Automated Reinforcement Management System (ARMS): Phase I Study
Phase: NA
Conditions: Alcohol Use Disorder
Sponsor: Washington State University

 
 
 AUTOMATED REINFORCEMENT MANAGEMENT SYSTEM (ARMS):  
PHASE 1 CLINICAL ANALOG TRIAL 
  
National Clinical Trial (NCT) Identified Number: NCT 04656925 
Principal Investigator(s):  
Dr. Sterling McPherson 
Ron Kim Johnson 
Dr. Michael McDonell 
Sponsor: NIH/NIAAA 
Grant Title: Automated Contingency Management System for Reduction of Alcohol Use 
Grant Number: R41 AA0267993 
Version Number:  v.1.1 
09 June 2020  
 
If found, please return to: 
Dr. Sterling McPherson   
Elson S. Floyd College of Medicine 
Washington State University 
Spokane, WA 99210-1495 
sterling.mcpherson@wsu.edu 
(509) 324-7459 

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CONFIDENTIALITY STATEMENT 
This document is confidential communication. Acceptance of this document constitutes 
agreement by the recipient that no unpublished information contained herein will be published or 
disclosed without prior approval of the Principal Investigator or other participating study leadership 
and as consistent with the NIH terms of the award.   
 

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Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 5 
INVESTIGATOR’S SIGNATURE .............................................................................................................................. 6 
1 
PROTOCOL SUMMARY ............................................................................................................................... 7 
1.1 
Synopsis ................................................................................................................................................ 7 
1.2 
Schedule of Activities ........................................................................................................................ 10 
2 
INTRODUCTION .......................................................................................................................................... 11 
2.1 
Study Rationale .................................................................................................................................. 11 
2.2 
Background ......................................................................................................................................... 11 
2.3 
Risk/Benefit Assessment .................................................................................................................. 11 
2.3.1 
Known Potential Risks ................................................................................................... 11 
2.3.2 
Known Potential Benefits .............................................................................................. 12 
2.3.3 
Assessment of Potential Risks and Benefits ............................................................. 12 
3 
OBJECTIVES AND ENDPOINTS .............................................................................................................. 12 
4 
STUDY DESIGN ........................................................................................................................................... 13 
4.1 
Overall Design .................................................................................................................................... 13 
5 
STUDY POPULATION ................................................................................................................................. 14 
5.1 
Inclusion Criteria................................................................................................................................. 14 
5.2 
Exclusion Criteria ............................................................................................................................... 14 
5.3 
Lifestyle Considerations .................................................................................................................... 10 
5.4 
Screen Failures .................................................................................................................................. 14 
5.5 
Strategies for Recruitment and Retention ...................................................................................... 14 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ............................................ 15 
7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
DISCONTINUATION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL ......................................... 16 
7.1 
Participant Discontinuation/Withdrawal from Study ...................................................................... 16 
7.2 
Lost to Follow-Up ............................................................................................................................... 16 
8 
STUDY ASSESSMENTS AND PROCEDURES...................................................................................... 16 
8.1 
Endpoint and Other Non-Safety Assessments .............................................................................. 16 
8.2 
Safety Assessments .......................................................................................................................... 18 
8.3 
Adverse Events and Serious Adverse Events ............................................................................... 18 
8.3.1 
Definition of Adverse Events ........................................................................................ 18 
8.3.2 
Definition of Serious Adverse Events .......................................................................... 19 
8.3.3 
Classification of an Adverse Event .............................................................................. 19 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ...................... 20 
8.3.5 
Adverse Event Reporting .............................................................................................. 20 
8.3.6 
Serious Adverse Event Reporting ............................................................................... 21 
9 
STATISTICAL CONSIDERATIONS ........................................................................................................... 21 
9.1 
Sample Size Determination .............................................................................................................. 21 

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9.2 
Populations for Analyses .................................................................................................................. 21 
9.3 
Statistical Analyses ............................................................................................................................ 21 
9.3.1 
General Approach .......................................................................................................... 21 
9.3.2 
Analysis of the Primary Endpoint(s) ............................................................................ 21 
9.3.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 22 
9.3.4 
Safety Analyses .............................................................................................................. 22 
9.3.5 
Baseline Descriptive Statistics ..................................................................................... 22 
9.3.6 
Planned Interim Analyses ............................................................................................. 21 
9.3.7 
Tabulation of Individual Participant Data .................................................................... 22 
9.3.8 
Exploratory Analyses ..................................................................................................... 22 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 22 
10.1 
Regulatory, Ethical, and Study Oversight Considerations........................................................... 22 
10.1.1 
Informed Consent Process ........................................................................................... 23 
10.1.2 
Study Discontinuation and Closure ............................................................................. 24 
10.1.3 
Confidentiality and Privacy ........................................................................................... 25 
10.1.4 
Future Use of Stored Specimens and Data ............................................................... 25 
10.1.5 
Safety Oversight ............................................................................................................. 25 
10.1.6 
Quality Assurance and Quality Control ....................................................................... 26 
10.1.7 
Data Handling and Record-Keeping ........................................................................... 26 
10.1.8 
Protocol Deviations ........................................................................................................ 27 
10.1.9 
Publication and Data Sharing Policy ........................................................................... 28 
10.1.10 
Conflict of Interest Policy............................................................................................... 28 
10.2 
Abbreviations and Special Terms .................................................................................................... 29 
10.3 
Protocol Amendment History ........................................................................................................... 31 
11 
REFERENCES .............................................................................................................................................. 32 
12  APPENDICES ---------------------------------------------------------------------------------------------------------------------------33 
 

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STATEMENT OF COMPLIANCE 
 
This trial will be conducted in compliance with International Conference on Harmonization Good Clinical 
Practice (ICH GCP) and the following:  
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 
CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812)  
National Institutes of Health (NIH) funded investigators and clinical trial site staff who are responsible for 
the conduct, management, or oversight of NIH-funded clinical trials have completed Human Subjects 
Protection and ICH GCP Training. 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted 
to the Washington State University Institutional Review Board (IRB) for review and approval. Approval of 
both the protocol and the consent form must be obtained before any participant is enrolled. Any 
amendment to the protocol will require review and approval by the IRB before the changes are 
implemented to the study. Also, all changes to the consent form will be IRB-approved; a determination will 
be made regarding whether a new consent needs to be obtained from participants who provided consent, 
using a previously approved consent form. 
 
 
 
 
 
 
 
 
 
 
 
 
 

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INVESTIGATOR’S SIGNATURE 
The signature below constitutes the approval of this protocol and provides the necessary assurances that 
this study will be conducted according to all stipulations of the protocol, including all statements regarding 
confidentiality, and according to local legal and regulatory requirements and applicable US federal 
regulations and ICH guidelines. 
 
Principal Investigator: 
 
Signed: 
 
 
Date: 
 
 
Name*: 
 Sterling McPherson, Ph.D. 
 
Title*: Associate Professor and Assistant Dean for Research  
 
Investigator Contact Information 
Affiliation*:  Washington State University Elson S. Floyd College of Medicine.  
Address: PO BOX 1495 Spokane, WA 99210-1495 
 
Telephone: 509-324-7459  
Email:  sterling.mcpherson@wsu.edu 
 
 
 
 
 
 
 
 
 
 
 
 

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1 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
Title: 
Automated Reinforcement Management System (ARMS)  
Grant Number: 
R41 AA0267993  
Study Description:  
 
Alcohol abuse remains a significant cause of preventable morbidity 
and mortality in the US, yet only 15% of those with alcohol use 
disorders receive treatment. Contingency Management (CM) is a 
cost-effective intervention for drug addiction where individuals are 
rewarded when they submit biological verification of drug abstinence. 
We propose to develop an integrated CM system capable of 
incorporating mobile device input and Electronic Medical Record 
(EMR) integration, that would allow us to deliver a CM intervention 
for problematic drinking to anyone who owns a smartphone. The 
mobile device input will incorporate ecological momentary 
assessments (EMA), geospatial mapping, and biomarker-based 
feedback from a portable measuring device. This novel approach will 
enable personalized CM goal setting and a new platform for clinician 
feedback and progress monitoring. The goal of the system will be to 
provide an end-to-end CM platform, which can aggregate and inform 
the understanding of mechanisms underlying the initiation, 
maintenance, and recovery from problematic drinking in both 
treatment and naturalistic settings with little to no required clinician 
involvement. 
Objectives*: 
 
Primary Objective: To develop and  combine mobile technology, 
geospatial mapping, and biomarker measurement, with individual 
goal setting and EMA feedback to launch behavioral modification 
strategies and progress monitoring. 
Secondary Objectives: To develop and consumer-test the mobile 
application component to help the patient alcohol-related treatment 
goals at home. 

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Endpoints*: 
 
Primary Endpoint: Our primary endpoint is biochemically confirmed 
alcohol abstinence, measured thrice daily throughout the 8-week 
study. 
Secondary Endpoints: Secondary endpoints will include self-
reported alcohol use measured by the Timeline Follow Back to 
assess the frequency and amount of daily drinking via multi-modal 
EMA data collection.  
Study Population: 
Twenty (20) subjects, male and female, between 18 and 65 years of 
age who have an Alcohol Use Disorders Identification Test (AUDIT) 
score of eight or higher. Subjects must read and speak English and 
have the ability to provide written informed consent. They must also 
live in the Greater Inland Northwest area (i.e., Spokane and Coeur 
d’Alene). 
Phase* or Stage: 
 
Phase I, Clinical Analog Trial with A-B-A phase design. 
Description of 
Sites/Facilities Enrolling 
Participants: 
 
 
This study will take place in Greater Inland Northwest area in 
cooperation with the Community Health Association of Spokane 
(CHAS) and other clinical referral entities throughout the Spokane 
region, including MultiCare Health System (MHS) and others. 
 

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Description of Study 
Intervention/Experimental 
Manipulation: 
 
We will utilize an A-B-A, completely within-subject design with the 
intent of recruiting twenty (n=20) total participants. 
During the first A phase, participants will receive reinforcement for 
simply submitting breath samples three times per day between 4 and 
6 hours apart. In this application, we will use a Bluetooth enabled 
breathalyzer developed by BACtrack, however our smartphone-
based technological solution will interact with any alcohol monitoring 
device, such as BACtrack Skyn.  
During the B phase, the delivery of reinforcers will be contingent upon 
the submission of an alcohol negative breath sample on an 
escalating schedule.  
The A phase or return to the baseline phase will involve the delivery 
of reinforcers for simply submitting a breath sample during the 
designated windows of time. We will also collect EMA data on stress, 
anxiety, depression, and other brief measures daily through their 
smartphone.  
Each phase will last a total of four weeks (i.e., two weeks of the first 
A phase, four weeks of the B phase, and then two more weeks of the 
A-phase) each for a total of 8 weeks of participation. To the extent 
possible, we will use existing protocols, procedures, and equipment 
that we have used in previous A-B-A studies.  
Study Duration*: 
Eight to twelve months.  
Participant Duration: 
Two months for each participant to complete all study-related tasks.  
 
 
 
 

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1.2 
SCHEDULE OF ACTIVITIES  
  
 
 
 
 
 
 
 
 
 
 
 
*The Mini-International Neuropsychiatric Interview (M.I.N.I.) is a short structured diagnostic interview, 
developed jointly by psychiatrists and clinicians. 
**Blood Alcohol Concentration (BAC). 
***The Fagerström Test for Nicotine Dependence is a standard instrument for assessing the intensity of 
physical addiction to nicotine. 
****The Alcohol Use Disorders Identification Test (AUDIT). 
*****The Brief Symptom Inventory (BSI). 
 
 
 
 
 
 
 
 
Table 1. Schedule of study activities. 
 
Baseline 
Week 0 
A-B-A 
Week 1-8 
Informed consent  
√ 
 
M.I.N.I*. Research Psychiatric Diagnosis 
√ 
 
Medical history form  
√ 
 
Other inclusion/exclusion criteria  
√ 
 
Alcohol use (biochemical BAC**) 
√ 
3x / day 
Alcohol Timeline Follow Back (self-report) 
√ 
3x / day 
Addiction severity Index: ASI-Lite (self-report) 
√ 
 
Alcohol cravings and withdrawal: visual analog scale 
(self-report) 
√ 
3x / day 
Location and Activity at time of the report 
√ 
3x / day 
Other substance use (biochemical) 
√ 
 
Health-related quality of life (self-report) 
√ 
 
Tobacco dependence (Fagerström***) 
√ 
 
Alcohol dependence (AUDIT****) 
√ 
 
Adverse Events  
√ 
weekly 
Psychopathology (BSI*****) 
√ 
 
Follow-up phone call  
√ 
weekly 
Sleepiness Scale  
√ 
Weekly 

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2 
 
INTRODUCTION 
2.1 
STUDY RATIONALE  
Alcohol abuse remains a significant cause of preventable morbidity and mortality in the US, yet only 15% of 
those with alcohol use disorders receive treatment. Contingency Management (CM) is a cost-effective 
intervention for drug addiction where individuals are rewarded when they submit biological verification of drug 
abstinence.1-7 We propose to develop an integrated CM system capable of incorporating mobile device input 
and Electronic Medical Record (EMR) integration, that would allow us to deliver a CM intervention for 
problematic drinking to anyone who owns a smartphone. The mobile device input will incorporate ecological 
momentary assessments (EMA), geospatial mapping, and biomarker-based feedback from a portable 
measuring device. This novel approach will enable personalized CM goal setting and a new platform for 
clinician feedback and progress monitoring. The goal of the system will be to provide an end-to-end CM 
platform, which can aggregate and inform the understanding of mechanisms underlying the initiation, 
maintenance, and recovery from problematic drinking in both treatment and naturalistic settings with little to 
no required clinician involvement.  
2.2 
BACKGROUND  
In a recently completed randomized controlled trial (RCT; n=79) we used ethyl glucuronide (EtG), a urine-
based biomarker capable of detecting heavy drinking for up to five days, as the basis for a CM intervention 
for alcohol use disorders in outpatients who suffered from comorbid mental illness (PI: McDonell, Co-I: 
McPherson; Am J Psychiatry). We found that participants randomized to CM were 3.13 times more likely 
than controls CI=2.18-4.50, p<0.01) to submit alcohol-negative urine samples during the 12-week treatment 
period. They also achieved longer duration of alcohol abstinence: 2.9 weeks (SD=3.30) versus 1.4 weeks in 
the control group (SD=2.10; p<.02). The CM group also had significantly:  
1) lower average EtG levels,  
2) fewer days of any drinking or heavy drinking during treatment, and  
3) fewer days of drinking during the 6-month follow-up. 
These results provide convincing evidence for the efficacy of CM in treating people who have an alcohol use 
disorder. 
 
