM by a provider will similarly be provided with 
information about the study. Veterans who have previously participated in Contingency Management 
treatment, or who have recently tested positive for cocaine, may also receive information about the 

IRBNet #1617313 Protocol Version 1.5 
study by mail.  As individuals who have previously participated in CM may now be in long-term recovery, 
these individuals may also receive information about participation as a healthy comparison subject. 
 
2) CTAD CORE Information Session and/or Announcement During Group Psychotherapy. The PI or other 
study representative may present information about the research study as an announcement during 
group psychotherapy sessions. Veterans interested in the research study will be provided with study 
contact information. 
 
3) Advertisements. Study brochures will be placed in the CTAD waiting room, as well as other public 
areas around the VAPHS University Drive and H. J. Heinz campuses. Flyers will also be placed in several 
community locations to target Veterans not currently receiving care at VAPHS.  Flyers or brochures may 
also be included in materials provided to Veterans admitted to the CTAD CORE residential treatment 
program. In order to recruit healthy controls, brochures will also be deposited in public spaces within 
the hospital as well as area Vet Centers and other Veteran-oriented organizations and social clubs.  
 
4) Referrals from Providers. Providers in the behavioral health service line will be informed about the 
study and the CTAD CM program. These providers will be encouraged to identify patients with 
problematic cocaine use and either (1) provide these patients with a study brochure or (2) refer these 
patients for a CTAD Initial Evaluation, whereupon they will have the opportunity to receive information 
about the study, if appropriate. We may additionally conduct outreach to other clinics expected to 
identify Veterans with active cocaine use on a semi-regular basis. For example, Veterans who are 
actively using cocaine may be identified in the course of routine services delivered through the VAPHS 
Cardiac Rehab program or during pre-surgical evaluations. Making providers in these clinics aware of the 
study (as well as the availability of CM more generally) may improve Veteran access to relevant 
treatment if active cocaine use is incidentally identified. 
5) Table with Recruitment Materials.  The study team may additionally set up a table to advertise for the 
study with approval from VAPHS or other relevant entities.  A table may be set up for recruitment 
purposes on VA grounds (e.g., University Drive Atrium) or may be hosted at a community-based 
recovery-oriented event (e.g., Overdose Awareness event at Veterans Place of Washington Blvd). 
Efforts to identify and recruit potential subjects will always respect personal rights to privacy and 
confidentiality, as outlined in the HIPAA guidelines. Patients with substance disorders will be recruited 
through referrals from inpatient and outpatient Behavioral Health providers at University Drive and 
Heinz Campuses of VAPHS. Clinicians in relevant clinics will be educated about the study's entry criteria 
and will be instructed to provide potentially eligible participants with study contact information. In 
addition, we request a waiver to conduct pre-screening of veteran records as this will be necessary to 
meet our recruitment goals. Specifically, Dr. Forster (PI) or an authorized research assistant will identify 
potentially eligible participants by pre-screening veteran medical records in CPRS. Specifically, Veterans 
who are initiating services through the Center for Treatment of Addictive Disorders (CTAD) or beginning 
a new episode of care will be identified as these patients will be scheduled for an initial assessment 
through the CTAD Clinic. Assessment clinic records will be screened on an ongoing basis and a mailing 

IRBNet #1617313 Protocol Version 1.5 
with a study brochure will either be sent to the patient or transmitted to the patient during an upcoming 
clinical contact. In the latter case, Dr. Forster or an authorized research assistant may contact the 
veteran’s provider by phone or encrypted Outlook email in order to alert the provider that the veteran 
may be eligible for the research study and to facilitate transmitting study information to the provider if 
he/she agrees. If the patient is interested in the study, he/she may contact the study directly to set up 
an appointment. In this way, the burden on the clinician will be minimal and it will not be necessary to 
store PHI related to potentially-eligible participants.  
All potentially-eligible individuals who are interested in the study will be screened for initial eligibility by 
phone (or in person, if preferred by the patient). Preliminary eligibility for the study will be assessed 
during a scripted interview with study staff. Veterans interested in the study will first receive detailed 
information about the study and will be asked to consent to the screening procedure (including access 
to relevant medical records). The screening interview will include questions about demographic (e.g., 
Veteran status, age, sex) and clinical information (e.g., substance use diagnoses, most recent cocaine 
use, history of neurological disease, etc.) relevant to eligibility. Prospective participants may also be 
asked to participate in a Mini MoCA cognitive screening at this time to assess eligibility - otherwise, this 
screening will take place at the first study visit for those eligible on the basis of the initial screening 
interview.  
Veterans meeting general criteria will be invited to schedule an initial study visit involving informed 
consent and diagnostic interview procedures. Veterans who are ineligible will be informed that they may 
be eligible for other research opportunities and that exclusion from the research study does not 
preclude access to CM treatment through CTAD if this treatment option is deemed appropriate by their 
CTAD provider(s). We will specifically ask for verbal consent to access electronic medical records during 
the telephone screening procedure. Patients who prefer to participate in an initial screening in person 
will provide written informed consent to participate in screening procedures only and will also be asked 
to sign a HIPAA Authorization permitting access to relevant patient medical records. Access to records 
will be used to confirm information provided by potential participants during the initial screening 
procedure. We will avoid accessing information beyond that which is immediately necessary to evaluate 
preliminary study eligibility.    
 
3.0  
* Provide the location (or locations) of the sites where participants will be recruited: 
Participants will be recruited within the Center for the Treatment of Addictive Disorders, as well as 
public spaces within the hospital and community, frequented by veterans. Brochures and flyers will be 
posted in public areas within VAPHS (e.g., clinic waiting areas, patient lounges, etc.) and may 
additionally be placed in clinical areas such as provider offices or group treatment rooms. In addition to 
Heinz and University Drive campuses, brochures and flyers may also be placed at local CBOCs, Vet 
Centers, and Vet Court / Veterans Justice Outreach locations, as well as community treatment locations 
(specifically, local Cocaine Anonymous meeting locations, needle exchange locations, Resolve Crisis 
Services, and community-based methadone clinics), community-based organizations or resources 
specifically targeting Veterans who may be in need of substance use treatment services (specifically, 
offices of Veterans Services at local universities, Soldier On, Veterans Leadership Program of Western 

IRBNet #1617313 Protocol Version 1.5 
Pennsylvania), and local homeless shelters/half-way houses/transitional housing facilities (e.g., Light of 
Life, Shepherd's Heart, Recovery House, etc.). 
   
4.0 Please include information regarding any advertisements (print, TV, radio, etc) that will be used to 
recruit subjects including a general description of where this information will be posted: 
Brochure flip cards and flyers have been prepared in concert with the Office of Public Affairs and are 
included as attachments below. Brochures and flyers will be posted in public areas within VAPHS (e.g., 
clinic waiting areas, patient lounges, etc.) and may additionally be placed in clinical areas such as 
provider offices or group treatment rooms. In addition to Heinz and University Drive campuses, 
brochures and flyers may also be placed at local CBOCs and Vet Centers, as well as community 
treatment locations (specifically, local Cocaine Anonymous meeting locations, needle exchange 
locations, community-based methadone clinics, and the Office of Veterans Services at the University of 
Pittsburgh). Brochures for recruitment of healthy veterans may also be distributed to area Vet Centers 
and other Veteran-oriented organizations and social clubs. 
5.0  
  
Please UPLOAD the documents that will be used for recruitment and an introductory statement or letter 
to accompany consent for those studies obtaining written informed consent using methods such as fax, 
email or mail (if applicable). Please also upload any screening/recruitment questions that will be verbally 
asked of potential research subjects.  Also, if you will be providing any retention materials, please 
upload them here. 
 
Name Reviewer Modified Date Version Number  
Appointment Reminder - WRAP BL Forster, Sarah Emily 10/17/2018 2:26 PM 0.01  
Appointment Reminder - WRAP Follow-Up Forster, Sarah Emily 10/17/2018 2:27 PM 0.01  
CM FAQ Document Forster, Sarah Emily 10/11/2018 7:31 PM 0.01  
Contact Information Form Forster, Sarah Emily 10/17/2018 1:33 PM 0.01  
Letter - Re-engage After Pandemic Hold  Forster, Sarah Emily 9/1/2020 4:32 PM 0.01  
Letter - WRAP Follow-Up Reminder Forster, Sarah Emily 10/17/2018 2:22 PM 0.01  
Letter - WRAP Lost to FU Forster, Sarah Emily 10/17/2018 2:23 PM 0.01  
Letter - WRAP Missed Research Appt Forster, Sarah Emily 10/17/2018 2:22 PM 0.01  
Letter - WRAP Missed Treatment Appt Forster, Sarah Emily 10/17/2018 2:22 PM 0.01  
A set of updated Recruitment letters dated 5/2/2022 has been uploaded with the current package. 
Letter - WRAP Recruitment Other Evaluation Forster, Sarah Emily 1/13/2020 4:43 PM 0.02  

IRBNet #1617313 Protocol Version 1.5 
Letter - WRAP Recruitment Outpatient Evaluation Forster, Sarah Emily 1/13/2020 4:44 PM 0.04  
Letter - WRAP Recruitment Previous CM Forster, Sarah Emily 1/13/2020 4:43 PM 0.02  
Letter - WRAP Recruitment Recent Referral Forster, Sarah Emily 1/13/2020 4:43 PM 0.02  
Letter - WRAP Remote Screening Reminder Forster, Sarah Emily 9/1/2020 4:33 PM 0.01  
Letter - WRAP Return Questionnaires Forster, Sarah Emily 10/17/2018 2:24 PM 0.01  
Letter - WRAP Scheduling BL or FU Forster, Sarah Emily 10/17/2018 2:23 PM 0.01  
Letter - WRAP Scheduling Check-In Forster, Sarah Emily 10/17/2018 2:23 PM 0.01  
Letter - WRAP Screening Reminder Forster, Sarah Emily 10/17/2018 2:21 PM 0.01  
Letter - WRAP Vendorization / Payment Forms Forster, Sarah Emily 10/17/2018 2:25 PM 0.01  
PAO Approval Forster, Sarah Emily 9/27/2018 1:15 PM 0.01  
WRAP Flier Forster, Sarah Emily 9/27/2018 1:05 PM 0.01  
WRAP Flip Card Forster, Sarah Emily 9/27/2018 1:05 PM 0.01  
WRAP Flip Card Printer Error Version Forster, Sarah Emily 8/26/2019 4:51 PM 0.01  
Updated Recruitment materials have been uploaded with the current package, dated 5/2/2022. 
View: 9 Informed Consent  
 Informed Consent 
1.0  
 
* Indicate the types of consent that will be involved in this study (check any or all that apply): 
Informed Consent Category  
Written/signed consent by subject  
Waivers are being requested.  
Verbal consent or written information sheet(Requires a Waiver of Documentation of Informed Consent - 
see below)  
 
2.0  
* Waivers: If you are applying for any waivers of consent (check any or all that apply): 
 
X  Waiver of Informed Consent  

IRBNet #1617313 Protocol Version 1.5 
X  Waiver of HIPAA Authorization   
 X Waiver of Documentation of Informed Consent ( telephone consent, verbal script)  
 No Waiver at all  
 
3.0 * Will this study include non-English speaking participants? 
  Yes No   
       
View: 9.1 Waiver of HIPAA  
  
You have indicated you are requesting a waiver of HIPAA.  
 
