Encouraging Opioid Abstinence Behavior: Incentivizing Inputs and Outcomes - Pilot
Phase: NA
Conditions: Substance-Related Disorders, Opioid-Related Disorders, Behavior Therapy
Sponsor: Wake Forest University Health Sciences

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Encouraging Opioid Abstinence Behavior: Incentivizing Inputs and 
Outcomes 
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NCT04235582 

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AURORA HEALTH CARE, INC. 
 
PROTOCOL TITLE: 
Encouraging Opioid Abstinence 
Behavior: Incentivizing Inputs and 
Outcomes 
 
 
 
 
 
PRINCIPAL INVESTIGATOR:  
Mindy R. Waite, PhD, MS 
 
Behavioral Health Research 
Scientist 
 
 
 
 
 
 
960 N. 12th Street, 4120 
Milwaukee, WI 53233 
 
 
 
 
 
 
414.219.7803 
 
 
 
 
 
 
Mindy.Waite@aah.org 
 
INVESTIGATORS  
AND KEY PERSONNEL: 
 Rebecca Dizon-Ross, PhD, 
Associate Professor of Economics 
University of Chicago 
Ariel Zucker, PhD, Post-doctoral 
Fellow (under Jeremy Magruder, 
PhD) 
UC Berkeley 
Varun Satish, Research Associate 
University of Chicago 
TBD, Research Associate 
 
 
 
This protocol was designed and developed by the University of Chicago, University 
of California - Berkeley University, and Aurora Health Care.  It is intended to be 
used only in conjunction with institution-specific IRB approval for study entry. 
The Aurora IRB requires that this protocol be conducted according to U.S. and 
international standards of Good Clinical Practice (International Conference on 
Harmonization (ICH) Guidelines), Common Rule, WI and the Aurora IRB policies and 
procedures. All Human Participant Research and all Clinical Investigations conducted at 
Advocate Aurora Health or by researchers employed by Advocate Aurora Health will be 

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guided by the ethical principles set forth in the Belmont Report of the National 
Commission for the Protection of Human Participants of Biomedical and Behavioral 
Research. 
I. Background and Significance 
Numerous studies have tested whether providing incentives to encourage abstinence from 
drugs can further reduce drug abuse in a drug-treatment setting. The results are 
promising: Incentives to reduce opioid abuse increase the average duration of abstinence 
by 25 – 60% relative to medication and counseling alone (Petry et al., 2006; Schottenfeld 
et al., 2005). Similar effects have been demonstrated repeatedly across a wealth of 
populations, substance-abuse disorders, and payment methodologies (see Lussier et al., 
2006; Higgins et al., 2011; Davis et al., 2016; and Higgins et al., 2016 for reviews of 
providing incentives for managing addiction).  
Despite evidence that incentives are effective and the increasing need for effective 
approaches to combat the addiction crisis, incentive programs have not been widely 
implemented. A key barrier is that while the benefits are largely borne by patients and 
taxpayers, there are large logistical costs that must be borne by clinics: most existing 
incentive programs involve manual, in-person measurement of behaviors, and prize or 
voucher purchase and delivery by clinic staff. The significant clinic-level legwork 
necessary to set up these programs, including setting up behavioral and payment tracking 
systems, training staff, etc., have prevented the programs from scaling widely (Benishek 
et al., 2014). In sum, prior experience has consistently shown that incentives increase 
duration of treatment and decrease substance abuse, but the logistical complications 
remain a hurdle to implementation. 
We propose to conduct the first randomized evaluation of an innovative, scalable 
incentives program for opioid addiction delivered through a mobile application. The 
application, which was developed by our implementing partner, DynamiCare Health, 
provides a “turnkey” solution that health clinics can easily prescribe. The app enables 
remote monitoring of behavior; for example, drug tests can be administered in patients’ 
homes, as patients submit “selfie-videos” showing them taking saliva drug tests, which 
are then verified by trained remote staff. Treatment adherence can similarly be checked 
through GPS tracking for on-site methadone pharmacotherapy. The efficacy of this 
approach has not been tested rigorously before. 
This study will address two key knowledge gaps in the logistics of existing incentive 
program design for opioid addiction. First, we will test the first technology that we know 
of for remote monitoring of abstinence behavior for opioid use. Remote monitoring of 
abstinence from cigarettes and alcohol has been integral in reducing the costs and 
extending the potential reach of incentive programs for people with nicotine/tobacco and 
alcohol use disorders (e.g. to vulnerable or rural populations), and our study promises to 
do the same for opioid addiction (see for a review of remote monitoring technologies for 
incentive delivery). Our second gap is in remote delivery of incentives. After a behavior 
is verified, the app will deliver incentives to patients as cash available on a linked debit 
card. The delay between monitoring of the target behavior and the delivery of financial 
incentives has been shown to be a significant moderator of treatment effect size (Lussier, 
Heil, Mongeon, Badger, & Higgins, 2006). Our technology allows patients to receive 

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incentives almost immediately following the undertaking of the incentivized behavior: a 
first in incentives for opioid addiction. 
Another novel feature of our design allows us to address a gap in the literature on 
incentive delivery: we compare both the isolated effects of incentives and of the 
monitoring needed to implement an incentive program. In addition to a control group, our 
full experiment includes both monitoring groups and incentives groups. While existing 
literature on incentives for addiction has included either a monitoring group or a control 
group, to our knowledge we are the first to include both, such that a comparison can be 
made between incentives that are distal (inputs) and proximal (outcome) to the targeted 
abstinence behavior.  
Finally, our experiment will directly address two key open questions in the literature on 
incentives for drug-users. The first question is whether it is more effective to directly 
incentivize the outcome of interest – drug abstinence – or to incentivize behaviors that are 
inputs into the production of abstinence. In a similarly designed study, Petry et al. (2012) 
did not detect different effects on abstinence from incentivizing treatment attendance and 
incentivizing cocaine abstinence among cocaine users (both were effective): however, not 
only was this study for a different substance use disorder, but because of differential rates 
of test submission among these two groups, the results were not conclusive. We will 
similarly compare two versions of the incentive program: one that incentivizes inputs to 
achieving abstinence, and one that incentivizes the outcome of abstinence. To address 
differential test submission rates, we will measure the impacts of the intervention with 
urine drug-tests administered identically to patients in both treatments. In addition, we 
will use a novel combination of baseline survey data and preferences among future 
incentive programs to inform our understanding of why, and for whom, incentives for 
inputs and outputs are differently effective.  
The second question is how to optimize the size of incentives over time to maximize 
incentive effectiveness. We propose to do this by randomly varying the size and timing of 
incentives offered to participants in both the Inputs and Outcomes groups. We will then 
use the variation in incentive amounts across participants and time to fit a structural 
model of abstinence behaviors over time. We will then use the model to describe the 
optimal shape of incentives over time.  
The results of this intervention will be directly relevant for potential users of this or 
similar mobile applications for incentive provision among people with opioid-use 
disorders, including insurers, treatment facilities, and governments. 
 