2.3 
RISK/BENEFIT ASSESSMENT  
2.3.1 KNOWN POTENTIAL RISKS  
The risk to patients from digital intervention is negligible. However, as in all trials of this nature, there is the 
possibility of unauthorized disclosure of confidential information; discomfort, or embarrassment related to 
biologic sample collection or administration of questionnaires or assessments dealing with sensitive 
information. There may be unforeseen and unpreventable risks to participants of encountering friends or 
associates at the research laboratory study visits. These are acknowledged and will be reduced as much as 
possible. 
 

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2.3.2 KNOWN POTENTIAL BENEFITS  
The potential benefit of this intervention is to decrease alcohol consumption during medication-assisted 
therapy. This benefit may occur by participating in the trial and the data collected may extend this benefit to 
future users of the technology. The application is expected to improve their self-awareness and 
understanding of their current alcohol use, cravings as related to their personal goals, and progress towards 
recovery goals.  
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
There is a small risk that information provided by a study participant will be seen by someone who is not 
supposed to see it. We will lower this risk by giving all the information provided by participants a unique 
identification number instead of their names. Participants are encouraged to discuss any distressing issues 
that may appear due to their participation in the study. If any identifiable information is released by 
accident, affected participants will be informed by the PI, apologies for the situation, and notified of steps 
the study team is taking to rectify the situation as best as possible.  
Questions about the participant's habits and history may make them feel uncomfortable. There may be 
discomfort, social stigmatization, or embarrassment related to giving a urine sample or being seen at the 
research lab. Our research team will take the utmost caution to avoid creating distress, stigmatization, 
offending, or degrading participants and their families.  
 
We anticipate that the intervention will lower the average alcohol levels, reduce the number of days of any 
drinking or heavy drinking during treatment, and decrease the number of days of drinking during the study.  
 
3 
OBJECTIVES AND ENDPOINTS  
Primary Objective:  
 To develop and combine mobile technology, geospatial mapping, and biomarker measurement, with 
individual goal setting and EMA feedback to launch behavioral modification strategies and progress 
monitoring. 
 
Secondary Objectives:  
To develop and consumer-test the mobile application component to help the patient alcohol-related treatment 
goals at home. 
 
Primary Endpoint: 
Biochemically confirmed alcohol abstinence measured thrice daily throughout the 8-week study. 
 
Secondary Endpoints:  
The secondary endpoint will include self-reported alcohol use measured by the Timeline Follow Back to 
assess the frequency and amount of daily drinking via multi-modal EMA data collection. 
 
 
 

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4 
STUDY DESIGN 
4.1 
OVERALL DESIGN 
This pilot study will utilize an A-B-A, completely within-subject design with the intent of recruiting twenty (n=20) 
total participants. During the first A phase, participants will receive reinforcement for simply submitting breath 
samples three times per day between 4 and 6 hours apart. In this application, we will utilize a Bluetooth 
enabled breathalyzer developed by BACtrack, but our smartphone-based technological solution will interact 
with any alcohol monitoring device, such as BACtrack Skyn. During the B phase, the delivery of reinforcers 
will be contingent upon the submission of an alcohol negative breath sample on an escalating schedule. The 
second A phase (i.e., return to the baseline phase) will involve the delivery of reinforcers for simply submitting 
a sample during the designated windows of time. We will also collect EMA data on stress, anxiety, depression, 
and other brief measures daily through their smartphone. Each phase will last a total of four weeks (i.e., two 
weeks of the first A phase, four weeks of the B phase, and then two more weeks of the A-phase) each for a 
total of 8 weeks of participation. To the extent possible, we will use existing protocols, procedures, and 
equipment that we have used in previous A-B-A studies. 
 
This study will take place in Greater Inland Northwest area in cooperation with the Community Health 
Association of Spokane (CHAS) and other outpatient entities, community recruitment, etc. under the auspices 
of the WSU Program of Excellence in Addictions Research and the Analytics and PsychoPharmacology 
(APPL). 
 
We will recruit n=20 patients throughout Greater Inland Northwest area. We anticipate a five-month 
recruitment period, necessitating four recruited per month which is far below our normal recruitment rates. 
Flyers will advertise the study, and staff and providers will be aware of the study and will be asked to refer 
potentially interested participants to our investigation. Initial eligibility for a referral will be provided by AUDIT 
screen and Screen, Brief Intervention, and Referral to Treatment performed at the different treatment centers . 
Once the treatment center  has completed its screening and intervention, they will utilize the AUDIT score to 
determine the patients that will be provided, the study Research Coordinator contact number for study 
screening. After an initial phone screening, eligible participants will be scheduled for an in-person study 
interview, during which they will provide informed consent and complete baseline data collection. During this 
time, participants will also receive a brief tutorial on how to use the BACtrack breathalyzer and how it 
integrates with the application on their smartphone. Participants who do not have a compatible iOS 
smartphone will be provided one for this study. The phones will be supplied from a testing inventory 
maintained by Managed Health Connections. Participant set-up instructions will also describe the time 
window for reporting, the definition of zones of use, and will be provided contact information for technical 
support to be used during the study.  
 
During the A-B-A phase (2-4-2 weeks), participants will be asked to submit thee breath samples daily for 8 
weeks. They will also be asked to fill out a weekly timeline follow back for alcohol, tobacco, and cannabis use 
during that period. At the end of the 8 weeks participation period, participants will bring back the phone and 
fill out the exit questionnaire.  
 
 
 

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5 
STUDY POPULATION 
5.1 
INCLUSION CRITERIA 
To be eligible to participate in this study, an individual must meet all the following criteria:  
1) Age 18-65 years. 
2) An Alcohol Use Disorders Identification Test (AUDIT) score of 8 or higher.  
3) Ability to read and speak English.  
4) Ability to provide written informed consent.  
5) Breath alcohol of 0.00 during informed consent. 
6) Operate a smartphone with an active service provider.  
    
5.2 
EXCLUSION CRITERIA 
An individual who meets any of the following criteria will be excluded from participation in this study:  
1) Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) alcohol use disorder, severe 
type. 
2) Significant risk of dangerous alcohol withdrawal, defined as a history of alcohol detoxification or seizure in 
the last 12 months and expression of concern by the participant about dangerous withdrawal. 
3) Diagnosis of a psychotic disorder. 
4) Lifetime suicide attempt or suicidality in the past year. 
5) Any other medical or psychiatric condition that would compromise safe participation. 
 
5.3  
 
5.4 
SCREEN FAILURES 
Screen failures are defined as participants who consent to participate in the study but are not subsequently 
assigned to the study intervention or entered in the study. Individuals who do not meet the criteria for 
participation in this trial (screen failure) because of meeting one or more exclusion criteria that are likely to 
change over time may be rescreened. Examples include the successful treatment of a previous affective 
DSM-5 alcohol use disorder, severe type, and overcoming the significant risk of dangerous alcohol 
withdrawal, defined as a history of alcohol detoxification or seizure in the last 12 months and expression of 
concern by the participant about dangerous withdrawal. Rescreened participants will be assigned the same 
participant number as for the initial screening. 
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
We anticipate a 5-month recruitment period, necessitating n=4 recruited per month which is far below our 
normal recruitment rates. Flyers will advertise the study, and staff and providers will be aware of the study 
and will be asked to refer potentially interested participants to our investigation. As noted elsewhere, while 

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we will partner with clinics we will also recruit from the community. After an initial phone screening, those 
deemed eligible will be scheduled for an in-person study interview, during which they will provide informed 
consent and complete baseline data collection. During this time, participants will also receive a brief tutorial 
on how to use the BACtrack breathalyzer and how it integrates with the application on their smartphone. 
Participants who do not have a compatible iPhone Operating System (iOS) smartphone will be provided one 
for this study. The phones will be supplied from a testing inventory maintained by Managed Health 
Connections. 
Participant set-up instructions will also describe the time window for reporting the definition of zones of use 
and will be provided contact information for technical support to be used during the study. During the baseline 
visit participants will receive a $30 gift cards for their time.  
During the first A phase, participants will receive $2 per sample (regardless of being positive or negative for 
breath alcohol) submitted instantly, for a maximum payout of $6 per day.  
During the B phase, participants will begin by receiving $2 per alcohol negative breath sample submitted, 
escalating by $0.25 per alcohol negative breath sample submission until a maximum value of $3.50 per 
sample is reached. Once this value is reached based on negative breath sample submissions, participants 
will continue to receive $3.50 per alcohol-negative breath sample submission. If a participant submits an 
alcohol positive breath sample, they will be reset to $2.00 per sample and will need to work up to receive 
$3.50 per sample again. Final onetime payment of $50 will be provided to participants upon return of study 
devices. Participants will receive electronic payment through a gift card. Payments will be loaded onto the 
card weekly. 
6 
STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
We will use the first A phase of data collection to define personalized 'cold' (i.e., lower than 50% probability 
of drinking) and 'hot' (i.e. greater than 50% probability of drinking) spots using the participant's geospatial 
location data (via smartphone). As part of this CM system, participants will have the capability to receive 
multi-modal message reminders when they enter a new window of needed biochemical sample submission 
and additional reminders when the window of sample submission is about to close. While participants will 
receive information messages to this effect during the A phase, participants will receive additional 
personalized multi-modal message reminders once our CM platform can detect that they have entered a cold 
or hot zone. This will be based on the participant entering a 2/10s (i.e., approximately 1,000 feet) of a mile 
radius near a cold or hot zone. For example, upon entering a hot zone radius during the B phase wherein 
they had 50% or greater likelihood of drinking in that zone during the A phase, they will receive a text message 
encouraging them to change surroundings in order better promote abstinence. Also, if the participant is within 
a window of time where they are eligible to submit a sample and receive a dose of reinforcement, this is 
another action that the individual can take to help bolster their attempt to remain abstinent. All of these data 
(e.g., biochemical results, location of sample submission, time of submission) will be warehoused in the 
individual's EMR to be presented in summary form on their primary care provider's dashboard. This will help 
the provider give counsel or otherwise devise an action plan if the patient's drinking behavior is proving 
impervious to intervention or if the patient's goals are being met, this is something the provider can encourage.  
 

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7 
STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
7.1 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants are free to withdraw from participation in the study at any time upon their request. 
An investigator may discontinue a participant from the study for the following reasons: 
• 
Significant study intervention non-compliance unless varying compliance is an aspect of the study 
objectives. 
• 
Lost-to-follow up; unable to contact subject. 
• 
Any event, medical condition or situation occurs such that continued collection of follow-up study data 
would not be in the best interest of the participant or might require an additional treatment that would 
confound the interpretation of the study. 
• 
The participant meets an exclusion criterion (either newly developed or not previously recognized) that 
precludes further study participation. 
 
The reason for participant discontinuation or withdrawal from the study will be recorded on REDCap.  
In this situation, participants will be asked to bring back the phone, fill out the exit questionnaire and received 
a $50 gift card.  
 
7.2 
LOST TO FOLLOW-UP 
A participant will be considered lost to follow-up if they fail to return for a scheduled visit and study staff are 
unable to contact the participant after at least 3 attempts.  
The following actions must be taken if a participant fails to return to the clinic for a required study visit: 
 
• 
The site will attempt to contact the participant, reschedule the missed visit, counsel the participant on 
the importance of maintaining the assigned visit schedule and ascertain if the participant wishes to 
and/or should continue in the study. 
• 
Before a participant is deemed lost to follow-up, the investigator or designee will make every effort to 
regain contact with the participant (where possible, 3 telephone calls and, if necessary, a certified letter 
to the participant’s last known mailing address or local equivalent methods). These contact attempts 
will be documented in the participant’s study file.  
• 
Should the participant continue to be unreachable, he or she will be considered to have withdrawn from 
the study with a primary reason for loss to follow-up. 
• 
Study phone provided at baseline will be disable remotely.  
  
8 
STUDY ASSESSMENTS AND PROCEDURES 
8.1 
ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
Our primary outcome is biochemically confirmed alcohol abstinence, measured thrice daily throughout the 8-
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drinking will be defined using the AUDIT and AUD diagnosis will be confirmed by administering the DSM-5 
checklist. Research staff will also use this interview to assess for possible exclusionary cognitive or psychotic 
disorders using the MINI Neuropsychiatric Interview (M.I.N.I.). At baseline data collection, potential 
participants will complete a medical history form.  
 
