Contingency Management to Improve Medication for Opioid Use Disorder Continuation After Discharge From the Emergency Department
Phase: NA
Conditions: Opioid Use Disorder
Sponsor: University of Vermont

Human Subjects Research Protocol 
Project Title: Contingency Management to Improve Medication for Opioid Use Disorder 
Continuation After Discharge from the Emergency Department
Protocol Version Date: 
7/22/2025
Principal Investigator:
Eric A. Thrailkill, Ph.D. 
Check the type of the review:
X
Full convened meeting – The IRBs employ the convened meeting review process for review and approval of studies that are 
more than minimal risk. 
Expedited review – The IRBs employ the expedited review process for approval of studies that are determined to be minimal 
risk and only involves activities such as prospective collection of biological specimens for research purposes by noninvasive 
means (blood collection, salvia, nail clippings), collection of data through noninvasive procedures (ultrasounds, MRI, physical 
sensors) and research on behavior such as perception, cognition, motivation, identity, language and communication. 
Federal regulations mandate that changes cannot occur until after IRB review and approval “except when 
necessary to eliminate apparent immediate hazards to the subject.” 
ALL modifications to the approved study materials (including Click forms) must be submitted to the IRB 
prior to implementation, regardless of the magnitude of change or effect on risk level.
PURPOSE AND OBJECTIVES
Purpose:  The importance of the research and the potential knowledge to be gained should be explained in detail.  Give 
background information.
Annual opioid overdose deaths passed 100,000 in 2021 and opioid use disorder (OUD) remains an 
epidemic in the United States (Ahmad et al., 2024; Wilson et al., 2020). Medications for Opioid Use 
Disorder (MOUD) are effective for reducing illicit opioid use and overdose (Santo et al., 2021) but access 
to MOUD among US adults with opioid use disorder (OUD) remains low (27.8%; Mauro et al., 2021). 
Given the high overdose rate, hospital Emergency Departments (ED) have become the front line for 
the opioid epidemic. Consistent with recent national efforts to increase access to treatment (Cao et al., 
2020), the University of Vermont Medical Center ED began offering MOUD and referral to a community 
provider in 2023 with the Start Treatment and Recovery (STAR) program. The number of patients 
prescribed MOUD has increased and the method of facilitating treatment by utilizing the ED has potential 
for broader implementation which would save many lives. However, according to STAR program data, 
51% of individuals who receive ED-initiated MOUD fail to attend their referral appointment to continue 
MOUD after discharge, which is consistent with findings from other states (Jennings et al., 2021). This is 
particularly concerning given the risk for overdose is markedly high after an ED visit, with over 20% of 
deaths occurring within the first 30 days after discharge (Weiner et al., 2020). 
Contingency management (CM), wherein patients receive financial incentives contingent on 
behavior change (Higgins et al., 1994), is a standardized and highly effective intervention to promote 
behavior change (Lussier et al., 2006). Meta-analyses demonstrate that CM is effective at increasing 
MOUD adherence (Bolívar et al., 2021) but, to our knowledge, CM has not been tested as an intervention 
to increase treatment retention after discharge from the ED. Recently, there has been a call to consider 
modifications to CM protocols to address the overdose crisis more effectively (Khazanov et al., 2024). As 
such, this pilot project will adapt CM to improve MOUD continuation during the high-risk period 
following discharge from the ED. 
The proposed pilot trial will assess the initial effectiveness and feasibility of CM for increasing 
engagement in outpatient MOUD treatment following discharge from the ED. The proposed CM protocol 
will utilize best practices and will be adapted to MOUD dosing schedules that differ between 
buprenorphine and methadone (described below). The primary outcome will be the proportion of 
participants that complete the initial outpatient clinic visit and receive a MOUD prescription following 
CHRMS (Medical) #STUDY00003121 Approved: 7/28/2025 

2
Human subjects protocol form 
   IRB form version 6/21/2023
discharge from the ED as verified in the EHR. The secondary outcome will be percent of scheduled 
MOUD clinic appointments attended in a 30-day period following discharge from the ED. Exploratory 
outcomes will be biochemically verified illicit opioid abstinence recorded at 30-day follow up, and rates of 
overdose and ED return visits obtained from chart review and self-report. 
References: Include references to prior human or animal research and references that are relevant to the design and conduct of 
the study.
Ahmad FB, Cisewski JA, Rossen LM, Sutton P. Provisional drug overdose death counts. National Center 
for Health Statistics. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm
Bolívar HA, Klemperer EM, Coleman SR, DeSarno M, Skelly JM, Higgins ST. Contingency management 
for patients receiving medication for opioid use disorder: a systematic review and meta-analysis. 
JAMA psychiatry. 2021;doi:10.1001/jamapsychiatry.2021.1969
Cao SS, Dunham SI, Simpson SA. Prescribing buprenorphine for opioid use disorders in the ED: a review 
of best practices, barriers, and future directions. Open Access Emergency Medicine. 2020:261-274.
Higgins ST, Budney AJ, Bickel WK. Applying behavioral concepts and principles to the treatment of 
cocaine dependence. Drug and Alcohol Dependence. 1994;34(2):87-97. 
Jennings LK, Lane S, McCauley J, et al. Retention in treatment after emergency department-initiated 
buprenorphine. The Journal of emergency medicine. 2021;61(3):211-221. 
Lussier JP, Heil SH, Mongeon JA, Badger GJ, Higgins ST. A meta‐analysis of voucher‐based 
reinforcement therapy for substance use disorders. Addiction. 2006;101(2):192-203. 
Mauro PM, Gutkind S, Annunziato EM, Samples H. Use of medication for opioid use disorder among US 
adolescents and adults with need for opioid treatment, 2019. JAMA network open. 
2022;5(3):e223821-e223821. 
Raiff BR, Jarvis BP, Turturici M, Dallery J. Acceptability of an Internet-based contingency management 
intervention for smoking cessation: views of smokers, nonsmokers, and healthcare professionals. 
Experimental and Clinical Psychopharmacology. 2013;21(3):204-216.
Santo T, Clark B, Hickman M, et al. Association of opioid agonist treatment with all-cause mortality and 
specific causes of death among people with opioid dependence: a systematic review and meta-
analysis. JAMA psychiatry. 2021;78(9):979-993. 
Weiner SG, Baker O, Bernson D, Schuur JD. One-year mortality of patients after emergency department 
treatment for nonfatal opioid overdose. Annals of emergency medicine. 2020;75(1):13-17. 
Wilson N, Kariisa M, Seth P, Smith IV H, Davis NL. Drug and opioid-involved overdose deaths—United 
States, 2017–2018. Morbidity and Mortality Weekly Report. 2020;69(11):290.
Objectives:  Clearly state the primary and secondary objective(s) of the study.
The proposed pilot trial will assess the initial effectiveness and feasibility of CM for increasing engagement 
in outpatient MOUD treatment following discharge from the ED. The proposed CM protocol will utilize best 
practices and will be adapted to MOUD dosing schedules that differ between buprenorphine and methadone 
(described below). 
The primary outcome will be the proportion of participants that complete the initial outpatient clinic visit 
and receive a MOUD prescription following discharge from the ED as verified in the EHR. 
The secondary outcome will be percent of scheduled MOUD clinic appointments attended in a 30-day period 
following discharge from the ED. 
Exploratory outcomes will be biochemically verified illicit opioid abstinence recorded at 30-day follow up, 
and rates of overdose and ED return visits obtained from chart review and self-report. 
CHRMS (Medical) #STUDY00003121 Approved: 7/28/2025 