II. Specific Aims 
Research Question:  
Our first research question is whether two incentive delivery approaches, one targeting 
inputs to abstinence and one targeting the outcome of abstinence, are effective in 
promoting abstinence from non-medical opioids. We will also investigate how incentive 
amounts and timing influences its effectiveness. Our primary hypotheses are listed below. 

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Hypothesis 1: Providing mobile-app-based incentives will increase the longest 
duration of abstinence from non-medical opioids relative to a control group receiving 
treatment as usual.  
To assess this, we will compare abstinence outcomes (longest duration and percent 
negative urine/saliva samples) between the pooled Inputs and Outcomes groups and 
pooled Monitoring and Control groups, during the intervention period. 
Hypothesis 2: Incentives have persistent effects on abstinence from non-medical 
opioids, even after the incentive program ends. 
We will compare abstinence outcomes between pooled Inputs and Outcomes groups and 
pooled Monitoring and Control groups, during the follow-up period.  
Hypothesis 3: Abstinence is differentially affected by whether incentives are 
provided for inputs to abstinence or for the outcome of abstinence.  
We will compare abstinence outcomes between the Inputs and Outcomes groups during 
the intervention period 
Hypothesis 4: The differential impact of inputs vs. outcomes incentives depends on 
underlying characteristics of patients and their environment. 
We will analyze the heterogeneity of the effectiveness of the two incentive treatments 
according to baseline measures of risk aversion, risk exposure, impatience, and 
knowledge of the pathway to abstinence.  
Hypothesis 5: The time-path of incentives can be modified to increase their cost-
effectiveness. 
We will model how patients respond to incentives of different amounts at different times 
and use the model to predict the optimal time path of incentives. 
The objective of this research is to assess the efficacy of two new incentives programs for 
abstinence behavior, thereby contributing to general knowledge on treatments for 
addiction.  
 
 
III. Study End Points 
The primary endpoint is the longest period of continuous abstinence from non-medical 
opioids, where abstinence is measured using lab-verified in-person urine-tests or video-
verified saliva tests.  
The secondary endpoints include the percent of three (3) scheduled urinalyses/saliva 
test results classified as negative, the percent of psychotherapy visits attended, the rate 
of discharging from treatment before completion (discharge against medical advice), 
and the adherence to medication assisted therapies. 
There are no intervention-related safety endpoints that we expect will cause participants 
to end participation due to safety concerns. 
 

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IV. Study Design 
To answer our research questions, we will conduct a randomized controlled trial pilot of 
temporary incentives to encourage either abstinence, or inputs to abstinence, among 600 
adults with opioid use disorders in Milwaukee, Wisconsin. Participants will be recruited 
from outpatients (partial and day treatment programs) with substance use disorders in 
treatment at the Adult Behavioral Health Program within the Aurora Health Care system. 
Incentivized behaviors will be monitored and rewarded through a mobile application 
developed by our implementing technology partner, DynamiCare Management. We will 
evaluate the incentives using a combination of administrative data and surveys. In 
preparation for this experiment, we will conduct a Phase 1 pilot of 36 individuals to test 
and fine-tune our study protocols. Any significant alteration to the protocol or any change 
that affects Human Participants concerns will be submitted to the IRB as a modification. 
Pilot Timeline:  
• The total duration of an individual participant’s participation in the pilot 
(including follow-up) is 3 months. 
• The anticipated duration to enroll all study participants is 3 months. 
• The estimated date for the investigators to complete this pilot (complete primary 
analyses) is September 30, 2020. 
 
Study Timeline: 
• The total duration of an individual participant’s participation in the study 
(including follow-up) is 9 months: a 3-month intervention, and a 6-month follow-
up. 
• The anticipated duration to enroll all study participants is 30 months. 
• The estimated date for the investigators to complete this study (complete primary 
analyses) is June 1, 2023. 
In addition to the prospectively collected data, we will pull EHR data for 
patients whose records indicate that they were treated for an opioid use disorder in 
the relevant treatment programs (SUD PHP, IOP, or outpatient) during similar 
dates of service to the pilot study. Dates of service for these retrospective patients 
will be between April 1 March 31, 2021. We will use data from these individuals 
for two purposes: First, to better understand potential enrollment rates going 
forward, as there may be seasonal variation in treatment enrollment. Second, to 
form a "Control" group of similar patients to our pilot program. Comparisons 
between "Control" and "Treatment" patients will allow us to estimate a treatment 
effect, which we will input into power calculations for assessing the necessary 
sample size for the full study. 
 
 

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V. Experimental Design and Methods (or Study Procedures) 
Interventions  
Pilot: During the pilot, the study population will be randomly divided into three treatment 
groups: Inputs, Outcomes, and Combined. The study will include a twelve-week 
intervention period, during which each group will receive different interventions in 
addition to their standard of care treatment through AAH.  
Inputs Group: During the intervention period, the “Inputs” group will receive incentives 
for behaviors that are inputs to abstaining from drug use. Patients in this group will 
receive the same services and urine drug-test schedule as standard of care. Additionally, 
patients will be registered for a mobile phone application (app) provided by DynamiCare 
Health and provided with a linked debit card. The debit card does not display the 
participant’s name and has restricted access for purchases of approved products (e.g., 
cannot be used for purchasing alcohol). The app will prompt patients to complete actions 
that are inputs to abstinence an average of three times per week. These actions will be 
tailored to the patient’s individual needs, and may include:  
• Drug adherence to prescribed drug-maintenance therapy.  
• Attendance at individual and group psychotherapy sessions (monitored by phone 
GPS for patients attending in-person or via EHR records for patients attending 
virtually).  
• Mobile Cognitive Behavioral Therapy (CBT) Modules offering patients self-
guided addiction counseling.  
Patients will receive immediate financial rewards for completing a subset of these actions 
prompted by the app.  
Control Group: This group will not have received any opportunity to enroll in the study 
because they were in treatment during times outside of the study enrollment period. As a 
result, they will not have had access to the DynamiCare app or any surveys/study data 
collection. 
The incentive amounts offered in the inputs group will vary randomly across participants 
in order to understand how effectiveness varies according to incentive amount.  
Outcomes Group: During the intervention period, the “Outcomes” group will receive 
incentives for abstaining from drug use. Patients in this group will receive the same 
services and urine drug-test schedule as standard of care and a similar mobile app and 
debit card as the Inputs group, as well as access to Mobile Cognitive Behavioral Therapy 
(CBT) Modules. However, the app will prompt patients in this group to submit saliva 
drug tests through their mobile phones on a random schedule (averaging three tests per 
week). Patients will receive immediate financial rewards in exchange for submitting 
drug-negative samples. Saliva tests typically have a window of detection between 24-48 
hours after drug use.  
Combined Inputs/Outputs Group: This group will receive interventions from both Inputs 
and Outputs groups, as well as standard of care therapy services and urine drug tests. 
Interventions include incentives for a combination of the following actions: 