Secondary outcomes will include self-reported alcohol use measured by the Timeline Follow Back to assess 
the frequency and amount of daily drinking via multi-modal EMA data collection. The Addiction Severity Index 
and the quality of life in several domains (e.g., psychiatric, legal, medical) will be assessed at baseline. The 
EMA application will also collect data to assess craving and withdrawal for alcohol and tobacco by using a 1 
to 5 Likert scale along with location and activity at the time of the report. Other substance use, including 
amphetamine, methamphetamine, cocaine, and marijuana, will be measured by urinalysis at baseline. We 
will characterize the psychiatric health of the participant sample by measuring psychopathology with the Brief 
Symptom Inventory, which assesses anxiety, depression, impulsiveness, and suicidality. We will also use 
the Fagerström Test of Nicotine Dependence to measure the severity of tobacco dependence and the Alcohol 
Use Disorders Identification Test to measure the severity of alcohol use disorder. 
 Our study variables and the schedule of data collection are summarized in Table 2.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 2. Data collection schedule 
Measure 
Baseline 
Week 0 
A-B-A 
Week 1-8 
Eligibility Criteria 
 
 
Demographics 
√ 
 
MINI Research Psychiatric Diagnosis 
√ 
 
Medical history form  
√ 
 
Other inclusion/exclusion criteria 
√ 
 
Primary Outcomes 
 
 
Alcohol use (biochemical BAC) 
√ 
3 times per day 
Secondary Outcomes 
 
 
Alcohol Timeline Follow Back (self-report) 
√ 
 
Addiction severity: ASI-Lite (self-report) 
√ 
 
Alcohol cravings and withdrawal: visual analog scale 
(self-report) 
√ 
3 times per day 
Location and Activity at time of the report 
√ 
3 times per day 
Other substance use (biochemical) 
√ 
 
Health-related quality of life (self-report) 
√ 
 
Tobacco dependence (Fagerström) 
√ 
 
Alcohol dependence (AUDIT) 
√ 
 
Psychopathology (BSI) 
√ 
 
Follow up phone call  
√ 
Weekly  
Sleepiness Scale  
√ 
Weekly 

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8.2 
SAFETY ASSESSMENTS 
Qualified personnel will perform the study according to the WSU IRB-approved application. 
The equipment, facilities, and procedures to be used in this research meet recognized standards for safety. 
We will assess participants alcohol use three times daily through the Automated Reinforcement Management 
System (ARMS) which will provide the following functions: Breathalyzer recording, EMA responses, and 
eventually geospatial mapping Patient Dashboard, and a Clinician Dashboard. The participant will be 
provided with a BACtrack breathalyzer device. The setup process will pair their phone with the breathalyzer 
device and establish a profile including locations and time of day for reporting.  
The mobile application will provide the participant user with the ability to input EMA information and control 
the breathalyzer function. It will utilize a hybrid iOS/mobile web application architecture for phase 1 enabling 
the integration of breathalyzer and geographic information with web-based dashboard information. The 
participant will be prompted to record EMA and breathalyzer samples based on their profile information and 
prior reporting. During a reporting window, the participant will receive a prompt to initiate breathalyzer 
measurement within the thirty (30) minute time window. The application will automatically record the location 
of the breathalyzer sample and categorize it as a "hot" or "non-hot" zone for future analysis. Following the 
breathalyzer report, the participant will be prompted to respond to EMA questions. Following the data entry, 
the participant will receive a multimedia message describing their progress and sample tailored messaging 
offering resources for additional information. 
To support compliance, if a participant does not record substance use in real-time and does not respond to 
the daily check-in, the system will send reminders. The reminders are multi-modal as they can reach the user 
through different means based on user preference. For the study, we will rely on application delivered PUSH 
messages for the assigned smartphones with text message back up and the option for voice calls from 
Research Coordinator.  
If the participant does not respond to the application and does not respond to reminders, their name and 
status will be communicated to the research coordinator. The research coordinator could place a personal 
call to the participant to follow up.  
The application provides a dashboard for each patient to show how the EMA answers are related to 
substance use outcomes. It informs the patient of progress toward CM rewards and provides suggestions 
regarding which factors are most likely to be associated with craving and substance use.  
Responses to EMA-assessed factors will provide the basis for creating a menu of customizable strategies to 
improve goal adherence for individuals and/or modify incentives. Certain patterns of responses will trigger 
the app to employ specific strategies to help the participant achieve his goal. 
 
  
8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
8.3.1 DEFINITION OF ADVERSE EVENTS 
According to the code of federal regulation title 21 of the Food and Drug Administration FDA, An Adverse 
event refers to any untoward medical occurrence associated with the use of a drug in humans, whether 
considered drug-related or not. 

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All AEs, whether volunteered, elicited, or noted on physical examination, will be recorded throughout the 
study (i.e., from signing of the ICF until completion).  
All AEs will be collected in a proper case report form and recorded in REDCap.  
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS 
An adverse event or suspected adverse reaction is considered "serious" if, in the view of either the 
investigator or sponsor, it results in any of the following outcomes: Death, a life-threatening adverse event, 
inpatient hospitalization, prolongation of existing hospitalization, a persistent or significant 
incapacity/substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth 
defect.  
Important medical events that may not result in death, though life-threatening or require hospitalization may 
be considered serious when, based upon appropriate medical judgment, they jeopardize the life or require 
medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such 
medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at 
home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of 
drug dependency or drug abuse. SAEs are life-threatening adverse events or life-threatening suspected 
adverse reactions. An adverse event or suspected adverse reaction is considered "life-threatening" if, in the 
view of either the investigator or sponsor, its occurrence places the patient at immediate risk of death. It does 
not include an adverse event or suspected adverse reaction that, had it occurred in a more severe form, 
might have caused death. 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
8.3.3.1 SEVERITY OF EVENT 
 
Each AE will be assigned a category by the Investigator as follows:  
Mild: An AE that is easily tolerated by the subject, require minimal or no treatment and does not interfere 
with the participant’s daily activities.  
 
Moderate: An AE that results in a low level of inconvenience or concern with the therapeutic measures. 
Moderate events may cause some interference with functioning. Intervention may be needed. 
 
Severe: An AE that prevents everyday activities and may require systemic drug therapy or other treatment. 
Severe events are usually potentially life-threatening or incapacitating. 
If there is a change in the severity of an AE, it must be recorded as a separate event. 
 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
The investigator will make every effort to assess the relationship of the AE, if any, to the study intervention. 
The investigator should use their knowledge of the subject, the circumstances surrounding the event, and 

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an evaluation of any potential alternative causes to determine whether an AE is related to the study 
treatment. Causality should be assessed using the categories presented below:  
Related: The AE is known to occur with the study intervention, there is a reasonable possibility that the 
study intervention caused the AE, or there is a temporal relationship between the study intervention and 
event. Reasonable possibility means that there is evidence to suggest a causal relationship between the 
study intervention and the AE. 
Not Related: There is not a reasonable possibility that the administration of the study intervention caused 
the event, there is no temporal relationship between the study intervention and event onset, or an alternate 
etiology has been established. 
 
Action Taken 
The investigator will describe the action taken in the proper section of the CRF, as follows: 
- 
None 
- 
Study procedure or the medication stopped 
- 
Study medication temporarily interrupted 
- 
Concomitant medication 
- 
Other, specify.  
 
8.3.3.3 EXPECTEDNESS   
A provider with expertise in alcohol withdrawal syndrome will be responsible for determining whether an 
adverse event (AE) is expected or unexpected. An AE will be considered unexpected if the nature, severity, 
or frequency of the event is not consistent with the risk information previously described for the study 
procedures. 
8.3.4 PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
The study coordinator will record events with start dates occurring any time after informed consent is obtained 
until seven (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. At each study 
visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed 
for outcome information until resolution or stabilization. 
  
8.3.5 ADVERSE EVENT REPORTING  
Investigators must report to the IRB as soon as possible, but in all cases within seven (7) working days after 
the reportable event had been made known to the investigator. All AEs occurring during the study must be 
documented on the relevant CRF pages. The following information should be documented for each AE: 
- 
Description of the symptom event 
- 
Classification of ‘’serious’’ or ‘’not serious’’ 
- 
Severity 
- 
Date of first occurrence and date of resolution (if applicable) 
- 
Action was taken 
- 
Causal relationship 
- 
The outcome of the event (unknown, recovered, not yet recovered, recovered with sequelae, death) 
 

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8.3.6 SERIOUS ADVERSE EVENT REPORTING  
The SAE form must be completed as thoroughly as possible with all available details of the event, signed 
by the investigator (or appropriately qualified designee), and emailed or faxed to medical monitor within 24 
hours of first becoming aware of the event. Such SAE will be reported to the Ringful and, the WSU IRB 
within 24 hours of first becoming aware of the event.  
 
 
9 
STATISTICAL CONSIDERATIONS  
9.1 
SAMPLE SIZE DETERMINATION 
This is a minimum viability proof of concept trial. The samples size is determined to provide preliminary 
usability data as required by an R41 project.  
9.2 
POPULATIONS FOR ANALYSES 
The dataset will consist of all enrolled subjects. This excludes all patients who failed the screening for this 
study or those who are eligible but uninterested in study participation.  
 
9.3 
STATISTICAL ANALYSES 
9.3.1 GENERAL APPROACH 
Raw data will be entered directly into the Research Electronic Data Capture (REDCap) system on a secure 
server by research staff at baseline and all subsequent data from participants via cell phone will flow directly 
into REDCap. 
 
First, we will perform generalized estimating equations for the repeated binary outcome of alcohol abstinence. 
This model will include the variables of 1) Time (individually varying timestamp from when the breath sample 
was submitted) and 2) Phase (A, B, A).  
Second, we will analyze the outcome of 1) self-reported heavy drinking days (4+ standard drinks per drinking 
day for women, 5+ standard drinks per drinking day for men), 2) self-reported craving, and 3) self-reported 
craving, all over time. 
   
9.3.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
Our primary outcome is biochemically confirmed alcohol abstinence, measured thrice daily throughout the 8-
week study. Age and risky drinking will be determined based on self-report at the screening interview. Risky 
drinking will be defined using the AUDIT and AUD diagnosis will be confirmed by administering the DSM-5 
checklist.27  Research staff will also use this interview to assess for possible exclusionary cognitive or 
psychotic disorders using the MINI Neuropsychiatric Interview (M.I.N.I.). This variable will be analyzed as a 
repeated dichotomous variable.  

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If data are missing, missingness will be handled in a manner consistent with current expert recommendations, 
some of which have been established by our own team.20,22,24,38-43  Our approach emphasizes 1) either 
maximum likelihood or multiple imputations, and 2) extensive sensitivity analyses, including missing not at 
random approaches, to examine the robustness of treatment effects across varying assumptions. Maximum 
likelihood and multiple imputations have both shown exceptional performance compared to other, more 
common methods of handling missing data when the assumption of "missing at random" can be safely 
satisfied.39      
9.3.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
Secondary outcomes will include mobile usage, EMA bout completions, and self-reported alcohol use 
measured by the Timeline Follow Back 28  to assess the frequency and amount of daily drinking via multi-
modal EMA data collection by time, date and location. The Addiction Severity Index and quality of life in 
several domains (e.g., psychiatric, legal, medical) will be assessed at baseline.  
9.3.4 SAFETY ANALYSES 
Medical coding will use MedDRA for the concomitant diseases (Medical History) and AEs and the World 
Health Organization (WHO) Drug Dictionary for medications.  
Each AE will be counted once only for a given participant. The AEs expectedness, severity, frequency, and 
their relationship to the study intervention will be presented by System Organ Class (SOC) and preferred 
term groupings. Adverse events leading to premature discontinuation from the study intervention and serious 
treatment-emergent AEs will be presented either in a table or a listing. 
 
9.3.5 BASELINE DESCRIPTIVE STATISTICS 
We will initially run descriptive statistics across baseline variables to characterize the sample. All inferential 
results will be presented as point estimates with 95% confidence intervals, and we will use an alpha error 
rate of 0.05 as the threshold for statistical significance. Our approach is consistent with that of several similar 
RCTs involving tobacco smoking and alcohol use disorders.12,13,24,34-37   
 
9.3.6 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
N/A 
9.3.7 EXPLORATORY ANALYSES 
N/A 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 

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Human subjects research at WSU is coordinated through the WSU Institutional Review Board (IRB). The 
IRB is responsible for the review and approval of all research activities involving human subjects. The IRB 
is charged with protecting the rights and welfare of human subjects to ensure that all study participants are 
treated physically, psychologically, and socially in such a way as to minimize embarrassment and stress 
and to avoid harm or other negative effects. 
All Research staff will complete online training through the Collaborative Institutional Training Initiative 
(CITI) https://about.citiprogram.org/en/homepage/, a web-based training program on Human Research 
Subject protections, before starting the study training. 
All Research Coordinators and Research Associates will complete all the following before interacting with 
participants: 
Thoroughly read the protocol and guidelines on consenting and safety procedures found below. Research 
Coordinator should be knowledgeable on all procedures and safety procedures. This includes HIPAA 
training. Documentation of course completion will be included in the study file. 
Practice all study procedures & consenting with existing study personnel. All study staff should be able to 
answer frequent questions from participants. 
Shadow and watch an approved Research Coordinator complete an entire study visit: recruiting, 
consenting, and enrolling a participant. 
Receive approval by the Principal Investigator to conduct the consenting.  
 