1.0 
* Is the request only for Screening/Recruitment purposes? 
  Yes No 
If yes, please describe your screening/recruitment method: 
Waiver for Telephone Screening 
Potential participants will self-initiate contact with study personnel after being informed of the study by 
a provider, study advertisement, or mailing and will be asked to engage in a screening process. We 
anticipate that the majority of patients will participate in this screening process by telephone. We will 
specifically ask for verbal consent to access records in CPRS during the telephone screening procedure. 
Access to records will be used to confirm key information provided by potential participants during 
phone screening - namely, mental health and general medical diagnoses listed in the individual's CPRS 
Problems List. We may also check active consults and/or recent progress notes for evidence of referral 
to the Contingency Management program. As the Problems List may not always reflect current 
diagnoses, it may also be necessary to access other recent records in order to confirm information 
provided by potentially-eligible participants. We will avoid accessing information beyond that which is 
immediately necessary to evaluate preliminary study eligibility. We will only access information beyond 
that which is immediately necessary to evaluate preliminary study eligibility (e.g. progress notes and 
laboratory results tracking progress in CM) following provision of written HIPAA authorization at the 
initial study visit. Potential participants will be asked to verbally provide identifiable information which 
may be necessary to access CPRS records (e.g., name, last 4 of SSN) and/or establish future contact 
(preferred phone number). Such information will not be acquired from patient medical records directly. 
Minimal identifiable information will be maintained in a secure location for scheduling purposes.  
Waiver for Pre-Screening Records 

IRBNet #1617313 Protocol Version 1.5 
We also request a waiver to conduct pre-screening of veteran records. Specifically, Dr. Forster (PI) or an 
authorized research assistant will identify potentially eligible participants by pre-screening veteran 
medical records in CPRS. Veterans who are scheduled for an Initial Evaluation appointment through the 
Center for Treatment of Addictive Disorders (CTAD) be screened with respect to basic eligibility criteria, 
either before or after the time of their Initial Evaluation appointment. Veterans who have previously 
participated in Contingency Management and may therefore have interest/need to re-engage with this 
type of treatment may also be identified for pre-screening. Individuals who have recently tested positive 
for cocaine (e.g., within the past 3 months) may also potentially benefit from this type of treatment and 
may additionally be identified for pre-screening.   When a potentially-eligible veteran is identified, Dr. 
Forster or an authorized research assistant will either (1) send out a mailing with study information 
(letter and brochure) directly to the patient if known to PI (e.g., if no further upcoming clinical 
encounters have been scheduled) or (2) contact that veteran’s provider by phone or encrypted Outlook 
email in order to alert the provider that the veteran may be eligible for the research study. If the 
clinician agrees, Dr. Forster (or an authorized research assistant) will provide study information (i.e., 
letter and brochure) to the clinician for distribution to the patient during an upcoming clinical contact. If 
the patient is interested in the study, he/she may contact the study coordinator directly to set up an 
appointment. In this way, the burden on the clinician will be minimal and it will not be necessary to 
store PHI related to potentially-eligible participants.  
Waiver for Initial Study Visit When Conducted Remotely 
We are requesting to extend our waiver of HIPAA for telephone-based screening to the initial Consent 
and Screening appointment for the study in order to offer the option that this appointment be 
conducted remotely.  
We will specifically ask for verbal consent to access records in CPRS during the remote study visit. Such 
access will be necessary to confirm information provided by the Veteran, document the research visit, 
schedule the first in-person visit, and facilitate coordination with other providers as needed. The 
participant will subsequently be asked to provide his/her written HIPAA authorization at the first in-
person initial study visit as part of the process for obtaining written informed consent to participate in 
the study. 
If no, the request is for the full study (e.g. retrospective chart reviews and certain observational studies) 
Please describe the types of records and/or databases to be accessed: 
We will review patient data in CPRS, as needed, to determine patient eligibility. We will begin by 
reviewing the Problems List and, if applicable, the recent CTAD Initial Evaluation report for the Veteran. 
It may also be necessary to review patient medications, recent DAU lab reports, psychiatric and medical 
reports, C&P reports, and clinical progress reports in some cases. In such cases, we will specifically target 
information in the record that may be necessary to determining eligibility and may specifically conduct a 
text-based search (e.g., for terms like "TBI" or "Traumatic Brain Injury") in order to check the patient's 
medical record against self-reported information provided during the screening interview. It may 
additionally be necessary to view the Veteran's upcoming appointments for scheduling purposes and/or 
enter study-related documentation into the chart. 
  THE IDENTIFIABLE INFORMATION BEING REQUESTED: 

IRBNet #1617313 Protocol Version 1.5 
Note: If participants will be receiving payment and HIPAA Authorization is not being obtained, you must 
select Names, Addresses and Social Security Numbers as that information will be disclosed for payment 
purposes.    
2.0  
* Identifiable Information per HIPAA Definition   
 None  
 Account numbers  
 Biometric identifiers, including finger and voice prints   
 Certificate/license numbers   
 Device identifiers and serial numbers  
 Elements of dates (except year, for example, date of birth, admission date, discharge date, date of 
death, date of procedures; and all ages over 89)    
 Email Address  
 Fax Numbers  
 Full-face photographic images or any comparable images  
 Geographical subdivisions smaller than a State (street address, city, county, precinct, zip code, and their 
equivalent geocodes, except for the initial three digits of a zip code)  X 
 Health plan beneficiary numbers  
 Internet Protocol (IP) address numbers  
 Medical Record Numbers  
 Name or any derivative of name such as initials  X 
 Social Security Numbers  X 
 Telephone Numbers  X 
 URLs (Web Universal Resource Locators)   
Vehicle identifiers and serial numbers, including license plate numbers  
 Any other unique identifying number, characteristic, or code (Note: The study ID number, code or other 
means of record identification is not considered one of the identifiers that must be excluded for de-
identification)  
 
3.0 
* Patient Protected Health Information: 
Demographic Information (e.g., Name, Address, Phone Number, Social Security Number  X 
 Billing and Payment Information   
 Hospital or Medical Records  X 
 History and Physical Exam Notes  X 
 Mental Health Records  X 
 Data Previously Collected for Research Purposes  X 
 Progress Notes  X 
 Consultation Reports  X 
 Laboratory Test Results X 
 Operative Reports   

IRBNet #1617313 Protocol Version 1.5 
 Other  
Please indicate the 'Other' Patient Protected Health Information: 
 
4.0  
Other Health Information: 
Name  
There are no items to display  
    
View: 9.1.1 Waiver of HIPAA - More Information  
Waiver of HIPAA- More Information  
1.0 * Describe how the identifiable information is to be used and/or disclosed only by members of the 
research team and the following persons (identify with specificity and justify the need to disclose the 
information to anyone outside the VHA.) Note: If participants will be receiving payment and HIPAA 
Authorization is not being obtained, you must also describe this disclosure to representatives of the VA 
for administrative purposes here.  
Also describe how this activity meets the “minimum necessary standard” described in the HIPAA Privacy 
Rule: 
Identifiable information will only be accessed by members of the research team who are immediately 
involved in pre-screening records, conducting telephone screening, making determinations about study 
eligibility, scheduling participants, and conducting the initial Consent and Screening Visit. These 
procedures will generally be conducted by a single member of the research team (Dr. Forster or a 
research assistant working under her direction). However, it may be necessary to share identifiable 
information within the research team in some cases (e.g., if a difficult eligibility question arises). In 
effect, the minimum necessary information to assess eligibility will be shared with the minimum 
necessary people. Identifiable information will not be shared outside the study team or with anyone 
outside the VHA.   
  The proposed study poses minimal risk to the privacy of the subjects because...    
2.0 * Describe how the identifiable information will be protected from improper use or disclosure by 
(detail how this will be accomplished including the limitations of physical or electronic access to the 
information and other protections): 
A record of pre-screening, telephone screening, and initial Consent and Screening visit activities will be 
maintained in a password protected database, stored behind the VA firewall and will include minimal 
necessary identifiers to reference patient records (i.e. Last Name and Last Four of SSN). Only those 
immediately involved with pre-screening/screening and scheduling will have access to this spreadsheet.   
3.0 * Describe how the identifiers will be destroyed at the earliest opportunity consistent with the 
research (discuss the timeframe or the reasons the identifiers must be retained, including health or 
research justifications or any legal requirement to retain them) (Note: At this time, identifiers used for 

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research screening and all other screening records must be retained indefinitely and this must be 
documented by checking “Other” below): 
All research records will be maintained in accordance with the Veterans Health Administration (VHA) 
Records Control Schedule. Paper records will be disposed of using methods deemed appropriate by the 
VAPHS Privacy Officer, and all electronic data will be sanitized using methods rendered appropriate by 
the VAPHS ISSO. 
* When will screening data be de-identified or destroyed: 
Name  
Other  
If Other, please describe: 
Research screening records and identifiers will be maintained in accordance with the records control 
schedule, as per VA requirements.   
4.0 * Describe how the identifiable information will not be reused or disclosed to any other person or 
entity outside the VHA other than the manner described in the protocol, except as a required by law, for 
authorized oversight of this research study, or as specifically approved for used in another study by an 
IRB: 
Identifiable information will only be accessed, reviewed, and maintained by study personnel who are 
immediately involved with pre-screening, screening, and scheduling. Identifiable information will not be 
shared with other persons or entities except in such cases that this is required by law or for qualified 
purposes of study oversight.    
5.0  * Describe why the proposed study cannot be practicably conducted  without a waiver of 
authorization: (discuss reasons why it would not be possible to obtain authorization from individual 
subjects.  Time constraints themselves are generally not considered adequate for this justification: 
Telephone Screening: 
In the current study, potential participants will be asked to self-initiate contact with study personnel but 
many may fail to meet our general eligibility criteria. We do not have sufficient resources (e.g., funding, 
personnel, etc.) to conduct an in-person screening session with each individual who expresses interest in 
the study. Potential participants will be asked to verbally report information necessary to evaluate 
eligibility during the telephone screening. However, it is necessary to confirm this information in the 
electronic medical record in order to ensure that it is accurate. For example, potential participants may 
be unaware of diagnoses that would preclude study participation. If a rule-out is identified at the time of 
the initial study visit (rather than during the phone screening), this may present a significant 
inconvenience to the potential participant, who would have set aside time for the study visit and may 
have travelled a considerable distance to attend. Limiting the occurrence of these situations is thus in 
the best interest of both potential study participants and the research team. We will ask potential 
participants for verbal permission to access CPRS records in order to confirm information provided 
through self-report. Potential participants will have the ability to decline, at which point we would 
refrain from accessing their records.  