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• Drug adherence to prescribed drug-maintenance therapy.  
• Attendance at individual and group psychotherapy sessions (monitored by phone 
GPS for patients attending in-person or via EHR records for patients attending 
virtually).  
• Mobile Cognitive Behavioral Therapy (CBT) Modules offering patients self-
guided addiction counseling.  
• Random saliva tests. 
Patients will receive immediate financial rewards if they complete each action prompted 
by the app.  
Other Procedures 
All participants in the study will continue to receive Aurora’s standard opioid use 
disorder treatment, which may be virtual or in-person. Standard of care treatment consists 
of pharmacotherapy, individual psychotherapy, group psychotherapy, and urine drug 
screens (if in-person). As part of in-person standard of care, urine drug screens are 
typically performed 3-4 times per 2-week period for both partial and day treatment.  
All patients will have access to mobile Cognitive Behavioral Therapy (CBT) Modules 
through DynamiCare Health offering patients self-guided substance use counseling, 
which will not be incentivized.  
Patients in all groups will be asked to submit saliva drug tests at Weeks 4, 8, and 12 
through the app, in addition to the routine clinical urine drug screens (and, for the 
Outcomes group, randomized saliva samples) mentioned above. The pre-scheduled saliva 
samples will be rewarded $20 non-contingent on positive/negative status. If no saliva 
tests are submitted, patients can be asked to submit a non-clinical urine sample in-person 
(incentivized with $20), their records will be checked for recent clinical urine samples 
(no incentive provided), or they will be asked about their recent drug use (no incentive 
provided). 
Any saliva/urine samples collected for research purposes over and above the routine urine 
testing that occurs in treatment as usual are not performed as part of clinical care and will 
not be shared with the clinical care team. 
Surveys: All patients will receive a baseline and endline survey. In addition, we will 
electronically administer the WHOQOL-BREF survey through the DynamiCare app at 
weeks 4, 8, and 12. The WHOQOL-BREF is a validated, commonly used survey to 
measure quality of life. 
No other procedures are performed on the participants of this study. 
We do not anticipate any risks associated with the saliva test. However, tests will be 
administered through the DynamiCare Rewards app and will be checked by trained 
remote staff.  
Incentives 
Payments will be made to all participants as part of the evaluation activities: We 
plan to provide incentives to all participants for completing the subset of non-standard-of-

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care saliva/urine tests completed during the course of the intervention period – those at 4, 
8, and 12 weeks after enrollment. Any urine tests administered as part of standard-of-care 
treatment at Aurora will not be incentivized; these could be on weeks 4, 8, and 12 as 
needed. The incentive will be provided to participants in all groups in the form of $20 via 
the app (if saliva) or via Amazon gift card (if in-person). In addition, we plan to provide 
$20 Amazon gift cards to patients for completing the Endline survey. The maximum that 
can be earned from primary outcomes saliva/urine collection and surveys (3 urine/saliva 
samples + 1 endline survey) is $80. 
Further, we are adding on $2/survey for secondary outcomes of the completing the 
WHOQOL survey at baseline, Weeks 0, 4, 8, and 12. Therefore, subjects could earn an 
additional $8for surveys. 
Payments made to participants assigned to one of the incentives groups as part of 
the incentives intervention: Patients in all Pilot groups will be awarded payments 
through the DynamiCare Rewards application. With up to 13 random tests per month, up 
to $130 can be earned per month; however, on average only about 70% of that amount is 
earned ($91). The debit card can only be used for restricted purchases; for example, it 
cannot be spent at bars, liquor stores, casinos, etc. 
The application has two types of reward schedules. For some tasks, the application uses 
an escalating rewards schedule with a hard reset (i.e., completing the first task earns a 
predetermined amount of money with an escalation at each successful step, and missing 
or failing a task reduces/resets the reward). This type of schedule is consistent with 
previous contingency management protocols.  
Rewards schedule for behaviors on the streak (i.e., saliva tests and medication 
adherence)  
• Amount of first reward: $2  
• Reward escalation interval: $2 (i.e., each time the behavior is successful, the 
incentive amount goes up by $2 for the next behavior) 
• Maximum reward for a single behavior: $10   
• Reward reset value: $2 (i.e., if a behavior is unsuccessful, the incentive amount 
for the next behavior resets to $2)  
• If action unverifiable/cancelled: no escalation/no reset  
 
Rewards schedule for non-streak behaviors (i.e., appointments)  
The application also allows for an independent rewards schedule (i.e., the reward 
received for a given task is determined independently of how the patient has performed 
on other tasks). In the independent rewards schedule, patients earn a preset number of 
dollars for activities. Missing or failing an independent-rewards task does not impact the 
reward for future tasks or depend on performance of previous tasks. Amount of each 
reward: $5  
This was necessary because the app cannot currently incorporate appointments into their 
streak formula, so every appoint is worth a fixed $6. 
The incentivized behaviors differ among the three groups.   
• “Outcomes” patients only receive incentives for illicit opioid-negative saliva tests  

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• “Inputs” patients only receive incentives for drug adherence and appointment 
attendance (including virtual appointments)  
• “Combined” patients receive incentives for all behaviors above   

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Schedule 1: Example Escalating Schedule Only (i.e., Outcomes Group)  
 
Task 1 
Task 2 
Task 3 
Task 4 
Task 5 
Task 6 
Task 7 
Task 8 
Task 9 
Task 10 
Pass/Fail 
Pass 
Pass 
Pass 
Pass 
Pass 
Pass 
Fail 
Pass 
Pass 
Pass 
Dollars 
earned 
2 
4 
6 
8 
10 
10 
0 
2 
4 
6 
Accumulated 
earned 
2 
6 
12 
20 
30 
40 
40 
42 
46 
52 
 
 
Schedule 2: Example Escalating Schedule + non-streak behaviors (i.e., Inputs Group)  
 
Task 1 
steak 
Task 2 
streak 
Task 3  
non-
streak 
Task 4 
streak 
Task 5 
non-
streak 
Task 6 
streak 
Task 7 
streak 
Task 8 
non- 
streak 
Task 9 
streak 
Task 10 
streak 
Pass/Fail 
Pass 
Pass 
Pass 
Pass 
Pass 
Pass 
Fail 
Pass 
Pass 
Pass 
Dollars 
earned 
2 
4 
5 
6 
5 
8 
0 
5 
2 
4 
Accumulated 
earned 
2 
6 
11 
17 
22 
30 
30 
35 
37 
41 
 
Schedule 3: Example Constant Schedule (not currently planned to be used in the pilot) 
 