 
10.1.1 INFORMED CONSENT PROCESS 
The process of obtaining informed consent is a basic ethical obligation and a required element of a human 
subject's research. The IRB will require that informed consent be documented using a written consent form 
approved by the IRB and signed and dated by the subject. The participant will be given ample time to read 
the consent document before it is signed. A copy of the document will be given to the person signing the 
form. 
The informed consent form will be presented to allow potential participants to review facts about the study 
and what will be asked of them so that they can voluntarily choose whether to participate as a research 
subject. 
Changes to the study protocol may result in the need for a new consent form. Only the current approved 
consent form will be used. The consent form document will have an IRB stamp of approval, version 
number, and date at the bottom of each page. 
Please note: Unless you have the PI’s authorization, do not conduct the consenting process. 
 
10.1.1.1 CONSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO PARTICIPANTS 

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Consent forms describing in detail the study procedures, and risks will be given to the participant and written 
documentation of informed consent will be completed before starting the study. The following consent 
materials are submitted with this protocol: 
1- Printed written consent form 
2- Web-based consent with an electronic signature 
3- HIPAA Authorization form 
   
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
The consenting process will be conducted consistently for every participant. 
If a participant is eligible, the iPad that was used for screening will display the consent form. The research 
assistant (RA) or research coordinator (RC) will explain that this document will explain the details of the 
study they are being asked to take part in. Allow the participant plenty of time to read. 
When the participant is done reading the consent, they will be asked if they have any questions about the 
study. If the answer to a question is not immediately obvious, the research coordinator or an investigator 
will be asked for their opinion, which must also be documented. The consent form will then be thoroughly 
reviewed to ensure that the participant understands what they are agreeing to. 
Eligibility for the study is determined by study procedures. Signing the consent does not ensure eligibility to 
participate. That said, it will be made clear to the prospective participant that participation will not impact 
their care. 
The key point to stress in the consenting process is that PARTICIPATION IS VOLUNTARY. Participants 
can choose not to consent to the study or discontinue at any time for any reason. They can choose not to 
answer any questions that make them feel uncomfortable.  
The RA/RC will show the participant where to type their name and date the consent form. The participant 
must date and place their signature or initials on consent. The RA/RC will give a paper copy of the consent 
to the participant for their records. 
Remember that consenting is an ongoing process. 
 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
This study may be suspended or prematurely terminated if there is sufficient reasonable cause. Written 
notification, documenting the reason for study suspension or termination, will be provided by the suspending, 
or terminating party to study participants, investigators, funding agencies, and regulatory authorities. If the 
study is prematurely terminated or suspended, the Principal Investigator (PI) will promptly inform study 
participants, the Institutional Review Board (IRB), and sponsor/funding agency and will provide the reason(s) 
for the termination or suspension. Study participants will be contacted, as applicable, and be informed of 
changes to the study visit schedule.  
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants. 
• 
Demonstration of efficacy that would warrant stopping. 
• 
Insufficient compliance with protocol requirements. 
• 
Data that are not sufficiently complete and/or evaluable. 
• 
The determination that the primary endpoint has been met. 
• 
Determination of futility. 

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The study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the funding agency, sponsor, IRB, or other relevant regulatory or oversight bodies. 
 
10.1.3 CONFIDENTIALITY AND PRIVACY  
The risk to patients from digital intervention is negligible. All data is collected in a HIPAA-complaint manner. 
Private identifiable information will be encrypted and kept secure. A research coordinator who has been 
trained in the proper performance of these duties will obtain informed consent.  
Study visits will be conducted in a manner to protect participant privacy. The consent process, administration 
of questionnaires, assessment and biologic sampling, medication dispensing, and CM draws will occur in a 
restricted area. To reduce the risk of unauthorized disclosure of confidential information all personal 
identifiers will be kept separate from participant files and a study-specific research identification number (key) 
will be assigned to each participant. Data will be collected, entered, and accessed by study personnel trained 
in issues of confidentiality related to human subject protection. The key will be kept separate and not in the 
same enclave component of the network. Data will be entered into a password-protected database that is 
encrypted and firewalled. All information provided by the participant will be kept private except in the case 
that this would immediately put the participant or someone else in danger. In that case, the Investigator would 
release information to keep the participant or another person safe. If the investigator learns about abuse to 
a child or an elder, that information must be reported to the proper authorities. 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
No specimens will be stored for this study. All paper records be shredded, physical tapes are erased, and 
physically destroyed, and electronic media be scrubbed after the files are deleted. (Entirely de-identified 
data where all links to individual identity including any information that could identify participants will be 
retained.) See: WSU BPPM 90.01 - https://policies.wsu.edu/prf/index/manuals/90-00-records/90-01-
research-sponsored-project-records/ 
All research materials (consent forms, surveys, digital) will be kept for a minimum of three years after 
completion of the study. See: WSU BPPM 90.01 - https://policies.wsu.edu/prf/index/manuals/90-00-
records/90-01-research-sponsored-project-records/ 
 
 
 
10.1.5 SAFETY OVERSIGHT 
The primary responsibility for monitoring the data and safety of the study will be with Dr. McPherson with the 
guidance and assistance of Mr. Johnson and Dr. McDonell. The study participants are at minimal risk from 
participation in the proposed research study. Comprehensive security measures will be deployed to protect 
participant data on the Managed Health Connections server and during transmission.  

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The participant database, web services and web applications will be hosted in a secure data center (PCI 
compliant and HIPAA compliant) in Austin, Texas. The data center physical building is under 24/7 video 
surveillance and is only accessible via two-factor authentication using both key cards and biometric sensors. 
The data center is connected directly to both the power grid and the fiber internet backbone. It is backed by 
diesel generators in case of power failure. All data on the server is continuously backed up to a centralized, 
hard drive-based storage system. The web site (dashboard) and web services API will be accessible from 
the Internet. All connections to the services will be encrypted with 256-bit SSL connection to maintain 
confidentiality. Except for the public web site and web service, the server is only accessible to authorized 
administrators via encrypted channels, such as VPN and SSH. Public and private access to the server is 
continuously monitored to detect any hacking or unauthorized access. When such attempts are detected, the 
system administrators are automatically alerted in real time. The databases will be password protected and 
only investigators and professionally trained and credentialed project staff on the study will have access to 
these files. Hard copies of signed consent forms and other study measures will be kept in a locked filing 
cabinet in a locked office accessible only to certified research staff. The master list that links participants’ 
names to subject identification numbers will be kept in a password-protected file only accessible by certified 
research staff. 
  
10.1.6 QUALITY ASSURANCE AND QUALITY CONTROL 
The clinical site will perform internal quality management of study conduct, data, and biological specimen 
collection, documentation, and completion. Quality control (QC) procedure will be implemented, and 
Inspection may be conducted by regulatory authorities at their discretion.  
10.1.7 DATA HANDLING AND RECORD KEEPING  
10.1.7.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Washington State University will oversee activities with the data management of this study. This includes 
setting up a relevant database and data transfer mechanism, along with the proper validation of data and 
resolution of queries.  
Study data will be collected directly at the study site into REDCap. Any data recorded directly on REDCap 
should be considered as a source document. Any changes in the data entered REDCap will be recorded 
and available for audit by the Food and Drug Administration (FDA) (CFR 21 part 11 compliant). Medical 
coding will use MedDRA for the concomitant diseases (Medical History) and AEs and the World Health 
Organization (WHO) Drug Dictionary for medications. Missing or inconsistent data will be queried within the 
REDCap system in writing to the Investigator for clarification. Any modification of the database will be 
documented. 
 
10.1.7.2 STUDY RECORDS RETENTION  
WSU's Business Policy & Procedures Manual requires that all research materials (consent forms, surveys, 
voice/video/digital/images, etc.) be kept for a minimum of three years after completion of the study. 
See: WSU BPPM 90.01 - https://policies.wsu.edu/prf/index/manuals/90-00-records/90-01-research-
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10.1.8 PROTOCOL DEVIATIONS   
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol, International 
Council on Harmonization Good Clinical Practice (ICH GCP). Noncompliance may be either on the part of 
the participant, the investigator, or the study site staff. As a result of deviations, corrective actions will be 
developed by the site and implemented promptly. 
 
These practices are consistent with ICH GCP:  
• 
Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3  
• 
Section 5.1 Quality Assurance (QA) and Quality Control, subsection 5.1.1  
• 
Section 5.20 Noncompliance, subsections 5.20.1, and 5.20.2.  
 
It will be the responsibility of the principal investigator to use continuous vigilance to identify and report 
deviations.  
 
At times, it may become clear to the researcher that acting in the best interest of a 
research participant will cause a deviation from an IRB approved protocol. The cause may be 
emergent (e.g. like present concerns involving the potential spread of a disease) or non-emergent 
(a chance occurrence). Potential issues that may be met in emergent situations include 
but are not limited to insufficient staff to conduct safely/effectively research or the research 
location becomes unsafe for the participants. Regardless of the cause, the IRB expectation is the same: 
always act (using your best judgment) to avoid unnecessary harm to research participants and staff. If 
doing so causes (or will cause) a deviation from the approved protocol, the following actions 
are recommended: 
1.  If deviation from the protocol is expected and became necessary and the investigators have time to 
submit an amendment to the IRB to address the expected deviation, they should do 
so. The IRB office will expedite the review of amendments intended to minimize (or 
decrease) risks to subjects. 
2.  If deviation from the protocol is expected but the investigators do not have time to submit  
the amendment, they should consider at least informing the IRB (phone or e-mail) that they anticipate 
they will need to deviate from the protocol. The IRB can provide guidance and 
document that notification was made in advance of the deviation and a reporting form 
can be submitted later (as soon as practicable). 
3. If a deviation is required to avoid harming a participant and there is insufficient time to 
either submit an amendment or inform the IRB via other means, the expectation of the 
IRB is that the investigator will report the deviation as soon as it is practicable. 
4.  If deviation is expected to repeat, the IRB office will work 
with them to determine the best approach (including potentially amending your protocol) 
to address these potential exceptions. 
5. Deviations from a protocol that are made, in good faith, solely for protecting research participants or 
others will rarely be considered non-compliance (e.g. only if the above guidance is not followed), these 
deviations will be classified as exceptions and the IRB office will collaborate with the PI to determine any 
future actions required to address the exception/deviation. 
 
To simplify this process, the IRB /HRPP (Human Research Protection Program) has implemented a new 
consolidated IRB reporting. The form that can be used to report any protocol related event including 

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deviations, exceptions, adverse events and UPIRSOs (unanticipated problems involving risks to subjects 
and others). This form can be used to report any type of event, even if you are unsure how to classify the 
event, simply describe the event and IRB staff will assist you in classifying and handling of the 
event. To access the reporting form, please go to http://irb.wsu.edu/forms.asp and select the "IRB 
Reporting Form". 
 
10.1.9 PUBLICATION AND DATA SHARING POLICY  
This study will be published under the National Institutes of Health (NIH) Public Access Policy, which ensures 
that the public has access to the published results of NIH funded research. It requires scientists to submit 
final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon 
acceptance for publication.  
All data collected for this research is the property of Managed Health Connection (MHC), which retains 
rights of access and ownership. https://policies.wsu.edu/prf/index/manuals/45-00-contents/45-35-
managing-research-records/ - “Ownership” Section. Washington State University (WSU) may retain a copy 
of the data, but can also use the data as prescribed by MHC. 
https://policies.wsu.edu/prf/index/manuals/60-00-personnel/60-74-employee-departure-procedures/ - 
“Facilities/Property” Section. 
10.1.10 
CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence, such as by Managed Health 
Connection, is critical. Therefore, any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed (e.g., WSU 
employed individuals). Persons who have a perceived conflict of interest will be required to have such 
conflicts managed in a way that is appropriate to their participation in the design and conduct of this trial. If 
the economic interest is a “significant economic interest” as defined in WSU’s Executive Policy #27, the 
management plan established with the Conflict of Interest Committee will be submitted.) See also: 
https://research.wsu.edu/resources-researchers/operations-support/coi  
 
 
 
 
 
 
 
 
 
 
 
 
 

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10.2 ABBREVIATIONS AND SPECIAL TERMS 
AE 
Adverse Event 
ASI 
Addiction Severity Index 
AUDIT 
Alcohol Use Disorders Identification Test 
BAC 
Blood Alcohol Concentration  
CFR 
Code of Federal Regulations 
CHAS 
Community Health Association of Spokane 
CLIA 
Clinical Laboratory Improvement Amendments 
CM 
Contingency Management  
COC 
Certificate of Confidentiality 
CONSORT 
Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DSMB 
Data Safety Monitoring Board 
DSM-5 
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition  
EMA 
Ecological momentary assessments  
eCRF 
Electronic Case Report Forms 
EMR 
Electronic Medical Record  
FDA 
Food and Drug Administration 
FFR 
Federal Financial Report 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
GWAS 
Genome-Wide Association Studies 
HIPAA 
Health Insurance Portability and Accountability Act  
HRPP 
Human Research Protection Program 
IB 
Investigator’s Brochure 
ICH 
International Council on Harmonization  
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 
iOS 
 iPhone Operating System  
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
ITT 
Intention-To-Treat 
LSMEANS 
Least-squares Means 
MedDRA 
Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
NIH IC 
NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 