IRBNet #1617313 Protocol Version 1.5 
Pre-Screening Records 
In order to ensure that all patients who might be appropriate for the evidence-based treatment offered 
through this study are made aware of this treatment option/research study, we are requesting to pre-
screen specific Veterans' medical records in order that they can be provided with study information. This 
is one element of a multi-pronged recruitment approach that was determined to be necessary in order 
to achieve the required sample size for the current study on the basis of recruitment feasibility 
information acquired through our earlier pilot project (Pro1787). 
Due to the nature of the study, establishing contact through a potential participant's provider is 
preferable for several reasons. As described in Section 6.2 (Vulnerable Populations) engaging providers 
in the recruitment process will help us to identify appropriate participants and ensure that they can be 
recruited into the study without undue influence or coercion. Our target population is also unlikely to 
respond to study advertisements, such as flyers or newspaper ads, making provider referrals absolutely 
critical. Without enlisting the support of providers in the recruitment process, it will not be possible to 
meet our recruitment aims. Providers who have contact with the target population do not directly 
benefit from involvement in research activities and have limited time with which to engage in 
recruitment activities. A waiver of HIPAA for the purpose of pre-screening records is thus necessary. 
Finally, we would like to offer the option to participate in our initial Consent and Screening visit through 
a remote modality such as telephone or video call. This will enable us to ensure that only those Veterans 
who are fully eligible to participate in the protocol are asked to attend an in-person study visit. While we 
will also take precautions to protect our participants and staff during in-person appointments to occur 
during COVID-19, it is preferable to conduct research activities remotely if and whenever possible.   
6.0  * Describe why the proposed study cannot be done without the specified identifiable information: 
Discuss reasons why it would not be possible to conduct the research without the identifiable 
information being collected. 
The Waiver of HIPAA is requested in order to pre-screen and screen veterans for potential study 
eligibility and, when necessary, conduct the initial Consent and Screening visit. Identifiers are thus 
necessary to ensure that the appropriate individual's records are accessed for review.   
    
View: 9.2 Waiver of Informed Consent  
Waiver of Informed Consent 
 
1.0  
* The proposed study poses minimal risk to the subjects because (outline the subject’s involvement in 
the project and why the study poses minimal risk): 
Waiver for Pre-Screening Records 
We also request a waiver to conduct pre-screening of veteran records. Specifically, Dr. Forster (PI) or an 
authorized research assistant will identify potentially eligible participants by pre-screening veteran 

IRBNet #1617313 Protocol Version 1.5 
medical records in CPRS. Veterans who are scheduled for an Initial Evaluation or other Intake/Screening 
assessment appointment through the Center for Treatment of Addictive Disorders (CTAD) be screened 
with respect to basic eligibility criteria, either before or after the time of their assessment appointment. 
When a potentially-eligible veteran is identified, Dr. Forster or an authorized research assistant will 
either (1) send out a mailing with study information (letter and brochure) directly to the patient (e.g., if 
no further upcoming clinical encounters have been scheduled) or (2) contact that veteran’s provider by 
phone or encrypted Outlook email in order to alert the provider that the veteran may be eligible for the 
research study. If the clinician agrees, Dr. Forster (or an authorized research assistant) will provide study 
information (i.e., letter and brochure) to the clinician or other CTAD representative for distribution to 
the patient during an upcoming clinical contact. If the patient is interested in the study, he/she may 
contact the study coordinator directly to set up an appointment. In this way, the burden on the clinician 
will be minimal and it will not be necessary to store PHI related to potentially-eligible participants.  
2.0  
* The waiver will not adversely affect the rights and welfare of the subjects because: 
Pre-screening activities will be conducted to identify Veterans who might benefit from treatment 
offered through the study because these Veterans may not otherwise be made aware of this treatment 
option. Veterans will always have the right to decline treatment and/or research participation. In 
addition, Veterans may be able to receive CM treatment even if they choose not to participate. In this 
way, the primary consequence of the proposed pre-screening process will be to make Veterans aware of 
an empirically-supported treatment option that may be added to their standard outpatient substance 
use treatment programming to better support cocaine abstinence. If clinically appropriate, Veterans 
may engage with this treatment option either in the context of the current study or outside the context 
of the current study, if they decline research participation. 
  
3.0  
* The research could not reasonably be carried out without the waiver because: 
Based on our earlier pilot project (Pro1787), we have determined that it will be necessary to add pre-
screening to our recruitment plan in order to meet monthly recruitment goals. We estimate that it will 
be necessary to recruit approximately 5 Veterans per month in order to successfully complete the 
current project on schedule. We have also made changes to our eligibility criteria to improve the 
feasibility of our recruitment plan; however, prescreening will also be necessary in order to ensure that 
potentially-eligible individuals are more reliably provided with study information. 
   
4.0 * The research could not practicably be carried out without using identifiable private information or 
identifiable biospecimens because: 
Access to identifiable information will be necessary to track participant progress through the study 
protocol and private information derived from participant medical records (i.e., urine drug test results) 
represents a key outcome variable for the current study. In addition, delivery of Prize-Based 
Contingency Management (CM) requires that supervised urine specimens be collected prior to each 

IRBNet #1617313 Protocol Version 1.5 
session and these specimens must be marked with identifying information in order to ensure that the 
correct specimen is tested at point-of-care during CM sessions and correctly documented in patient 
medical records following confirmatory processing by our on-site lab.   
5.0  
* When appropriate, subjects will be provided with the following additional pertinent information after 
participation (if you have no plans to provide additional information to subjects please provide 
justification): 
Individuals who are prescreened will be provided with information about the study including contact 
information for study personnel. If these individuals contact study personnel to express interest in 
participation, they will be provided with additional pertinent information about the study during the 
screening process (see Screening Script). 
    
View: 9.3 Waiver of Documentation of Informed Consent  
 
Waiver of Documentation of Informed Consent 
 
You have selected a waiver of Documentation of Informed Consent 
1.0  
This is a request for Waiver of Documentation of Informed Consent because this research study 
conforms to either A and/or B (Check if ‘yes’ and provide the verifying information requested):  
* A: The only record linking the subject and the research would be the consent document and the 
principal risk would be potential harm resulting from a breach of confidentiality.  Each subject will be 
asked whether the subject wants documentation linking the subject with the research, and the subject's 
wishes will govern.    Yes No 
AND/OR   
* B: The proposed study poses minimal risk to the subjects.   Yes No 
If yes, please explain why the proposed study poses minimal risks to the subjects.  (Outline the subject’s 
involvement in the project and why the study poses minimal risk) : 
If yes, please explain why the proposed study poses minimal risks to the subjects. (Outline the subject’s 
involvement in the project and why the study poses minimal risk) : 
A Waiver of Documentation of Informed Consent is requested for the telephone screening procedure 
and initial Consent and Screening appointment only. Eligible participants will be asked to provide written 
informed consent during their first in-person study visit. During the screening procedures conducted by 
phone or video call, potentially eligible participants will be asked to answer questions necessary to 
evaluate study eligibility. They will be informed that they are not required to answer any questions they 

IRBNet #1617313 Protocol Version 1.5 
do not wish to. Potentially eligible participants will also have the option of providing verbal consent for 
study personnel to access their medical record in order to confirm eligibility. Screening data will be 
maintained in a secured location for eligible participants. Data from ineligible participants, as well as 
those who do not subsequently provide written informed consent, will also be maintained in a secured 
location. In lieu of written consent at the time of the remotely conducted Consent and Screening visit, 
when applicable, the investigator will send a written consent form by mail. Participants who are 
determined through remote screening to be eligible and willing to enroll in the study will bring their 
signed consent form to the baseline appointment (the first in-person encounter) or will return the 
signed form by mail. If the signed form has not been received by the time of the initial in-person visit 
(either by mail or personal delivery by the participant), the participant will be asked to sign a new copy 
the consent form before any in-person research procedures commence. In this way, written informed 
consent will be documented by/at the time of the first in-person study visit. 
2.0 *  The research involves no procedures for which written consent is normally required outside of the 
research context. Research procedures include:  
1.) Potentially eligible participants will be asked to listen to information about the study. 
2.) Potentially eligible participants will be asked to consent to study personnel accessing their medical 
record in order to evaluate eligibility. They will have the option to decline. 
3.) Potentially eligible participants will be asked to answer a series of questions in order to determine 
eligibility to participate in the study. Questions will focus on health and substance use history, as well as 
basic demographic data. They will have the option to decline to answer any question they do not wish 
to. 
4.) Eligible participants will be asked to provide contact information and to schedule a study visit if they 
are interested in participating. 
5.) Participants may also be asked to answer questions in the context of interview, cognitive screener, 
and/or self-report measures.   
3.0 * Explain how whenever appropriate, the subjects will be provided with additional pertinent 
information (e.g. an information sheet): 
Participants will provide written consent and will be provided with a copy of the signed study consent 
form, upon presentation at the first in-person study visit.   
4.0  
Please upload SCRIPT here: 
Document Description Version Number  
 
View Screening Script - Phone & In-Person Versions(0.06)   0.06  
 ID: Pro00002689  
    

IRBNet #1617313 Protocol Version 1.5 
View: 9.4 Consent Forms & Process of Consent  
Consent Forms & Process of Consent 
 
1.0 Upload the completed forms into the correct lists below.   
1.1  
Informed Consent Form (clean copy): 
  Document Modified Date Version Number  
 
View Goldstein Substudy Consent(0.03) 2/11/2021 12:00 AM 0.03  
View Patient Consent(0.08) 11/16/2020 12:00 AM 0.08  
View Telehealth Substudy Consent(0.03) 11/4/2020 12:00 AM 0.03  
 
1.2  
Provider Behavior Informed Consent Form (clean copy): 
  Document Modified Date Version Number  
 There are no items to display  
    
1.3  
Screening Informed Consent Form (clean copy): 
  Document Modified Date Version Number  
View Screening Consent(0.08) 11/16/2020 12:00 AM 0.08  
 
 
  
2.0  
Consent Forms (modified copy): 
  Document Modified Date Version Number  
 
View Goldstein Substudy Consent Tracked Changes(0.01) 2/12/2021 9:45 AM 0.01  

IRBNet #1617313 Protocol Version 1.5 
View Patient Consent - Tracked Changes(0.04) 8/27/2019 1:16 PM 0.04  
View Screening Consent - Tracked Changes(0.06) 10/9/2020 1:10 PM 0.06  
A Healthy Comparison Subject Consent has now been added. 
   