Task 1 
Task 2 
Task 3 
Task 4 
Task 5 
Task 6 
Task 7 
Task 8 
Task 9 
Task 10 
Pass/Fail 
Pass 
Pass 
Pass 
Pass 
Pass 
Pass 
Fail 
Pass 
Pass 
Pass 
Dollars 
earned 
4 
4 
4 
4 
4 
4 
0 
4 
4 
4 

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Task 1 
Task 2 
Task 3 
Task 4 
Task 5 
Task 6 
Task 7 
Task 8 
Task 9 
Task 10 
Accumulated 
earned 
4 
8 
12 
16 
20 
24 
24 
28 
32 
36 
 
Task examples: saliva test, attend group meeting, take pharmacotherapy 

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a. Screening Visit (T = 0) 
• Treating therapists will briefly describe the study to their psychotherapy 
groups receiving AODA treatment. 
• Screening will be performed at Aurora (APH) or virtually via HIPAA-
compliant zoom meeting, depending on the patient’s treatment type (in-person 
or virtual) and preferences. Potential participants will be referred to the RA 
and/or principal investigator by their clinician, APH intake, other APH 
professional, or will be identified from the EMR. Virtual enrollment is 
necessary for patients who are receiving virtual treatment or who prefer 
virtual enrollment as a way to maximize social distancing for safety. 
• The RA and/or PI will conduct a preliminary screening survey. If patients are 
eligible for the study, the RA and/or PI will then explain the study and obtain 
informed consent to participate from willing participants. Only patients whose 
potential participation is approved by the person responsible for their 
treatment plan will be approached, per WI DHS 94. 
• Per RSPP requirements, if the subject is being enrolled virtually (via Zoom 
platform), the RA must make a determination on the identity of the subject by 
having the subject show a viable form of identification. The consent may be 
signed either physically or via approved e-signature (Adobe Sign), which is 
owned by the AARI Research Business Services team. 
• Following informed consent, the RA and/or PI will conduct a Baseline survey 
using a tablet or computer.  
• The RA will send an invitation link to the subject’s email and help the subject 
download, log into, and navigate the app. This can be done either in person or 
via Zoom. 
• Treatments will be assigned via stratified randomized lists generated in 
statistical software. Participants will be provided with instructions pertinent to 
their treatment group following the baseline survey. Subjects will be offered 
$2 on their debit card to complete the baseline WHOQOL survey.Participants 
in all Pilot groups will receive a debit card, either in-person or in the mail, on 
which to receive their rewards. 
 
b. Visit 1 (T = 4 weeks) 
• Visit 1 will occur 4 weeks after the screening visit with +/- one (1) week. 
• Participants may receive urine tests as part of usual in-person treatment. 
• If participants do not receive urine tests as part of usual treatment, they will 
be contacted by the research associate to complete a research-only saliva or 
urine test either in-person or via DynamiCare. If they complete the 
saliva/urine test, they will receive a $20 incentive.  
• If they refuse to complete the saliva/urine test, they will be briefly asked 
about their recent non-medical drug use (presence/absence and type) but 
will not be provided a financial incentive. 
• The WHOQOL survey will be delivered using RedCap. Completed surveys 
will be incentivized with $2 on their debit card . 
 

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c. Visit 2 (T = 8 weeks) 
• Visit 2 will occur 8 weeks after the screening visit with +/- one (1) week. 
• Participants may receive urine tests as part of usual treatment. 
• If participants do not receive urine tests as part of usual treatment, they will 
be contacted by the research associate to complete a research-only saliva or 
urine test either in-person or via DynamiCare. If they complete the 
saliva/urine test, they will receive a $20 incentive.  
• If they refuse to complete the saliva/urine test, they will be briefly asked 
about their recent non-medical drug use (presence/absence and type) but 
will not be provided a financial incentive.  
• The WHOQOL survey will be delivered using RedCap. Completed surveys 
will be incentivized with $2 on their debit card.. 
 
 
d. Visit 3 (T = 12 weeks) 
• Visit 3 will occur 12 weeks after the screening visit with +/- one (1) week. 
• Participants may receive urine tests as part of usual treatment. 
• If participants do not receive urine tests as part of usual treatment, they will 
be contacted by the research associate to complete a research-only saliva or 
urine test either in-person or via DynamiCare. If they complete the 
saliva/urine test, they will receive a $20 incentive.  
• If they refuse to complete the saliva/urine test, they will be briefly asked 
about their recent non-medical drug use (presence/absence and type) but 
will not be provided a financial incentive.  
• The RA will conduct an Endline survey using a tablet (if in-person) or via 
phone or Zoom. They will receive a $20 gift card for finishing the survey.  
• The WHOQOL survey will be delivered using RedCap. Completed surveys 
will be incentivized with $2 on their debit card.. 
 
 
Study Procedure 
Screening 
Visit 
VISIT 
1:  
VISIT 
2:  
VISIT 
3: 
Sign Informed Consent 
X 
 
 
 
Incentive for Saliva/Urine 
Drug Screen and WHOQOL 
 
X 
X 
X 
Survey Interview 
X 
 
 
X 
 
VI. Risks 
The purpose this study is to measure the effectiveness of Contingency Management (as 
delivered by the smartphone-based DynamiCare Rewards system) as an adjunct to 
standard treatment for opioid use disorders. This is a low-risk study, as the proposed 

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intervention is a mobile application, which does not provide any diagnosis or treatment 
for any disease.  This project does not involve invasive tests or procedures. Saliva and 
urine samples will be collected, but these procedures pose no direct risk to participants, 
and aside for our research use, could be considered standard clinical practice in addiction 
treatment. However, mild stress may occur when performing self-administered saliva 
testing. Since participants have the potential to earn money for abstinence, they may 
become distressed if they believe that the equipment is not performing accurately.  
Although these indirect risks tend not to be of a large magnitude, participants may 
experience discouragement if they don’t meet their goal, or if they do meet the goal but 
do not get appropriately rewarded due to rare but possible false positive results in the 
tests. In addition, although we purposefully mitigate risk by constraining the use of debit 
cards only to certain activities (e.g., not for payment at a liquor store), participants may 
still use the debit card for contra-therapeutic purposes and engage in harmful behaviors 
such as purchasing alcohol or cigarettes. 
A final potential risk is that participant confidentiality could be breached, in regard to 
patient health information, during transmission of electronic data including patient names 
or exercise adherence. Participants can decline to be in the study or leave the study early 
if they have any concerns and, as an alternative to study participation, they can continue 
in usual care.   
It is not expected that participation in the study will contribute any significant cost to 
participants. However, requisite to participation in the study, their smart phones must 
have a data plan in order to run the application. Each saliva test video is ~60 MB. In the 
app settings there is an option, "Upload only over Wi-Fi." This will store the video on 
their phone until the participant’s phone establishes a Wi-Fi connection, at which point 
the app will automatically upload the video (even if the phone is just in their pocket). As 
such, participants with low data caps can choose to use that feature to avoid potentially 
adding extra data charges. 
Risk Associated with a Breach of Confidentiality 
To protect confidentiality, all research participants will be assigned unique participant 
identification codes that will be used on all study-related forms and online websites. 
Documents that include the participants’ full names (e.g., signed informed consent forms) 
will be stored in an independent binder, consistent with FDA Good Clinical Practice 
Guidelines, and will be kept in a locked area. Confidential information will never be 
shared with anyone outside of the research program without the explicit written 
permission of the research participant, and a Certificate of Confidentiality will be 
obtained from the NIH for the study in order to protect participant data. Only selected 
designated staff members will be approved to share confidential information after explicit 
written permission is obtained from the participant and the participant will be able to 
revoke written permission at any time. In accordance with IRB requirements, all research 
staff will be formally trained in these procedures. No identifying participant information 
will be used in written reports, manuscripts and/or conference presentations. 
Dr. Waite (PI), behavioral economist Lead Investigators (Dr. Dizon-Ross and Dr. 
Zucker), and the AAH research associate will be the only individuals who will have 
access to cross-linking information that connects the study identification number to 

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identifiable personal information, such as participant name or email address. Even though 
the final dataset will be stripped of identifiers prior to release for sharing, we believe that 
there remains the possibility of deductive disclosure of participants with unusual 
characteristics. Thus, we will make the data and associated documentation available to 
users only under a data-sharing agreement that provides for: (1) a commitment to using 
the data only for research purposes and not to identify any individual participant; (2) a 
commitment to securing the data using appropriate computer technology; and (3) a 
commitment to destroying or returning the data after analyses are completed. 
In addition to written participant data, videos of participants are uploaded into the 
DynamiCare platform for saliva assessments. DynamiCare Rewards is a HIPAA-
compliant platform designed for use in healthcare settings. It protects patient information 
with encryption in-transit and at-rest, and limits visibility of patient data to only those 
with authorized access. These data are automatically uploaded to the DynamiCare 
HIPAA-compliant server. Only staff working on the research project at the various sites 
(i.e. DynamiCare Health, Aurora Health Care, University of California-Berkeley, and 
University of Chicago) will have access to participant data. 
Further, accounts for DynamiCare access will be issued, tracked, and removed/added by 
the Aurora PI if personnel leave or are added to the study. If the Aurora PI is scheduled to 
leave the study, then a replacement (interim) PI will be identified and put in place before 
the original PI leaves to ensure that a PI is always available to add/change personnel 
access. In an emergency situation (e.g., the PI in incapacitate), the Aurora research 
associate is authorized to make these changes. 
If the subject is receiving virtual behavioral health therapy, it is likely that interactions between 
the subject and RA will occur via Zoom. AAH has access to a HIPAA-compliant Zoom platform, 
which is currently used for providing behavioral health therapy. This same platform will be used 
to offer Zoom meetings with subjects; no videos or photos will be recorded during these Zoom 
meetings. Zoom links will be sent either to personal emails or personal phone texts as provided 
by the client (in other words, the patient will provide these emails/phone numbers). 
Zoom meetings with potential subjects may or may not immediately follow their group therapy 
meetings; this depends entirely on the patient’s availability. Zoom meetings may be scheduled at 
other times, and the scheduling agreement with the patient may be done via personal email or via 
phone call. Zoom meeting confirmations will If done via email, the email will be generic and not 
point to the study purpose (e.g., the email may be titled: “Zoom Meeting: AAH Research Study” 
or something similarly vague and not mentioning substance use or any other diagnosis/disorder 
category. The consent form will be provided during the Zoom call via Zoom download and via 
link to DocuSign. The patient may sign the consent form via DocuSign during the meeting or, if 
the patient provides approval, the consent form or DocuSign link may be emailed to the patient’s 
personal email. There are no clinical parameters for arranging these meetings as they are not 
clinical visits. 
Provisions for Research Related Harm/Injury 
Although this study involves minimal risk and no adverse events are expected, the resources 
of Aurora Health’s clinical team are available to handle any unforeseen events, as they would 
be for patients not involved in a research protocol. Each of Aurora’s OTP sites is medically 
staffed to assess acute issues that may arise in the context of OUD treatment, and the 
programs have access to standard psychiatric and counseling services.  

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VII. Benefits 
By incentivizing inputs to opioid abstinence as well as opioid abstinence itself, this 
project aims to improve the outcomes of participants in this study with severe opioid use 
disorders by reducing the barriers to abstinence. This may lead to direct long-term 
improvements in health and employment, as well as wellbeing of the participants and 
their friends and families. Several previous studies have suggested these benefits are 
likely to occur. 
If the study endpoints are positively affected, it will serve as evidence of the effectiveness 
of the DynamiCare mobile application: the first scalable, turnkey solution for incentives 
for healthy behaviors among people (i.e., contingency management) among people with 
opioid-use disorders. 
In addition, the study will push the frontier of knowledge on how incentives in general 
can be more effectively applied in similar populations, leading to potential improvements 
in the design of contingency management broadly. This will result in more efficacious 
interventions for people seeking treatment for substance use disorders. 
 
VIII. Sample Size 
We will recruit 36 participants to pilot the incentive programs during the Pilot.  
 
IX. Study Population 
Include 
Exclude 
Vulnerable Population Type 
 
 
Adults unable to consent due to cognitive impairment (i.e., 
current diagnosis for psychosis or non-English speaking) 
 
 
Individuals who are not yet adults (e.g. infants, children, 
teenagers) 
 
 
Wards of the State (e.g. foster children) 
 
 
Mentally ill 
 
 
Women, including pregnant women 
 
 
Economically disadvantaged 
 
 
Minorities  
 
 
Prisoners 
 

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The study will be conducted among outpatients with opioid use disorders at Aurora 
Health. This population includes a number of vulnerable population types that will be 
included in the study. For example, economically disadvantaged individuals, people with 
mental-health comorbidities, women (including pregnant women) and minorities are 
included in the category of vulnerable populations.  
That stated, the potential risks of this minimal-risk study are far outweighed by the 
potential benefits of study participation, both for the individuals involved and for the 
vulnerable populations as a collective. First, participants will have the chance to receive 
contingencies for abstinence-promoting behaviors, which may both reduce substance 
abuse. Second, the results of the study will be published. These results will inform the 
academic and treatment community of the availability and effectiveness of smartphone-
based contingency management, and whether inputs- or outcomes-based reinforcement 
has larger clinical effect sizes. Third, the study results will inform the further refinement 
of the mobile app, which will increase its effectiveness in helping people with substance 
use disorders (and perhaps make it more effective for the participants themselves if they 
choose to use the app later). It is critical that solutions for opioid use disorders be studied 
among the multi-faceted populations who can benefit from treatment, and these 
populations naturally include a number of vulnerable groups.  
Because this is minimal-risk research, there is comparatively greater upside benefit for 
participants than there is any research-related risk of harm. 
The benefit of non-exclusion of vulnerable populations from research participation is the 
improvement in understanding strategies to encourage abstinence among the populations 
where these strategies are needed most.   
In order to protect the welfare of vulnerable populations, individuals in the study must be 
already enrolled in Aurora Health’s Behavioral Treatment Program for treatment of their 
opioid use disorder and any co-occurring mental health diagnoses. This will ensure they 
already have access to standard-of-care treatment necessary for their medical needs. 
Qualifying candidates meet the following Inclusion and Exclusion criteria: 
 