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QC 
Quality Control 
RA 
Research assistant  
RC 
Research coordinator 
REDCap 
Research Electronic Data Capture  
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
UPIRSOs 
Unanticipated Problems involving risks to subjects and others 
US 
United States 
WA 
Washington State 
WHO 
World Health Organization  
WSU 
Washington State University  
 
 
 

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10.3 PROTOCOL AMENDMENT HISTORY 
The table below is intended to capture changes of IRB-approved versions of the protocol, including a 
description of the change and rationale. A Summary of Changes table for the current amendment is in the 
Protocol Title Page.  
Version 
Date 
Description of Change  
Brief Rationale 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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11 REFERENCES 
 
1. Stitzer ML, Bigelow GE, Liebson I. Reinforcement of drug abstinence: a behavioral approach to drug 
abuse treatment. NIDA Res Monogr. 1979(25):68-90. PMIDi: 117377. 
2. Higgins ST, Budney AJ, Bickel WK, Foerg FE, Donham R, Badger GJ. Incentives improve outcome in 
outpatient behavioral treatment of cocaine dependence. Arch Gen Psychiatry. 1994;51(7):568- 
576.PMID: 8031230. 
3. Higgins ST, Stitzer ML, Bigelow GE, Liebson IA. Contingent methadone delivery: effects on illicit opiate 
use. Drug Alcohol Depend. 1986;17(4):311-322.PMID: 3757767. 
4. Robles E, Stitzer ML, Strain EC, Bigelow GE, Silverman K. Voucher-based reinforcement of opiate 
abstinence during methadone detoxification. Drug Alcohol Depend. 2002;65(2):179-189.PMID: 
11772479. 
5. Budney AJ, Higgins ST, Radonovich KJ, Novy PL. Adding voucher-based incentives to coping skills and 
motivational enhancement improves outcomes during treatment for marijuana dependence. J Consult 
Clin Psychol. 2000;68(6):1051-1061.PMID: 11142539. 
6. Roll JM. Contingency management: an evidence-based component of methamphetamine use disorder 
treatments. Addiction. 2007;102 Suppl 1:114-120.PMID: 17493060. 
7. Dutra L, Stathopoulou G, Basden SL, et al. A meta-analytic review of psychosocial interventions for 
substance use disorders. The American journal of psychiatry. 2008;165(2):179-187.PMID: 18198270. 
8. McDonell MG, Angelo F, Sugar A, et al. A Pilot Study of the Accuracy of Onsite Immunoassay Urinalysis 
of Illicit Drug Use in Seriously mentally ill outpatients. Am J Drug Alcohol Abuse. Jan 11 2011.21219262. 
9. McDonell MG, Howell D, Srebnik D, et al. Monitoring alcohol abstinence using ethyl glucuronide urinalysis in 
alcohol-dependent outpatients with comorbid drug dependence and mental illness. In Press. 
10. National Institute on Alcohol Abuse and Alcoholism. Strategic Plan 2017-2021: National Institute on 
Alcohol Abuse and Alcoholism (NIAAA); 2017. 
11. McDonell MG, Leickly E, McPherson S, et al. A Randomized Controlled Trial of Ethyl Glucuronide-Based 
Contingency Management for Outpatients with Co-Occurring Alcohol Use Disorders and Serious Mental Illness. Am J 
Psychiatry. Apr 01, 2017;174(4):370-377.28135843. 
12. McDonell MG, Howell DN, McPherson S, et al. Voucher-based reinforcement for alcohol abstinence 
using the ethyl-glucuronide alcohol biomarker. J Appl Behav Anal. Spring 2012;45(1):161-165.22403460. 
13. Packer RR, Howell DN, McPherson S, Roll JM. Investigating reinforcer magnitude and reinforcer delay: a 
contingency management analog study. Exp Clin Psychopharmacol. Aug 2012;20(4):287- 
292.22686494. 
14. Roll JM, Howard JT. The relative contribution of economic valence to contingency management efficacy: A pilot 
study. Journal of applied behavior analysis. 2008;41(4):629-633. 
15. Cameron JM, Howell DN, White JR, Andrenyak DM, Layton ME, Roll JM. Variable and potentially fatal 
16. Shishani K. Physiological and subjective effects associated with nicotine-containing hookah smoking. Paper 
presented at National Conference on Tobacco or Health (August 15-17, 2012)2012.  
17. Petry NM, Peirce JM, Stitzer ML, 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. Oct 2005;62(10):1148-1156.16203960. 

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18. Roll JM, Petry NM, Stitzer ML, et al. Contingency management for the treatment of methamphetamine use 
disorders. Am J Psychiatry. Nov 2006;163(11):1993-1999.17074952. 
19. Peirce JM, Petry NM, Stitzer ML, et al. Effects of lower-cost incentives on stimulant abstinence in methadone 
maintenance treatment: A National Drug Abuse Treatment Clinical Trials Network study. Arch Gen Psychiatry. Feb 
2006;63(2):201-208.16461864. 
20. Roll JM, Chudzinski J, Cameron JM, Howell DN, McPherson S. Duration effects in contingency management 
treatment of methamphetamine disorders. Addict Behav. Sep 2013;38(9):2455- 2462.23708468. 
21. Roll JM, Higgins ST, Badger GJ. An experimental comparison of three different schedules of reinforcement of 
drug abstinence using cigarette smoking as an exemplar. J Appl Behav Anal. Winter 1996;29(4):495-504; quiz 504-
495.8995832. 
 22. McDonell MG, Srebnik D, Angelo F, et al. Randomized controlled trial of contingency management for stimulant 
use in community mental health patients with serious mental illness. Am J Psychiatry. Jan 1, 2013;170(1):94-
101.23138961. 
23. McPherson S, Brooks O, Barbosa-Leiker C, et al. Examining Longitudinal Stimulant Use and Treatment Attendance 
as Parallel Outcomes in Two Contingency Management Randomized Clinical Trials. J Subst Abuse Treat. Feb 2016; 
61:18-25.26456717. 
24. McPherson S, Packer RR, Cameron JM, Howell DN, Roll JM. The biochemical marker of use is a better predictor of 
outcomes than self-report metrics in a contingency management smoking cessation analog study. Am J Addict. Jan 
2014;23(1):15-20.24313236. 
 25. Packer RR, Howell DN, McPherson S, Roll JM. Investigating reinforcer magnitude and reinforcer delay: A 
contingency management analog study. Experimental and Clinical Psychopharmacology. Aug 2012;20(4):287-
292.22686494. 
 26. McDonell MG, Nepom JR, Leickly E, et al. A culturally tailored behavioral intervention trial for alcohol use 
disorders in three American Indian communities: Rationale, design, and methods. Contemp Clin Trials. Dec 16 
2015.26706667. 
 27. Sheehan DV, Lecrubier Y, Sheehan KH, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the 
development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 
1998;59 Suppl 20:22-33; quiz 34-57.9881538. 
28. Sobell LC, Sobell MB. Alcohol timelines follow-back (TLFB). In: Rush AJ, Pincus HA, First MB, Task Force for the 
Handbook of Psychiatric Measures, eds. Handbook of Psychiatric Measures. Washington DC: American Psychiatric 
Association; 2000:477-479.  
29. Preston NJ, Harrison TJ. The brief symptom inventory and the positive and negative syndrome scale: discriminate 
validity between a self-reported and observational measure of psychopathology. Compr Psychiatry. 2003;44(3):220-
226.PMID: 12764710. 
30. Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a 
revision of the Fagerstrom Tolerance Questionnaire. British journal of addiction. Sep 1991;86(9):1119-1127.PMID: 
1932883. 
31. Reinert DF, Allen JP. The alcohol use disorders identification test: an update of research findings. Alcohol Clin Exp 
Res. Feb 2007;31(2):185-199.17250609. 
32. Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders 
Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol 
Consumption--II. Addiction. Jun 1993;88(6):791-804.8329970.  

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33. Saunders JB, Aasland OG, Amundsen A, Grant M. Alcohol consumption and related problems among primary 
health care patients: WHO collaborative project on early detection of persons with harmful alcohol consumption--I. 
Addiction. Mar 1993;88(3):349-362.8461852. 
34. McDonell M, McPherson S, Vilardaga R, et al. Preliminary findings: Contingency management targeting psycho-
stimulant use results in secondary decreases in smoking for severely mentally ill adults. Am J Addict. Jul-Aug 
2014;23(4):407-410.2496136. 
 35. Litten RZ, Ryan ML, Fertig JB, et al. A double-blind, placebo-controlled trial assessing the efficacy of varenicline 
tartrate for alcohol dependence. J Addict Med. Jul-Aug 2013;7(4):277-286.23728065. 
 36. Winhusen TM, Brigham GS, Kropp F, et al. A randomized trial of concurrent smoking-cessation and substance 
use disorder treatment in stimulant-dependent smokers. J Clin Psychiatry. Apr 2014; 75(4):336-343.24345356. 
37. Winhusen TM, Adinoff B, Lewis DF, et al. A tale of two stimulants: mentholated cigarettes may play a role in 
cocaine, but not methamphetamine, dependence. Drug Alcohol Depend. Dec 15, 2013; 133(3):845- 851.24075226  
38. Graham JW. Missing data analysis: making it work in the real world. Annu Rev Psychol. 2009; 60:549- 
576.18652544.  
39. Enders CK. Applied Missing Data Analysis. New York: Guilford Press; 2010.  
40. Enders CK. Missing not at random models for latent growth curve analyses. Psychol Methods. Mar 2011;16(1):1-
16.21381816.  
41. McPherson S, Barbosa-Leiker C, McDonell M, Howell D, Roll J. Longitudinal missing data strategies for substance 
use clinical trials using generalized estimating equations: an example with a buprenorphine trial. Human 
psychopharmacology. Sep 2013;28(5):506-515.24014144. 
42. McPherson S, Barbosa-Leiker C, Burns GL, Howell D, Roll J. Missing data in substance abuse treatment research: 
Current methods and modern approaches. Experimental and Clinical Psychopharmacology. Jun 2012;20(3):243-
250.22329556 Contact PD/PI: Johnson, Ron Kimberly References Cited Page 67. 
43. McPherson S, Barbosa-Leiker C, Mamey MR, McDonell M, Enders CK, Roll J. A 'Missing Not at Random' (MNAR) 
and 'Missing at Random' (MAR) Growth Model Comparison with a Buprenorphine/Naloxone Clinical Trial. Addiction. 
Aug 29 2014.25170740.  
44. Murphy S, McDonell, M, McPherson S, Srebnik D, Angelo F, Roll J, Ries R. An economic evaluation of a 
contingency-management intervention for stimulant use among community mental health patients with serious 
mental illness. Drug and Alcohol Dependence May 2015; 153:293-299. 
 
 
 
 
 
 
 
 
 
 
 
 
 

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12 APPENDICES 
AUDIT 
Place an “X” in one box that best describes your answer to each question. 
Questions 
0 
1 
2 
3 
4 
1. How often do you have a 
drink containing alcohol? 
Never 
Monthly or less 
2-4 times a 
month 
2-3 times a 
week 
4 or more times a 
week 
2. How many drinks 
containing alcohol do you 
have on a typical day when 
you are drinking? 
1 or 2 
3 or 4 
5 or 6 
7 to 9 
10 or more 
3. How often do you have six 
more drinks on one occasion? 
Never 
Less than 
Monthly 
Monthly 
Weekly 
Daily or almost 
daily 
4. How often during the last 
year have you found that you 
were not able to stop drinking 
once you had started? 
Never 
Less than 
Monthly 
Monthly 
Weekly 
Daily or almost 
daily 
5. How often during the last 
year have you failed to do 
what was normally expected 
of you because of drinking? 
Never 
Less than 
Monthly 
Monthly 
Weekly 
Daily or 
almost daily 
6. How often during the last 
year have you needed a first 
drink in the morning to get 
yourself going after a heavy 
drinking session? 
Never 
Less than 
Monthly 
Monthly 
Weekly 
Daily or 
almost daily 
7. How often during the last 
year have you had a feeling of 
guilt or remorse after 
drinking? 
Never 
Less than 
Monthly 
Monthly 
Weekly 
Daily or 
almost daily 
 
8. How often during the last 
year have you been unable to 
remember what happened the 
night before because of your 
drinking? 
Never 
Less than 
Monthly 
Monthly 
Weekly 
Daily or 
almost daily 
9. Have you or someone else 
been injured because of your 
drinking? 
No 
 
Yes, but not 
during the last 
year 
 
Yes, during the 
last year 
10. Has a relative, friend, 
doctor, or other health care 
worker been concerned about 
your drinking or suggested 
you cut down? 
No 
 
Yes, but not 
during the last 
year 
 
Yes, during the 
last year 
 
Total: 
 

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Addiction Severity Index Lite - CF 
 