3.0 * Describe how, where, when, and by whom the consent process will be initiated: 
The consent document(s) will be thoroughly and extensively reviewed with participants and we will 
allow sufficient time to make an informed, voluntary decision. For those adults who wish to involve a 
family member or friend in the consent process, we will arrange to do so. We will make it clear that the 
Veteran's decision to participate or not will have no effect on their treatment or relationship with the VA 
Healthcare System. 
For the majority of participants, an initial eligibility screening will be conducted by telephone and 
written consent will not be provided at this time. (A Waiver of Documentation of Informed Consent has 
been requested to cover telephone screening procedures). However, it is possible that interested 
patients may also prefer to participate in the initial eligibility screening in person and, in such cases, a 
separate Screening Consent will be used to document written consent for initial screening procedures 
only and will also include HIPAA authorization . This document covers all information conveyed through 
the telephone screening script and will be thoroughly and extensively reviewed with all individuals who 
participate in in person eligibility screening. In person eligibility screening procedures will be conducted 
in a private interview room or office at the Research Office Building (Building 30) or a private office at 
Building 29.  
Interested participants who are eligible on the basis of initial eligibility screening (either by phone or in 
person) will be scheduled for a separate appointment with a member of the research team, during 
which the informed consent document for the full protocol will be extensively reviewed for 
comprehension and witnessed oral and written consent to participate will be obtained. Potential risks 
and benefits from this research will be reviewed. This appointment will typically be conducted in a 
private interview room or office at the Research Office Building (Building 30) or a private office at 
Building 29. However, it is also possible that this appointment will conducted remotely if judged to be in 
the best interest of the Veteran. In such cases, written consent will then be obtained at the time of the 
first in-person visit for those who are eligible to continue on to baseline assessment and randomization. 
Participants will be provided with a copy of their signed consent form at that time.  
 
Participants may be asked to consent to optional activity and heartrate monitoring (i.e., Goldstein 
Substudy 2) after they have been assigned to one of the two Contingency Management treatment 
conditions. 
 4.0  
* Will you be maintaining a Master List of Subjects? 
Yes   

IRBNet #1617313 Protocol Version 1.5 
  
5.0 * Describe when the subject’s name will be added to the master list and how the list will be 
maintained in a secure fashion.    
A record of all participants screened for participation in this study will be maintained in our secure 
Dacima database; identifiable information will only be accessible to those with a need to view this 
information. Participants who have provided written, informed consent to participate in the full study 
protocol will be added to a secure master list, maintained in Dacima. All data will be retained in 
accordance with the Records Control Schedule.  
    
View: 10.0.0 Data Security and Privacy: Data Types Storing  
  
10.0 Data Types Collecting and Storing 
1.0  
Click the add button (below) to open an entry form to indicate the types and/or sources of the data that 
will be collected/stored as part of the project.  
Instructions: For each type/source of data that will be collected as part of the project, this includes 
screening data, click the add button to open an entry form that lists the types and/or sources of data. 
Select a source/type of the data that will be collected/stored. Then indicate what, if any, identifiers or 
sensitive information will be collected/stored from the source/type (None is an option). To add another 
source/type click “OK Add Another” button to open up a new entry form to repeat the process. 
Example 1: You are collecting data from VA Medical records including names, last 4 of SSN, and 
addresses. Therefore, you would select “VA medical record data” as the source, and then select in the 
identifiers: “Name or any derivative of name, such as initials,” “Social Security Numbers,” and 
“Geographical subdivisions smaller than a State (street address, city, county, precinct, zip code, and 
their equivalent geocodes, except for the initial three digits of a zip code)” as the identifiers being 
collected. 
Example 2:  You are screening VA Medical Records and recording the information you use to screen (i.e.: 
names, last 4 of SSN, and addresses, etc.)  Note: This information must be treated as a Source 
document, please select “Screening” as the source and then select the identifiers “Name or any 
derivative of name, such as initials,” “Social Security Numbers,”, as applicable. 
 Data Type/Source Collection Details Identifiers  
View  
VA medical record data (i.e., diagnoses, procedures, visits) via chart review  
Urinalysis results, number/type/dates of treatment encounters and missed/cancelled appointments, 
medications, diagnoses, and other relevant data will be extracted from participant medical records. 
These data will be de-identified and entered into a secure research database. Identifiers will be present 

IRBNet #1617313 Protocol Version 1.5 
in VA medical record data. However, only de-identified data will be collected and stored. Social Security 
Numbers 
Name or any derivative of name such as initials  
View  
Other 
Behavioral/Cognitive Performance Measures (Response Time and Accuracy, Etc.)  
Response time and accuracy data will be recorded during computerized experimental paradigms. 
Participants will perform one or more computer-based tasks during which they will make behavioral 
responses to stimuli. A computer program will be used to record the timing and accuracy of responses. 
In addition, data on cognitive performance will be collected by hand (e.g., using pencil/paper/stop 
watch) during the SLUMS/MoCA and Brown Peterson/Auditory Consonant Trigrams memory task. These 
data will be collected under the supervision of study investigators during the experimental session. A 
timestamp with the session date will be included in data files generated by the task presentation 
software. Otherwise, data will only be identified by the Study ID. Elements of dates (except year, for 
example, date of birth, admission date, discharge date, date of death, date of procedures; and all ages 
over 89) 
Device identifiers and serial numbers 
View  
Other 
Electroencephalography Data  
EEG data will be acquired by study personnel using a standard EEG system. These data will be collected 
under the supervision of study investigators during the experimental session. A timestamp with the 
session date will be included in data files generated by the task presentation software. Information 
about the EEG device may also be included in this file. Otherwise, data will only be identified by the 
Study ID. Elements of dates (except year, for example, date of birth, admission date, discharge date, 
date of death, date of procedures; and all ages over 89) 
Device identifiers and serial numbers 
View  
Other 
Eye Movement / Pupillometry Data  
Eye movement and pupillometry data may also be acquired by study personnel using a standard eye 
tracking / pupillometry system. These data will be collected under the supervision of study investigators 
during the experimental session. A timestamp with the session date will be included in data files 
generated by the task presentation software. Information about the eye tracking / pupillometry device 
may also be included in this file. Otherwise, data will only be identified by the Study ID. Elements of 

IRBNet #1617313 Protocol Version 1.5 
dates (except year, for example, date of birth, admission date, discharge date, date of death, date of 
procedures; and all ages over 89) 
Device identifiers and serial numbers 
View  
Questionnaires/Surveys, paper  
Participants will complete a demographic information sheet, including general information (age, race, 
sex, etc.), as well as several self report questionnaires - these forms will only be identified by the 
participant's study ID. None  
View  
Other 
For participants who enroll in the optional Goldstein substudy (Substudy 2), heart rate and activity 
monitoring (e.g., accelerometer-based physical activity and sleep metrics, ambient light, device wear-
time) data will be recorded using an ActiGraph wGT3X-GT and paired Polar H7 heart rate monitor.  
Data will be collected using wearable devices worn by participants (i.e., ActiGraph wGT3X-GT and paired 
Polar H7 heart rate monitor). Data collected by both the ActiGraph wGT3X-GT and Polar H7 heart rate 
monitor will be temporarily stored on the ActiGraph wGT3X-GT device during the two week recording 
interval. Data will subsequently be downloaded using TRM-approved ActiLife software. Data will 
generally be downloaded to a VA computer that is not connected to the VA network due to the need for 
a USB-based connection between the computer and the ActiGraph wGT3X-GT device. This computer is 
located in the PI's locked lab space in Building 30. Data will subsequently be transferred to the secure 
network drive for this study (behind the VA firewall) for storage. Elements of dates (except year, for 
example, date of birth, admission date, discharge date, date of death, date of procedures; and all ages 
over 89) 
Device identifiers and serial numbers 
View  
Drug or alcohol abuse information  
These data will be collected during interview procedures and will only be identified by the participant's 
study ID number in records maintained for the study. Patients will also be asked to report information 
including dates of recent substance use and prize preferences in the course of Contingency 
Management treatment sessions and this information will be recorded on CM session tracking forms; 
however, these forms will not include any identifying information. Specific information provided by self-
report during CM treatment sessions may also be entered in the patient's chart based on guidelines for 
documenting CM treatment encounters, established by the VA CM National Implementation team. None  
View  
Interviews/focus groups  

IRBNet #1617313 Protocol Version 1.5 
Participants will complete clinical/diagnostic interviews, as well as an interview about upcoming life 
events and the timeline follow-back procedure (a short interview addressing recent substance use). 
Notes will be taken regarding patient responses but will not include any identifying information. An 
audio-recording of interview procedures will not be made. Patients will also be asked to report 
information including dates of recent substance use and prize preferences in the course of Contingency 
Management treatment sessions and this information will be recorded on CM session tracking forms; 
however, these forms will not include any identifying information. Specific information provided by self-
report during CM treatment sessions may also be entered in the patient's chart based on guidelines for 
documenting CM treatment encounters, established by the VA CM National Implementation team. None 
     
View: 10.0.1 Data Security and Privacy: Social Security Numbers  
10.0.1 Data Security and Privacy: Social Security Numbers 
 
1.0 You indicated that you will be using all or some part of the research subjects' SSNs as part of this 
study.  Which of the following will you be using: 
  
Real Social Security numbers  *   Yes No  
Scrambled Social Security numbers *   Yes No  
Last 4 digits of Social Security Number *   Yes No  
Other (some derivation of the SSN) *   Yes No  
If other, please explain: 
    
2.0 * Please describe how subjects’ Social Security numbers will be used in this study: 
Subjects will be asked to provide their last name and the last four digits of the SSN in order to identify 
medical records for review during the telephone screening process. This information will be maintained 
in screening records, as per VA requirements. The last four digits of the SSN may also be used when 
accessing medical records for chart review after participants have provided written HIPAA authorization. 
In addition, specific study-related documentation including informed consent forms, HIPAA 
authorizations forms, and study payment forms may require that full SSN or last four SSN information be 
included for administrative and/or oversight purposes.    
3.0 * Please describe the security measures that will be taken to protect SSNs. 
The minimum necessary information related to the SSN (i.e., the last four digits) will be stored in a 
password protected database (powered by Dacima Clinical Suite) that will be maintained behind the VA 
firewall on a secure server, only accessible to study personnel. All paper documents including full or 

IRBNet #1617313 Protocol Version 1.5 
partial SSN information will be stored in a locked filing cabinet on a secure floor of Building 30 and/or 
inside a locked office.    
    
View: 10.1.0 Data Security and Privacy: Incoming Data  
  
10.1.0 Incoming Data  
1.0  
* Will data be transferred into VAPHS? 
No. Data is not being transferred into this facility     
View: 10.2.0 Data Security and Privacy: Outgoing Data  
  
10.2.0 Outgoing Data  
1.0  
* Will any of the data being collected/stored be transferred outside of VAPHS? 
Yes. The data will be transferred outside of VAPHS, but will remain within the VA.     
View: 10.3.0 Data Security and Privacy: Local Data Storage Types  
  
10.3.0 Local Data Storage Types  
1.0  
* How will data be stored on this project? (Select all that apply) 
On Paper   X 
Electronically  X 
 
    
View: 10.3.1 Data Security and Privacy: Local Data Storage Types - Paper  
 
10.3.1 Local Data Storage Types - Paper  
1.0  
* All VA research data collected in paper must be stored in a locked room at VAPHS.  