3
Human subjects protocol form 
   IRB form version 6/21/2023
The research team for the planned study includes the STAR program staff and administrators that regularly 
conduct the STAR program in the ED. STAR staff will approach individuals deemed research eligible by 
the attending physician in the ED. STAR staff will conduct informed consent procedures, deliver study 
payment cards with use instructions, and provide study materials (baseline assessment) in the ED.
Once enrolled in the study, individuals will be assigned to either continue best practices in ED care 
delivered by the STAR program (BP) or to receive BP plus contingency management (BP+CM). We will 
measure adherence in the form of completing the outpatient clinic intake appointment and receiving 
MOUD, and MOUD prescriptions across the first 30-days post discharge from the ED.
We will randomize 30 adults who initiated MOUD in the ED to: 
(A) BP alone: Best practices will consist of STAR program referral in ED to local outpatient services 
(Addiction Treatment Center at the University of Vermont Medical Center [UVMMC] or 
Chittenden Clinic) with reminders and support from STAR program staff. 
(B) BP+CM: In addition to BP, participants will receive financial incentives contingent upon MOUD 
clinic attendance to receive an MOUD prescription. Incentives will be contingent on provider or 
electronic health records (EHR) verification of a filled MOUD prescription. Participants in the 
BP+CM condition will have the opportunity to earn a maximum of $485 over 30 days. The 
incentives will consist of a $15 priming incentive in the ED, $50 for attending the first outpatient 
visit, and the remaining $420 distributed evenly according to the number of scheduled clinic visits 
attended during the 30 days following discharge from the ED.
For example, participants who are prescribed methadone and visit the Chittenden Clinic to pick up their 
prescription daily will earn $15/per visit, while those prescribed buprenorphine and visit the ATC to pick 
up their prescription once every 3 days will earn $45/per visit. Note that individuals vary in the number of 
days between MOUD doses but we will adjust the payment so that the amount is equivalent to $15 per day. 
Individuals prescribed methadone and buprenorphine will have the potential to earn the same total amount 
but distributed according to clinical requirements for their respective prescribed MOUD. Participants in 
BP-alone and BP+CM conditions will receive $55 for completing assessments at baseline (in the ED) and 
30-day follow up (in clinic), for a total of $110.
This two-arm pilot randomized clinical trial has two specific aims: 
Specific Aim 1: Provide a preliminary test of whether BP+CM is more effective than BP alone at 
promoting MOUD clinic attendance after discharge from the ED. 
Hypothesis 1.1: BP+CM will increase the proportion of participants who initiated MOUD in the ED 
that complete outpatient intake assessment and receive a MOUD prescription.
Hypothesis 1.2: Individuals in the BP+CM condition will complete a higher percentage of MOUD 
clinic appointments during the 30-day study period.
Specific Aim 2: Demonstrate feasibility of providing CM in the ED and outpatient MOUD clinic settings.  
Hypothesis 2.1: The study team will successfully recruit and consent 30 patients in the ED who meet 
inclusion criteria.
Hypothesis 2.2: The CM protocol will prove to be feasible across both outpatient clinics by delivering
incentives in response to all MOUD prescriptions, as confirmed by monitoring BP+CM participants’ 
EHR.
Exploratory Aim: Explore the potential for BP+CM to increase illicit opioid abstinence and decrease harm.
Hypothesis 3.1: BP+CM will have a greater proportion of biochemically verified illicit opioid negative 
urine screens recorded at the 30-day follow up compared to BP.
CHRMS (Medical) #STUDY00003121 Approved: 7/28/2025 