a. Inclusion Criteria 
1. Age at least 18 years old; 
2. Meet DSM-5 opioid use disorder criteria as evidenced by an opioid disorder CPT 
code F11 (opioid related disorders) or other clinical notes indicating illicit opioid 
use for treatment; 
3. Have access to a smartphone (iOS or Android) with data plan and willing to 
download DynamiCare app; 
4. Are in day (PHP), partial day (IOP), residential, or outpatient AODA treatment in 
Aurora Health’s Behavioral Health Program; 
5. Are currently prescribed or will be prescribed within 1-4 days buprenorphine, 
naltrexone, or methadone for their OUD; 

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6. Are likely to be helped by contingency management because at least ONE of the 
following conditions is true: 
a. Were first enrolled in day or partial day opioid treatment no longer than 2 
treatment weeks (14 days/encounters of treatment) prior to providing 
informed consent. 
b. Currently using non-medical opioids. 
c. Regularly missing scheduled AODA appointments. 
7. Understands English. 
b. Exclusion Criteria 
1. Have evidence of active (non-substance related) psychosis that might impair 
participation as determined by the PI. 
2. Has significant cognitive impairment that might confound participation as 
determined by the PI or are so significantly cognitively impaired that they have a 
legal guardian. 
Note that pregnant women are not excluded from participating in the study. 
 
 
X. Recruitment and Screening 
Participants will be actively recruited into the study in one of two ways. Either patients 
will be recruited at patient intake at Aurora’s Behavioral Health Program or referred to 
the study by their clinician at Aurora with the patient’s assent. 
The first stage of recruitment (eligibility screening) will be conducted by the research 
team. This team will determine if potential participants (who have or have not yet 
expressed interest in the study) meet all inclusion criteria below except Smartphone and 
data plan access, and no exclusion criteria. Qualifying potential participants will then be 
directed to the Research Associate to determine whether their phone and data plan access 
meet study requirements.  
If an interested patient meets inclusion criteria (specified above), the Research Assistant 
will arrange for the patient to complete research consent as described in Section XV 
below. Patients will be offered the opportunity to consent to participation. However, 
eligible patients that are not prepared to give informed consent on the same day will be 
given the contact number of the Research Associate and may consent at a later date as 
long as they are within eligibility timelines. 
There are no materials needed for recruitment.  
We do not anticipate withdrawing participants from the study without their consent. 
However, participants can decline to be in the study, or leave the study early if they have 
any concerns, and as an alternative to study participation they can continue in usual care.    
Research participants who wish to fully withdraw from the study can do so by contacting 
the research associate or Principal Investigator. Contact details will be given in the 

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informed consent at the consent stage. In the event that a participant wishes to fully 
withdraw, all survey and drug test data will be removed from research databases, and the 
mobile app will be deactivated. In the event that a participant wishes to discontinue use of 
the app, but allows continued analysis of their data, the mobile app will be deactivated, 
but we will analyze and, where possible, continue to collect urine samples and other 
available outcome data from that participant. 
 
XI. Privacy Plan 
All communication with the participants during the study will be through in-person 
appointments, through the DynamiCare application, via patient-provided email, phone, 
and/or AAH-purchased Zoom. DynamiCare will execute a Business Associates 
Agreement with Aurora Health Care to provide a HIPAA umbrella over the patient-
generated data. The smartphone application requires the user to input a username and 
password, allowing for their control over their private information. 
Questions asked will be minimally intrusive. However, participants will be told in 
advance that they may refuse to answer any question at any time. Research Assistants 
who are trained in working with patients with substance use disorders, and who are 
culturally sensitive, will conduct enrollment. Examinations and procedures, such as 
urinalysis, will be no more intrusive than standard care as provided in the Aurora 
substance use disorder treatment programs. 
The geographical locations system within the app only tracks the location of the 
participant within a small window of time related to their programmed clinical 
appointments. As a result, the data collected on phone location are specific and minimal. 
 
XII. Data Collection 
Data Sources & Description 
Survey data, mobile application data, and clinic data will be used during the study.  
Baseline survey data will measure characteristics such as risk aversion, time preferences, 
knowledge about the pathway to abstinence, and a real-stakes measure of preferences for 
inputs-based versus outcomes-based incentive programs. Administrative data will include 
urine test results, medication compliance measures, appointment attendance, and CBT 
module usage in groups randomized to use the app. Baseline survey data will measure 
characteristics such as risk aversion, time preferences, knowledge about the pathway to 
abstinence, phone and data plan access, and a real-stakes measure of preferences for 
inputs-based versus outcomes-based incentive programs. Periodic surveys administered 
through the DynamiCare app will measure other behaviors such as avoidance of “trigger” 
situations and stress-relieving activities. Endline survey data will measure self-reported 
drug use, drug avoidance behavior, health, and quality-of-life data. 
The survey instruments are currently under development with the intent to be 
administered digitally through participants’ smart phones. We will begin piloting in 

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Phase I without survey instruments. Mockups and screenshots of the final surveys will be 
submitted to the IRB in a protocol amendment before they are implemented. 
DynamiCare Rewards is a HIPAA-compliant platform designed for use in healthcare 
settings. It protects patient information with encryption in-transit and at-rest, and limits 
visibility of patient data to only those with authorized access. In this study, data will be 
collected on saliva tests, medication adherence, treatment attendance, and self-guided 
Cognitive Behavioral Therapy (CBT) modules; these data are automatically uploaded to 
the DynamiCare HIPAA-compliant server.  Data on participant utilization of the smart 
debit card will be available from True Link Financial, Inc., via a confidential data-sharing 
agreement.  
Administrative data will be collected from Aurora Health Care clinical records, including 
alcohol and/or substance use records. These records will be integral to the study for a 
number of reasons. First, we will stratify our randomization by dosage history and 
number of times in treatment, and conduct sub-analyses based on these variables. Second, 
we need to verify upcoming appointments at the Aurora Behavioral Health Program (to 
be incentivized or prompted in the app in the Inputs or Combined groups). Third, we will 
use clinical urinalysis results to measure non-medical drug use in the construction of our 
primary outcome measure. 
Only designated staff working on the research project at Aurora Health Care will have 
access to participant PHI. All personal data collected will be used for research purposes 
only, including determination of study eligibility and to characterize the sample. All 
records and data will be kept strictly confidential and will only be released to research 
staff with the specific written consent of the participant. Participants will be assigned a 
unique identifying code at the time of study enrollment to help ensure confidentiality. All 
data will be stored in RedCap, which is an encrypted program designed specifically for 
research and clinical trials. The RedCap database is only accessible to AAH employees.  
Data to be collected for prospective participants: 
 
Purpose 
Variable 
Potential sources 
Eligibility/analysis 
Identifiers (MRN, Patient Name) 
 
clinical data 
Eligibility/analysis 
Dates of service 
 
clinical data 
Eligibility/analysis 
Demographics (age, gender, 
race/ethnicity) 
patient interview, 
clinical data 
Eligibility/analysis 
Opiate use in the past 30 days (yes/no) patient interview, 
clinical data 
Eligibility/analysis 
Current opioid use 
clinician interview, 
clinical data 
Eligibility/analysis 
ICD 10 opioid use diagnosis (F11) 
clinician interview, 
clinical data 
Eligibility/analysis 
Other significant psychiatric disorders 
and mental illnesses and whether they 
currently have a legal guardian 
clinician interview, 
clinical data, patient 
interview 

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Eligibility/analysis 
Other substance-use disorders 
clinician interview, 
clinical data 
Eligibility/analysis 
Access to smart phone and data plan 
and willing to download DynamiCare 
app 
patient interview 
Analysis 
Appointment adherence, program 
length of stay, and reason or discharge 
clinician interview, 
clinical data, app 
Analysis 
Standard-of-care drug test outcomes 
and EHR notes regarding recent 
substance use 
clinical data 
Analysis 
Study-specific drug test outcomes 
app data 
Analysis 
Distance to clinic 
patient interview, 
clinical data 
Analysis 
Standard-of-care drug quality of life 
survey (Wisconsin Recovery Pulse): 
https://www.dhs.wisconsin.gov/public
ations/p01922a.pdf) 
clinical data 
Analysis 
Pregnancy status 
patient interview, 
clinical data 
Analysis 
Commute time to clinic 
patient interview 
Analysis 
Medication-assisted therapy drug, 
dosage, schedule, and adherence (e.g., 
buprenorphine, vivitrol, methadone)  
clinician interview, 
clinical data, app 
Analysis 
Receipt of previous treatment for 
opioid dependence (yes/no) 
clinician interview, 
patient interview, 
clinical data 
Analysis 
Psychotherapy type (level enrolled 
across time) and attendance  
clinician interview, 
patient interview, 
clinical data 
Analysis 
Therapy appointment schedule and 
adherence 
(updated realtime during intervention 
period) 
clinician interview, 
clinical data, app data 
Analysis 
Reinforcement activity from app 
(updated realtime during intervention 
period) 
app 
Analysis 
Average medication adherence during 
intervention period  
clinician interview, 
clinical data, app data 
Analysis 
Admissions to substance use treatment 
during three time periods: 12 weeks 
before enrollment, 12 weeks during 
DynamiCare access, and 12 weeks 
after DynamiCare access is turned off. 
Treatment = inpatient admission for 
SUD reason, SUD residential 
admission, SUD IOP, SUD PHP, and 
clinical data 

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SUD outpatient. Will include reasons 
for treatment. 
Analysis 
App reward amounts and reward 
expenditures (purchases from 
DynamiCare debit card) 
App data 
Data to be collected for retrospective subjects: 
Purpose 
Variable 
Potential sources 
Eligibility/analysis 
Identifiers (MRN) 
 
clinical data 
Eligibility/analysis 
Dates of service 
 
clinical data 
Eligibility/analysis 
Demographics (age, gender, 
race/ethnicity) 
patient interview, 
clinical data 
Eligibility/analysis 
Opiate use in the past 30 days (yes/no) clinical data 
Eligibility/analysis 
Current opioid use 
clinical data 
Eligibility/analysis 
ICD 10 opioid use diagnosis (F11) 
clinical data 
Eligibility/analysis 
Other significant psychiatric disorders 
and mental illnesses and whether they 
currently have a legal guardian 
clinical data 
Eligibility/analysis 
Other substance-use disorders 
clinical data 
Analysis 
Appointment adherence, program 
length of stay, and reason or discharge 
clinical data 
Analysis 
Standard-of-care drug test outcomes 
and EHR notes regarding recent 
substance use 
clinical data 
Analysis 
Standard-of-care drug quality of life 
survey (Wisconsin Recovery Pulse): 
https://www.dhs.wisconsin.gov/public
ations/p01922a.pdf)  
clinical data 
Analysis 
Drug urine test outcomes during 
similar timeframe of enrolled subjects 
(e.g., 12 weeks plus 3 month follow-
up) 
clinical data 
Analysis 
Distance to clinic 
clinical data 
Analysis 
Pregnancy status 
clinical data 
Analysis 
Medication-assisted therapy drug, 
dosage, schedule, and adherence (e.g., 
buprenorphine, vivitrol, methadone) 
clinical data 
Analysis 
Receipt of previous treatment for 
opioid dependence (yes/no) 
clinical data 
Analysis 
Psychotherapy type (level enrolled 
across time) and attendance 
clinical data 
Analysis 
Medication schedule (updated realtime 
during intervention period) 
clinical data 
Analysis 
Therapy appointment schedule 
clinical data 

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(updated realtime during intervention 
period) 
Analysis 
Admissions to substance use treatment 
during three time periods: 12 weeks 
before enrollment, 12 weeks during 
DynamiCare access, and 12 weeks 
after DynamiCare access is turned off. 
Treatment = inpatient admission for 
SUD reason, SUD residential 
admission, SUD IOP, SUD PHP, and 
SUD outpatient. Will include reasons 
for treatment. 
clinical data 
 
 
Secure Data Storage and Transmission 
The PHI will be collected digitally by a Research Associate and will be stored in RedCap 
at Aurora Health Care. De-identified data will be stored in encrypted files on a secure 
server at the University of Chicago. Data will be shared only among the key project 
personnel, using hard encryption methods. 
After data analysis and publication, all available study data will be permanently stripped 
of identifiers. The de-identified data will be kept until 7 years after the data analysis is 
complete per BCBA ethics guidelines (https://www.bacb.com/wp-
content/uploads/BACB-Compliance-Code-english_190318.pdf). After 7 years, the data 
will be destroyed. However, if at any point there is no PI to lead the study, the data may 
be destroyed at that time. 
Only certain selected members from the research team will have access to the delinked 
data. 
The Research Associate and PI are responsible for the receipt and transmission of 
administrative clinical data. The principal investigators are responsible for the receipt and 
transmission of survey data, as well as for data collected through the DynamiCare 
Rewards app.  
The data will be shared only among the key project personnel and shared using 
encryption methods. DynamiCare Rewards is a HIPAA-compliant platform designed for 
use in healthcare settings. It protects patient information with encryption in-transit and at-
rest and limits visibility of patient data to only those with authorized access. In this study, 
data will be collected on saliva tests, medication adherence, treatment attendance, and 
self-guided Cognitive Behavioral Therapy (CBT) modules; these data are automatically 
uploaded to the DynamiCare HIPAA-compliant server. Remote testing data will be 
verified through inspection of “selfie-videos” to guarantee quality. Data on participant 
utilization of the smart debit card will be available from True Link Financial, Inc., via a 
confidential data-sharing agreement. Only staff working on the research project at the 
various sites (i.e. DynamiCare Health, UC Berkeley, University of Chicago, Aurora 

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Health Care) will have access to participant data. Names that are linked to identifiers will 
be stored in independent binders as well as the password-protected, encrypted electronic 
database separate from the data. 
Personally-identifying information will be delinked completely from the data set and all 
data will be presented in aggregate in any report.  
 
XIII. Statistical Plan 
For the pilot, we will descriptively analyze the Inputs versus Outcomes versus Combined 
groups. The treatment groups will also be compared to the historical control group. 
For the full study, the randomized design allows us to directly compare abstinence 
(longest duration and percent negative urine samples) between our different treatment 
arms as follows: 
1. Inputs Group vs. Outcomes Group 
2. Pooled Inputs and Outcomes Groups vs. pooled Control and Monitoring 
Groups 
3. Pooled Inputs and Outcomes Groups vs. Control Group 
4. Pooled Inputs and Outcomes Groups vs. Monitoring Group 
We will test for differences in the mean of our primary outcome variables – longest 
duration of abstinence and percent negative urine samples - using a two-tailed t-test at a 
95% confidence level.  We will control for baseline characteristics (e.g. time since most 
recent non-medical drug use at baseline, total time in treatment, and distance from clinic). 
We will also look at the heterogeneity by measures collected in the baseline survey and 
described above. Finally, we will conduct exploratory sub-analyses according to dosage 
history and number of times in treatment.  
Our target sample size of 200 patients in each of two incentives groups (Inputs and 
Outcomes), and 100 each in the Control and Monitoring groups is based on power 
calculations using patient outcome data from a similar patient population in a different 
health system. This sample size gives us power to detect minimum effects between the 
incentive groups of one additional week of continuous abstinence in our 12-week 
intervention, and a 7.5 percentage point increase in opioid-negative urine samples. 
 
XIV. Monitoring Plan 
Not applicable: the human research involves minimal risk to participants. 
The study has no premature stopping rule: it will continue until the target sample size is 
reached.   
 
XV. Regulatory Requirements 

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Consent will be acquired by a trained Research Assistant or the PI, who identifies eligible 
patients by assessing the Partial Hospitalization Program (PHP) or Intensive Outpatient 
(IOP) schedules or by clinician referral. Eligible persons will be provided a copy of the 
IRB-approved informed consent form to review. 
If prospective participants wish to consider the opportunity and weigh more information 
before signing consent in person or electronically, they will be permitted to do so without 
time constraints. However, they must be eligible to enroll at the time of enrollment.  
• The prospective participant will sit in a private space and have a chance to read 
through the consent with a study staff member present. Participants will be invited 
to discuss any questions or concerns with a study staff member who is authorized 
to witness the informed consent and will be provided as much time as they need 
to make an informed decision about study participation. The staff member will 
answer questions posed by the potential participant and clarify any issues that are 
brought up.  
• Prospective participants will be informed that neither study participation, 
voluntary withdrawal from the study, or discharge from the study will have any 
impact on any past, present nor future medical treatment they may receive at any 
Aurora Health Care treatment facility.  
• Prospective participants will be invited to include outside parties (e.g., spouse, 
family members, advocate, legal counsel, and/or independent specialist) to 
participate in the consenting process discussion, if desired. The site will not 
assume anyone external into the consenting process nor contact an external party 
without a prospective participant’s permission.   
• The study coordinators will review the consent document with potential 
participants, will answer questions about study treatments, and potential risks, 
conduct a review that indicates the potential participant’s understandings, and 
complete the signing process. Any identified gaps in understanding will then be 
addressed until resolved. 
• At that point, the patient and staff performing the consent will sign a physical or 
HIPAA-compliant virtual consent form. 
• All participants will be provided with a copy of their signed informed consent 
form to keep and will be encouraged to contact study staff with any questions that 
may arise at any time during the study. The original, signed informed consent 
form will be kept with the participant’s research chart. Individuals who are unable 
(for any reason) to provide voluntary informed consent will not be enrolled. 
• The PI will oversee and be responsible for the consenting process. 
• The PI and staff that are involved in the consenting process adhere to rigorous 
ethical principles in the conduct of research.  
XVI. References 

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Benishek, L. A., Dugosh, K. L., Kirby, K. C., Matejkowski, J., Clements, N. T., 
Seymour, B. L., & Festinger, D. S. (2014). Prize-based Contingency Management 
for the Treatment of Substance Abusers: A Meta-analysis. Addiction (Abingdon, 
England), 109(9), 1426–1436. https://doi.org/10.1111/add.12589 
Kurti, A. N., Davis, D. R., Redner, R., Jarvis, B. P., Zvorsky, I., Keith, D. R., … Higgins, 
S. T. (2016). A Review of the Literature on Remote Monitoring Technology in 
Incentive-Based Interventions for Health-Related Behavior Change. Translational 
Issues in Psychological Science, 2(2), 128–152. 
https://doi.org/10.1037/tps0000067 
Lussier, J. P., Heil, S. H., Mongeon, J. A., Badger, G. J., & Higgins, S. T. (2006). A 
meta-analysis of voucher-based reinforcement therapy for substance use 
disorders. Addiction, 101(2), 192–203. https://doi.org/10.1111/j.1360-
0443.2006.01311.x 
Petry, N. M., Alessi, S. M., Carroll, K. M., Hanson, T., MacKinnon, S., Rounsaville, B., 
& Sierra, S. (2006). Contingency management treatments: Reinforcing abstinence 
versus adherence with goal-related activities. Journal of Consulting and Clinical 
Psychology, 74(3), 592–601. https://doi.org/10.1037/0022-006X.74.3.592 
Schottenfeld, R. S., Chawarski, M. C., Pakes, J. R., Pantalon, M. V., Carroll, K. M., & 
Kosten, T. R. (2005). Methadone Versus Buprenorphine With Contingency 
Management or Performance Feedback for Cocaine and Opioid Dependence. 
American Journal of Psychiatry, 162(2), 340–349. 
https://doi.org/10.1176/appi.ajp.162.2.340