IRBNet #1617313 Protocol Version 1.5 
List the room number(s) and the campus(es) where data will be stored in the text box below. 
Paper data will be stored at the VAPHS University Drive Campus in Building 30. Data will either be stored 
in a locked filing cabinet within a locked room (GA-136) or in a locked filing cabinet on a secure floor of 
Building 30 (Cubicle 1-12 and/or Office 1A-130). Files related to CM treatment sessions may additionally 
be stored with CM supplies in a locked filing cabinet in a secure room within a secure area in Building 29 
or secure office used for CM treatment sessions within Building 30.  
View: 10.3.2 Data Security and Privacy: Local Data Storage Types - Electronic  
10.3.2 Local Data Storage Types - Electronic 
1.0  
* Where is the electronic data being stored? Select all that apply. 
VAPHS Network (shared drive)  
VAPHS Encrypted laptop  
VA Encrypted VA external drive or thumb drive  
VA Encrypted CD/DVD  
CPRS  
Other  
 
If "Other" please describe OR if you would like to provide additional information for clarification, please 
elaborate in the text box below. 
Dacima Clinical Suite will be used for database management, participant tracking, and randomization. 
Dacima Clinical Suite is a web-based Electronic Data Capture (EDC) software that allows setup and 
configuration of research study databases. The Dacima Clinical Suite has been approved for the intended 
use in the Technical Reference Manual 
(https://www.oit.va.gov/Services/TRM/ToolPage.aspx?tid=9433&tab=2) and has also been reviewed 
and approved for the intended use by VAPHS Privacy and Information Security Officers.  
 
The software is designed to be very flexible so it can be used for different types of study designs 
including: Randomized Clinical Trial, Observational studies (Cohort, Case-Control, Cross-sectional), 
patient registries, web surveys, electronic Patient Report Outcomes (ePRO), Patient diaries and 
administrative databases. Dacima uses a SQL Server database (backend) to store meta data and study 
data, and a web interface (front end) that was developed with Microsoft .Net (C#), html, and Java Script. 
Wireless transmission is not allowed. Secure SSL connection ensures that all data sent between the 
browsers and the web servers is encrypted based on the SSL protocol. Only the data entered by the user 
in the browser is sent to the servers. 
 
The software is housed on a virtual server provided and maintained by the VA at the VA Pittsburgh 
Healthcare System, Heinz Campus, Building 32, Room BA120. The software is compliant with FDA 21 CFR 
Part 11 requirements and includes a complete and comprehensive audit trail. It requires use of SSL/TLS 
certificates, and allows critical and routine OS and system security patches per VA requirements.  
 

IRBNet #1617313 Protocol Version 1.5 
Use of the DACIMA software program requires user authentication with a strong user password, and the 
software has an auto logoff/lock program. The DACIMA software program will be accessed directly and 
the data will be stored on the VAPHS server. The data are backed up nightly in accordance with VAPHS 
protocol. Installation or updates to the software program require IT administrator privileges.  
 
Deidentified electronic data from EEG recording sessions may additionally be backed-up (i.e., archived) 
using unencrypted CD/DVD storage which will be maintained inside a locked filing cabinet in a locked 
office location (GA-136) or in a cubicle on a secure floor of Building 30 (Cubicle 1-12 or Office 1A-130). 
 
Examples of Dacima forms used for data entry are included under Section 15 (Miscellaneous 
Documents). It is noted that study personnel will enter all data into Dacima and that participants will not 
directly interact with Dacima in any way. 
 
Additional Information: 
 
A VAPHS encrypted laptop may be used in the acquisition of behavioral and/or EEG data in the current 
study. While the intention is not to permanently store these data on the encrypted laptop, they may be 
maintained there prior to transfer to the designated VA Network drive for storage. We additionally 
anticipate that machines used for acquisition of behavioral and EEG data may be disconnected from the 
VA network (i.e., not connected to the internet) in order to ensure accurate timing of stimuli in 
behavioral paradigms and event markers in EEG data acquisitions. Consequently, we may use a VA 
encrypted thumb drive or an encrypted CD/DVD to transfer data to the VA Network Drive. Once again, 
the intention will not be to permanently store these data on encrypted portable media. Files will be 
deleted and/or CD/DVD discs will be destroyed (using approved methods) following confirmation that 
files have been successfully transferred and that a back-up version of raw EEG data files has been 
successfully created. Importantly, these behavioral and EEG data files will not include any direct 
personal identifiers. As already noted, raw EEG data files will be backed up using CD/DVDs (either 
encrypted or unencrypted) and will be maintained in a locked filing cabinet on a secure floor of Building 
30.  
 
If you selected VAPHS or VA Network (Shared Drive), please provide the name of the drive (i.e. 
"MySharedDriveName (\\vapthshsare) (X:)"): 
\\PTH_Groups\PRO2689WRAP 
      
View: 10.4.0 Data Security and Privacy: Reusing Data  
  
10.4.0 Data Security and Privacy: Reusing Data 
 
1.0  

IRBNet #1617313 Protocol Version 1.5 
* Will the data collected in this study be reused in other studies?   Yes No 
 
If yes, please describe where the data to be reused will be stored and how access to that data will be 
provided and monitored: 
There is currently no plan to reuse the data collected in this study for other studies. However, per our 
DMAP, we must ensure that a de-identified version of the dataset will ultimately be made available to 
the public. Per our DMAP, de-identified, anonymized data will be made available to the public through 
government-approved mechanisms for dissemination such as the NIMH Data Archive. Preparation of de-
identified, anonymized datasets will be conducted in consultation with VA Privacy and Security Officers. 
VA Privacy Officers will review all datasets prior to dissemination in order to verify that all personally-
identifiable information has been removed. ORD guidance on specific data sharing requests will be 
consulted, if necessary. It is acknowledged that removal of PII/PHI may lead to additional restriction of 
shared information. Subject identifiers will only be accessible to authorized staff and will be securely 
maintained behind the VA firewall. 
2.0  
If this research is part of a grant, please upload the Data Management Access Plan (DMAP) or Resource 
Sharing Plan for this study. 
Name Modified Date  
 
DMAP 8/15/2018 2:53 PM  
    
View: 10.5.0 Data Security and Privacy: Off-Site Storage and Transfer of Data  
10.5.0 Off-Site Storage and Transfer of Data 
 
1.0 * You indicated that data collected as part of this study will be transferred outside of VA/VAPHS. 
Please provide a justification for why the data must be stored, transmitted, and/or transferred off-site: 
The current project will be conducted as part of the PI's Career Development Award. Dr. Siegle will serve 
as a mentor to the PI during the funding period and will provide critical guidance with respect to data 
quality optimization, selection and execution of data preprocessing and analytic techniques, as well as 
result interpretation and dissemination.  
Click here for Research Data Security and Privacy Frequently Asked Questions  
Specify in detail how data will be collected, entered, and analyzed. For multisite studies, if no data entry 
and/or analysis will occur on site, this should be specified. Specify how long each phase of the study will 
take to complete and provide a time line for each aspect of the study ending with the final analyses and 
projected publication/presentation timeframe. If you are seeking exempt status on the basis of 

IRBNet #1617313 Protocol Version 1.5 
retrospective medical records review, please include the start and end dates (dates of creation) of the 
medical records you wish to use (Note: In order for the study to be granted exempt status the data must 
have already been collected prior to the date of submission of the application for exempt status)   Also, 
provide all data entry forms or a complete list of the variables you will be collecting.  
2.0 Please list all locations or individuals who will receive/be provided with the data, including sponsor, 
site monitors, coordinating center, University of Pittsburgh, non-VA investigators/collaborators, reading 
centers, core laboratories, other research laboratories, data monitoring committee, etc.    
 
* Data Recipients and Identifiers: 
Recipient and Description  
Identifier Identifier Description Transfer Methods  
  
University of Pittsburgh 
Greg Siegle, PhD, Associate Professor of Psychiatry and Psychology University of Pittsburgh Western 
Psychiatric Institute and Clinic 3811 O'Hara Street Pittsburgh, PA 15213 gsiegle@pitt.edu  
 
None De-identified, aggregate data (such as group averages of behavioral, EEG, or self-report data)  
Electronic file transfer 
 
Other (list below) 
Hard copy transfer via mail or from person-to-person.  
  
Any identifiable information that is being shared with these individuals/entities must be described in the 
HIPAA authorization (in the disclosure section).   
   
View: 10.5.1 Data Security and Privacy: Keeping a Copy of the Data  
  
  
  
 
 

IRBNet #1617313 Protocol Version 1.5 
10.5.1 Data Security and Privacy: Keeping a Copy of the Data 
1.0  
* How will the study team keep a copy of the data at VAPHS that is being transferred? 
CPRS (source data)  
Paper (copies of CRFs, questionnaires, etc.)  
Other (specify)  
 
Specify other method of maintaining a copy of the data being transferred: 
All primary data (source data, paper data, and raw electronic data files) will be maintained at VAPHS. 
Only copies (either electronic or hard copy) of de-identified aggregate data (for example, plots depicting 
single subject or group average data) will be transferred to recipients outside of VAPHS.  
   
2.0 * Upload the VA Data Storage and Retrieval Worksheet: 
VA Data Storage Placeholder(0.01)       
View: 10.6.0 Data Security and Privacy: HIPAA  
  
10.6.0 Data Security and Privacy: HIPAA 
 
The Healthcare Insurance Portability and Accountability Act (HIPAA) prohibits the use of a person's 
Protected Health Information without a valid authorization. 
 
1.0  
* Select the option which fits this study: 
 Not applicable: No PHI is being used or disclosed by VAPHS  
 Not applicable: Waiver has been requested  
 HIPAA Authorization (Combined Consent and HIPAA Authorization)  
 HIPAA Authorization (Standalone)  
 
   
 Upload HIPAA authorization (Standalone) here: 
  Document Modified Date Version Number  

IRBNet #1617313 Protocol Version 1.5 
View HIPAA Placeholder(0.02) 8/13/2019 3:15 PM 0.02  
 
 2.0 
  
 At screening will clinical personnel be asked to share potential participants PHI: 
  Yes No 
 If yes, please upload the 10-5345: 
     
View: 10.7.0 Data Security and Privacy: Additional Information  
 
10.7.0 Data Security and Privacy: Additional Information 
 
1.0  
Does this research involve... 
 
* ...specially obtained software?   Yes No 
 
If yes, please describe the software and what it is being used for: 
Specialty software will be used for the presentation of experimental stimuli (e.g., STIM, E-Prime, and/or 
other presentation program TBD), acquisition of EEG data (SCAN and/or other acquisition program), 
analysis of EEG data (SCAN, EEGlab, and/or other analysis program TBD), and acquisition/analysis of eye 
tracking and/or pupillometry data (acquisition/analysis program TBD). ActiLife software will additionally 
be used to download and analyze activity and heart rate data for Substudy 2. Only TRM-approved 
software will be used. 
 * ...one or more Web-based applications?   Yes No 
 
If yes, please describe the application and what it is being used for: 
Dacima Clinical Suite is a web-based Electronic Data Capture (EDC) software that allows setup and 
configuration of research study databases. The software is designed to be very flexible so it can be used 
for different types of study designs including: Randomized Clinical Trial, Observational studies (Cohort, 
Case-Control, Cross-sectional), patient registries, web surveys, electronic Patient Report Outcomes 
(ePRO), Patient diaries and administrative databases. Dacima uses a SQL Server database (backend) to 

IRBNet #1617313 Protocol Version 1.5 
store meta data and study data, and a web interface (front end) that was developed with Microsoft .Net 
(C#), html, and Java Script. Wireless transmission is not allowed. Secure SSL connection ensures that all 
data sent between the browsers and the web servers is encrypted based on the SSL protocol. Only the 
data entered by the user in the browser is sent to the servers. 
The software is housed on a virtual server provided and maintained by the VA at the VA Pittsburgh 
Healthcare System, Heinz Campus, Building 32, Room BA120. The software is compliant with FDA 21 CFR 
Part 11 requirements and includes a complete and comprehensive audit trail. It requires use of SSL/TLS 
certificates, and allows critical and routine OS and system security patches per VA requirements.  
Use of the DACIMA software program requires user authentication with a strong user password, and the 
software has an auto logoff/lock program. The DACIMA software program will be access directly and the 
data will be stored on the VAPHS server. The data are backed up nightly in accordance with VAPHS 
protocol. Installation or updates to the software program require IT administrator privileges.  
VA Video Connect (or other VA-approved telehealth technology, if available) may also be used to 
remotely interact with research participants via video call. 
 