Revised- 06/02/99 DC/TRJ 
CONFIDENCE RATINGS:⇒ Last two items in each section. 
⇒ Do not over interpret. 
⇒ Denial does not warrant 
misrepresentation. 
⇒ Misrepresentation = overt contradiction in 
information. 
Probe and make plenty of comments! 
If a question asks the number of months, 
round up periods of 14 days or more to 1 
month. Round up 6 months or more to 1 
year. 
HALF TIME RULE: 
INTERVIEWER INSTRUCTIONS: 
1. Leave no blanks. 
2. Make plenty of Comments (if another person reads this ASI, they should 
have a relatively complete picture of the client's perceptions ofhis/her 
problems). 
3.X = Question not answered. 
N = Question not applicable. 
4.Terminate interview if client misrepresents two or more sections. 
5.When noting comments, please write the question number. 
6.Tutorial/clarification notes are preceded with "•". 
ALCOHOL/DRUG USE INSTRUCTIONS: 
The following questions look at two time periods: the past 30 days and lifetime. 
Lifetime refers to the time prior to the last 30 days. However if the client has been 
incarcerated for more than 1 year, you would only gather lifetime information, unless 
the client admits to significant alcohol /drug use during incarceration. This guideline 
only applies to the Alcohol/Drug Section. 
⇒30 day questions only require the number of days used. 
⇒Lifetime use is asked to determine extended periods of use. 
⇒Regular use = 3+ times per week, binges, or problematic irregular use 
in which normal activities are compromised. 
⇒Alcohol to intoxication does not necessarily mean "drunk", use the 
words felt the effects", “got a buzz”, “high”, etc. instead of intoxication. 
As a rule of thumb, 5+ drinks in one setting, or within a brief period of 
time defines “intoxication". 
⇒ “How to ask these questions: 
→ "How many days in the past 30 have you used....? 
→ "How many years in your life have you regularly used....?" 
LIST OF COMMONLY USED DRUGS: 
Alcohol: 
Beer, wine, liquor 
Methadone: 
Dolophine, LAAM 
Opiates: 
Pain killers = Morphine, Dilaudid, Demerol, 
Percocet, Darvon, Talwin, Codeine, Tylenol 2,3,4, 
Syrups = Robitussin, Fentanyl 
Barbiturates: 
Nembutal, Seconal, Tuinal, Amytal, Pentobarbital, 
Secobarbital, Phenobarbital, Fiorinal 
Sed/Hyp/Tranq: 
Benzodiazepines = Valium, Librium, Ativan, Serax 
Tranxene, Dalmane, Halcion, Xanax, Miltown, 
Other = Chloral Hydrate, Quaaludes 
Cocaine: 
Cocaine Crystal, Free-Base Cocaine or Crack, and 
"Rock Cocaine" 
Amphetamines: 
Monster, Crank, Benzedrine, Dexedrine, Ritalin, 
Preludin, Methamphetamine, Speed, Ice, Crystal 
Cannabis: 
Marijuana, Hashish 
Hallucinogens: 
LSD (Acid), Mescaline, Psilocybin (Mushrooms), 
Peyote, Green, PCP (Phencyclidine), Angel Dust, 
Ecstacy 
Inhalants: 
Nitrous Oxide (Whippits), Amyl Nitrite (Poppers), 
Glue, Solvents, Gasoline, Toluene, Etc. 
Just note if these are used: 
Antidepressants, 
Ulcer Meds = Zantac, Tagamet 
Asthma Meds = Ventolin Inhaler, Theodur 
INTRODUCING THE ASI: Seven potential problem areas: Medical, 
Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and 
Psychological. All clients receive this same standard interview. All 
information gathered is confidential. 
There are two time periods we will discuss: 
1. The past 30 days 
2. Lifetime Data 
Patient Rating Scale: Patient input is important. For each area, I will ask 
you to use this scale to let me know how bothered you have been by any 
problems in each section. I will also ask you how important treatment is for 
you for the area being discussed. 
The scale is: 
0 - Not at all 
1 - Slightly 
2 - Moderately 
3 - Considerably 
4 - Extremely 
If you are uncomfortable giving an answer, then don't answer. 
Please do not give inaccurate information! 
HOLLINGSHEAD CATEGORIES: 
1.Higher execs, major professionals, owners of large businesses. 
2.Business managers if medium sized businesses, lesser professions, i.e., 
nurses, opticians, pharmacists, social workers, teachers. 
3.Administrative personnel, managers, minor professionals, 
owners/proprietors of small businesses, i.e., bakery, car dealership, 
engraving business, plumbing business, florist, decorator, actor, reporter, 
travel agent. 
4. Clerical and sales, technicians, small businesses (bank teller, bookkeeper, 
clerk, draftsman, timekeeper, secretary). 
5. Skilled manual - usually having had training (baker, barber, brakeman, 
chef, electrician, fireman, lineman, machinist, mechanic, paperhanger, 
painter, repairman, tailor, welder, policeman, plumber). 
6. Semi-skilled (hospital aide, painter, bartender, bus driver, cutter, cook, 
drill press, garage guard, checker, waiter, spot welder, machine operator). 
7. Unskilled (attendant, janitor, construction helper, unspecified labor, 
porter, including unemployed). 
8. Homemaker. 
9. Student, disabled, no occupation. 
Thomas McLellan, Ph.D. 
John Cacciola, Ph.D. 
Deni Carise, Ph.D. 
Thomas H. Coyne, MSW 
Remember: This is an interview, not a test 
Item numbers circled are to be asked at follow-up. 
Items with an asterisk* are cumulative and should 
be rephrased at follow-up. 
Items in a double border gray box are questions for the 
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Brief Symptom Inventory (BSI) 
INSTRUCTIONS: Below is a list of problems and complaints that people sometimes have. 
Read each one carefully and select one of the numbered descriptors that best describes HOW 
MUCH DISCOMFORT THAT PROBLEM HAS CAUSED YOU DURING THE PAST 
MONTH INCLUDING TODAY. Write that number next to the question. Do not skip any 
item.  
Descriptors:  
0. Not at all 
1. A little bit 
2. Moderately  
3. Quite a bit  
4. Extremely  
HOW MUCH WERE YOU DISTRESSED BY:  
1. Nervousness or shakiness inside __________ 
2. Faintness or dizziness __________ 
3. The idea that someone else can control your thoughts __________  
4. Feeling others are to blame for most of your troubles __________ 
5. Trouble remembering things __________ 
6. Feeling easily annoyed or irritated __________ 
7. Pains in heart or chest __________ 
8. Feeling afraid in open spaces __________ 
9. Thoughts of ending your life __________ 
10. Feeling that most people cannot be trusted __________ 
11. Poor appetite __________ 
12. Suddenly scared for no reason __________ 
13. Temper outbursts that you could not control __________ 
14. Feeling lonely even when you are with people __________ 
15. Feeling blocked in getting things done __________ 
16. Feeling lonely __________ 
17. Feeling blue __________ 
18. Feeling no interest in things __________ 
19. Feeling fearful __________ 
20. Your feelings being easily hurt __________ 
21. Feeling that people are unfriendly or dislike you __________ 
22. Feeling inferior to others __________ 
23. Nausea or upset stomach __________ 
24. Feeling that you are watched or talked about by others __________  

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25. Trouble falling asleep __________ 
26. Having to check and double check what you do __________  
27. Difficulty making decisions __________  
28. Feeling afraid to travel on buses, subways, or trains __________ 
29. Trouble getting your breath __________ 
30. Hot or cold spells __________ 
31. Having to avoid certain things, places, or activities because they frighten you 
__________ 
32. Your mind going blank __________ 
33. Numbness or tingling in parts of your body __________ 
34. The idea that you should be punished for your sins __________  
35. Feeling hopeless about the future __________  
36. Trouble concentrating __________  
37. Feeling weak in parts of your body __________  
38. Feeling tense or keyed up __________  
39. Thoughts of death or dying __________  
40. Having urges to beat, injure, or harm someone __________  
41. Having urges to break or smash things __________  
42. Feeling very self-conscious with others __________  
43. Feeling uneasy in crowds __________  
44. Never feeling close to another person __________  
45. Spells of terror or panic __________  
46. Getting into frequent arguments __________  
47. Feeling nervous when you are left alone __________  
48. Others not giving you proper credit for your achievements __________ 
49. Feeling so restless you could not sit still __________  
50. Feelings of worthlessness __________ 
51. Feeling that people will take advantage of you if you let them __________  
52. Feelings of guilt __________ 
53. The idea that something is wrong with your mind __________  
 
 
 
 
 
 
 
 
 
 
 
 
 

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Personal Health Questionnaire Depression Scale (PHQ-9) 
How often during the past 2 weeks were you bothered by? 
Not at all 
Several 
days 
More 
than half 
the days 
Nearly every 
day 
1. Little interest or pleasure in doing things 
0 
1 
2 
3 
2. Feeling down, depressed, or hopeless 
0 
1 
2 
3 
3. Trouble falling or staying asleep, or sleeping too 
much 
0 
1 
2 
3 
4. Feeling tired or having little energy 
0 
1 
2 
3 
5. Poor appetite or overeating 
0 
1 
2 
3 
6. Feeling bad about yourself - or that you are a failure, 
or have let yourself or your family down 
0 
1 
2 
3 
7. Trouble concentrating on things, such as reading the 
newspaper or watching television 
0 
1 
2 
3 
8. Moving or speaking so slowly that other people 
could have noticed. Or the opposite – being so 
fidgety or restless that you have been moving 
around a lot more than usual 
0 
1 
2 
3 
9. Thoughts that you would be better off dead, or of 
hurting yourself 
0 
1 
2 
3 
 
Not difficult 
at all 
Somewhat 
difficult 
Very 
difficult 
Extremely 
difficult 
10. If you checked off any problems, how difficult these 
problems made it for you to do your work, take care 
of things at home, or get along with other people? 
  
0 
1 
2 
3 

 
NIH Behavioral and Social Intervention Clinical Trial Protocol Template v3.0 - 20180827 
 
 
Alcohol Urge Questionnaire 
Listed below are questions that ask about your feelings about drinking. The words "drinking" and 
"have a drink" refer to having a drink containing alcohol such as beer, wine, or liquor. Please indicate 
how much you agree or disagree with each of the following statements by selecting one number for 
each question between STRONGLY DISAGREE and STRONGLY AGREE. The closer you select a 
number to one end or the other indicates the strength of your disagreement or agreement. Please 
complete every item. We are interested in how you are thinking or feeling right now as you are filling 
out the questionnaire. 
RIGHT NOW 
1. All I want to do now is have a drink. 
STRONGLY   1[]           2[ ]           3 [ ]           4 [ ]            5 [ ]            6 [ ]           7 [ ]  STRONGLY DISAGREE                   
AGREE 
2. I do not need to have a drink now. 
STRONGLY   1[]           2[ ]           3 [ ]           4 [ ]            5 [ ]            6 [ ]           7 [ ]  STRONGLY DISAGREE                   
AGREE 
3. It would be difficult to turn down a drink this minute. 
STRONGLY   1[]           2[ ]           3 [ ]           4 [ ]            5 [ ]            6 [ ]           7 [ ]  STRONGLY DISAGREE                   
AGREE 
4. Having a drink now would make things seem just perfect. 
STRONGLY   1[]           2[ ]           3 [ ]           4 [ ]            5 [ ]            6 [ ]           7 [ ]  STRONGLY DISAGREE                   
AGREE 
5. I want a drink so bad I can almost taste it. 
STRONGLY   1[ ]           2[ ]           3 [ ]           4 [ ]            5 [ ]            6 [ ]           7 [ ]  STRONGLY DISAGREE                  
AGREE 
6. Nothing would be better than having a drink right now. 
STRONGLY   1[ ]           2[ ]           3 [ ]           4 [ ]            5 [ ]            6 [ ]           7 [ ]  STRONGLY DISAGREE                  
AGREE 
7. If I had the chance to have a drink, I don’t think I would drink it. 

 
NIH Behavioral and Social Intervention Clinical Trial Protocol Template v3.0 - 20180827 
 
STRONGLY   1[ ]           2[ ]           3 [ ]           4 [ ]            5 [ ]            6 [ ]           7 [ ]  STRONGLY DISAGREE                  
AGREE 
8. I crave a drink right now. 
STRONGLY   1[ ]           2[ ]           3 [ ]           4 [ ]            5 [ ]            6 [ ]           7 [ ]  STRONGLY DISAGREE                  
AGREE 
Scoring Procedure and Interpretation 
Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 
are reverse scored. A total score is computed by averaging the item scores. Higher scores reflect 
greater craving. 
 

 
NIH Behavioral and Social Intervention Clinical Trial Protocol Template v3.0 - 20180827 
 

 Automated Reinforcement Management System (ARMS) 
 
                                                                                                                                                                               Version 0.1 
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 Automated Reinforcement Management System (ARMS) 
 
                                                                                                                                                                               Version 0.1 
Protocol 01 
 
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NIH Behavioral and Social Intervention Clinical Trial Protocol Template v3.0 - 20180827 
 
 
2 
Name/ID#:  
 
 
Date:  
 
TIMELINE FOLLOWBACK CALENDAR: 2020 
 
 
 
 
 
 
 
 
 
 
 
2020 
SUN 
MON 
TUES 
WED 
THURS 
FRI 
SAT 
 
 
 
 
1 New Year’s 
Day 
2 
3 
4 
J 
5 
6 
7 
8 
9 
10 
11 
A 
12 
13 
14 
15 
16 
17 
18 
N 
19 
20 M. King Day 
21 
22 
23 
24 
25 
 
26 
27 
28 
29 
30 
31 
1 
F 
2 
3 
4 
5 
6 
7 
8 
E 
9 
10 
11 
12 
13  
14 Valentine 
15 
B 
16 
17 Pres. Day 
18 
19 
20 
21 
22 
 
23 
24 
25 
26 
27 
28 
29 
M 
1 
2 
3 
4 
5 
6 
7 
A 
8 
9 
10 
11 
12 
13 
14 
R 
15  
16 
17 St. Patrick 
18 
19 
20  
21 
 
22 
23 
24 
25 
26 
27 
28 
 
29 
30 
31 
1 
2 
3 
4 
A 
5 
6 
7 
8 
9 
10 Good Friday 
11 
P 
12 Easter 
13 
14 
15 
16 
17 
18 
R 
19 
20 
21 
22 
23 
24 
25 
 
26 
27 
28 
29 
30 
1 
2 
M 
3 
4 
5 
6 
7 
8 
9 
A 
10 Mother’s Day 
11 
12 
13 
14 
15 
16 
Y 
17 
18  
19 
20 
21 
22 
23 
 
24 
25 Memorial Day 26 
27 
28 
29 
30 
31 
 
 
 
 
 
 
One 5 oz glass 
of regular (12%) 
1 ½ oz of hard liquor 
(e.g. rum, vodka, 
1 mixed or straight 
drink with 1 ½ oz 
hard liquor  
1 Standard Drink is Equal to 
One 12 oz 
can/bottle 
Complete the Following 
Start Date (Day 1):   
 
 
 
   End Date (yesterday): 
 
 
 

 Automated Reinforcement Management System (ARMS) 
 
                                                                                                                                                                               Version 0.1 
Protocol 01 
 
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3 
 
2020 
SUN 
MON 
TUES 
WED 
THURS 
FRI 
SAT 
J 
 
1 
2 
3 
4 
5 
6 
U 
7 
8 
9 
10 
11 
12 
13 
N 
14  
15 
16 
17 
18 
19 
20 
 
21 Father’s Day 22 
23 
24 
25 
26 
27 
 
28 
29 
30 
1 
2  
3 
4 
Independence 
Day 
J 
5 
6 
7 
8 
9 
10 
11 
U 
12  
13 
14 
15 
16 
17 
18 
L 
19 
20  
21 
22 
23 
24 
25 
 
26 
27 
28 
29 
30 
31 
1 
A 
2 
3 
4 
5 
6 
7 
8 
U 
9 
10 
11 
12 
13 
14 
15 
G 
16  
17 
18 
19 
20 
21 
22 
 
23 
24 
25 
26 
27 
28 
29 
S 
30 
31  
1 
2 
3 
4 
5 
E 
6 
7 Labor Day 
8 
9 
10 
11 
12 
P 
13 
14 
15 
16 
17 
18 
19 
 
20 
21 
22 
23 
24 
25 
26 
 
27 
28 
29 
30 
1 
2 
3 
O 
4 
5 
6 
7 
8 
9 
10 
C 
11 
12 Columbus 
Day 
13 
14 
15 
16 
17 
T 
18 
19 
20 
21 
22 
23 
24 
 
25 
26 
27 
28 
29  
30 
31 Halloween 
N 
1 
2 
3 Election Day 
4 
5 
6 
7 
O 
8 
9  
10 
11
Veterans Day 
12 
13 
14 
V 
15 
16 
17 
18 
19 
20 
21 
 
22 
23 
24 
25 
26 
Thanksgiving 
27 
28 
 
 

 Automated Reinforcement Management System (ARMS) 
 
                                                                                                                                                                               Version 0.1 
Protocol 01 
 
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4 
D 
29 
30 
1 
2 
3 
4 
5 
E 
6 
7 
8 
9 
10 
11 
12 
C 
13 
14 
15 
16 
17 
18 
19 
 
20 
21 
22 
23  
24 
25 Christmas 
26 
 
27 
28 
29 
30 
31 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 Automated Reinforcement Management System (ARMS) 
 
                                                                                                                                                                               Version 0.1 
Protocol 01 
 
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5 
Unified Theory of Acceptance and Use of Technology (UTAUT) 
 
 
Strongly 
Disagree 
- 
Strongly 
Agree 
 
Question 
1 
2 
3 
4 
5 
6 
7 
1 
I find the system useful for the course. 
 
 
 
 
 
 
 
2 
Using the system will enable me to accomplish 
tasks more quickly. 
 
 
 
 
 
 
 
3 
Using the system will increase my productivity. 
 
 
 
 
 
 
 
4 
If I use the system, I will increase my chances of 
getting a raise. 
 
 
 
 
 
 
 
5 
My interaction with the system will be clear and 
understandable. 
 
 
 
 
 
 
 
6 
It will be easy for me to become skilful at using the 
system. 
 
 
 
 
 
 
 
7 
I find the system easy to use. 
 
 
 
 
 
 
 
8 
Learning to operate the system is easy for me. 
 
 
 
 
 
 
 
9 
Using the system is a good idea. 
 
 
 
 
 
 
 
10 
The system will make work more interesting. 
 
 
 
 
 
 
 
11 
Working with the system is fun. 
 
 
 
 
 
 
 
12 
I like working with the system. 
 
 
 
 
 
 
 
13 
 
People who are important to me think that I should 
use the system. 
 
 
 
 
 
 
 
14 
People who influence my behaviour think that I 
should use the system. 
 
 
 
 
 
 
 
15 
The Doctor has been helpful in the use of the 
system. 
 
 
 
 
 
 
 
 
16 
 
In general, the organization has supported the use 
of the system. 
 
 
 
 
 
 
 
17 
 
I have the resources necessary to use the system. 
 
 
 
 
 
 
 
18 
 
The system is not compatible with other systems I 
use. 
 
 
 
 
 
 
 
19 
 
I have the knowledge necessary to use the 
system. 
 
 
 
 
 
 
 
20 
A specific person (or group) is available for 
assistance with system difficulties. 
 
 
 
 
 
 
 
21 
 
I could complete a job or task using the system... 
 
 
 
 
 
 
 

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21.a 
 
If there was no one around to tell me what to do 
as I go. 
 
 
 
 
 
 
 
21.b 
 
If I could call someone for help if I got stuck. 
 
 
 
 
 
 
 
21.c If I had a lot of time to complete the job for which 
the software was provided. 
 
 
 
 
 
 
 
21.d 
 
If I had just the built-in help facility or assistance. 
 
 
 
 
 
 
 
22 
I hesitate to use the system for fear of making 
mistakes I cannot correct. 
 
 
 
 
 
 
 
23 
It scares me to think that I could lose a lot of 
information using the system by hitting the wrong 
key. 
 
 
 
 
 
 
 
24 
 
I feel apprehensive (anxious) about using the 
system. 
 
 
 
 
 
 
 
25 
 
The system is somewhat intimidating to me. 
 
 
 
 
 
 
 
26 
 
I plan to use the system in the next <n> months. 
 
 
 
 
 
 
 
27 
 
I predict I would use the system in the next <n> 
months. 
 
 
 
 
 
 
 
28 
 
I have used the system a lot in the past 4 weeks. 
 
 
 
 
 
 
 
29 
 
I have been using the system regularly in the past 
4 weeks. 
 
 
 
 
 
 
 
 
 
 
 
Phone Screening Script: 
 
Research  staff will call potential participants and will greet and present themselves to 
participants. When appropriate in the conversation, they will use the following script: 
 
“We have a research Study that is testing the usefulness of an application based psychosocial 
treatment called Contingency Management that uses a mobile application to see if it can 
improve alcohol secession treatment response by reducing the days of heavy alcohol use. This 
intervention involves sending remote alcohol breathalyzers samples (via mobile phone) and 
getting paid if samples have alcohol levels below (Blood Alcohol Concentration ‘’BAC’’) 0.08. 
The study is titled: “Automated Contingency Management System for Reduction of 
Alcohol Use. The National Institute on Alcohol Abuse and Alcoholism funded this study, 
and the Washington State University Institutional Review Board has approved it. The study 
looks at the ability of this  technology to help individuals to reduce the number of days of heavy 
alcohol use for eight weeks.  If you are interested and qualify, we will set a 2 hours in-person 
interview in a date and time that is convenient for you. People who take part will receive up to 
$536.75 for 8 weeks of participation  to compensate for their time.  
Would you be interested in answering a few questions to see if you qualify  for the study? 
➔ If no “Thank you so much for your time, have a wonderful day” 
 

 Automated Reinforcement Management System (ARMS) 
 
                                                                                                                                                                               Version 0.1 
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➔ If yes “Great! Do you have time now to go over the screening questions”? 
 
➔ If no “Can I call you another time?” 
Write the number here: _____________________________ 
 
➔ If yes (Handoff to the research recruiting team) 
 Great! Now I am going to ask you the screening questions. Some of the questions might be 
sensitive in nature because they are about your current alcohol use behavior. We ask that you be 
as honest and accurate as possible. You do not have to answer any question that you do not wish 
to answer. However, if you choose not to answer some questions, you may not be eligible to take 
part in the study, because your answers are needed to determine if you are a match.   
 
SD1. How old are you? ________________ years 
If under 18 or older than 65 years → ineligible, stop screening 
SD2. Do you know how to use  a smartphone ? 
If no→ ineligible, stop screening 
If yes→ Do have an iPhone? 
If yes→ is your iPhone an iPhone 7 or newer version with an iOS 13.5?  
If no→ If you do not have an iPhone 7 or newer, we can loan you one if you know how to 
use it, but it must be returned at the end of the study. Upon completion of or withdrawal from the 
study AND return of the phone you will receive a $50 Amazon gift card. 
If yes→ Do you have an active and consistent service provider? 
If no→  ineligible, stop screening  
 
SD3.What is your gender? 
 
(0) 
Female 
 
 
(1) 
Male 
 
(2)       Non-binary 
SD4. What is your race?  
 
(0) 
African American 
 
(1) 
Asian 
 
(2) 
Caucasian 
 
(3) 
American Indian or Alaska Native 
 
(4) 
Native Hawaiian or Other Pacific Islander 
 
(5) 
Multiple 
SD3m. Specify: _____________________________________________________ 
 
(6) 
Other 
SD3o. Specify: _____________________________________________________ 
 
SD5. Are you of Hispanic origin? 
 
(0) 
No 
 
(1) 
Yes 
 
SD6. What is your current employment status? Circle all that apply 
 
 
(0) 
Fulltime (36 hours or more) 
 
 
(1) 
Part-time 
 
 
(2) 
Homemaker 
 
 
(3) 
Student 
 
 
(4) 
Disabled 
 
 
(5) 
Unemployed 

 Automated Reinforcement Management System (ARMS) 
 
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SD7. What is your marital status? 
 
 
(0) 
Single 
 
 
(1) 
Married or cohabitating with a partner 
 
 
(2) 
Divorced or separated 
 
 
(3) 
Widowed 
 
SD8. How often do you drink alcohol beverages in a month? 
If less than 5→ ineligible, stop screening 
 
SD9. How many drinks containing alcohol do you have in a typical day when you are drinking?  
If less than 3 → ineligible, stop screening 
 
SD10. In the last 12 months, did you have seizure due to alcohol withdrawal?  
If yes→ ineligible, stop screening 
SD11. Can you read in English?  
If no→ ineligible, stop screening 
 
 
➔ If not eligible “I am sorry but based on your answers, you are not currently a good match 
for our study. However, we appreciate your interest in our study and thank you for taking 
the time to answer our questions.” 
 
➔ If eligible “Great thank you, it looks like you may be a good match for the study.”  
 
If you are interested in taking part in this study would it be ok for us to set an appointment next 
week? 
- 
Schedule appointment. 
Ok great I will see you then. Thank you again for your interest in our study! 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Individual Exit Interview ARMS Phase I study  
 
 
1. What are your general thoughts about the application?  
a) Was it easy?  
b) Was there anything frustrating about it? 
 
2. What are your general thoughts about the BACTrack device?  
                   a) Was it easy?  
             b) Was there anything frustrating about it? 
 
 
3. Which features of the application did you use most? Why? 
 
4. Prompt for response to “Record BAC” 
 
5. Prompt for response to “Snooze function” 
 
6. Prompt for feelings about EMA questionnaire response ease of use, frequency 
 
7. Prompt for “Rewards” 
 
8. Prompt for “Reports” 
 
9. Prompt for “Daily messaging” 
 
10. Was there anything else that would have helped you? 
 
11. Do you think the application helped you understand or manage your alcohol use? 
 
12. What would you absolutely change about the application? 
 
13. Would you recommend the application to others trying to manage their alcohol use? 
Why or why not? 
 
 
 

 Automated Reinforcement Management System (ARMS) 
 
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10 
 
 
 
 
 
Karolinska Sleepiness Scale (KSS). How sleepy are you? 
Rate  
Verbal Descriptions 
1 
Extremely alert  
2 
Very alert  
3 
Alert  
4 
Fairly alert  
5 
Neither alert nor sleepy  
6 
Some signs of sleepiness  
7 
Sleepy, but no effort to keep awake 
8 
Sleepy, some effort to keep awake  
9 
Very sleepy, great effort to keep awake, fighting sleep 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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11 
 
WASHINGTON STATE UNIVERSITY 
Elson S. Floyd College of Medicine,  
Program of Excellence in Addictions Research/Analytics and PsychoPharmacology 
Laboratory 
 
 
 
Research Study Consent Form 
 
Study Title: 
Automated Reinforcement Management System (ARMS): Phase I 
study 
Researchers: 
Sterling McPherson, Ph.D., Associate Professor, and Director, Washington State 
University Elson S. Floyd College of Medicine, (509-324-7459), Principal 
Investigator. 
Michael G. McDonell, Ph.D., Associate Professor, Washington State University Elson S. 
Floyd College of Medicine, (509-324-7444), Co-Investigator. 
Crystal Lederhos Smith, Ph.D., Assistant Research Professor, and Research 
Supervisor, Washington State University Elson S. Floyd College of Medicine, 
(509-324-7235), Co-Investigator.  
Ron Kim Johnson, General Manager/COO, Managed Health Connections, (512) 657-
0675, Co-Investigator. 
André Miguel, Ph.D., Assistant Research Professor, Elson S. Floyd College of 
Medicine, Program of Excellence in Addictions Research, (509-368-6896), Co-
Investigator. 
Paul Kamate, M.D., Clinical Research Coordinator/Scientific Assistant, Washington 
State University Elson S. Floyd College of Medicine, 509-368-6928, Co-
Investigator. 
 
 
 
Sponsor:  
NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM 
 
What you should know:  
You are being asked to take part in a research study conducted by Dr. Sterling 
McPherson. This form explains the research study and your part in it if you decide to 
join the study. Please read the form carefully. Take as much time as you need. Ask the 
researcher to explain anything you do not understand. Your participation in the study is 

 Automated Reinforcement Management System (ARMS) 
 
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12 
 
voluntary. You can decide not to join the study. If you join the study, you can change 
your mind later or quit at any time. You may refuse any question, test, or procedure. 
There will be no penalty or loss of services or benefits if you decide to not take part in 
the study or quit later. This study has been approved for human subject participation by 
the Washington State University Institutional Review Board. 
 
What is the purpose of this study? 
The purpose of this study is to evaluate the effectiveness of a phone application when 
paired with a behavioral method in increasing alcohol abstinence. This behavioral 
approach, known as contingency management, means that a person is rewarded for not 
using alcohol or reducing their alcohol use. In this study, we will ask you to provide urine 
and breath samples at study visits to assess whether you are drinking. The breath 
sample measures recent alcohol use. We will ask you to fill out questionnaires during 
the study.  
 
You are being asked to take part because during our screening interview you indicated 
that you are between 18 and 65 years old, you regularly drink 3 or more drinks at least 4 
times a week. 
 
If you decide to take part. There will be an initial visit called a baseline interview after 
filling out this consent form. We will ask you to provide urine and breath samples to 
assess your drinking status and fill out questionnaires.  
 
You cannot be in this study if you are under 18 years old or over 65 years old. You also 
cannot be in the study if you are pregnant or trying to get pregnant. You cannot be in 
this study if you have attempted suicide in the past or you were suicidal in the past 12 
months. Also, you cannot be in the study if you have a psychotic disorder or severe 
alcohol use disorder, or if the researchers determine that your safety may be in danger.  
 
What will I be asked to do if I am in this study? 
If you take part in the study, you will be asked to do the following:  
• Complete the baseline interview after you fill out this consent form. This will take 
about 2 hours. You will be asked to fill out questionnaires and to provide urine, 
and breath samples. A urine test, ethyl glucuronide (EtG), will be used to detect 
the presence of alcohol. We will ask that you supply about half a cup of urine into 
a cup. The sample will be labeled with a unique study ID number to protect your 
privacy and we will evaluate your urine at our lab. Providing samples is a 
condition of taking part in the study.  
You will be asked to sign a release of health information that allows us to get 
information about your substance use. The locations of frequently used 
resources, and your physical and mental health. You will be asked to fill out 
questionnaires about your alcohol, tobacco, and drug use. 
You will be provided with instruction on the phone application and how to use the 
breathalyzer. The application works only on iPhone 7 or newer version with an 

 Automated Reinforcement Management System (ARMS) 
 
                                                                                                                                                                               Version 0.1 
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(iPhone Operating System) iOS 13.5. If you do not have an iPhone 7 or newer 
version, we can loan you one if you know how to use it, but it must be returned at 
the end of the study.  
You will receive a $30.00 Amazon electronic gift card for completing this visit.  
After the baseline interview, you will be asked to log into the phone application 
every 4-6 hours and provide a breath sample via the BACtrack breathalyzer. This 
takes 2 to 3 minutes each time.  
 
• Complete 2 weeks of introduction period. You will be asked to provide 3 breath 
samples a day, 4-6 hours apart via your BACtrack breathalyzer, and the phone 
application. You will receive $2.00 for each sample submitted, regardless of what 
if that sample is positive or not, for a total of $6.00 a day.  
 
• Complete 4 weeks of the contingency management period. You will be asked to 
submit 3 samples a day, 4-6 hours apart. You will be rewarded for submitting 
negative samples (a breathalyzer of 0.00). You will begin at $2.00, but rewards 
will escalate by $0.25 per alcohol negative breath sample submission until a 
maximum value of $3.50 per sample is reached. 
o If you submit a positive sample your rewards will reset back to $2.00. 
 
• Complete the 2 weeks follow up phase. You will be asked to provide 3 breath 
samples a day, 4-6 hours apart via your BACtrack breathalyzer, and the phone 
application. You will receive $2.00 for each sample submitted, regardless of if it is 
positive or not, for a total of $6.00 a day.  
 
• At the end of the 8 weeks. You will be asked to fill out a questionnaire and to 
return the study phone. This will take 2 to 3 minutes. Upon completion of or 
withdrawal from the study and return of the iPhone, you will receive a $50 
Amazon electronic gift card.  
 
• Supplying samples is a condition of participating in the study. At any time, you 
may decide not to provide samples, however, this may result in you not receiving 
the full amount of rewards. 
 
• We will call you weekly to fill out a survey about your alcohol, tobacco, and 
cannabis use and your sleepiness.  
 
• Follow study safety procedures. For safety purposes, we ask that you do not 
attempt to drive to your appointment if you are intoxicated or under the influence. 
If you provide a breath sample greater than .08, or team members observe overt 
behaviors of intoxication, you will be asked to remain in our laboratory or office 
until your blood alcohol level returns to below legal limit. If your blood alcohol 
level is above the legal limit one hour before our office closes you will be asked 
to either call a friend or family member or a cab to pick you up. No funds are 
allocated for transportation while you are intoxicated. If you are experiencing 

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symptoms of alcohol withdrawal, you may be asked to be evaluated by a medical 
professional or by the research team, Dr. McDonell. These procedures are to 
make sure that you and others are safe. Should a medical emergency occur at a 
study visit, Dr. McDonell (509-324-7444), will be contacted to assess medical 
treatment needs. The study team may call 911. Dr. McDonell may also be 
contacted about medical referral information. There are no funds allotted for 
compensation for study-related injuries. There are no funds for transportation, but 
you are provided with free parking.  
 
• The total time of this study is estimated to be 09 hours 30 minutes spread out 
over 8 weeks of participation.  
• You are not waiving any legal rights by consenting to take part in this study. 
 
Are there any benefits to me if I am in this study? 
The potential benefits to you for taking part in this study are that you may decrease or 
stop using alcohol. If you take part in this study, you may help others in the future. It is 
hoped that the results from this study will help develop effective treatment strategies for 
alcohol use disorders.  
 
Are there any risks to me if I am in this study? 
The following are some potential risks that may occur because of taking part in this 
study and explanations of how we have tried to minimize these risks.  
 
• You may continue to use alcohol. This study may not help you stop drinking. We 
provide referrals to other treatment providers. 
 
• There is a small risk that the information you provide to the study will be seen by 
someone who is not allowed to see it. We will try to lower this risk by assigning 
all data you provide with a unique identifier.  
 
• There is a small risk that you may encounter another study participant in the clinic 
which would result in a loss of your confidentiality. We will attempt to schedule 
participants at times that would prevent this from occurring.  
 
• You may be asked some questions about your habits and history that make you 
feel uncomfortable. Likewise, you may feel uncomfortable providing urine or 
breath samples. We selected questionnaires and sample collection procedures 
that are like those that you might encounter if you went to a medical or treatment 
facility.  
 
• You may experience alcohol withdrawal symptoms if your drinking decreases 
during the study. Examples of withdrawal symptoms are feeling like you need 
another drink to make you feel better. Delirium Tremens, shakes, and other 
physiological symptoms. We will try to lower this risk by evaluating the withdrawal 

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symptoms at every study contact. If you score higher than 10 points on our 
withdrawal scale you will be evaluated by Dr. McDonell. 
 
Researchers will contact 911 or Dr. McDonell should a medical issue arise during 
any study visit or study contact, depending on the severity of the reported issue. 
If a serious medical issue should arise outside of your visits, you should contact 
911 immediately. There is no compensation being offered through this 
investigation should a medical emergency occur while being part of this study. 
There will be no cost for you for Dr. McDonell’s services.  
 
• We will follow Washington State University guidelines to decrease your chance of 
exposure to the 2019 coronavirus disease (COVID-19). We will ask you to keep 
6 feet apart and wear masks. 
 
Will my information be kept private? 
Yes. The data for this study will be kept confidential to the extent allowed by law. You 
will be assigned a unique identification number. This number is stored separately from 
your personal information. All recorded data will be kept in a locked file cabinet in a 
locked research office that is only accessible by members of the research team. Only 
research team members will have access to the study database storing participants’ 
information, which is saved on a firewall-protected computer. The computer is under 
password protection. The results of this study may be published or presented at 
professional meetings, but the identities of all research participants will remain 
anonymous. The data for this study will be kept for 3 years. 
 
If keeping any information private would immediately put you or someone else in 
danger. The investigators would release that information to keep you or another person 
safe. If investigators learn about abuse to a child or an elder, we will report that 
information to the proper authorities. Also, if the safety procedures described in this 
consent form are not followed, campus security or local police may be notified. 
 
Are there any costs or payments for being in this study? 
There are no costs to you for taking part in this study. There are free parking spots 
outside of the facility for study visits. The payment for study participation is based on 
rewards. If you choose to take part. You will be eligible to receive a $30 Amazon 
electronic gift card for completing the baseline.  
You will receive a total of $168.00 during the first 2 weeks of the introduction period and 
the last 2 weeks of the follow-up period. The payment will be $42.00 weekly.  
 
During the 4 weeks of the contingency management period. You will begin by receiving 
$2.00 per alcohol negative breath sample submitted. This will be escalating by $0.25 
per alcohol negative breath sample submission until a maximum value of $3.50 per 
sample is reached. For instance: 
Day1, sample1 ($2.00), sample2 ($2.25), sample3 ($2.50) 
Day2, sample1 ($2.75), sample2 ($3.00), sample3 ($3.25) 

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Day2, sample1 ($3.50), sample2 ($3.75), sample3 ($3.75) 
Once this value is reached based on negative breath sample submissions. You will 
continue to receive $3.50 per alcohol-negative breath sample submission. If you 
submitted an alcohol positive breath sample. You will be reset to $2.00 per sample and 
you will need to work up to receive $3.50 per sample again. If you submitted all negative 
samples during this period. You will receive a total of $288.75. This will be paid weekly 
($68.25 the first week, and then $73.5/week the second, third, and fourth week). 
A final onetime payment of $50.00 Amazon electronic gift card will be given to you upon 
return of study iPhone. 
During the 8 weeks study, if you submitted all negative samples and returned the study 
phone, you will receive a total of $536.75.  
 
If you decide to quit the study, you will not receive any payment beyond any rewards 
already earned for any completed study visits. 
 
Who can I talk to if I have questions? 
If you have questions about this study or the information in this form. Please contact the 
researcher, Dr. Sterling McPherson at 412 East Spokane Falls Blvd, WA 99202-2131; 
509-324-7459; sterling.mcpherson@wsu.edu. 
If you have questions about your rights as a research participant or would like to report 
a concern or complaint about this study. Please contact the Washington State 
University Institutional Review Board at (509) 335-7646, or e-mail irb@wsu.edu, or 
regular mail at Neill 427, PO Box 643143, Pullman, WA 99164-3143. 
 
What if I have a study-related injury or want to withdraw? 
If you have a study-related injury, illness, distress, or want to withdraw please contact 
Dr. Sterling McPherson. 
 
What are my rights as a research study volunteer? 
Your participation in this research study is completely voluntary. You may choose not to 
be a part of this study. There will be no penalty to you if you choose not to take part. 
You may choose not to answer specific questions or to stop taking part at any time. You 
will be given a copy of the consent form for your records. 
 
What does my signature on this consent form mean? 
Your signature on this form means that: 
• You understand the information given to you in this form 
• You have been able to ask the researcher questions and state any concerns 
• The researcher has responded to your questions and concerns 
• You believe you understand the research study and the potential benefits and 
risks that are involved. 
• You are giving your voluntary consent to take part in the study. 
 

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Statement of Consent   
 
Yes,  
I agree 
No,  
I disagree  
 
 
 
This is the proof of my “intent” to sign the consent document to 
take part in this research. 
 
 
Your signature documents your permission to take part in this research. You will be 
provided a copy of this signed document. 
 
________________________________________      __________________ 
Printed Name of Participant                                                   Date   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Follow-up screening script.  
 
Hello, my name is ……………………………... I am calling from Washington State University.  
May I please speak to ………………………?  
[If the participant is available to continue if not thank the person who answered and call again later]  
I am calling to follow-up on your participation in the ARMS study. Is this a proper time to talk 
about it?  
[If yes]: Great. How are you doing today? 
We are conducting the weekly follow-up today. It will take about 2-3 minutes.  
[If no] What is the best time to call you back? [Note the time and politely end the 
call]........................................................... 
[Complete the participant’s weekly follow-up questionnaire with them. After filling out the 
questionnaire, ask,]  
Do you have any concerns about your study participation? 
[If Yes, note concerns and contact study PI as necessary] …………………………………. 
Thank you for taking the time to talk with me today. If you have any additional questions or concerns, 
please feel free to contact me. My name is ……………………… and I can be reached at phone 
number……………. and/or [email address…………………].