4
Human subjects protocol form 
   IRB form version 6/21/2023
Hypothesis 3.2: BP+CM will decrease the number of overdoses self-reported and recorded (as 
indicated by chart review) by participants during the 30-day study period compared to BP. 
Hypothesis 3.3: BP+CM will decrease ED visits (indicated in chart review) during the 30-day study 
period compared to BP.
SUBJECT CHARACTERISTICS, 
IDENTIFICATION AND 
RECRUITMENT
Subject Selection:  Provide rationale for subject selection in terms of the scientific objectives and proposed study design.
To assess whether incentives improve outpatient visits for individuals prescribed MOUD in the ED, 
participants will be individuals from the ED that receive MOUD prescription (methadone or 
buprenorphine) and referral to an outpatient clinic (Addiction Treatment Center and Chittenden Clinic) 
through the STAR program.
Vulnerable Populations:  Explain the rationale for involvement of subjects (e.g., cognitively impaired, non-English speaking, 
prisoners, students).  Discuss what procedures or practices will be used in the protocol to minimize their susceptibility to undue 
influences and unnecessary risk (physical, psychological, etc.).
Not applicable
Subjects will be individuals with OUD as documented by physicians and medical staff in the ED. This is a 
vulnerable group for which we plan to assess a potentially life-saving intervention. There is potential for 
undue influence created by impairment. We will follow standard procedures in the ED for determining 
capacity to provide consent. Specifically, STAR staff in the ED will consult with the attending physician in 
the ED to determine whether impairment precludes consent to enter the study. Per the existing STAR 
protocol, ED patients will only be approached after confirming with the patient's ED clinical team that the 
patient has the capacity to provide informed consent and is appropriate to approach.
Inclusion/Exclusion Criteria:  Eligibility and ineligibility criteria should be specific. Describe how eligibility will be determined, by 
whom and how it will be documented in the research record.  
Please note:  Inclusion and exclusion criteria must be documented for all criteria (e.g., EPIC notes, eligibility checklist with associated 
source documents, notes to file). Participant reported information must be documented in the research record; a lack of 
documentation does not prove absence of a criteria. 
Inclusion and exclusion criteria will be minimal to recruit a diverse population of individuals and to meet 
study goals for assessing the feasibility of the CM intervention in a hospital ED setting.
Inclusion Criteria
-STAR referral to outpatient clinic (Addiction Treatment Center and Chittenden Clinic) with prescription for 
buprenorphine or methadone.
-Age ≥18 years.
-Provide informed consent.
Exclusion Criteria
-Pending incarceration in the next 30 days.
-Plan to leave the area (Burlington/Chittenden County) in the next 30 days.
-Physical, health, or structural challenge that prevents attendance at outpatient clinic.
CHRMS (Medical) #STUDY00003121 Approved: 7/28/2025 

5
Human subjects protocol form 
   IRB form version 6/21/2023
Inclusion of Minorities and Women:  Describe efforts to include minorities and women.  If either minorities or women are excluded, 
include a justification for the exclusion.
We will do everything we can to include minorities and women in the study. Frequency of ED admittance 
will influence opportunity to enroll individuals from these groups.
Inclusion of Children: Describe efforts to include children.  Inclusion is required unless a clear and compelling rationale shows that 
inclusion is inappropriate with respect to the health of the subjects or that inclusion is inappropriate for the purpose of the study.  If 
children are included, the description of the plan should include a rationale for selecting or excluding a specific age range of children.  
When included, the plan must also describe the expertise of the investigative team in working with children, the appropriateness of 
the available facilities to accommodate children, and the inclusion of a sufficient number of children to contribute to a meaningful 
analysis relative to the purpose of the study.  Provide target accrual for this population. Identify whether children are wards of the 
state. If children are excluded then provide appropriate justification.
We will not include individuals aged <18 years as these individuals do not typically receive referrals to 
outpatient clinics to receive MOUD prescribed in the ED.
For protocols including the use of an investigational drug, indicate whether women of childbearing potential have been included and, 
if not, include appropriate justification.
n/a
If HIV testing is included specifically for research purposes explain how the test results will be protected against unauthorized 
disclosure.  Include if the subjects are to be informed of the test results.  If yes, include the process and provision for counseling.  If 
no, a rationale for not informing the subjects should be included.
X
Not applicable
Will the SONA Psychology Pool be utilized? Include documentation indicating permission to use this 
recruiting tool 
Yes
No
X
METHODS AND PROCEDURES
Study Design: Describe the research design, including a description of any new methodology and its advantage over existing 
methodologies.
This proposed two-arm pilot randomized clinical trial will randomize 30 adults who initiated MOUD in the 
ED to (A) BP + CM or (B) BP alone. 
We will record clinic attendance as evidence that an MOUD prescription was dispensed as reported by a 
Chittenden Clinic or Addiction Treatment Center provider or as recorded in the participant’s electronic health 
record (EHR) by the attending physician. This binary variable will be recorded for all participants for a 30-
day period following discharge from the ED. Participants will complete a follow-up visit on day 30 which 
will consist of a urine drug screen and questionnaires (acceptability, self-reported abstinence, self-reported 
overdose). Participants will be allowed a 10-day window to complete the follow-up visit.
Procedures and Methods:  Describe all procedures (sequentially) to which human participants will be subjected. Describe required 
screening procedures performed before enrollment and while on study. Identify all procedures that are considered experimental 
and/or procedures performed exclusively for research purposes. Describe the types, frequency and duration of tests, study visits, 
interviews, questionnaires, etc. 
Note: A clinical research protocol may involve interventions that are strictly experimental, or it may involve some aspect of research 
(e.g., randomization among standard treatments for collection and analysis of routine clinical data for research purposes). It is 
important for this section to distinguish between interventions that are experimental and/or carried out for research purposes versus 
those procedures that are considered standard therapy. In addition, routine procedures performed solely for research purposes (e.g., 
additional diagnostic/follow-up tests) should be identified.
CHRMS (Medical) #STUDY00003121 Approved: 7/28/2025 