* ...mobile devices?   Yes No 
 
If yes, please describe: 
A research-grade wearable activity monitor (wGT3X-BT) and heart rate monitor (Polar H7) will be used in 
the context of optional Substudy 2. Data collected by both devices will be logged to the wGT3X-BT. Data 
stored on this device cannot be directly accessed through the device and will not be transmitted over 
the internet. Data will be downloaded from the device via USB using ActiLife software on a VA machine 
on VA property. 
 
2.0  
* Will a Certificate of Confidentiality be obtained for this study?   Yes No 
 
If yes, please attach the Certificate of Confidentiality: 
 
3.0  
* Will VA sensitive information be transported and utilized outside protected environments?   Yes No 
   
   

IRBNet #1617313 Protocol Version 1.5 
If you answered yes above, please upload a fully executed VAPHS Memo to Take VA Sensitive 
Information Outside a Protected Environment by following  these instructions .     
View: 10.8.0 Data Security and Privacy: Certifications  
 
10.8.0 Certifications 
 
1.0 * I certify that all study staff are up-to-date and will remain up-to-date with Information Security 
Awareness Training, Rules of Behavior, and VHA Privacy Training.   Yes No   
2.0 * I also certify that when an individual is no longer part of the study team, access will be removed to 
research study data.   Yes No   
3.0 * I certify that all research records will be maintained in accordance with the Veterans Health 
Administration (VHA)Records Control Schedule. Paper records will be disposed of using methods 
deemed appropriate by the VAPHS Privacy Officer, and all electronic data will be sanitized using 
methods rendered appropriate by the VAPHS ISO.   Yes No   
4.0 * I certify that any loss or compromise of any VA sensitive information (including research data), VA 
equipment or device, or any non-VA equipment or device that is used to transport, access, or store VA 
information will be reported in accordance with the reporting requirements outlined in VA Handbook 
6500.   Yes No   
5.0 * I certify that, in accordance with VA Handbook 6500, no personal laptops will be used  for official 
VA business in conjunction with this study.   Yes No   
   
View: 11 Local Data Safety Monitoring Plan  
  
Local Data Safety Monitoring Plan 
 For local studies, a data and safety monitoring plan (DSMP) must be established.    
1.0 * Please describe how the study procedures and data being collected will be continuously monitored 
so that changes in the risk/benefit ratio can be determined in a timely fashion during the course of the 
study: 
Our data and safety-monitoring plan will be implemented to ensure that there are no changes in the 
benefit/risk ratio during the study and that confidentiality of research data is maintained.  Human 
Subjects safety training for all personnel is required. Upon learning of any adverse events, we shall 
report such events as soon as possible and within IRB guidelines using the standard forms and/or 
procedures set forth by the VA Pittsburgh IRB regulations. The biannual renewal for this study will also 
serve as the update of the data safety-monitoring plan. The Principal Investigator holds the role of Study 
Monitor and is responsible for implementation and performance of the Data Safety Monitoring Plan. 

IRBNet #1617313 Protocol Version 1.5 
2.0 * Describe how frequently Investigators, study personnel, and the clinical coordinators involved in 
the study will meet and/or review study data. 
Investigators, study personnel, and study coordinators involved in the study meet a minimum of four 
times per year (quarterly) to discuss the study (e.g., study goals, progress, modifications, 
documentation, adverse events, protocol deviations) and address any issues or concerns at this time.  
The Principal Investigator or her designee oversees these meetings.   
  
3.0 * Will this study use a Data Safety Monitoring Board or Data Monitoring committee?  
  Yes No   
4.0 * Will this study use a Medical Monitor?   
  Yes No   
     
View: 11.1 Data Safety Monitoring Board/ Data Monitoring Committee  
Data Safety Monitoring Board/ Data Monitoring Committee  
 
1.0 * List the affiliations and qualifications of those monitors who are not associated with the study or 
describe the composition of the DSMB: 
The current study has been assigned to the CSR&D Data Monitoring Committee (DMC). This DMC 
committee is made up of the following members 
 
Steven D. Forman, M.D., Ph.D. 
Chair of DMC/Recused 
Moderates meetings for both initial review and ongoing study reports 
 
David Smelson, Psy.D. 
Voting member 
Primary Reviewer of protocol and ongoing reports 
 
Denise May Sloan, Ph.D. 
Voting Member 
Secondary Reviewer for protocol and ongoing reports 
 
Ping Luo, Ph.D. 
Voting Member 
Biostatistical Reviewer for protocol and ongoing reports 
  
 

IRBNet #1617313 Protocol Version 1.5 
  
2.0 * Describe how frequently the independent monitor(s) or DSMB will meet and/or review study data: 
The DMC has conducted a pre-review and initial review prior to the start of data collection; the date of 
the initial review was 2/28/19. Following the start of recruitment, meetings to review study data will 
subsequently occur every 4 months.   
3.0 * Describe the type of data (e.g., blinded or unblinded) to which the independent monitor(s) or 
DSMB will have access: 
The DMC will have access to unblinded data.   
4.0 Document that minutes will be kept. 
The DMC will keep meeting minutes. Any meeting minutes and/or reports provided by the DMC will be 
uploaded on an annual basis at the time of Continuing Review.   
5.0 * Please upload the DSMB/DMC Charter: 
DMC Charter(0.03)     
    
View: 12 Costs and Payments  
Costs and Payments 
 
1.0 * Does this study have a budget?: 
  Yes No 
If yes, please upload the current budget: 
CDA Budget(0.01)     
2.0  
* Will patients receive payments for this study? 
  Yes No 
 
If yes, please upload the financial letter of support (either from the Business Service line or the Veterans 
Health Foundation) or documentation waiving the requirement of a letter of support: 
 
Financial Letter of Support 0.03  
VHF Letter of Support (Substudy 2) 0.01  

IRBNet #1617313 Protocol Version 1.5 
 
3.0  
* Are you paying patients using the WePay system? 
no     
View: 12.1 Costs  
 
Costs  
1.0 * Will subjects be required to pay for any services outside of the VHA that may be required as part of 
participating in this research study? 
No, participants will not be required to pay for services and procedures outside the VHA as part of this 
study.      
View: 12.2 Participant Payments  
Participant Payments  
1.0 * Please explain how the proposed payments are reasonable and commensurate with the expected 
contributions of the subject: 
Payment for study visits will help to cover the cost of time and effort by study participants. 
A payment of $5-10 will be provided for short visits related to the study (e.g., Weekly and Monthly 
Check-in visits), lasting 5-30 minutes in duration. It may be possible to conduct Check-in appointments 
by phone in some cases. However, we would prefer that participants attend appointments in person and 
must provide an adequate payment to ensure that this is an option for all individuals involved in the 
study. Due to the necessity of longitudinal data collection, we would also like to incentivize study 
completion by offering a $10 completion bonus to participants who complete their final study contact. 
Longer study appointments (Screening , Baseline Assessment, and Follow-Up assessment) will take 2.5-4 
hours to complete and therefore warrant increased compensation for time spent completing study 
procedures. We will therefore provide $20 for completion of the Screening visit and $35 for completion 
of Baseline and Follow-Up Assessments.  
We will also provide performance based bonus payments of $12-25 to encourage naturalistic responses 
during one or more cognitive-behavioral tasks involving responses to hypothetical reward. This 
performance-based bonus will generally be paid out at the time of Baseline and Follow-Up Assessment. 
During a modified Monetary Incentive Delay task, participants will earn points based on their responses 
and these points will be translated into a monetary bonus after the task is complete. Responses during 
our personalized delay discounting task may additionally be factored in when determining the specific 
amount and timing of this monetary bonus in order to encourage naturalistic decision-making during the 
delay discounting task. Performance-based bonus amounts have been determined such that they are 
similar to prizes routinely won in the context of Contingency Management. 

IRBNet #1617313 Protocol Version 1.5 
Participants in Substudy 2 will additionally be eligible to receive a payment of $40 to compensate them 
for time, effort, and inconvenience related to engaging in remote activity and heart rate monitoring over 
the first two weeks of treatment.   
2.0 * Please provide information on how the subject payments are fair and appropriate, and that they 
do not constitute (or appear to constitute) undue pressure or influence on the prospective research 
subjects to volunteer for, or to continue to participate in, the research study. In additional the payments 
do not constitute (or appear to constitute) coercion to participate in, or continue to participate in, the 
research study: 
A performance-based bonus of $12-25 will be provided based performance during our modified 
monetary incentive delay task and/or our personalized delay discounting task. The amount and/or 
timing of this bonus will be determined on the basis of participant responses during computerized 
cognitive tasks. In effect, we do not anticipate that this payment will directly bear on any participant's 
decision to participate as the amount and timing of the payment will be unknown at the time of 
informed consent. Participants will be informed that they will receive this payment (even if provided at 
some delay after the assessment) regardless of continued participation in the study. 
A payment of $40 is also considered to be a fair and appropriate for remote monitoring activities. 
Remote monitoring will require low effort on the part of the participant but will represent a daily 
inconvenience over a two week period.   
3.0 * Specify the amount, form of payment and the specific disbursement schedule of payments: 
For participating in the study explanation/consent review session and pre-assessment screening and 
testing procedures (Screening Visit), participants will be authorized for $20 (via EFT) to compensate 
them for time and effort. After the enrollment and assessment procedures (Baseline Assessment), 
participants will be authorized for an additional $35 (via EFT) to compensate them for time and effort 
during that session. After each weekly check-in visit during the 12 Week Treatment Interval, participants 
will be authorized for an additional $5 to compensate them for the time and effort spent on the study. 
Participants will generally be asked to complete a Follow-Up Assessment at the 12 week timepoint and 
will receive a payment of $35 to compensate them for time and effort during that visit. Under 
circumstances that a Follow-Up Visit cannot be conducted and a standard Check-in Visit occurs instead, 
the participant will be compensated $5. Participants assigned to VoucherPBCM or TangiblePBCM 
conditions will additionally be asked to participate in monthly check-in visits for 6 months after 
treatment and will receive $10 for each of these assessments. All participants will be eligible for a 
completion bonus of $10 at the time of their last study contact (i.e., 6 Month Post-Treatment Check-In 
for CM participants). In addition to regular study payments, participants will also receive a performance-
based bonus from tasks completed at Baseline and Follow-up Sessions. The amount and/or timing of this 
bonus payment will be determined by task performance. Performance-based bonuses are frequently 
used to improve motivation and naturalistic responses in human subjects research involving reward 
processing. The average performance-based bonus payment will be $20 (range = $12-25) at both 
Baseline and Follow-Up. Taken together, full participation in the study will result in an average total 
payment of $260 over 9 months for CM-assigned Veterans (range: $250-$270).  
Participants in Substudy 2 will receive a single $40 payment via Greenphire ClinCard at the conclusion of 
the two week monitoring period. 

