Effectiveness of Bridge Clinic Following Emergency Department-Initiated Intervention for Opioid Use Disorder
Phase: NA
Conditions: Opioid-use Disorder, Mental Disorder, Opioid Medication Assisted Treatment
Sponsor: University of Vermont

HS Protocol Form 02/13/2020 
 
 
 
 
Human Subjects Research Protocol  
 
The Common Human Subjects Protocol Cover Form must be completed and accompany this form. This Protocol form should 
be completed for any human subjects research proposal that does not have a specific “protocol,” such as a grant application.  
This form must be submitted along with a copy of the complete grant proposal and all the information in this form must be 
consistent with that proposal.  This protocol form, once IRB approved, will be the working protocol for that research.  When 
completing this document, do not refer to page numbers within your grant.   If revisions are necessary during the course 
of the research, amendments should refer to this protocol form, not the grant proposal.  Enter responses for all sections.  
Check N/A if the section does not apply. All materials must be submitted electronically to the IRB via InfoEd. Proper 
security access is needed to make electronic submissions. Visit the InfoEd Resource Materials page for more 
information. 
 
 
 
PROTOCOL SUMMARY 
 
Project Title: 
Protocol Version Date: 
Emergency Department Initiated Buprenorphine Intervention for Opioid 
Use Disorder 
04/07/2021 
 
 
Principal Investigator:   
Scott Mackey, Sanchit Maruti, Dan Wolfson, and Roz Bidad 
 
Grant Sponsor: 
Pilot grant from  the Northern New 
England Center for Translational 
Research  (NNE-CTR) grant  
awarded to the Maine Medical 
Center and funded by the NIH’s 
National Institute on General 
Medical Sciences (NIGMS); 
SAMHSA; 
NIDA 
Grant  Number: 
 
SAMHSA: 1H79TI081515-01 
 
NIDA: 1R21DA049859-01 
 
Northern New England Center for 
Translational Research: U54GM115516 
                                                                                              (For grants routed through UVM, indicate the OSP Proposal ID # 
                                                                                                 located at the top of the OSP Routing Form) 
 
 
Lay Language Summary:  (Please use non-technical language that would be understood by nonscientific IRB members to 
summarize the proposed research project.  The information must include: (1) a brief statement of the problem and related 
theory supporting the intent of the study, and (2) a brief but specific description of the procedure(s) involving the human 
subjects.  Please do not exceed one single-spaced 8 ½ X 11” page.) 
 
Opioid-related overdose deaths have quadrupled since 1999 making drug overdose the new leading cause of 
accidental death in the U.S.1 The current practice of providing emergency department (ED) patients who endorse 
opioid use disorder (OUD) with only a referral to local treatment programs, which often have long waiting lists, 
represents a tragic missed opportunity to engage patients in sustained medical care.2,3 We hypothesize that a 
novel intervention at the UVM Medical Center (UVMMC), which will 1) initiate buprenorphine treatment in patients 
presenting at the ED with OUD, and 2) guarantee enrollment in the UVMMC Addiction Treatment Program (ATP) 
within 24 to 72 hours, will address the acute crisis period when individuals are most vulnerable to relapse and lead 
to increased long-term participation in Medication-Assisted Treatment (MAT). This project is expected to generate 
immediate benefits for those enrolled and will provide proof of concept evidence for a new model of engaging 
individuals with OUD in long-term care. 
 
Vermont has a lower rate of fatal opioid overdoses than the national average and a significantly lower rate than 
other rural New England states (e.g. 13.9 deaths per 100,000 in Vermont compared to 26.2 in New Hampshire in 
2014).4 This situation has been attributed to the development of an effective “Hub and Spoke” OUD treatment 
system and proactive state-sponsored programs to increase access to emergency opioid overdose rescue kits and 
needle exchanges.4,5 Despite this, the number of drug-related fatalities in Vermont continues to increase in 
parallel with the alarming national upward trend, surging 37% from 2015 to 2016.6 Thus, the Vermont response to 
the opioid epidemic urgently requires further improvement to address a still growing problem. A key challenge in 
addressing OUD is that most individuals who would benefit from a medical intervention do not receive any 
assistance. Only 10.8% of the estimated 21.7 million people in the U.S. with a past year substance use disorder 
received specialized treatment.7 Consequently, the presentation of patients with OUD at the ED is a critical 

HS Protocol Form 02/13/2020 
 
opportunity to identify individuals in need and direct them toward long-term treatment programs. The current 
standard of care for individuals with OUD presenting to the ED provides management of acute symptoms and 
contact information for treatment programs, which often have long waiting lists.3 Here, we will compare the 
standard practice with a novel intervention that will provide 1) immediate initiation of buprenorphine treatment at 
the ED and 2) guaranteed placement in a specialized OUD treatment program (i.e. UVMMC Addiction Treatment 
Program -ATP) within 24 to 72 hours after discharge. The primary outcome measure will be opioid use at 1 week 
and 3 & 6 months after buprenorphine initiation.  
 
Aim 1. To determine whether ED-initiated buprenorphine treatment coupled with enrollment in a bridge clinic that 
will supervise MAT until the patient is stabilized and placed with a local MAT provider will reduce illicit opioid use 
compared to ED-initiated buprenorphine treatment coupled with immediate referral to a local MAT provider. 
Hypothesis: Patients assigned to the ED-initiated buprenorphine plus ATP bridge clinic intervention will have 
significantly reduced illicit opioid use as determined by urine drug screen at 1 week, and 3 & 6 months than 
patients who only receive direct referral to a local MAT provider. .  
 
 
 
 
PURPOSE AND OBJECTIVES   
 
Purpose:  The importance of the research and the potential knowledge to be gained should be explained in detail.  Give 
background information.  
The explosive increase in opioid use in the U.S. over the past two decades poses a formidable threat to the 
national welfare.10-13 In the last month, an estimated 400,000 individuals have used heroin and over four million 
individuals have used prescription pain medication for non-medical purposes.14,15 The latest estimates released 
by the CDC for the year 2016 indicate that a dramatic surge in opioid related deaths has produced a population 
level decline in average life expectancy.16 Opioid-related overdose fatalities have quadrupled since 1999.1 In 
2016 alone, 63,200 Americans died of an opioid-related overdose, which represents a 21% increase over the 
preceding year. The rapid development of evidence-based approaches to manage the opioid epidemic is critical at 
this time. Here, we will examine whether an ED-initiated intervention will lead to lower rates of opioid use and 
higher enrollment in medical treatment for OUD.  
 
Currently, the most effective treatments for opioid withdrawal are methadone and buprenorphine.17-19 
Medication-Assisted Treatments (MATs), which prevent cravings and withdrawal, lower the rate of fatal overdoses 
and transmission of infectious disease through needle sharing and increase patient functioning and ultimately 
retention in treatment.20,21 However, most individuals who would benefit from a medical intervention do not 
receive any assistance. Only 10.8% of the estimated 21.7 million people in the U.S. with past year substance use 
disorder received specialized treatment.7 Thus, the presentation of patients with OUD to the ED represents a 
significant opportunity to identify and direct these individuals toward treatment services.3,22-24 
 
Stakeholders in the Vermont health care system have pioneered the Hub and 
Spoke model to deliver MATs in the state (Figure 1).4 Since Vermont is a 
predominantly rural state, the Hub and Spoke model emphasizes local 
providers and distributed services, which lowers the barrier to treatment 
imposed by the necessity of travelling long distances to receive services.25,26 
Each of five geographical regions in Vermont are serviced by one or more Hub 
clinics, which dispense and monitor treatment with methadone or 
buprenorphine. Patients with the greatest monitoring requirements are 
enrolled in the Hub clinics, while local providers (i.e. Spokes) who have 
received specific training in the prescription, monitoring, and diversion control 
of buprenorphine manage patients requiring a less intensive level of care. 
Referrals to the Hub and Spoke system are provided by services listed in the 
outer ring of Figure 1, e.g. pain management clinics, family services, etc. The 
innovative Hub and Spoke model in combination with proactive state-
sponsored programs to increase access to emergency opioid overdose rescue 
kits and needle exchanges have been credited with driving the rate of fatal 
opioid overdoses in Vermont below the national average, and significantly 
lower than other rural New England states.4,5 Despite this, the number of drug-related fatalities in Vermont 
continues to parallel the national upward trend, jumping 37% from 2015 to 2016.6 Thus, the Vermont response to 
the opioid epidemic urgently requires further improvement to address a still growing problem. 
 
Figure 1. Diagram of the 
Vermont hub and spoke model 

HS Protocol Form 02/13/2020 
 
Here, we will investigate whether ED-initiated MAT with buprenorphine and sustained clinical follow-up for patients 
presenting with OUD at ED lowers opioid use and increases retention in treatment Preliminary evidence suggests 
that ED-initiated MAT will produce positive short-term outcomes. In a randomized trial, opioid dependent patients 
receiving ED-initiated buprenorphine treatment with 10 weeks of supervised MAT were significantly more likely to 
be enrolled in a treatment program at 30 days after study recruitment than patients who only received a simple 
referral (i.e. 95% vs. 37%, respectively).8 Retention rates remained elevated at 2 months.9 However, these effects 
had completely disappeared by 6 and 12 months. We believe that the long-term failure of this intervention at 6 and 
12 months was due to lack of opportunity for most participants to continue supervised MAT after the end of the 
study. The present study will examine whether ED-initiated MAT combined with sustained clinical supervision at 
ATP, which monitors patients until they transfer to long-term care, results in lower rates of opioid use. ED-initiated 
of treatment for OUD would mirror immediate treatment of other chronic life-threatening diseases presenting to the 
ED.                                                          
 
INNOVATION 
• 
Integration of ED-initiated buprenorphine treatment with sustained treatment follow-up at ATP, a MAT 
bridge clinic. 
• 
ATP will eliminate the treatment waitlist for study participants and effectively bridge the critical relapse 
period between the ED visit and entry into long-term treatment. 
 
Impact: The ED initiated buprenorphine treatment and ATP intervention is expected to effectively bridge the risk of 
relapse in the critical period between ED presentation and integration into the standard Vermont Hub-and-Spoke 
system for monitoring long-term MAT. Opioid use disorder contributes to frequent re-admission rates in certain 
patients. Improving the chances that these individuals enroll in long-term care will reduce ED burden and free up 
resources for other patients. Positive findings on Aim 1 will support network-wide adoption of this intervention in 
Vermont.  
References. Include references to prior human or animal research and references that are relevant to the design and conduct 
of the study. 
1 
CDC. Wide-ranging online data for epidemiologic research (Wonder). (CDC, National Center for Health Statistics, Atlanta GA, 
2016). 
2 
Substance Abuse and Mental Health Services Administration (SAMHSA), C. f. B. H. S. a. Q. The DAWN Report: Highlights of the 
2011 Drug Abuse Warning Network (DAWN) Findings on Drug-Related Emergency Department Visits. (Rockville, MD, 2013). 
3 
Weiner, S. G. et al. Opioid-related Policies in New England Emergency Departments. Acad Emerg Med 23, 1086-1090, 
doi:10.1111/acem.12992 (2016). 
4 
Brooklyn, J. R. & Sigmon, S. C. Vermont Hub-and-Spoke Model of Care for Opioid Use Disorder: Development, Implementation, 
and Impact. J Addict Med 11, 286-292, doi:10.1097/ADM.0000000000000310 (2017). 
5 
Chen, H. & VanDonsel, A. The Effectiveness of Vermont's System of Opioid Addiction Treatment. 
https://legislature.vermont.gov/assets/Legislative-Reports/Opioid-system-effectiveness-1.14.15.pdf. 1-23 (Montpelier VT, 2015). 
6 
Kretzer, L. & A., J. Drug related fatalities in Vermont. (Vermont Department of Health, Montpelier, 2016). 
7 
Lipari, R. N., Park-Lee, E. & Van Horn, S. in The CBHSQ Report     (2013). 
8 
D'Onofrio, G. et al. Emergency department-initiated buprenorphine/naloxone treatment for opioid dependence: a randomized 
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9 
D'Onofrio, G. et al. Emergency Department-Initiated Buprenorphine for Opioid Dependence with Continuation in Primary Care: 
Outcomes During and After Intervention. J Gen Intern Med 32, 660-666, doi:10.1007/s11606-017-3993-2 (2017). 
10 
HHS_PressOffice. HHS Acting Secretary Declares Public Health Emergency to Address National Opioid Crisis, 
<https://www.hhs.gov/about/news/2017/10/26/hhs-acting-secretary-declares-public-health-emergency-address-national-
opioid-crisis.html> (October 26, 2017). 
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Brady, K. T., McCauley, J. L. & Back, S. E. Prescription Opioid Misuse, Abuse, and Treatment in the United States: An Update. Am J 
Psychiatry 173, 18-26, doi:10.1176/appi.ajp.2015.15020262 (2016). 
12 
Okie, S. A flood of opioids, a rising tide of deaths. N Engl J Med 363, 1981-1985, doi:10.1056/NEJMp1011512 (2010). 
13 
Birnbaum, H. G. et al. Societal costs of prescription opioid abuse, dependence, and misuse in the United States. Pain Med 12, 
657-667, doi:10.1111/j.1526-4637.2011.01075.x (2011). 
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doi:10.1056/NEJMsa1406143 (2015). 
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Schuckit, M. A. Treatment of Opioid-Use Disorders. N Engl J Med 375, 1596-1597, doi:10.1056/NEJMc1610830 (2016). 
18 
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19 
Bart, G. Maintenance medication for opiate addiction: the foundation of recovery. J Addict Dis 31, 207-225, 
doi:10.1080/10550887.2012.694598 (2012). 

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20 
Schwartz, R. P. et al. Opioid agonist treatments and heroin overdose deaths in Baltimore, Maryland, 1995-2009. Am J Public 
Health 103, 917-922, doi:10.2105/AJPH.2012.301049 (2013). 
21 
Hser, Y. I. et al. Treatment retention among patients randomized to buprenorphine/naloxone compared to methadone in a 
multi-site trial. Addiction 109, 79-87, doi:10.1111/add.12333 (2014). 
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Ellison, J. et al. Identifying Patients for Overdose Prevention With ICD-9 Classification in the Emergency Department, 
Massachusetts, 2013-2014. Public Health Rep 131, 671-675, doi:10.1177/0033354916661981 (2016). 
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Samuels, E. A. et al. Emergency Department-based Opioid Harm Reduction: Moving Physicians From Willing to Doing. Acad 
Emerg Med 23, 455-465, doi:10.1111/acem.12910 (2016). 
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Frazier, W. et al. Medication-Assisted Treatment and Opioid Use Before and After Overdose in Pennsylvania Medicaid. JAMA 
318, 750-752, doi:10.1001/jama.2017.7818 (2017). 
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359-360, doi:10.1001/jamapsychiatry.2013.4450 (2014). 
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Sigmon, S. C. & Kennedy, A. G. The prescription opioid abuse epidemic in rural America: a look at how it begins. J Opioid Manag 
10, 225-226, doi:10.5055/jom.2014.0210 (2014). 
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HS Protocol Form 02/13/2020 
 
Objectives:  Clearly state the primary and secondary objective(s) of the study. 
 
The primary outcome will be urine specimens for illicit opioids at 1 week and 3 & 6 months after ED initiated 
treatment Urine specimens will be collected under observation of same-sex staff and immediately analyzed for 
opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs 
(cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay. Missing urine 
specimens will be considered positive for illicit opioids, consistent with an intent-to-treat approach.  
 
Secondary outcomes will include self-reported illicit opioid or other (non-opioid) drug use, treatment enrollment 
status and behavioral questionnaires (i.e. the GPRA Client Outcome Measures questionnaire  the Treatment 
Effectiveness Assessment (TEA),43 and the Vermont Treatment Needs Questionnaire (TNQ)21). 
 
 
 
 

HS Protocol Form 02/13/2020 
 
METHODS AND PROCEDURES  
 
Study Design: Describe the research design, including a description of any new methodology and its advantage over existing 
methodologies.   
This pilot project will test whether ED-initiated buprenorphine treatment for individuals presenting to the UVMMC ED with 
OUD combined with a MAT bridge clinic leads to a reduction in illicit opioid use at 1 week, and 3 & 6 months compared 
ED-initiated treatment with a direct referral to a local MAT provider. The intervention and study design include 5 main 
stages (see figure below): 1) Patients admitted to the ED with indicators of OUD will be consented and screened for study 
eligibility;  2) Participants will undergo buprenorphine induction at the ED; 4) Participants enrolled at Central Vermont 
Medical Center and Porter Medical Center will be referred directly to a local MAT provider. Participants enrolled at 
UVMMC will be referred to  the UVMMC ATP, a MAT bridge clinic that will supervise MAT with buprenorphine in all 
participants who enroll in the program until the individual is transferred to a long-term MAT provider, referred to a higher 
level of care or drops out of treatment --treatment duration at ATP is typically 8 weeks before referral of stable patients to 
primary care providers; 5) All participants will be contacted at 1 week, and 3 & 6 months after randomization to determine 
current illicit opioid use. 
 
We expect to enroll 200 participants over 3 years. 
 
Procedures:  Describe all procedures (sequentially) to which human participants will be subjected. 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.   Include required screening procedures performed before enrollment and while on 
study. Please provide in table, list or outline format for ease of review. (describe and attach all instruments) 
 
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. 
Our project team (Drs. Maruti, Mackey, Barkhuff and Wolfson) includes clinical and research expertise 
required to undertake the study. Dr. Maruti is an addiction psychiatrist who heads the UVMMC ATP 
and Dr. Mackey is clinical research faculty. Drs. Barkhuff and Wolfson are UVMMC ED physicians. Ms. 
Bidad, RN and Ms. Mahler, LCMHC, LADC will coordinate research support at the ED Research 
Program and ATP, respectively. 
 
The study consists of 4 parts: 1) Recruitment, 2) Buprenorphine Induction, 3) Referral, and 4) Outcome 
Assessment at 1, 3, and 6 months.  
 
Recruitment, Randomization and Buprenorphine Induction or Referral all occur during the initial visit to 
the ED. The part of the protocol performed at the ED can be summarized in 11 steps. See also 
illustration of EMRAP staff structure in Informed Consent section.   
 
 
 
Brief Summary Table Listing 11 Steps During Initial ED Visit 
1. Recruitment   
          Step 1. Patients arrive at Emergency Department. 
    Identification 
          Step 2. Research Associates (EMRAP undergrad trainees) identify potential participants based  
          on indicators of OUD in EPIC Electronic Health Records (EHR). 
          Step 3. Research Associates will notify an EMRAP Research Coordinator of potentially eligible  
          participants. The Research Coordinators are full-time EMRAP research employees.  
     Prescreening    

HS Protocol Form 02/13/2020 
 
Step 4 Research Coordinator will confirm in-person or via telephone with ED physicians/nurses 
providing care for patient that approaching the individual is appropriate and will not interfere with 
service.  
Step 5 Research Associate or Research Coordinator approaches potential participant and 
performs prescreen either in-person or via telephone. The prescreen text is attached to this 
application. Prescreening information is stored in REDCap. If a subject is found to be 
ineligible, data entered for that subject will be deleted from REDCap at that time. 
          Step 6 Based on answers consistent with opioid use disorder, proceed to next step otherwise  
          thank individual and destroy prescreen answers.  
          Step 7 If patient declines continuing enrollment process, will be provided with informational wallet  
          card describing research study, informing patients that they may return to the ED at a later date  
          to reattempt enrollment  
    Consenting 
Step 8 Participant is consented into the study by one of the Research Coordinators either in 
person or via telephone with coordination from ED care team to sign appropriate documentation. 
If eligible participant does not consent, individual will be thanked and prescreen information 
destroyed. Prescreening information is stored in REDCap. If a subject is found to be ineligible, 
data entered for that subject will be deleted from REDCap at that time. Consent may be 
completed via eConsent form. Printed copy of signed consent form will be provided to the 
consent after completing consent process.           
Step 9 Research Coordinator confirms OUD diagnosis. 
2. Buprenorphine Induction 
          Step 10 Participants receive induction treatment from ED physician who  
          has been certified to prescribe Suboxone. 
3. Referral  
          Step 11 Participants enrolled at Central Vermont Medical Center or Porter Medical Center are 
referred to a local MAT provider. Participants enrolled at UVMMC are refered to the UVMMC ATP, a 
MAT bridge clinic.      
          Step 12 Research Associate leads participant through behavioral questionnaire battery on ipad.  
          (This step may occur before step 10 while the participant is waiting to see ED physician). 
 
Note that Central Vermont Medical Center and Porter Medical Center are not yet prepared to 
start data collection. Details about procedures at these sites will be added by amendment as it 
becomes necessary. No protocol procedures will be performed at CVMC or Porter until these 
amendments have been reviewed by the IRB. We ask that the IRB approve the UVMMC site to 
continue enroll participants while the other sites are prepared.  
 
Part 1) Recruitment.  
 
Identification (Steps 2 and 3). Potential participants will be identified by indicators in presentation and 
medical history consistent with OUD, including presentation with acute overdose or symptoms 
consistent with opioid withdrawal (such as piloerection, diarrhea, tachycardia, cravings, and pupillary 
dilation), and EMS use of naloxone on scene or en route to the hospital as reported verbally to ED 
physician or nurse. Patients with abscesses, especially in the antecubital fossa and other areas 
consistent with injection drug use and patients with a history of endocarditis will be asked about opioid 
use and prescreened for enrollment. Research Associates or a Research Coordinator will screen health 
information of incoming patients on EPIC EHR system to identify study candidates. “Request for Partial 
Waiver of Authorization for Recruitment Purposes” is attached. In addition, ED physicians may alert 
ED research staff to patients with suspected opioid use disorder based upon physician’s observations 
in the course of ED medical care. Note: Research Associates will not access ambulance run sheets or 
Siren because these may contain information about new patients from sources for which the UVM IRB 

HS Protocol Form 02/13/2020 
 
does not monitor HIPAA compliance. 
 
Prescreening (Steps 4 and 5). Research Coordinator will confirm with physician/nurses providing 
medical care to patient that it is appropriate to approach individual and will not interfere with ED service. 
Research Associate or Research Coordinator will perform prescreening following a written script (see 
attached prescreening script). Prescreening includes self-report questions on opioid use that could 
indicate OUD to determine eligibility. Since the prescreen contains PHI questions about opioid use 
“Request for Waiver or Alteration of Informed Consent/Authorization/Documentation” related to the 
prescreen is attached. Information shared during  prescreen represents a minimal risk to the patient.  
 
Consenting (Steps 7 and 8). Consent will be performed according to standard Emergency Medicine 
Research procedures.  More information on this is outlined in the Informed Consent section of this 
protocol. Consent will be performed by a Research Coordinator who is paid employee of EMRAP. 
Consent form is attached.  
 
Eligibility. English-speaking patients over the age of 18 presenting at the UVMMC ED with indicators 
of an OUD will be assessed for eligibility. Exclusion criteria will include: current participation in an 
alternate treatment program for OUD (Exception: Individuals recently released from correctional 
facilities or residential treatment programs who do not have a current prescription will allowed to 
participate  
–Note: Parolees have the opportunity to join the study voluntarily. Participation is not a condition of 
their parole and thus they do not fit the definition of a prisoner under the OHRP guidelines which would 
require greater scrutiny.), inability to communicate, altered mental status, suicidality, medical extremis 
or requiring admission, prisoners, history of Suboxone injection in the past year, and hepatic 
impairment.  
 
After consent, Research Coordinator will immediately confirm eligibility criteria including diagnoses of 
OUD by asking only the questions related specifically to OUD diagnosis in the Mini-International 
Neuropsychiatric Interview (MINI).37,38 The remainder of the MINI will be performed in step 11. The 
Research Coordinator will also immediately assess suicidality by asking the question: “Are you thinking 
about suicide?” If the individual endorses suicidal ideation, the attending physician will be notified 
immediately and standard ED operating procedures for patients endorsing self-harm ideation will be 
followed. The Research Coordinator will also ask for locator information after the subject consents to 
participate in the study. The locator information form is attached. Research coordinators will have 
access to the locator form for the course of the study in order follow up with subjects at 1 week, 3 
months, and 6 months.  
 
 
Part 2) Buprenorphine Induction (Steps 10 and 11).  
 
Participants will meet with an ED physician who will utilize rules for emergency prescription of 
Suboxone and who will have received training on buprenorphine induction from ATP. The physician 
will use the Clinical Opioid Withdrawal Scale (COWS) to assess level of withdrawal.   
 
Note that besides Investigators Daniel Wolfson and Daniel Barkhuff other ED physicians waivered to 
prescribe Suboxone will not be listed as key personnel according to the following definition. Individuals 
who are Not Key Personnel: An individual who will be interacting with research subjects during the 
course of a research study, but only in his/her regular non-research employment capacity. That is, ED 
physicians will be interacting with participants of the study only in their clinical roles as ED care 
providers. Additionally, the requirement that physicians perform 4 hours of CITI training as Key 
Personnel would significantly limit the number of ED physicians willing to be associated with critical 

HS Protocol Form 02/13/2020 
 
research on ED best practices.  
 
Participants will be given a 3-day Starter Pack containing 12 x 2/0.5 mg films of Suboxone for a total 
daily dose of 8mg of buprenorphine for 3 days (i.e. 4 x 2/0.5 films each day = 12 films).  
 
Patients in withdrawal will be given an immediate dose of two 2/0.5 mg films of Suboxone (i.e. two 
Suboxone films containing 2mg of buprenorphine and 0.5mg of naloxone each) from the Starter Pack 
and instructions to take two more 2/0.5mg films at home the same day for a total daily dose of 8mg of 
buprenorphine. Patients not manifesting withdrawal, but with presentation and history consistent with 
moderate to severe OUD, will be instructed to take the first two films of Suboxone from the Starter Pack 
when experiencing mild to moderate withdrawal symptoms, and to take another two films if symptoms 
persist 1-2 hours after taking the first two films.  Patients will be given a written explanation of the 
rationale for the induction process and the risk of precipitated withdrawal if Suboxone is taken when 
not experiencing withdrawal symptoms (see attached “Home Induction Instructions”). Participants will 
receive detailed verbal instructions in addition to a written self-medication guide.44  
 
Participants will also receive in the Starter Pack Suboxone for two additional days of treatment (i.e. the 
remaining 8 films containing 2/.5mg Suboxone with instructions to take 4 films on day 2 and the 
remaining 4 films on day 3). The additional Suboxone doses will accommodate those entering the study 
on the weekend because the ATP only accepts new patients during week days (i.e. Monday to Friday). 
Participants are instructed to bring any extra doses with them to the first appointment at the ATP which 
will be incorporated into the maintenance prescription provided at the ATP. Research and clinical 
experience indicate that many patients will require daily doses of buprenorphine greater than 8mg to 
fully suppress craving and withdrawal, and for these patients dose escalation will be available under 
medical supervision when starting treatment at ATP. The initial 8mg dose limit is for self-administered 
doses only, to provide immediate relief of withdrawal symptoms and craving while limiting potential for 
excessive dosing or diversion.44-48   
 
Potential for Medication Diversion. To reduce the potential for drug diversion, individuals will be allowed 
to enroll only once in the present study. Treatment initiation at ED will start with a dose sufficient to 
diminish withdrawal and craving but less than has been used in previous studies of linkage to treatment 
or home induction.e.g. 45,49 Rapid follow-up including upward adjustment of dose if needed under medical 
supervision will be provided at the bridge clinic or the local MAT provider  
 
The range of dates (i.e. week period around 3 and 6 months after randomization) for the last two follow-
up visits will be written down and given to participants with other study materials at the initial ED visit. 
Participants will be told that they will be contacted in the week before the follow-up visits at 3 and 6 
months to arrange the specific time and place of the follow-up visit. 
 
 
Step 11. Collection of additional information will occur by phone within seven days of randomization. 
This will include psychiatric history assessed by the 15 minute Mini-International Neuropsychiatric 
Interview (MINI),37,38 opioid use history (e.g. onset, duration of use, route of administration) assessed 
with the Pattern of Substance Use -Adult questionnaire in the PhenX toolkit, and the GPRA Client 
Outcome Measures questionnaire. Data will be collected on an iPad. 
 
 
Part 4) Referral 
Participants enrolled at Central Vermont Medical Center or Porter Medical Center are referred to a local 
MAT provider. Participants enrolled at UVMMC are referred to the UVMMC ATP, a MAT bridge clinic. 
 

HS Protocol Form 02/13/2020 
 
Addiction Treatment Program. The ATP is a part of the UVM Department of Psychiatry. Its mission 
is to expand treatment capacity and increase access to high-quality, evidence-based treatment for 
individuals with OUD in Vermont. The ATP team includes two fellowship-trained addiction psychiatrists, 
one general psychiatrist, and one family physician who are all experienced in treating OUD, as well as 
resident and fellow trainees from psychiatry, family medicine, and internal medicine, and licensed 
professionals in nursing, alcohol and drug counseling, mental health counseling and clinical social 
work. The staff is experienced in providing MAT to patients in all phases of treatment, in diverse settings 
and across levels of acuity, as well as in educating, training and supporting colleagues with varying 
levels of experience, training and comfort in addictions treatment. The ATP was selected by the State 
of Vermont to lead a state-wide Learning Collaborative Project to provide training and education to 
MAT practices throughout the state of Vermont. 
 
ATP is housed in the UHC building on 1 South Prospect Street in downtown Burlington. The 
ATP offices are a five-minute walk to the UVMMC ED. Both ATP and ED contain meeting rooms where 
the PIs and study staff will be able meet to review recruitment targets, ongoing training, and other 
methodological issues which arise during the study. Successful participation in ATP is characterized 
by 3 stages (Figure 5).   
 
Stage 1. Entry. This stage includes weekly 
follow-up with a physician and random urine 
drug testing 1-2 times weekly in addition to 
weekly individual or group counseling. Doses of 
buprenorphine/naloxone 
are 
adjusted 
as 
required 
to 
address 
persistent 
craving, 
withdrawal symptoms, or opioid use. 
 
Stage 
2. 
Intermediate. 
Includes 
weekly 
physician follow-up, once-weekly random urine 
drug testing, and ongoing counseling. Doses of 
buprenorphine/naloxone can be adjusted as in 
the entry period, though in practice this is 
required less frequently at this stage. 
 
Stage 3. Stable. Includes physician follow-up 
every 2 weeks, once-weekly random urine drug 
testing, 
and 
ongoing 
counseling. 
Dose 
adjustments are rarely needed at this stage, and 
patients typically transition to primary care after 
approximately one month of stable-level follow-up. 
 
Referral to primary care for continuation of MAT is initiated when a patient reaches the stable treatment 
level, and the transition typically occurs approximately 4 weeks later. Actual duration of enrollment at 
ATP varies depending on substance use, nonadherence such as missed appointments or urine drug 
tests necessitating treatment adjustments, as well as availability of appointments in primary care. 
Patients with ongoing substance use who are determined to require residential or Hub-level treatment 
are referred to those settings, and their treatment at ATP is continued while referrals are in process. 
Patients who complete residential treatment may return to ATP to resume office-based treatment if 
clinically appropriate. Since its formation in 2016, ATP has treated 248 patients of which 40 are 
currently enrolled in the program. Approximately 90% of patients treated at the ATP continue to remain 
in treatment with 70% of them receiving their treatment from Primary Care providers (Spokes). Of the 
patients treated at the ATP approximately 18% were referred back to the ATP for additional 
stabilization. 
Figure 5. Flow chart typical 8-week program 

HS Protocol Form 02/13/2020 
 
 
Note that if a participant withdraws or is withdrawn from the study, they will continue to receive services 
from ATP. Conversely, if a participant decides they no longer want treatment at ATP, they may continue 
to participate in the study.  
 
Part 5) Outcome Assessment. The primary outcome will be illicit opioid use at 1 week and 3 & 6 
months after buprenorphine induction. Consistent with standard ATP practice, urine sample collection 
and analysis will be performed by Aspenti Labs (https://www.aspenti.com/), a clinical drug testing 
service which is open Monday to Friday 7AM-7PM and has multiple locations throughout Vermont. 
Urine specimens will be collected under observation of same-sex staff and analyzed for opioids 
(buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other 
drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay. 
Missing urine specimens will be considered positive for illicit opioids, consistent with an intent-to-treat 
approach. Additional outcomes will include self-reported illicit opioid or other (non-opioid) drug use, 
treatment enrollment status and behavioral questionnaires (i.e. the GPRA Client Outcome Measures 
questionnaire to track self-reported drug-use and life conditions). The Treatment Effectiveness 
Assessment (TEA)43 will be included at 1 week, 3 months and 6 months to track patient perception of 
treatment progress. Additional follow-up questions based on the PhenX toolkit are attached. 
 
Retention. Participating in OUD treatment has health advantages for the participants which is a 
motivation to remain in the study. Participants will receive a $25 gift card after answering questionnaires 
in Step 11. In addition, as an incentive to provide a urine sample and answer questions at follow-up, 
participants will receive a $25 gift card for answering questions by phone and a $50 gift card for a urine 
sample at each of the three outcome time points completed (i.e. 1 week, 3 and 6 months post 
randomization). In total, participants can earn up to $250 for their participation in the study.  To avoid 
altering the motivation to stay in MAT, participants will earn payment for providing the urine samples 
and answering questions at each of the 3 follow-up time points, regardless of whether they are currently 
in treatment. Missing urine specimens will be considered positive for illicit opioids, consistent with an 
intent-to-treat approach. 
Participants will be contacted by phone, text and/or email. A letter will also be mailed to participants 
(see attached). In the event the participant cannot be reached by any other means, a letter will be sent 
to the contact person provided by the participant at intake on the Locator Form. Contact information for 
phone, text and email will be collected at the initial ED visit. The dates (i.e. 1 week, 3 months and 6 
months after randomization) for the follow-up visits will be written down and given to participants with 
other study materials during the initial ED visit. Participants will be contacted in the week before the 
follow-up visits at 3 and 6 months to remind them of the date and answer any question about where 
and how urine samples will be collected. Participants will also be reminded again the day before.  
 
 
 
 
For research involving survey, questionnaires, etc.:  Describe the setting and the mode of administering the instrument and the 
provisions for maintaining privacy and confidentiality.  Include the duration, intervals of administration, and overall length of 
participation. (describe and attach all instruments) 
 
Not applicable 
 
Behavioral questionnaires  will be used to assess participants at the following time points.  
 
At baseline, participants will be assessed using the Locator Form, Referral, Suicidality, GPRA, MINI Neuropsychiatric Interview,  
Why are you enrolling in this program: Prevent overdose/Want to be sober/Family pressure/Legal pressure/Job pressure/Other. Total 
duration 1 hour.  
At week 1, participants will be complete the MINI questionnaire Part II. Total duration 25 minutes.  
 
At 3 months, participants will be assessed using a modified version of the PhenX drug use toolkit, the TEA and attached follow-up 
questionnaire and the GPRA. Total duration 25 minutes.  
 

HS Protocol Form 02/13/2020 
 
At 6 months, participants will be assessed using a modified version of the PhenX drug use toolkit, the TEA and attached follow-up 
questionnaire based on the PhenX toolkit Total duration 35 minute. 
 
At 3 and 6 month follow-up: 
1. Since you received buprenorphine (suboxone) in the ED have you taken any more buprenorphine prescribed 
for you by a doctor or other prescriber? (If No, skip to item 3) 
2. If you answered yes to #1: are you currently (last 30 days) enrolled in treatment with a prescriber? 
3. If you are not currently receiving suboxone from a prescriber, why? 
4. Since you started receiving treatment in the ED have you experienced any of the following side effects of 
buprenorphine? (Constipation, diarrhea, stomach pain, nausea, vomiting, brain fog, sleeping too little, tiredness, 
sexual problems, feeling depressed or down, feeling anxious, headache) 
If yes follow up with: How much discomfort did this cause you on a scale 1 to 5 where 1 is mild and 5 is 
severe? 
5. Have you been doing more of any of the following since starting treatment in the ED: 
Have you been eating more than before you started treatment? 
Have you been drinking caffeine more than before you started treatment? 
Have you been smoking more cigarettes or other nicotine products more than before you started treatment? 
Have you been using more marijuana than before you started treatment? 
Have you been drinking more alcohol than before you started treatment? 
Have you been using other drugs more than before you started treatment? If yes, which ones? 
Have you been spending more time online than before you started treatment? 
Have you been gambling more than before you started treatment? 
Have you been having more sex than before you started treatment? 
Have you been exercising more than before you started treatment? 
Any other activities? If yes, what are they? 
6. How often over the last two weeks have you been bothered by not being able to stop or control how much 
you eat? 
How often over the last two weeks have you been bothered by how much caffeine you drink? 
How often over the last two weeks have you been bothered by how many cigarettes you smoke or use other 
nicotine products? 
How often over the last two weeks have you been bothered by how much marijuana you use? 
How often over the last two weeks have you been bothered by how much alcohol you drink? 
How often over the last two weeks have you been bothered by how much other drugs you use? If yes, which 
ones? 
How often over the last two weeks have you been bothered by how much time you spend online? 
How often over the last two weeks have you been bothered by how much time spent gambling? 
How often over the last two weeks have you been bothered by how much time spent having sex? 
How often over the last two weeks have you been bothered by how much time spent exercising? 
 
 
Individual questionnaire durations are as follows:  
MINI Neuropsychiatric Interview takes approximately 15 minutes to complete.  
Follow up questionnaire (attached) based on PhenX drug use history toolkit takes approximately 105 minutes to completeTEA takes 
approximately 5 minutes to complete 
The GPRA Client Outcome Measures questionnaire takes approximately 30 minutes to complete.  
 
Baseline questionnaires will be administered on an iPad by the EMRAP staff or the study RA in patient care areas or by phone. 
 
At 1 week, 3 months and 6 months, questionnaires will be administered by the study RA by phone. Participants may be contacted in 
advance by text or email to arrange a time for the call that is convenient for the participant. 
 
Questionnaires will be labelled with the participant’s unique study ID number and stored separately from identifiable information (e.g. 
name, address, phone number etc).   
  

HS Protocol Form 02/13/2020 
 
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.  
 
200 hundred individuals will be recruited to the study over the course of 3 years.  
 
The primary outcome measure will be illicit opioid use at 1 week and 3 & 6 months.. Group differences (i.e. with or without the MAT 
bridge clinic) in opioid use will be assessed by logistic regression at each of the three time points. A power analysis using G*Power50 
indicates that a medium effect size, e.g. 0.3, related to the comparison of illicit opioid use in the experimental and control groups will be 
correctly identified with a power of 0.93 in a total sample of 200 individuals. Statistical tests will be performed in SPSS Statistics for 
Windows, Version 21.0. (Armonk, NY: IBM Corp). Logistic regression will be one-tailed with significance defined as p < 0.05. 
 
 
 
Risks/Benefits:  Describe any potential or known risks.  This includes physical, psychological, social, legal or other risks.  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.   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. 
Risks 
Identifiable Information. Information that uniquely identifies individuals will be collected from 
participants. This will include name, phone number, email, and address to facilitate contact with the 
participant at study follow-up points (i.e. 1 week, 3 months, 6 months). This information will be kept 
separate from other study materials, which will be coded with a subject number based on order of entry 
into the study.   
 
Demographic, Behavioral and Drug Use Information. Demographic information including age, sex, 
marital status, and occupation will be collected. Opioid Use Disorder will be assessed with the 15 
minute Mini-International Neuropsychiatric Interview (MINI). Opioid use history (e.g. onset, duration of 
use, route of administration) will be assessed with the opioid related items on the Pattern of Substance 
Use 
-Adult 
questionnaire 
in 
the 
PhenX 
toolkit 
(https://www.phenxtoolkit.org/index.php?pageLink=browse.protocoldetails&id=510302). In addition, 
the Addiction Severity Index-Lite CF (ASI-Lite), the 12-item Short Form Health Survey (SF-12), the 
Treatment Effectiveness Assessment (TEA)43 and the Vermont Treatment Needs Questionnaire 
(TNQ) interviews will be conducted. 
 
Biological samples. Urine samples will be collected at 1 week, 3 months, and 6 months. Urine 
specimens will be collected under observation of same-sex staff and immediately analyzed for opioids 
(buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other 
drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay 
(Microgenics, Fremont, CA). Missing urine specimens will be considered positive for illicit opioids, 
consistent with an intent-to-treat approach. 
 
Risks. The participants enrolled in this study have OUD. The most effective current treatment for the 
disorder is Medication-Assisted Treatment which will be provided to enrolled participants. The risks of 
participating in the study are weighed against sequelae of not seeking treatment, which include death 
due to acute overdose, birth defects in pregnant women and health risks related to needle sharing.   
 
We will obtain careful informed consent to ensure that every potential participant fully understands all 
of the possible risks. In addition, we will not include individuals who we believe would not be able to 
tolerate the study procedures. 
 
Medication related risks will be mitigated by medical supervision at the ATP who will train ED staff.  

HS Protocol Form 02/13/2020 
 
 
Risks from Buprenorphine (Suboxone): 
Common side effects of Suboxone include:  
• 
nausea; 
• 
constipation or abdominal pain; 
• 
sweating;  
• 
tiredness or sleep other problems (insomnia);  
• 
headache;  
• 
redness, pain, or numbness in your mouth;  
• 
feeling drunk; or,  
• 
trouble concentrating. 
Less common side effects of Suboxone include:  
• 
vomiting 
• 
mild dizziness; 
• 
tingling 
• 
muscle cramps;  
• 
distress and irritability; or,  
• 
fever.  
 
Risk of Accidental Exposure in Children: There is an increased chance of child exposure to 
buprenorphine resulting from this medical intervention. However, this should be viewed in a wider 
health perspective. Most medications prescribed by ED (hypoglycemics, CCBs, BBs, cholchicine, other 
opioids, etc) are dangerous in exploratory ingestions and many of these are on the “one pill can kill” 
list for kids. It is likely the adults who will receive a Suboxone Starter Pack have opioids in the home 
already. In fact, the study is attempting to trade illicit use (e.g. heroin/fentanyl) for a safer opioid which 
should lead to improved adult supervision of children and reduce risk of parental death by overdose. 
The benefits to families of treating the disease appear to outweigh the risks. 
Risks from Opioid Withdrawal: Opioid withdrawal symptoms which include tearing up, muscle aches, 
agitation, trouble falling and staying asleep, excessive yawning, anxiety, nose running, sweats, racing 
heart, hypertension, nausea and vomiting, diarrhea, stomach cramps, depression and drug cravings. 
Symptoms of withdrawal will be managed with buprenorphine. Participants will be educated about 
opioid withdrawal with a fact sheet that includes a brief list of coping strategies. If participants still 
experience opioid withdrawal after buprenorphine induction, research staff will cue the participant to 
use coping strategies. Clinical support will be provided by addiction psychiatrists at the ATP. 
Risks from Research Assessments: The assessments being used in this study (e.g. measures of 
substance use, symptoms, information about patient history, and urine assessments) may cause some 
discomfort, boredom, anxiety or fatigue. Participants will be advised that they can take a break, refuse 
to answer question(s), or end the study session if they become uncomfortable in any way. Additionally, 
psychiatrists experienced in the treatment of addiction, will be present or rapidly available via pager for 
emergency consultation at any time. 
 
Risk Related to Confidentiality: This research involves monitoring and treatment of patients who use 
illicit opioids. Participants may engage in other illegal drug use activities. Maintaining confidentiality is 
an area of utmost importance for this population. 
 
Protections Against Risks 
Clinical support for withdrawal will be provided by addiction psychiatrists at the ATP. Participants who 
receive ED-initiated buprenorphine treatment are guaranteed placement in the ATP. The ATP team 
includes two fellowship-trained addiction psychiatrists, one general psychiatrist, and one family 

HS Protocol Form 02/13/2020 
 
physician who are all experienced in treating OUD, as well as resident and fellow trainees from 
psychiatry, family medicine, and internal medicine, and licensed professionals in nursing, alcohol and 
drug counseling, mental health counseling and clinical social work. The staff is experienced in providing 
MAT to patients in all phases of treatment, in diverse settings and across levels of acuity, as well as in 
educating, training and supporting colleagues with varying levels of experience, training and comfort in 
addictions treatment. The ATP was selected by the State of Vermont to lead a state-wide Learning 
Collaborative Project to provide training and education to MAT practices throughout the state of 
Vermont. 
 
Participant data will be coded to protect privacy. Each patient will be assigned a unique identification 
number. The list of participant names and identification numbers will be kept in a locked file cabinet 
separate from the database. Access to the computerized data system is carefully protected by a 
secured password entry system. Participants will be made aware of the various parties who will have 
access to their data in the informed consent document. Access to participants' data will be restricted to 
project investigators and other study staff on a need to know basis. Patient information, if reported, will 
be reported as group data. No patients will be individually identified. 
 
To minimize risk of divulging confidential information regarding substance use or other illegal activities 
as well as other study information, strict attention to confidentiality will be maintained throughout every 
aspect of this research with standard policies and procedures, and protected by a Certificate of 
Confidentiality issued by NIH. 
 
Individuals from vulnerable populations will not be included in the study.  
 
Incidental findings will be reported to the participant by a study MD. 
 
 
Potential Benefits 
Participants enrolled in the study will either receive standard of care or buprenorphine MAT, which is 
the most effective current treatment for the disorder. Participants will be provided guaranteed access 
to treatment by specialized addiction psychiatrists at the ATP. 
 
The proposed intervention will allow ED physicians to move beyond the mere treatment of the acute 
symptoms of the disorder toward treatments that will mirror the medical response to other chronic life-
threatening diseases presenting to the ED, such as diabetes or cardiovascular disease. Similar to these 
other chronic conditions, the ED is a critical opportunity to connect patients who are not receiving 
adequate care with long-term treatment options. In addition, OUD contributes to frequent re-admission 
rates in certain patients. Improving the chances that these individuals enroll in long-term care will 
reduce ED burden and free up resources for other patients. This research is intended to provide pilot 
results to support an R01-funded research program to determine best practices for effectively engaging 
untreated individuals with OUD presenting to ED in MAT. Positive findings on Aim 1 will support 
network-wide adoption of this intervention in Vermont.  
 
 
 
 
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 
Alternate Treatment. 
Participants will be informed that they are free to leave the study at any time. The most effective current 
treatment for the disorder is medication-assisted treatment, which will be provided to enrolled 

HS Protocol Form 02/13/2020 
 
participants. 
 
Alternate local treatment providers include: the Chittendon Clinic Hub, the Community Health Centers 
of Burlington, and Safe Recovery. 
 
 
Data Safety and Monitoring:  The specific design of a Data and Safety Monitoring Plan (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.   
The PIs will monitor safety and review current literature throughout the study. The study team will meet 
for a full review of safety procedures and any adverse events every 6 months.  
 
The PI will report adverse events directly to the University of Vermont IRB.  In this study, we will use 
the FDA definition of serious adverse events (SAEs). The Principal Investigator will verbally report 
SAEs to the IRB immediately, followed by a written report to the IRB within one week 
 
We will follow the guidelines established by the Committee on Human Research for reporting adverse 
events or unanticipated problems. We will use the FDA definition of serious adverse events (SAE). 
Adverse events reported to or noted by the study personnel will be reported to the key personnel within 
24 hours. The guidelines established by the Committee on Human Research “Adverse Event and 
Unanticipated Problems Reporting Policy” will be followed. The key personnel will verbally report SAEs 
to the IRB within 48 hours, followed by a written report to the IRB within one week. The key personnel 
will review all adverse events and other safety information semi-annually. Any unanticipated problems 
(protocol deviations, issues with confidentiality, or problems reported by the subject) that do not meet 
the definition of an adverse event that occur during this study will be reported by the key personnel 
within 24 hours. The key personnel will report the unanticipated problem to the appropriate university 
officials (IRB). 
 
New safety information is not expected during the proposed intervention. However, in the event new 
safety information adversely affecting the intervention became available, it would be communicated 
immediately to the PI and Co-Is, and they will contact the IRB for further guidance including terminating 
the intervention to insure the safety of the participants. 
 
We will obtain careful informed consent and insure that each participant fully understands the study 
procedures. We will not attempt to obtain consent from anyone with a legal guardian. Study participants 
may discontinue a study procedure at any time if they are uncomfortable or the study procedures 
appear to be causing exacerbation of illness. 
 
Participants who are receiving buprenorphine will be monitored by specialized addiction psychiatrists 
at the ATP who are part of the study team. The ATP team includes two fellowship-trained addiction 
psychiatrists, one general psychiatrist, and one family physician who are all experienced in treating 
OUD, as well as resident and fellow trainees from psychiatry, family medicine, and internal medicine, 
and licensed professionals in nursing, alcohol and drug counseling, mental health counseling and 
clinical social work. The staff is experienced in providing MAT to patients in all phases of treatment, in 
diverse settings and across levels of acuity, as well as in educating, training and supporting colleagues 
with varying levels of experience, training and comfort in addictions treatment. The ATP was selected 
by the State of Vermont to lead a state-wide Learning Collaborative Project to provide training and 
education to MAT practices throughout the state of Vermont. 
 
Electronic data will be kept in password-protected files and on secure servers and will be identifiable 

HS Protocol Form 02/13/2020 
 
by subject code number only. No one outside of the research group will have access to records 
identifying subjects' names at any time, except for the Office of Human Research Protections, the 
Institutional Review Board and other oversight personnel may be granted direct access to records as 
indicated in their oversight responsibilities. The information gathered will be used only for scientific, 
educational, or instructional purposes.   
 
 
 
 
Adverse Event and Unanticipated Problem (UAP) Reporting:  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 the 
Committees on Human Research “Adverse Event and Unanticipated Problems Reporting Policy” will be followed.  The UVM/UVM 
Medical Center process for review of adverse events and UAPs to subjects or others should be included in the DSMP.   
The study team will follow the guidelines established in the committees on Human Research “Adverse Event and Unanticipated 
problems Reporting Policy”. 
 
 
 
Withdrawal Procedures:  Define the precise criteria for withdrawing subjects from the study.   Include a description of study 
requirements for when a subject withdraws him or herself from the study (if applicable). 
A subject may decline to join the study, or may withdraw from the study at any time.  Subjects declining consent or withdrawing from 
the study will have all data deleted, with the exception of the logs that document the destruction.  The study code assigned to the 
subject will remain in the database with “voluntarily withdrawn from the protocol” as the only information retained about the subject 
(patient identifiers will not be saved except on the study master list).   
 
Note: Participants are not required to test negative on urine drug tests at the assessment time points of 1 week, 3 months and 6 
months. It is expected that many will test positive. Although drug tests are part of the ATP treatment program, this is independent of 
observational urine drug tests performed for the study at 1 week, 3 months and 6 months which will be used to determine the success 
of the ED-initiated intervention. Individuals who decline or withdraw from ATP services are not automatically withdrawn from the 
research study. Additionally, individuals who withdraw or are withdrawn from the study may continue to seek treatment services from 
the ATP. Participation or not in the study will not affect medical care provided by ED or the ATP.     
 
Sources of Materials:  Identify sources of research material obtained from individually identifiable human subjects in the form of 
specimens, records or data.  Indicate whether the material or data will be obtained specifically for research purposes or whether use 
will be made of existing specimens, records or data. 
Urine samples, Questionnaires, Medical History 
 
 
 
DRUG AND DEVICE INFORMATION  
 
 
Investigators are encouraged to consult the UVM Medical Center Investigational Pharmacy Drug Service (847-4863) prior to finalizing 
study drug/substance procedures. 
 
*Investigational Pharmacy Drug Service was consulted. They determined that IDS will not be involved in the current study because 
Suboxone is not be investigated as an IND. Rather, the research investigates a novel method to increase treatment enrollment with an 
already established use of Suboxone.   
 
Drug (s) 
 
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. (attach investigational drug brochure) 
Buprenorphine-naloxone (Suboxone). Sublingual film, FDA approved formulation available as 2 mg-0.5 mg, 4 mg-1 mg, 8 mg-2 mg, 12 
mg-3 mg. Buprenorphine is a mu-opioid receptor partial agonist and a kappa-opioid receptor antagonist. The opioid agonist properties 
of buprenorphine are limited by a ceiling effect which occurs at higher doses. Naloxone is a mu-opioid receptor antagonist. When 
administered parenterally, naloxone produces opioid withdrawal symptoms in patients who are physically dependent on full opioid 
agonists. Naloxone is minimally active when administered orally. Buprenorphine in combination with naloxone for the treatment of 
opioid addiction reduces the possibility of parenteral misuse by producing withdrawal symptoms when injected. 
Preparation:  Reconstitution instructions; preparation of a sterile product, compounded dosage form; mixing guidelines, including fluid 
and volume required.  Identify who will prepare. 
Buprenorphine-naloxone sublingual films are commercially available, therefore further compounding or reconstitution is not required.  
Storage and stability – for both intact and mixed products.   
Store at a controlled room temperature of 25 degrees C (77 degrees F), with excursions permitted between 15 and 30 degrees C (59 
and 86 degrees F). 
Administration – Describe acceptable routes and methods of administration and any associated risks of administration. 

HS Protocol Form 02/13/2020 
 
Administer whole; do not cut, chew, swallow or move after placement. Place under the tongue near the base on the right or left side 
and leave under tongue until it is completely dissolved; proper administration techniques should be demonstrated for the patient.  
 
If more than 1 film is needed to achieve the prescribed dose, place the second film SL on the opposite side as the first film, and 
minimize overlap as much as possible. If a third film is necessary, place it under the tongue on either side after the first 2 films have 
dissolved. 
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. 
Severe toxicity is rare. Ingestion of 88 mg of buprenorphine in an adult resulted in severe opiate withdrawal. Ingestion (oral instead of 
sublingual) of 112 mg of buprenorphine resulted in severe hepatitis/acute renal failure.  
 
Respiratory depression has been associated with buprenorphine when administered intravenously. In many cases, coma and death 
have been reported in opioid addicted patients who have concomitantly taken benzodiazepines and misused IV buprenorphine. 
Buprenorphine should be used cautiously in patients with COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, 
or any preexisting respiratory depression. Patients who receive buprenorphine should be educated on the dangers of concomitant self-
administration of benzodiazepines or other CNS depressants. 
 
There is no specific known toxic dose with naloxone, though deaths have occurred in varying doses associated with its use. However, 
these case reports do not provide any direct evidence that the use of naloxone was solely responsible for mortality. 
 
Interactions: 
Drug-ethanol: Concurrent use of BUPRENORPHINE and ETHANOL may result in increased risk of respiratory depression and CNS 
depression. 
Drug-food: Concurrent use of BUPRENORPHINE and GRAPEFRUIT JUICE may result in increased plasma concentrations of 
buprenorphine. 
Drug-drug: Concurrent use of NALOXONE and OPIOID AGONISTS may result in decreased opioid efficacy and precipitation of opioid 
withdrawal. This interaction is unlikely to result in any adverse effects within this study as naloxone produces negligible antagonist 
effects when administered orally. 
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. 
Yes 
2.  for the route of administration specified?  If no, provide justification for route and describe the method to accomplish. 
Yes 
3.  for the intended action? 
Yes 
 
Device (s) 
X 
Not applicable 
Device name and indications (attach investigational device brochure) 
 
Is it FDA approved: (include FDA IDE Number) 
1.  for indication specified? If no, provide justification for proposed use and source of the device. 
 
Risk assessment (non-significant/significant risk) - PI or sponsor needs to assess risk of a device based upon the use of the device 
with human subjects in a research environment.   
 
 
 
 
SUBJECT CHARACTERISTICS, IDENTIFICATION AND RECRUITMENT  
 
Subject Selection:  Provide rationale for subject selection in terms of the scientific objectives and proposed study design. 
Subjects will be screened for inclusion if they present to the ED with signs of opioid use disorder (i.e. self-report or 
symptoms consistent with the disorder) Symptoms consistent with the disorder include:  presentation with acute overdose 
or symptoms consistent with opioid withdrawal (such as piloerection, diarrhea, tachycardia, cravings, and pupillary 
dilation), and EMS use of naloxone on scene or en route to the hospital, patients with abscesses, especially in the 
antecubital fossa and other areas consistent with injection drug use and patients with a history of endocarditis. 
 
Vulnerable Populations:  Explain the rationale for involvement of special classes of subjects, if any.  Discuss what procedures or 
practices will be used in the protocol to minimize their susceptibility to undue influences and unnecessary risk (physical, psychological, 
etc.).  
X 
Not applicable 
 
 
 
Number of Subjects:  What is the anticipated number of subjects to be enrolled at UVM/UVM Medical Center and in the case of a 
multi-center study, with UVM/UVM Medical Center as the lead, the total number of subjects for the entire study. 

HS Protocol Form 02/13/2020 
 
We expect to enroll 140 participants at UVMMC and 200 participants in total. 
 
Inclusion/Exclusion Criteria:  Eligibility and ineligibility criteria should be specific. Describe how eligibility will be determined and by 
whom.  Changes to the eligibility criteria at a later phase of the research have the potential to invalidate the research. 
  
 
Inclusion Criteria: 
-Present to the UVMMC Emergency Department (and later after IRB review the Emergency Departments at Central 
Vermont Medical Center and Porter Medical Center) 
-Endorse criteria for Opioid Use Disorder (OUD) as defined by the DSM-V 
- Over the age of 18 
 
Exclusion Criteria: 
-Non-english speaking 
-Current participation in an alternate treatment program for OUD (except recent release from correctional facility or 
residential treatment program and does not have a current prescription), 
-Inability to communicate 
-Altered mental status 
-Suicidality 
-Medical extremis or medical issue requiring admission 
-Prisoners 
-History of Suboxone injection in the past year 
-Hepatic impairment 
 
 
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.  
-Sex/gender will not be a selection/exclusion factor for the recruitment. In Vermont, women compose ~50% of the general 
population. Thus, we anticipate a similar proportion in the proposed research. However, participants will be recruited to 
the study because they present to the ED and are eligible. The predetermined randomization tables which include a 
stratification by sex will insure that equal numbers of women are sorted to the control and experimental groups.  
 
Pregnant and nursing mothers will not be excluded. Opioids such the buprenorphine contained in Suboxone can cause 
birth defects. However, opioid withdrawal can be especially harmful during pregnancy, potentially resulting in preterm 
labor, fetal distress, or even miscarriage. Buprenorphine reduces opioid craving and alleviates withdrawal symptoms 
without the safety and health risks related to acquiring and abusing street drugs. Treatment with Suboxone is considered 
to be a lower clinical risk to the fetus than uncontrolled use of illicit opioids. In contrast to earlier recommendations about 
buprenorphine+naloxone, recent research is consistent with Suboxone being as safe or safer than buprenorphine 
monotherapy during pregnancy. This pilot project will inform practical aspects of the network-wide implementation of an 
ED-initiated intervention for OUD in Vermont including patients who are pregnant.   
 
-Minorities. There will be no exclusion criteria concerning race or ethnicity. In Vermont, minorities represent approximately 
5% of the general population. Thus, we anticipate a similar proportion in the proposed study. We will do all that we can to 
assure that minorities are represented in the research. 
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.  If children are excluded then provide appropriate justification. Provide target accrual for this 
population. 
Individuals under the age of 18 are excluded. The minimum age limit is intended to exclude younger individuals who are 
under adult legal guardianship. Compared to the adult sample, the involvement of a guardian would significantly alter the 
motivational structure of seeking and staying in treatment to be tested.  
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.   

HS Protocol Form 02/13/2020 
 
X 
Not applicable 
 
 
Recruitment:  Describe plans for identifying and recruitment of subjects.  All recruitment materials (flyers, ads, letters, etc) need to be 
IRB approved prior to use.   
Participants will be recruited from patients presenting to the ED. Thus, there are no recruitment materials to be reviewed.  
 
 
 
FINANCIAL CONSIDERATIONS  
 
Expense to Subject:  If the investigation involves the possibility of added expense to the subject (longer hospitalization, extra 
studies, etc.) indicate in detail how this will be handled. In cases where the FDA has authorized the drug or device company to 
charge the patient for the experimental drug or device, a copy of the authorization letter from the FDA or sponsor must 
accompany the application. Final approval will not be granted until the IRB receives this documentation. 
There are very limited circumstances under which study participants may be responsible (either directly or via their insurance) 
for covering some study-related expenses. If the study participant or their insurer(s) will be billed for any portion of the research 
study, provide a justification as to why this is appropriate and acceptable. For example, if the study involves treatment that is 
documented standard of care and not investigational, state so. In these cases, the protocol and the consent should clearly 
define what is standard of care and what is research. 
The costs of urine drug screening at 1 week, 3 months and 6 months will be paid by the study  
Payment 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 
 
As an incentive to provide a urine sample and answer questions, participants will receive a $25 gift card after responding to 
questionnaires at baseline.  They will also receive a $25 gift card for answering  $50 gift card for each of the three outcome time 
points completed (i.e. 1 week, 3 and 6 months post randomization) up to a total of $250. To avoid altering the motivation to stay 
in MAT, participants will earn payment for providing the urine samples and answering questions at each of the 3 follow-up time 
points, regardless of whether they are currently in treatment. 
 
Collaborating Sites.  When research involving human subjects will take place at collaborating sites or other performance sites 
when UVM/UVM Medical Center is the lead site, the principal investigator must provide in this section a list of the collaborating 
sites and their Federalwide Assurance numbers when applicable.  (agreements may be necessary) 
X 
Not applicable 
 
Note that Central Vermont Medical Center and Porter Medical Center are not yet prepared to start data collection. Details about 
procedures at these sites will be added by amendment as it becomes necessary. No protocol procedures will be performed at 
CVMC or Porter until these amendments have been reviewed by the IRB. We ask that the IRB approve the UVMMC site to 
continue enroll participants while the other sites are prepared. 
 
 
 
 
 
INFORMED CONSENT  
 
Consent Procedures:  Describe the consent procedures to be followed, including the circumstances under which consent will 
be obtained, who will seek it, and the methods of documenting consent.  Specify the form(s) that will be used e.g. consent (if 
multiple forms explain and place identifier on each form), assent form and/or HIPAA authorization (if PHI is included).  These 
form(s) must accompany the protocol as an appendix or attachment.   
 
Note:  Only those individuals authorized to solicit consent may sign the consent form confirming that the prospective subject was 
provided the necessary information and that any questions asked were answered. 
Informed consent will be obtained by Emergency Medicine Research staff with the support of the Emergency Medicine 
Research Associate Program (EMRAP).  EMRAP is led by Dr. Daniel Barkhuff and Roz Bidad and is structured as follows: 
 

HS Protocol Form 02/13/2020 
 
 
Although Research Chiefs offer guidance and support to the Research Associates, it is paid staff and faculty that directly 
oversee the students. Students do not supervise other students.  The research team are stationed in the clinical care area of the 
Emergency Department and remotely.  The Research Associates will perform the task of screening for eligible subjects.  They 
will utilize the EHR to identify patients they believe qualify for the study based on inclusion and exclusion criteria.  Once they 
have identified an eligible patient, the Research Coordinator will contact a member of the ED clinical care team to confirm that 
they are appropriate and approachable for this study.  At this point, a paid member of staff (Research Coordinator) will contact 
the patient for informed consent.  Informed consent discussions will occur in the patient care areas of the Emergency 
Department with research staff in-person or via telephone.  Informed consent discussions will NOT be performed in the waiting 
room, in triage or in the halls of the ED. 
 
This study will utilize a prospective consent form.  Consent will only be obtained from the patient and will include HIPPA 
authorization.  The study team will document the process of informed consent using a form based on the UVM IRB’s 
recommended template. Informed consent may be completed via eConsent on RedCap. Subjects will be provided with a printed 
copy of the signed consent form. Subjects may request the signed PDF be emailed to them, acknowledging that email is not a 
secure means of communication as UVM can’t control the security of email or text messages once we send them. A field is 
included in the eConsent for subjects to indicate whether they would like their signed PDF emailed, acknowledging the 
understanding that these communications are not secure. 
 
Information Withheld From Subjects:  Will any information about the research purpose and design be withheld from potential 
or participating subjects?  If so, explain and justify the non-disclosure and describe plans for post-study debriefing.   
 
Not applicable 
 
 
No information will be withheld from participating subjects 
 
 
 
 
Attach full grant application, including budget information and/or any contract or draft 
contract associated with this application.  
 
All materials must be submitted electronically to the IRB via InfoEd. Proper security access is 
needed to make electronic submissions. Visit the InfoEd Resource Materials page for more 
information. 
 
Students enrolled in SURG 
201 (minimum of 60 hours 
of research training)
Students enrolled in SURG 
220 (minimum of 175 hours  
of research training)
Paid Staff
Director of Research in 
Emergency Medicine (REM)
Roz Bidad, 
RN, BSN
EMRAP 
Research 
Coordinator
Research 
Chief
Research 
Associates
Research 
Chief
Research 
Associates
EMRAP 
Research 
Coordinator
Research 
Chief
Research 
Associates
Research 
Chief
Research 
Associates