6
Human subjects protocol form 
   IRB form version 6/21/2023
Staff that coordinate the STAR program will identify eligible participants. The order of events are expected to 
proceed as follows:
In the ED:
1. Standard STAR procedures: (Note these procedures are described for informational purposes and 
are not part of this protocol; these all occur prior to consent for this study)
o
OUD diagnosis confirmed and Clinical Opioid Withdrawal Scale (COWS) completed. 
o
Patient submits sample for Drug Screen 11, Urine (whenever possible). 
o
Patients are provided with an initial dose of buprenorphine or methadone. 
2. Screening: Patients identified as eligible by STAR research team are screened for study. STAR 
research staff in the ED explains the CM trial and, if interested, patient signs consent form. Patient 
also signs a HIPAA authorization for release of protected health information and multi-party release 
form for either the Howard Center Chittenden Clinic if prescribed methadone, or Addiction Treatment 
Center if prescribed buprenorphine.
o
If they decline to participate, they will continue to receive treatment as usual from the STAR 
program, including the STAR baseline survey
3. Randomization: Participants are randomized to BP condition or BP+CM condition.
o
All participants will receive a Focus Blue Visa card in the ED.
o
All participants will receive instructions on payment acknowledgement forms (PAF) and 
complete their first form in the ED on REDCap.
4. STAR baseline survey: Participants will be informed that approximately 25% of the STAR baseline 
survey questions are the same as the research baseline survey questions, so study staff will be 
documenting their responses to those questions twice: Once on a clinical form (for STAR) and once 
on a separate research form (for the research study). We will inform them each time a question applies 
to both the research study and the STAR clinical service. They will have the option to skip any 
question at any time or withdraw from the research study at any time and continue to receive clinical 
treatment. The baseline survey will be administered by interview and responses will be recorded on a 
study iPad into a secure REDCap form or by paper-and-pencil to be entered into REDCap later 
depending on participant preference and/or wifi connectivity. 
o
Staff will document the ~25% of baseline questions that apply to both the STAR clinical 
service and the financial incentive research study twice, on separate forms. The research data 
will always be stored separately from the clinical data as Staff will recorded the data in a 
secure REDCap form. Staff will use a study iPad to enter data into REDCap research form at 
the same time as the clinical form, or later from paper-and-pencil depending on participant 
preference and/or wifi connectivity.
5. ED Staff submits EPIC referral.
6. Depending on type of MOUD prescribed, referral will direct participants to services at the Addiction 
Treatment Center (ATC) or Chittenden Clinic. The consent process in the ED is expected to take 1-2 
hr.
o
For Buprenorphine:

Patient provided with Buprenorphine in the ED per STAR workflow. 

Note this medication is administered as BP per STAR procedures. This protocol 
does not alter or supersede ongoing STAR program activities in the ED.

Buprenorphine in the ED by STAR is an initial “bridge” prescription to span the 
time between ED discharge and the scheduled outpatient clinic intake. Bridge 
CHRMS (Medical) #STUDY00003121 Approved: 7/28/2025 

7
Human subjects protocol form 
   IRB form version 6/21/2023
prescriptions consist of take-home doses for buprenorphine until the date of the 
scheduled outpatient clinic intake.

Patient given instructions to come to ATC promptly at 10:00am the following business 
day + reminder of incentive that will be earned if in BP+CM condition.
o
For Methadone:

Patient provided with Methadone in the ED per STAR workflow. 

Note this medication is administered as BP per STAR procedures and is not part 
of this protocol.

Per STAR protocols, methadone bridge prescriptions consist of daily doses of 
methadone from the ED until the date of the scheduled outpatient clinic intake.

The present protocol does not supersede BP that are ongoing in the ED as part 
of the STAR program.

ED provider refers them directly to Howard Center Chittenden Clinic and provides info 
sheet on walk-in hours @ 7:15am + reminder of incentive that will be earned if in 
BP+CM condition.
Outpatient Treatment Provider:
1. Study Staff in will monitor MOUD prescription via EHR or by receiving attendance data from 
provders at the Chittenden Clinic/Howard Center or Addiction Treatment Center/UVMMC. Number 
of prescriptions is experimental data.
2. Participant attends clinic, prescription is dispensed and entered into patient EHR by dispensing 
physician.
3. If prescription is confirmed and patient is in BP+CM condition, Study Staff will contact patient 
(patient preference of text message/email/phone call) to deliver a notice of incentive delivery and 
deliver link to complete PAF on REDCap. 
a.
Note that Addiction Treatment Center and Chittenden Clinic Staff will notify Study Staff of 
participant attendance by marking a checkbox next to participant code in a REDCap form. 
While Addiction Treatment Center and Chittenden Clinic staff provide data via REDCap 
surveys, they will not have access to participant research data or the REDCap projects. Study 
Staff will administer PAF and payment to participants at each clinic.
4. Study Staff monitors REDCap form and supports participant in case of trouble accessing online form. 
5. Once PAF is completed, Study Staff transfers incentive to participant’s Focus Blue Visa card and 
sends message to notify participant of incentive delivery.
30-day Follow up and Study Termination:
1. As part of standard protocol, STAR staff will contact participants each week.
2. For participants enrolled in the study, STAR will include a reminder to come to the clinic to complete 
a 30-day follow-up survey and urine drug screen administered by the study staff in UHC. 
3. All participants that complete this survey will receive $55 in compensation delivered to the Focus 
Blue card (with completed PAF). The follow-up survey is experimental data.
4. Participants will have a 10-day window to complete the 30-day follow-up appointment. 
Assessments:
Clinical Opioid Withdrawal Scale (COWS) – Tool to assess signs and symptoms of opioid withdrawal 
[ClinicalOpiateWithdrawalScale.pdf] – Administered in ED by STAR staff. Study staff will have access to 
these measures and coded data will be recorded in REDCap.
CHRMS (Medical) #STUDY00003121 Approved: 7/28/2025 

8
Human subjects protocol form 
   IRB form version 6/21/2023
Baseline Survey: Demographic and substance use questionnaire administered at study intake in the ED 
[Baseline_questionnaire_3-10-25.docx]. Administered by STAR staff on an iPad. Study staff will have access 
to these measures and coded data will be recorded in REDCap.
Follow up survey: Items on number ED visits and overdoses in the past 30 days. Did receiving payments 
influence whether you can to the clinic? Treatment acceptability items (Raiff et al., 2013) - Responses to 
individual questions using a 100-mm visual analog scale (1 = lowest satisfaction, 100 = greatest satisfaction). 
1) overall satisfaction; 2) acceptability of receiving payments; 3) belief that program needs were met 
(response options: did not meet my needs at all, only met a few of my needs, met most of my needs, met 
almost all of my needs); 4) satisfaction with the program (Quite Dissatisfied, Dissatisfied, Mildly Satisfied, 
Very Satisfied); 5) willingness to participate again in the future (Definitely Not, Probably Not, Probably So, 
Definitely So). Administered by clinic staff at 30-day follow-up visit. Coded data will be recorded in 
REDCap.
Treatment:
Usual Care – All participants (BP and BP+CM conditions) will receive standard outpatient care at their clinic.
Study Compensation - Once consented, eligible participants will be issued a study Visa card (FocusBlue, US 
Bank). All compensation will be administered to this card.
Incentives – Participants assigned to the BP+CM condition will be eligible to receive additional incentives 
delivered to their Study Visa card by study staff. 
TYPES OF PROCEDURES (Please do not use the “other” option unless the procedure is not listed.)
Check all that apply
X
Survey (mail, telephone, in-
person, on-line)
Blood 
drawing:
Vol.
Over days, 
weeks?
X
Medical exams/history
Type & Amt.
Deception *see below
Surgery
X
Collection of Urine and/or Feces
Observation
Drug Administration 
Communicable Disease Testing
Photographs
Device Use 
Ultrasound (e.g., echocardiogram)
Audio Recording
Exercise
Imaging (e.g., CT scan, DEXA, mammogram, PET scans, 
SPECT)
Video Recording
Diet
Use of Radiation treatment
Interviews in person or by 
phone
Pathology Specimens 
(retrospective)
Use of Radioactive substances (e.g., 
radiolabeled antibodies, drugs, or contrasts)
Focus Groups
Genetic Materials (DNA)** 
see below
MRI (for treatment studies)
Review of prospective data
X
Questionnaires
MRI (not for treatment studies)
Review of retrospective data
Diaries
Tissue (obtained for clinical purposes)
X
Pregnancy Tests
Tissue (obtained solely for research)
Recording of Identifiable 
Data
Electrocardiograms
X
Sensitive Data (criminal or sexual conduct, drug or 
alcohol conduct or use)
(specify): 
Individuals enrolled in the study will be in 
outpatient treatment for opioid use and 
receiving medications for opioid use disorder
Drug use information is involved since all 
participants are prescribed MOUD. 
Procedures therefore involve personal health 
information that is related to a substance use 
disorder and subject to 42 CFR Part 2.
The main risk is breach of confidentiality. We 
have taken steps to mitigate this risk. Risk for 
breach of confidentiality is very low (<10%).
**If genetic information is being collected, GINA language must be added to the consent form.
*Deception typically involves withholding information from the potential subject and would require an alteration to 
CHRMS (Medical) #STUDY00003121 Approved: 7/28/2025 

9
Human subjects protocol form 
   IRB form version 6/21/2023
the consent process.
If you are requesting Radiology services (equipment and professional needs)  you will need to contact the 
Radiology Research Coordinator John.Little@uvmhealth.org and complete this form.
Statistical Considerations: Delineate the precise outcomes to be measured and analyzed. Describe how these results will be 
measured and statistically analyzed. Delineate methods used to estimate the required number of subjects. Describe power 
calculations if the study involves comparisons.  Perform this analysis on each of the primary and secondary objectives, if possible.
Outcomes to be measured and analyzed. The primary outcome data will be daily MOUD prescription 
dispensing for each participant. Staff at Addiction Treatment Center and Chittenden Clinic will enter 
attendance data into REDCap survey forms. Once participants complete the study, we will conduct a 
retrospective chart review and record overdose and ED admission during the 30-day study period for all 
participants. All data (baseline questionnaire, prescription dispensing, follow-up surveys, chart review, 
urinalysis) will be entered into REDCap will be coded for further analysis. 
Statistical methods. Baseline participant characteristics, including sociodemographic information, will be 
compared between the two conditions using analyses of variance for continuous, and chi-square tests for 
categorical variables. Differences between conditions at baseline will be considered as potential covariates in 
subsequent analyses. Our primary analysis will include all randomized participants. Missing survey data will 
be imputed using multiple imputation. 
The proportion of participants who receive an MOUD prescription following discharge from the ED is the 
primary outcome of interest. A secondary outcome will be the proportion of participants who remained in 
outpatient MOUD treatment at the end of the 30-day study period between BP+CM and BP conditions. An 
exploratory outcome will be biochemically verified illicit opioid abstinence during the 30-day study period. 
Comparisons will be made using logistic regression and ANOVA. Analyses will be performed using SAS 
Statistical Software V9.4 (SAS Institute, Cary, NC). Statistical significance will be determined based on 
p<.05 for all analyses. 
Sample size justification. This is a pilot trial and intended to provide an estimate of effect size upon 
which to base future power analyses. Planned sample size is based on previous pilot trials using CM 
conducted by our group. Meta analyses (Lussier et al., 2006; Bolivar et al., 2021) suggest about twice the 
outcome in the CM condition. We expect an effect size to be consistent with these prior meta-analyses: Cohen 
d=0.32 [95% CI, 0.15–0.47] to Cohen d=0.58 [95% CI, 0.30-0.86].    
Risks:  Describe any potential or known risks.  This includes physical, psychological, social, legal or other risks (including breach of 
confidentiality, which is always a risk when collecting identifiable information).  Estimate the probability that given risk may occur, its 
severity and potential reversibility.  If the study involves a placebo or washout period, the risks related to these must be addressed in 
both the protocol and consent.  Describe the planned procedures for protecting against or minimizing potential risks and assess their 
likely effectiveness.  Where appropriate, discuss plans for ensuring necessary medical or professional intervention in the event of 
adverse effects to the subjects.   
Breach of confidentiality – Study data include contact information, socio-demographic characteristics, 
medical history, and opioid use information. The risk of a breach of confidentiality is low and we will take 
precautions to minimize this risk as described below in the Protection Against Risks section.
Opioid withdrawal – Participants who succeed in transitioning to MOUD may experience withdrawal 
symptoms (i.e., anxiety, depression, difficulty concentrating, hunger/weight gain, insomnia, irritability and 
restlessness).
Protection Against Risks 
CHRMS (Medical) #STUDY00003121 Approved: 7/28/2025 

10
Human subjects protocol form 
   IRB form version 6/21/2023
Risk for breach of confidentiality will be addressed by utilizing staff in the UVMMC and Chittenden 
Clinic/Howard Center that possess credentialed access to electronic health records (EHR). Study staff will 
monitor REDCap and EHR for provider entries that indicate the participant has received their prescription. 
Once identified, staff will notify participants of payment pending completion of a REDCap PAF. Study staff 
will send a link to complete the form online or arrange a meeting with the participant to complete the form. 
Once the PAF has been completed, staff will administer the incentive to the study Visa card using the Focus 
Blue platform. Breach of confidentiality is unlikely (0-10% chance) due to trained study staff managing 
identifiable information.
Participants will be informed about possible AEs related to MOUD in the consent form. At study onset, 
participants will be provided with a phone number and e-mail to report any AEs that are urgent. We will 
withdraw participants who have an FDA-defined serious AE (SAE) that are likely or probably related to the 
study procedures. Traditional methods of collecting AEs can be insensitive, thus we will instruct participants 
to contact research personnel if they experience a severe AE. We will encourage participants to contact 
research personnel if they have questions about withdrawal symptoms or believe any withdrawal symptoms 
require treatment, which is part of Best Practices care that MOUD patients receive. 
Potential participants are free not to participate in this study and participants are free to withdraw at any 
time and still receive Best Practices care. Potential participants who screen ineligible or do not consent to 
participate will be provided with Best Practices care as conducted by the STAR program within the ED, this 
includes, but is not limited to, resources to access OUD treatment, including MOUD, outside of this study.
Benefits:  Discuss the potential benefits of the research to the subjects and others.  Discuss why the risks to the subjects are 
reasonable in relation to the anticipated benefits to subjects and others.  Discuss the importance of the knowledge gained or to be 
gained as a result of the proposed research and why the risks are reasonable in relation to the knowledge that reasonably may 
result.  If there are no benefits state so.
Therapeutic Alternatives:  List the therapeutic alternatives that are reasonably available that may be of benefit to the potential 
subject and include in the consent form as well.
Not Applicable
Benefits
The potential benefits to the subjects include reduced risk of mortality due to opioid overdose. Participation in 
this study could increase the chances of illicit opioid cessation and prevent long-term morbidity and mortality 
from illicit opioid use. This research also stands to provide scientific benefit by improving understanding of 
incentives to promote outpatient clinic attendance. Further, the intervention tested in this research has the potential to 
benefit public health by decreasing the substantial personal and societal costs associated with illicit opioid use in the 
United States. Thus, we believe the risks to participation in the proposed research are reasonable in relation to the 
anticipated benefits. 
Therapeutic Alternatives 
Referral to outpatient clinics with follow-up calls from STAR staff is the standard procedure in the STAR 
program operated in the ED. Best Practices is offered to every MOUD-eligible patient in the ED, as well as 
included in each study condition (BP+CM and BP).
Data Safety and Monitoring: Please note that this is not the same as the Data Management and Security Plan that will be uploaded 
as a separate document. 
Describe the data and safety monitoring plan (DSMP).  This should provide for a regular review of accrued research data and other 
relevant information to ensure the validity and integrity of the data and that there is no change to the anticipated benefit-to-risk ratio 
of study participation.  In addition, there should be an ongoing review of study procedures to ensure that the privacy of research 
subjects and the confidentiality of research data has not been violated. 
CHRMS (Medical) #STUDY00003121 Approved: 7/28/2025 

11
Human subjects protocol form 
   IRB form version 6/21/2023
The specific design of a DSMP for a protocol may vary extensively depending on the potential risks, size, and complexity of the 
research study.  For a minimal risk study, a DSMP could be as simple as a description of the Principal Investigator’s plan for 
monitoring the data and performance of safety reviews or it could be as complex as the initiation of an external, independent Data 
Safety and Monitoring Board (DSMB). The UVM/UVM Medical Center process for review of adverse events should be included in the 
DSMP.
Patient eligibility and status
All intake data collection will be conducted online using a secure platform (e.g., REDCap). The PI and 
trained IRB-approved research personnel will review intake data as needed to determine eligibility. 
Research personnel and the PI will review the status of all active participants during weekly study 
meetings. 
Rigorous data management/Quality assurance
All data will be collected via secure, HIPAA-compliant software (e.g., REDCap). All data will be 
collected using self-report questionnaires and EHR. All participant data will be directly loaded from the 
secure online surveys (e.g., REDCap) to the secure UVMMC server. Participants’ identities will be 
disguised using ID numbers keyed to a master list. Identifying information such as telephone number and 
email address will be stored in a separate, secure, and password protected data file. All data will be 
accessible to only the PI and IRB-approved research personnel. The IRB approved biostatistician and PI 
will consult regularly to discuss ongoing data management and any problems that arise.
Data and safety monitoring plan
Weekly monitoring of data quality and integrity will be conducted by the study team and evaluated 
monthly by the PI. The study Medical Monitor, James Whitledge, MD will provide independent feedback 
and monitoring of the quality and safety of the study measures.
The study team will meet each week to monitor and evaluate the 1) study progress and 2) safety of the 
proposed pilot trial. With regard to study progress, screening, recruitment, and retention, data will be 
reviewed on a regular basis to assure that the study can be completed in a reasonable time frame to be of 
significant clinical relevance. With regard to safety, interim safety data for the trial will be reviewed on a 
regular basis in order to assure the continuing safety of participants. Of note, all serious adverse events, 
study or non-study related, will be reported to the IRB by the PI within 72 hours of the PI learning of the 
event. Any study-related IRB actions will be reported to the NIGMS by the PI within 72 hours of the PI 
learning of the action.
Participants will be informed about possible AEs related to MOUD in the consent form. At study onset, 
participants will be provided with a phone number and e-mail to report any AEs that are urgent. We will 
withdraw participants who have an FDA-defined serious AE (SAE) that are likely or probably related to 
the study procedures. Traditional methods of collecting AEs can be insensitive, thus we will instruct 
participants to contact research personnel if they experience a severe AE. We will encourage participants to 
contact research personnel if they have questions about withdrawal symptoms or believe any withdrawal 
symptoms require treatment, which is part of Best Practices care that MOUD patients receive.
Auditing procedures
The PI and study personnel will meet weekly to review any problems related to the quality of data 
collection and any AEs or SAEs that occurred during the past week. In addition, we will conduct an interim 
analysis of AEs halfway through data collection as well as interim analyses of AEs required by the DSMB. 
We will present findings from all interim analyses to the DSMB. 
Define criteria to be used for decision making regarding continuation, modification, or termination of the entire study (not individual 
participation) (i.e. stopping rules).
CHRMS (Medical) #STUDY00003121 Approved: 7/28/2025 

12
Human subjects protocol form 
   IRB form version 6/21/2023
Continuation will be determined based on the status of participant recruitment. Modifications will be made 
in response to Unanticipated Problems (UAPs) and otherwise at the discretion of the study PI. 
Termination criteria include sudden discontinuation of ability to conduct study (e.g., participant payment 
can no longer be delivered; change in rules regarding PAF; discontinuation of STAR program in ED). 
What will be the frequency of the review?  Please note that the frequency of reviews should be commensurate with the risk of 
the study.  At a minimum, a review of the data should be conducted annually at time of continuing review.  These reviews must be 
conducted at the frequency indicated below and must be documented in the regulatory binder or files.  
Forward copies of data and safety monitoring board reports to the IRB via a modification.
Monthly
x
Annually
Quarterly
Other (e.g., by dosing level, no. of subjects enrolled):
Bi-annually
Will the sponsor be conducting data monitoring visits for this study?
Yes
X
No
NA
If yes, how often?
Adverse Event, Unanticipated Problem (UAP), Reportable New Information (RNI):  Describe how events and UAPs will be 
evaluated and reported to the IRB.  All protocols should specify that, in the absence of more stringent reporting requirements, the 
guidelines established in “Section 18: Reportable New Information” of the IRB Policies and Procedures will be followed.  
UAPs will be evaluated and reported to the IRB by the study PI. Correspondence regarding modifications to 
the protocol will be handled by the study PI or designated staff. Guidelines established in “Section 18: 
Reportable New Information” of the IRB Policies and Procedures will be followed.
Withdrawal Procedures:  Define the precise criteria for PI withdrawal of subjects from the study.   Include a description of study 
procedures for when a subject withdraws themself from the study.
Since our primary measure is the proportion of participants who receive an MOUD prescription following 
discharge from the ED, study withdrawal is a primary outcome in this study. If a participant discontinues 
outpatient clinic attendance, we will not attempt to contact them. 
Participants may be withdrawn from the study based on the judgement of the PI following consultation with 
study staff and/or clinicians. 
DRUG INFORMATION
Investigators are encouraged to consult the UVM Medical Center Investigational Pharmacy Drug Service (847-4863) prior to 
finalizing study drug/substance procedures.
Drug (s)
X
Not applicable
Drug name – generic followed by brand name and common abbreviations. Availability – Source and pharmacology; vial or product 
sizes and supplier.  If a placebo will be used, identify its contents and source. 
Preparation:  Reconstitution instructions; preparation of a sterile product, compounded dosage form; mixing guidelines, including fluid 
and volume required.  Identify who will prepare.
Storage and stability – for both intact and mixed products.
Administration – Describe acceptable routes and methods of administration and any associated risks of administration.
Toxicity – Accurate but concise listings of major toxicities.  Rare toxicities, which may be severe, should be included by indicated 
incidence.  Also, adverse interactions with other drugs used in the protocol regimen as well as specific foods should be noted.  
Address significant drug or drug/food interactions in the consent form as well.  List all with above details.
CHRMS (Medical) #STUDY00003121 Approved: 7/28/2025 

13
Human subjects protocol form 
   IRB form version 6/21/2023
Is it FDA approved: (include FDA IND Number)
1.  in the dosage form specified?  If no, provide justification for proposed use and source of the study drug in that form.
2.  for the route of administration specified?  If no, provide justification for route and describe the method to accomplish.
3.  for the intended action?
FINANCIAL CONSIDERATIONS 
Describe all potential research related expenses to subjects:  
Study payments will be conducted via online form. Participants may encounter costs associated with data 
charges from their cell phone provider. There will be no additional cost to participants for any aspect of this 
research study. 
Compensation for participation:  Describe all plans to pay subjects, either in cash, a gift or gift certificate. Please note that all 
payments must be prorated throughout the life of the study. The IRB will not approve a study where there is only a lump sum 
payment at the end of the study because this can be considered coercive. The amount of payment must be justified. Clarify if 
subjects will be reimbursed for travel or other expenses.
Not applicable
Figure 1. 
Schedule of payments for each study condition.
Note. This schedule shows maximum possible payment for individuals prescribed methadone and 
buprenorphine under idealized conditions. 
Figure 1 shows a diagram of the possible payments earned during the study. Participants randomized to 
the BP+CM condition have the potential to receive $595 in compensation. Those randomized to the BP-alone 
condition have the potential to receive $110 in compensation for completing assessments in the ED and in the 
outpatient clinic at 30-day follow up. The figure is intended to illustrate the flexibility of the payment 
schedule for delivering incentives according to the different frequencies of clinic attendance that characterize 
buprenorphine and methadone treatment. 
Compensation During the Study
All participants will receive study compensation via a US Bank Focus Blue Visa card. Once enrolled in 
the study in the ED, study staff will issue participants a Focus Blue card along with instructions on how to 
access the card balance via the web or phone and how to contact study staff to replace a card if lost or 
CHRMS (Medical) #STUDY00003121 Approved: 7/28/2025 

14
Human subjects protocol form 
   IRB form version 6/21/2023
damaged. Upon receipt, the card will be loaded with compensation for the study screening and consent ($55) 
to account for additional time spent completing questionnaires and eligibility assessments. 
All participants who complete the follow-up assessment on Day 30 will be compensated $55 to account 
for additional time spent completing questionnaires and debriefing.
BP-alone condition: In the ED, participants in the BP-alone condition will receive clinic referral 
materials along with their prescription. Study staff will make contact with each BP-alone participant 
on a weekly basis to increase chances of retention at 30-day follow up.
BP+CM condition: In the ED, participants in the BP+CM condition will receive clinic referral 
materials and instructions on the payment schedule and notified of the $50 intake incentive to be 
delivered upon completion of the first outpatient clinic visit. Their card will also be preloaded with the 
($15) incentive for their first prescription pickup in the ED (the total amount loaded upon receipt of 
the card will be $70). 
Each subsequent outpatient clinic visit completion (as communicated by Clinic staff to Study staff  
through REDCap) will be compensated. The incentive amount delivered to the card will depend on the 
number of days since the last verified attendance such that the amount increments by $15 each day 
(Figure 1). STAR program data show that approximately half of individuals referred to MOUD 
treatment in the ED receive prescriptions for methadone and half receive prescriptions for 
buprenorphine. Methadone prescriptions are typically filled at the outpatient clinic each day whereas 
buprenorphine prescriptions can be filled once every 3-5 days. The study is designed to address this 
natural variation in clinic attendance frequency by matching the total incentive amount across 
participants prescribed buprenorphine and methadone. As shown in Figure 1, a daily incentive value 
($15) will be possible and otherwise allowed to accumulate each day between visits (e.g., 
buprenorphine outpatient visit on Friday had last visited on Monday receives 4x$15 = $60). 
Payment Administration
Coordination of payment will involve ED STAR staff (entering information into REDCap and 
distributing Focus Blue cards), Study Staff with access to medical records (monitoring participant REDCap 
to verify attendance, monitoring completion of PAFs, administering payments, replacing lost Focus Blue 
cards), and the Participants (receiving payment notifications via study texts and/or emails, completing 
PAFs).
ED STAR staff. At study intake, staff  will issue all participants a US Bank Focus Blue card and will 
deliver instructions on how to access their balance on the US Bank website. Instructions will include how to 
contact study staff to report and replace a lost card. Instructions will include how to contact study staff in case 
of barriers to accessing online PAF or other problems arise. ED Staff will enter participant ID, note of study 
participation condition (BP+CM or BP alone), and standard referral information into a REDCap form.
Study Staff with access to EHR. UVM/UVMMC study staff in UHC will maintain secure REDCap 
forms with the randomization list corresponding to study condition (BP alone or BP+CM). Study  also have 
credentialed access to 42 CFR Part 2 health information in the UVMHN Epic system. Study staff in 
Chittenden Clinic have access and training specific to the Howard Center EHR system. Study Staff will have 
access to all study payment cards through the US Bank Focus Blue platform and be able to cancel cards if 
reported lost and issue new cards. Study Staff will keep a record of card numbers and corresponding 
participant identification codes (ID) in a secure REDCap form. 
CHRMS (Medical) #STUDY00003121 Approved: 7/28/2025 

15
Human subjects protocol form 
   IRB form version 6/21/2023
Incentive delivery: Study staff will monitor EHR of each participant for prescriptions received. Once 
the record indicates a prescription receipt and depending on participant study condition (BP alone or 
BP+CM), Study Staff will calculate the amount of money to allocate to the participant card based on 
their study condition and last recorded attendance. This amount will be entered into a REDCap PAF, 
and a link to complete on REDCap will be created and sent via text and/or email to the participant. 
Once completion of PAF has been confirmed in REDCap, Study Staff will use the US Bank Focus 
Blue online platform to allocate funds indicated on PAF to the corresponding participant card. 
Payments will be tracked on a REDCap form and adjusted to reflect the amounts determined by the 
study incentive procedure described above.
Participants will receive weekly text messages and/or emails from STAR staff. Participants will 
complete PAF on REDCap and acknowledge the amount of money to be received. If a card is lost, the 
participant will be able and encouraged to contact study staff immediately to arrange receipt of a new card. 
Participants at risk for unreliable access to internet via cell phone or other device will be provided resources 
(e.g., pre-paid phone) on a case-by-case basis by study staff. Participants will not be reimbursed for travel or 
other expenses. 
 
Research Data Management Plan: The Research Data Management and Security Plan form must be completed. The form, 
along with guidance, can be found in our forms library and must be submitted with your initial application.
CHRMS (Medical) #STUDY00003121 Approved: 7/28/2025