IRBNet #1617313 Protocol Version 1.5 
For Healthy Controls: 
For participating in the screening visit (informed consent, cognitive screening and interviews, 
questionnaires, activity monitoring procedures), baseline assessment (breathalyzer, urine and/or oral 
saliva drug screens, cognitive-behavioral tasks, EEG procedures) and the follow-up visit, participants will 
be authorized $20 for the screening visit, $50-60 for the Baseline assessment, $50-60 for the Follow-up 
assessment, and $40 for participation in activity monitoring. Taken together, full participation in the 
study will result in a total payment of $160-$180.  
4.0 * Are the subjects being paid employees? 
yes  
If yes, please describe how it will be in accordance with the SOP: 
It is possible that a participant in the study may also be a paid VA employee. In such cases the 
participant will be informed that he or she may not participate in any study activities for which he/she 
may be compensated during his/her VA tour of duty.   
    
View: 14 References  
References: 
1.0  
 * Please provide a list of references (Multi-site protocols: You may reference the page numbers in the 
original protocol): 
References 
 
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comparable nonveterans from the National Survey on Drug Use and Health.Psychol Serv, 2007.4: p.149-
57. 
2. Lan, C., Fiellin, D., Barry, D., et al., The epidemiology of substance use disorders in US Veterans: A 
systematic review and analysis of assessment methods. Am J Addict, 2016. 25:7-24. 
3. Tsai, J & R Rosenheck, Risk factors for homelessness among US veterans. Epidemiol Rev, 2015. 37: 
p.177-95. 
4. Trivedi, R., Post, E., Sun, H., et al., Prevalence, Comorbidity, and Prognosis of Mental Health Among US 
Veterans. Am J Public Health, 2015. 105: p.2564-9. 
5. Erickson, S., Rosenheck, R., Trestman, R. et al., Risk of incarceration between cohorts of veterans with 
and without mental illness discharged from inpatient units. Psychiatr Serv, 2008. 59: p.178-83. 
6. Vazan, P., A. Golub, & A. Bennett, Substance use and other mental health disorders among veterans 
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7. el-Serag, H., Kunik, M., Richardson, P., et al., Psychiatric disorders among veterans with hepatitis C 
infection. Gastroenterology, 2002. 123: p.476-82. 

IRBNet #1617313 Protocol Version 1.5 
8. Roux, P., Lions, C., Vilotitch, A., et al., Correlates of cocaine use during methadone treatment: 
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9. Hien, D.A., et al., Posttraumatic stress disorder and short-term outcome in early methadone 
treatment. J Subst Abuse Treat, 2000. 19: p. 31-7. 
10. Manhapra, A, E Stefanovics, & R Rosenheck, Treatment outcomes for veterans with PTSD and 
substance use: Impact of specific substances and achievement of abstinence. Drug Alcohol Depend, 
2015.156:p.70-7. 
11. Dixon, L., Dual diagnosis of substance abuse in schizophrenia: prevalence and impact on outcomes. 
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12. Bombardier, C., Fann, J., Temkin, N., et al., Rates of major depressive disorder and clinical outcomes 
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13. Schoenhard, W,Dept of VA memorandum: Evidence based treatment for substance use disorders, 
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after residential rehabilitation: predictors among US veterans. Am J Drug Alcohol Abuse, 2015: p.1-7. 
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serious psychological distress among veterans: a nationwide analysis using the NSDUH.Mil 
Med,2013.178:107-14. 
23. Wagner, T., P. Sinnott, & A. Siroka, Mental health and substance use disorder spending in the 
Department of Veterans Affairs, fiscal years 2000-2007. Psychiatr Serv, 2011. 62: p.389-95. 
24. Oliva, E., Trafton, J., Harris, A., et al., Trends in opioid agonist therapy in the Veterans Health 
Administration: is supply keeping up with demand? Am J Drug Alcohol Abuse, 2013. 39: p.103-7. 
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p.29-59. 
26. Vocci, F., Can replacement therapy work in the treatment of cocaine dependence? And what are we 
replacing anyway? Addiction, 2007. 102: p.1888-9. 
27. Higgins, S., Budney, A., Bickel, W., et al., Incentives improve outcome in outpatient behavioral 
treatment of cocaine dependence. Arch Gen Psychiatry, 1994. 51: p.568-76. 

IRBNet #1617313 Protocol Version 1.5 
28. Petry, N., Pierce, J., Stitzer, M., et al., Effect of prize-based incentives on outcomes in stimulant 
abusers in outpatient psychosocial treatment programs: a national drug abuse treatment clinical trials 
network study. Arch Gen Psychiatry, 2005. 62: p.1148-56. 
29. Prendergast, M., Podus, D., Finney, J., et al., Contingency management for treatment of substance 
use disorders: a meta-analysis. Addiction, 2006. 101: p.1546-60. 
30. Lussier, J., Heil, S., Mongeon, J., et al., A meta-analysis of voucher-based reinforcement therapy for 
substance use disorders. Addiction, 2006. 101: p.192-203. 
31. Stitzer, M. & G. Bigelow, Contingent reinforcement for carbon monoxide reduction: within-subject 
effects of pay amount. J Appl Behav Anal, 1984. 17: p.477-83. 
32. Silverman, K., Wong, C., Higgins, S., et al., Increasing opiate abstinence through voucher-based 
reinforcement therapy. Drug Alcohol Depend, 1996. 41: p.157-65. 
33. Petry, N., Martin, B., Cooney, J. et al., Give them prizes, and they will come: contingency 
management for treatment of alcohol dependence. J Consult Clin Psychol, 2000. 68: p.250-7. 
34. Petry, N., Alessi, A., Marx, J., et al., Vouchers versus prizes: contingency management treatment of 
substance abusers in community settings. J Consult Clin Psychol, 2005. 73: p. 1005-14. 
35. Schmitz, J., Green, C., Stotts, A., et al., A two-phased screening paradigm for evaluating candidate 
medications for cocaine cessation or relapse prevention: modafinil, levodopa-carbidopa, naltrexone. 
Drug Alcohol Depend, 2014. 136: p.100-7. 
36. Hagedorn, H., Noorbaloochi, S., Simon, A., et al., Rewarding early abstinence in Veterans Health 
Administration addiction clinics. J Subst Abuse Treat, 2013. 45: p.109-17. 
37. Ghitza, U., Epstein, D., Schmittner, J., et al., Effect of reinforcement probability and prize size on 
cocaine and heroin abstinence in prize-based contingency management. J Appl Behav Anal, 2008. 41: 
p.539-49. 
38. Ahmed, S., Validation crisis in animal models of drug addiction: beyond non-disordered drug use 
toward drug addiction. Neurosci Biobehav Rev, 2010. 35: p.172-84. 
39. Bigelow, G., R. Griffiths, & I. Liebson, Experimental models for the modification of human drug self-
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Proc, 1975. 34: p.1785-92. 
40. Yi, R., Stuppy-Sullivan, A., Pickover, A., et al., Impact of construal level manipulations on delay 
discounting. PLoS One, 2017. 12: p. e0177240. 
41. Washio, Y., Higgins, S., Heil, S., et al., Delay discounting is associated with treatment response among 
cocaine-dependent outpatients. Exp Clin Psychopharmacol, 2011. 19: p.243-8. 
42. Ling Murtaugh, K., Krishnamurti, T., Davis, A., et al., Spend today, clean tomorrow: predicting 
methamphetamine abstinence in a randomized controlled trial. Health Psychol, 2013. 32: p.958-66. 
43. Aharonovich, E., Hasin, D., Brooks, A., et al., Cognitive deficits predict low treatment retention in 
cocaine 
dependent patients. Drug Alcohol Depend, 2006. 81: p.313-22. 
44. Aharonovich, E., E. Nunes, & D. Hasin, Cognitive impairment, retention and abstinence among 
cocaine 
abusers in cognitive-behavioral treatment. Drug Alcohol Depend, 2003. 71: p.207-11. 
45. Dean, A., London, E., Sugar, C., et al., Predicting adherence to treatment for methamphetamine 
dependence from neuropsychological and drug use variables. Drug Alcohol Depend, 2009. 105: p.48-55. 

IRBNet #1617313 Protocol Version 1.5 
46. Ledgerwood, D. & N. Petry, Rating contingency management sessions that reinforce abstinence 
using the 
Contingency Management Competence Scale, U.o.C.H. Center, Editor. 2010. 
47. Rass, O., Schacht, R., Buckheit, K., et al., A randomized controlled trial of the effects of working 
memory 
training in methadone maintenance patients. Drug Alcohol Depend, 2015. 156: p.38-46. 
48. Bickel, W., Li, R., Landes, R., et al., Remember the future: working memory training decreases delay 
discounting among stimulant addicts. Biol Psychiatry, 2011. 69: p.260-5. 
49. Balodis, I., Kober, H, Worhunsky, P., et al., Neurofunctional Reward Processing Changes in Cocaine 
Dependence During Recovery. Neuropsychopharmacology, 2016. 41: p.2112-21. 
50. Prause, N., Siegle, G., Deblieck, C., et al., EEG to Primary Rewards: Predictive Utility and Malleability 
by 
Brain Stimulation. PLoS One, 2016. 11: p.e0165646. 
51. Simon, J., Skunde, M., Wu., M., et al., Neural dissociation of food- and money-related reward 
processing 
using an abstract incentive delay task. Soc Cogn Affect Neurosci, 2015. 10: p.1113-20. 
52. Forster, S., Carter, C., Cohen, J., et al., Parametric manipulation of the conflict signal and control-
state 
adaptation. J Cogn Neurosci, 2011. 23: p.923-35. 
53. Fedota, J., Matous, A., Salmeron, B., et al., Insula Demonstrates a Non-Linear Response to Varying 
Demand for Cognitive Control and Weaker Resting Connectivity With the Executive Control Network in 
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54. Peters, J. & C. Buchel, Episodic future thinking reduces reward delay discounting through an 
enhancement 
of prefrontal-mediotemporal interactions. Neuron, 2010. 66: p.138-48. 
55. Finn, P., R. Gunn, & K. Gerst, The Effects of a Working Memory Load on Delay Discounting in Those 
with 
Externalizing Psychopathology. Clin Psychol Sci, 2015. 3: p.202-214. 
56. Raabe, A., Grusser, S., Wessa, M., et al., The assessment of craving: psychometric properties, factor 
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Psychological Constructs, Boyle, Saklofske, & Matthews, Editors. 2015, Academic Press. p.352-380. 
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59. Miller, W. & J. Tonigan, Assessing drinkers' motivation for change: the Stages Of Change Readiness 
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Treatment Eagerness Scale (SOCRATES). Psychology of Addictive Behaviors, 1996. 10: p.81-89. 
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sudden 
relapse in substance dependence. Am J Drug Alcohol Abuse, 2010. 36: p.140-9. 
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Approach 

IRBNet #1617313 Protocol Version 1.5 
System (BAS) assessment: a shortened Sensitivity to Punishment and Sensitivity to Reward 
Questionnaire 
version (SPSRQ-20). J Pers Assess, 2011. 93: p.628-36. 
62. Crawford, J., Smith, G., Maylor, E. et al., The Prospective and Retrospective Memory Questionnaire 
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63. Sklar, S., H. Annis, and N. Turner, Development and validation of the drug-taking confidence 
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67. Shura, R., J. Rowland, & H. Miskey, Auditory Consonant Trigrams: A Psychometric Update. Arch Clin 
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68. Petry, N. & M. Stitzer, Contingency Management: Using motivational incentives to improve drug 
abuse treatment. Psychotherapy Development Center Training Series 6, 2002, Yale U: New Haven, CT. 
69. Gajewski, P., G. Freude, & M. Falkenstein, Cognitive Training Sustainably Improves Executive 
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70. Horowitz-Kraus, T. & Z. Breznitz, Can the error detection mechanism benefit from training the 
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71. Rash, C., Olmstead, T., Petry, N., Income does not affect response to contingency management 
treatments among community substance abuse seekers. Drug Alcohol Depend, 2009. 104: p.249-53.  
    
View: 15 Miscellaneous Documents  
 
Miscellaneous Documents 
If you have any documents that need to be included in this submission, but do not fit in any of the 
previous sections please upload them here. 
 
  Document Description Version Number  
View Approved COVID Risk Assessment(0.01)   0.01  
View Letter of Support - CTAD(0.01)   0.01  
View Letter of Support - Lab and Ancillary Testing(0.01)   0.01  

IRBNet #1617313 Protocol Version 1.5 
View Protocol For Cleaning EEG Caps(0.02)   0.02  
View Remote Monitoring Handout - Substudy 2(0.01)   0.01  
 
    
View: SF - Final Page  
Final Page 
 
You have completed your application! 
 
Please hit "Finish" to save and exit the application.  Doing so will NOT submit the application for review. 
 
Please note that a submission may only be forwarded to the IRB by the Principal Investigator.  To do this, 
the Principal Investigator must press the "SUBMIT STUDY" button in My Activities for this Study 
ID:Pro00002689. 
 
You can track the ongoing status of your submission by logging into the study workspace. 
 
Please feel free to contact the IRB with any questions or concerns. 
   
View: Create/Edit  
 
Study Funding Source 
1.0 * Funding Source Name: 
Clinical Science R&D  
If you can't find the Funding Source above, choose "Other" and enter it here: 
      
View: Create/Edit  
  
  

IRBNet #1617313 Protocol Version 1.5 
  
 
 
  
 
Study Funding Source 
1.0 * Funding Source Name: 
View  
If you can't find the Funding Source above, choose "Other" and enter it here: 
Veterans Research Foundation of Pittsburgh (VRFP)   
    
View: VA Create-Edit  
 
*  Device Name: acti32Champ EEG Acquisition System  
*  Use of Device: Investigational Device Not Yet Approved for use  
 Manufacturer: Brain Products GmbH  
 IDE Class:   
 IDE Number(if Applicable):   
  Risk Level Determined by Sponsor: Non-Significant Risk   
   
Upload Device Brochure  
 actiCHamp Manual(0.01)    
 
Provide any other notes about how this device will be used or justification for lack of IDE number 
This is a nonmedical device that will be used for the acquisition of electroencephalography (EEG) data in 
accordance with manufacturer operating standards. This device is non-invasive and will only be used to 
monitor naturally-occurring biological signals and processes in vivo. 
 
The actiCHamp is intended to be used for research applications only and is not sold, designed or 
intended to be used as medical devices as defined in EU Directive 93/42/EEC, nor is it intended to be 

IRBNet #1617313 Protocol Version 1.5 
used for other medical applications such as diagnosis or treatment of disease. The actiCHamp hardware 
has been tested and certified as per the relevant EMC and electrical safety standards. A non-medical CE 
certificate is available on request. 
 
This equipment was reviewed and approved for purchase by the VAPHS Bio Medical Review committee 
on 5/9/2019. 
 
Is the investigator hold the IDE for this device? 
  Yes No 
 
If yes please provide a basis for risk level.  
    
View: VA Create-Edit  
 
*  Device Name: GT3XP-BTLE 4GB Activity Monitor  
*  Use of Device: FDA Approved Device used in approved manner  
 Manufacturer: Actigraph, LLC  
 IDE Class: Class II   
 IDE Number(if Applicable): n/a  
  Risk Level Determined by Sponsor: Non-Significant Risk   
   
Upload Device Brochure  
 Actigraph Brochure(0.01)    
 
Provide any other notes about how this device will be used or justification for lack of IDE number 
GOLDSTEIN SUBSTUDY ONLY: This device will be used in accordance with manufacturer instructions. The 
device tracks physical activity, sleep, and heartrate data (logged from a linked Polar H7 device). 
ActiGraph activity monitors are FDA 510(k) cleared and ActiGraph is ISO-13485:2016 certified. 
Is the investigator hold the IDE for this device? 
  Yes No 

IRBNet #1617313 Protocol Version 1.5 
 
If yes please provide a basis for risk level.     
View: VA Create-Edit  
  
*  Device Name: ISCAN model RK406 Infra-red Pupillometer  
*  Use of Device: FDA Approved Device used in approved manner  
 Manufacturer: ISCAN  
 IDE Class:   
 IDE Number(if Applicable): n/a  
  Risk Level Determined by Sponsor: Non-Significant Risk   
   
Upload Device Brochure  
 ISCAN Website(0.01)    
 
Provide any other notes about how this device will be used or justification for lack of IDE number 
This is a Class I medical device that will be used in an approved manner to monitor eye movement, pupil 
dimensions, and blinks during the EEG procedure. This device is non-invasive and will only be used to 
monitor naturally-occurring biological signals and processes in vivo. 
 
Is the investigator hold the IDE for this device? 
  Yes No 
 
If yes please provide a basis for risk level.  
    
View: VA Create-Edit  
 
*  Device Name: Polar H7  
*  Use of Device: FDA Approved Device used in approved manner  
 Manufacturer: Polar  

IRBNet #1617313 Protocol Version 1.5 
 IDE Class: Class II   
 IDE Number(if Applicable): n/a  
  Risk Level Determined by Sponsor: Non-Significant Risk   
   
Upload Device Brochure  
 Polar H7 Info Sheet(0.01)    
Provide any other notes about how this device will be used or justification for lack of IDE number 
GOLDSTEIN SUBSTUDY ONLY: This device will be worn around the chest to remotely measure heart rate. 
These data are transmitted via Bluetooth to the linked ActiGraph device for storage. Polar fitness 
monitors have been provided FDA 510(k) clearance. The Polar H7 is currently marketed as a commercial 
device and will not be used to diagnose, treat, or prevent a medical condition. 
 
Is the investigator hold the IDE for this device? 
  Yes No 
If yes please provide a basis for risk level.  
    
View: Risk Detail Entry  
Address for each screening procedure, research intervention/interatction, and follow-up/monitoring 
procedure:  
* Research Activity: 
Activity / HR Monitoring (GOLDSTEIN SUBSTUDY ONLY)   
Common Risks:    
Infrequent Risks: 
A mild allergic reaction (e.g., skin irritation) to the ActiGraph wrist strap or Polar HR chest strap is 
possible. Participants will be informed of this risk and asked to disclose known allergies to rubber or 
synthetic textiles during the informed consent process for Substudy 2. Participants will also be provided 
with a handout with instructions for reducing the risk of skin irritation, as well as discontinuing use and 
contacting the study team if irritation does occur.   
Other Risks: 
View: Risk Detail Entry  
 

IRBNet #1617313 Protocol Version 1.5 
Address for each screening procedure, research intervention/interatction, and follow-up/monitoring 
procedure:  
 
* Research Activity: 
Confidentiality   
Common Risks:  
As private information is collected as part of this study, there is a risk of loss of privacy and 
confidentiality. This risk will be described during the informed consent procedure. In addition, all 
electronic and paper data will be stored in an approved, secure location and will not be transmitted 
outside the VA. All possible efforts will be made to limit the inclusion of personally identifiable 
information on study-related documents. Personally identifiable information may, however, appear in 
chart-based (i.e., CPRS) documentation generated in the course of clinical services administered through 
the study.    
Infrequent Risks: 
Other Risks: 
View: Risk Detail Entry  
 
Address for each screening procedure, research intervention/interatction, and follow-up/monitoring 
procedure:  
 
* Research Activity: 
Interviews   
Common Risks:  
There are no common risks associated with this procedure.   
Infrequent Risks: 
It is possible that participants could experience psychological distress due to questions during diagnostic 
or substance use assessments. However, participants will be informed that they can skip questions they 
do not wish to answer.   
 
Other Risks: 
View: Risk Detail Entry  
 

IRBNet #1617313 Protocol Version 1.5 
Address for each screening procedure, research intervention/interatction, and follow-up/monitoring 
procedure:  
 
* Research Activity: 
EEG Recording   
Common Risks:  
There are no common risks associated with this procedure.   
Infrequent Risks: 
Infrequent Risks: 
1. On rare occasions, participants may experience slight itchiness due to the conductive gel used at 
electrode sensor sites. This reaction occurs in less than 1% of people. Participants will be instructed to 
let study personnel know if they experience discomfort during the EEG procedure and may choose to 
stop the EEG procedure at any time.  
2. On rare occasions (~5% of the time), temporary redness of skin is noted following an EEG in locations 
where sensors were placed. Redness of skin will generally resolve within a few minutes without 
discomfort.  
3. On rare occasions (~5% of the time), the placement of the sensors on the skin will cause a very small 
portion of the skin, less than 1 centimeter, to swell slightly; this might appear like a very small welt. This 
is caused by the retention of moisture under sensors and goes away soon after the sensors are 
removed.    
 
Other Risks: 
View: Risk Detail Entry  
Address for each screening procedure, research intervention/interatction, and follow-up/monitoring 
procedure:  
 
* Research Activity: 
Self Report Questionnaires   
Common Risks:  
There are no common risks associated with this procedure.   
Infrequent Risks: 

IRBNet #1617313 Protocol Version 1.5 
It is possible that participants could experience psychological distress due to questions included on self-
report questionnaires. However, participants will be informed that they can skip questions they do not 
wish to answer.   
 
Other Risks: