Clinical trial NCT03150173
Conditions: Opiate Addiction
Keywords: opioid use disorder, syringe exchange, HIV risk reduction
Sponsor: Montefiore Medical Center
Start date: 2019-01-02; Completion date: 2024-03-31
Enrollment: 97 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will recruit syringe exchange participants with opioid use disorder in New York City and test whether starting buprenorphine treatment at the syringe exchange program is more effective than referral to a community health center for buprenorphine treatment.

Detailed description:
In a 24 week randomized controlled trial based in a large urban area with high rates of opioid use disorder (OUD) and HIV, 250 out-of-treatment opioid users who utilize syringe exchanges will be recruited and randomize to receive an onsite treatment intervention (O-BMT) or enhanced referral to buprenorphine treatment. Over 2 weeks, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment. In the control arm, participants will receive enhanced referral to the community health center for maintenance buprenorphine treatment. Data collection will include urine drug tests, questionnaires, and medical and pharmacy record review. Key outcomes will include engagement in buprenorphine treatment, treatment outcomes, and programmatic costs. Buprenorphine diversion will be assessed by using electronic monitors that estimate medication adherence, testing urine samples for buprenorphine, and through sequential surveys regarding buying or selling illicit buprenorphine.

Arms: arm 1: Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment arm 2: In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment
Interventions: intervention 1: Onsite treatment intervention 2: Enhanced referral intervention 3: Buprenorphine
Intervention descriptions: intervention 1: Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy. intervention 2: Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment intervention 3: all participants will receive buprenorphine

Protocol documents:
Prot_SAP_000.pdf: 
Title: Buprenorphine Treatment at syringe exchanges to reduce opioid misuse and 
HIV risk
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NCT03150173
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Study Protocol
Title: Buprenorphine treatment at syringe exchanges to reduce opioid misuse and HIV risk
Principal investigator: Aaron D. Fox, MD MS
Co-Investigators: 
Chinazo O. Cunningham, MD MS
Sean Murphy, PhD
Brianna Norton, DO MPH
I. Overview and Specific Aims:
The goal of this research is to change the paradigm of addiction treatment by starting opioid use 
disorder (OUD) treatment in community settings frequented by opioid users, instead of relying 
on referral to treatment facilities. In 2014, of the 2.5 million Americans in need of treatment for 
OUD, fewer than 490,000 were admitted to treatment facilities, leaving a large treatment gap.1,2 
Barriers to OUD treatment are often structural, including health system fragmentation, costs, 
and stigma toward people who use drugs in traditional medical settings.3-8 Buprenorphine 
maintenance treatment (BMT) may be offered in diverse settings addressing some structural 
barriers; however, after buprenorphine became available in the US, up to 80% of those with 
OUD remained out-of-treatment.9 BMT reduces illicit opioid use, HIV risk behaviors, and opioid 
overdose, which makes BMT engagement critical to address the consequences of opioid use, 
including overdose deaths and HIV transmission. This project will bring BMT directly to out-of-
treatment opioid users reducing barriers to care. 
The objective of this study is to test the effectiveness and safety of initiating buprenorphine 
treatment onsite at syringe exchange programs. In 2013, there were 204 syringe exchange 
programs (SEPs) in the United States and Puerto Rico, distributing 46 million syringes, and at 
least 80% of SEP participants report use heroin or other illicit opioids.32 Our research group has 
years of experience studying attitudes of SEP participants and working with SEP staff.10 We 
found that most opioid-using SEP participants express interest in BMT, but experience structural 
barriers to BMT -- most commonly, not knowing where to go for treatment.5,11-13 Therefore, we 
trained SEP staff to facilitate linkage to BMT for participants who were interested in treatment, 
but this did not increase BMT engagement.14 However, most SEP participants reported that they 
would prefer to receive BMT onsite at SEPs instead of referral to addiction treatment facilities or 
medical clinics.15 Thus, based on formative data and experience, we propose to initiate BMT 
onsite at SEPs before transferring care to a community health center (CHC) for maintenance 
treatment.
In a 24 week RCT based in a large urban area with high rates of OUD and HIV, we will recruit 
250 out-of-treatment opioid users who utilize syringe exchanges and randomize 1:1 to O-BMT 
or enhanced referral. Over 2 weeks, participants in the O-BMT arm will see a buprenorphine 
provider twice, receive weekly medication, and then their care will be transferred to a CHC for 
maintenance BMT. In the control arm, participants will receive enhanced referral to the CHC for 
maintenance BMT. Data collection will include urine drug tests, questionnaires, and medical and 
pharmacy record review. We will study rates of BMT engagement (defined as receiving BMT at 
30 days following randomization), treatment outcomes (opioid use, HIV risk behaviors), and 
programmatic service utilization and costs to establish effectiveness and economic viability. We 
will assess buprenorphine diversion by using electronic monitors that measure medication 
adherence, testing urine samples for buprenorphine, and through sequential surveys regarding 
buying or selling illicit buprenorphine. We will also explore changes in self-efficacy and quality of 
life in both study arms. Our specific aims are:
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1. To test the effectiveness of initiating onsite buprenorphine treatment at syringe exchange 
programs. 
Hypothesis 1: More participants randomized to O-BMT (vs. referral) will be engaged in BMT at 
30 days.
Hypothesis 2: Reductions in opioid use (on self-report and weekly urine drug testing) will be 
greater among participants randomized to O-BMT (vs. referral) over 24 weeks of follow-up.
Hypothesis 3: Reductions in HIV risk behaviors will be greater among participants randomized 
to O-BMT (vs. referral) over 24 weeks of follow-up.
2. To test the safety of O-BMT by determining the frequency of buprenorphine diversion. 
Hypothesis 4: Diversion of buprenorphine during the 24 weeks of follow-up will not be 
significantly greater among participants randomized to O-BMT (vs. referral).
3. To determine the cost effectiveness of O-BMT by comparing costs and health service 
utilization between study arms.
 Hypothesis 5: O-BMT will be cost-effective according to commonly accepted thresholds.
II. Background
Most Americans with OUD remain out-of-treatment. Rates of opioid use, disorder, and 
overdose have skyrocketed over the past decade. In 2014, of the 2.5 million Americans in need 
of treatment for opioid use disorder (OUD), fewer than 490,000 were admitted to addiction 
treatment facilities, leaving a large treatment gap.1,2 Buprenorphine maintenance treatment 
(BMT) was approved in the United States in 2002 with the goal of improving access to 
treatment. BMT may be offered in diverse medical settings, addressing the stigma of attending 
addiction treatment programs and increasing the number of locations where opioid use disorder 
treatment is available;16-20 however, despite BMT availability, 80% of those with OUD remained 
out of treatment in the United States through 2013.9 Therefore, there is a large and increasing 
population of out-of-treatment opioid users (approximately 1.9 million), but with thirty-eight 
states having more than ¾ of their opioid treatment programs operating above 80% capacity, 
new treatment venues will be necessary.21,22  
Efforts needed to engage out-of-treatment individuals. After buprenorphine became 
available, between 2003 and 2013, OUD treatment utilization remained low (<20%) with minimal 
change.9  Instead of recruiting out-of-treatment opioid users, early BMT models may have 
encouraged methadone patients to change to BMT. Between 2007-9 in a large Medicaid 
population, rates of OUD treatment increased, and buprenorphine prescriptions doubled, but 
overall utilization of agonist medications (i.e, buprenorphine and methadone) did not change.23 
White race, insurance type, and living in areas with more waivered physicians have been 
associated with receiving BMT, but more marginalized groups may remain out of care.24-26 
Barriers to OUD treatment are often structural, including health system fragmentation, costs, 
and stigma in medical settings toward people who use drugs.3-7,27 Thus, structural interventions 
are needed to improve engagement. 
Syringe exchange programs (SEPs) reach a high-risk, out-of-treatment population. 
Emergency departments, hospitals, and correctional facilities have been targeted as novel sites 
for BMT initiation because they frequently encounter out-of-treatment opioid users who need 
linkage to treatment.28-31 Likewise, SEPs, which provide sterile syringes and other health-related 
services to PWID, are important locations to target. In 2013, there were 204 known SEPs in 33 
states, Washington DC, and Puerto Rico, distributing 46 million syringes, and at least 80% of 
SEP participants report using heroin or other illicit opioids.32-34 Recently, states that have 
opposed syringe exchange have changed laws to allow SEPs, and programs in high-risk areas 
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like rural appalacia are developing best practices.35 SEP participants have greater drug use and 
HIV risk behaviors than other PWID; however, many are unwilling or unable to access traditional 
medical services.5,33,36 Because SEPs reach a high-risk population, others have studied linkage 
to addiction treatment, but with referral alone as few as 9-16% enroll in opioid agonist 
treatment.37,38 Importantly, structural interventions, focusing on on case management or 
financial assistance, appear to be more promising than behavioral interventions, such as  
motivational enhancement therapy, to improve linkage to treatment.37-40 However, none of these 
interventions  have become standard practice at SEPs. BMT regulations allow for prescribing 
from diverse settings, including SEPs, which means that initiating BMT from SEPs is possible 
and could increase engagement in OUD treatment.41 Small pilot programs have implemented 
BMT at SEPs or provided outreach to SEPs with a mobile clinic, which supports feasibility of this 
approach (see below).42-45 Thus, in order to address structual barriers to care and facilitate 
initiation of BMT, we propose to bring BMT directly to SEP participants and rigorously 
investigate an onsite model of BMT at SEPs.
Pilot programs have demonstrated that onsite treatment is feasible. Descriptions of three 
BMT pilot programs at SEPs have been published. In New York City, a single physician 
assessed SEP participants for interest in BMT, substance use and co-morbidities, gave 
instructions for home induction, and prescribed one week of medication with a follow-up 
appointment after one week. At the follow-up appointment, the physician made dose 
adjustments, referred for psychosocial support, and continued to see the patient every 1-2 
weeks. Treatment retention was 68% at 3 months and 42% at 12 months, but self-reported drug 
use, urine drug testing, and diversion of medication was not reported.42 In Los Angeles, heroin-
using SEP participants were offered a 15-day onsite buprenorphine treatment protocol where 
medication was dispensed twice weekly. Participants were also provided with psychosocial 
counseling and support. Of 9 participants in the pilot, 7 completed the protocol, and 3 (33%) 
were transferred to a maintenance treatment program.43 In New Haven, a mobile medical clinic 
provided BMT to SEP participants, including both induction and maintenance treatment. By 
2006, more than 166 PWID were engaged using this model, but long-term outcomes were not 
reported.45
Theoretical framework of health service utilization. The Behavioral Model for Vulnerable 
Populations is commonly used to explain health seeking behaviors and predict health outcomes 
of vulnerable populations, including PWID.46 According to this model, predisposing, enabling, 
and need components will predict BMT utilization, which in turn will predict health outcomes. 
The model is useful in health services research, because factors that contribute to vulnerability 
may impede service utilization and should be considered as predisposing or enabling factors. 
Figure 1 outlines the components of the model that are relevant to this proposal. As illustrated, 
our target population is likely to have many predisposing factors that affect health behaviors and 
outcomes, including minority race/ethnicity, criminal behavior, substance use,and mental illness. 
Enabling factors are resources that facilitate OUD treatment, including insurance, transportation, 
ability to negotiate complex systems, and access to BMT providers. Need factors are 
determined by individuals’ perceived and evaluated health care needs. In an environment with 
adequate insurance (i.e., Medicaid), transportation (i.e., public transportation), and access to 
BMT providers (see section D.3), our structural intervention of onsite treatment, is predicted to 
increase BMT initiation and engagment. The enabling factor of onsite treatment will allow 
participants to initiate BMT when they are ready, instead of finding a provider, scheduling and 
waiting for an appointment, completing paperwork, and then waiting for assessment – 
potentially while in withdrawal. Of previously described barriers to BMT, health system 
fragmentation, waiting times, and fear of discrimination in medical settings can addressed 
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through onsite treatment.45 This enabling factor will help participants meet their perceived health 
needs (i.e., need for OUD treatment), which will have a positive effect on health outcomes.         
Concerns about buprenorphine diversion are common, but data are lacking. Diversion, 
meaning that patients who are prescribed buprenorphine (including buprenorphine-naloxone) 
give or sell the medication to others who are not engaged in treatment is a major concern for 
prescribers and policy makers.47-50 Those taking diverted medication may be “self-treating” 
withdrawal symptoms, which is common among PWID, or seeking euphoric effects.48,51-56 
Buprenorphine-naloxone is more commonly prescribed than buprenorphine alone, because the 
naloxone may reduce abuse potential.57 Buprenorphine is a partial opioid agonist that is unlikely 
to cause euphoria among individuals with high levels of opioid tolerance when taken 
sublingually. However, it can be adulterated and injected for euphoric effects. The naloxone in 
the combination product is unabsorbed when take sublingually, but it is more bioavailable if 
injected and will provide antagonism at opioid receptors.58 Therefore, PWID are unlikely to seek 
diverted buprenorphine-naloxone to inject for euphoric effect; however, they could divert 
medication to others posing a public health risk.48,51,59 Making BMT available at SEPs, where 
there is active drug use, could increase risk of diversion; however, it could also address an 
unmet need for treatment. In 2013, we found that among 102 SEP participants, 57 had taken 
diverted buprenorphine, and this was most common among those with barriers to BMT.13 In 
focus groups, SEP participants directly reported that they took diverted buprenorphine due to 
insufficient access to BMT.5 Other studies have found inadequate BMT access as a risk factor 
for using diverted buprenorphine.51,60 Therefore, onsite BMT at SEPs could also paradoxically 
reduce diversion. There are also other important areas that require inquiry. Though 35-100% of 
BMT patients initiating treatment have reported taking diverted buprenorphine, estimates of how 
many BMT patients divert their own medication to illicit markets are limited.56,59,61,62 Among 
inmates enrolled in trials of BMT initiation prior to jail or prison release, 10-20% were removed 
from the trials for attempting to divert their medication;28,29 however, data relevent to community 
BMT patients are needed to inform clinical practice and policies regarding buprenorphine 
prescribing (e.g., establishing monitoring guidelines).        
Measuring diversion. There are no standard measures to assess buprenorphine diversion, but 
we will draw upon a robust adherence literature related to HIV and other chronic conditions. 
Electronic monitors measure adherence most accurately.63 Wisepill electronic monitors can 
measure the time when participants remove their dose from the Wisepill monitor.64 Prior studies 
have mostly relied on self-report of diversion, while one study attempted to quantify diversion by 
testing parolees’ urine samples for buprenorphine.50 Estimating diversion solely based on 
collected urine has major methodologic limitations, though. The investigators did not know 
whether subjects had been prescribed buprenorphine, and examining those taking diverted 
buprenorphine does not answer questions about the amount of prescribed buprenorphine that 
BMT patients divert to others. Electronic monitors will allow us to study whether medication is 
taken at prescribed intervals, supplementing self-report and urine drug testing data. Improving 
methods to detect buprenorphine diversion could also improve the safety of office-based BMT.
Predisposing
Enabling
Need
Health Behavior
Health Outcome
Abstinence 
Improved quality 
of life
Engagement in 
BMT
Perceived need 
Evaluated need
Medicaid 
Transportation       
Access to BMT
Demographics 
Criminal Behavior 
Substance Use 
Mental Illness 
Housing Status 
Onsite Treatment
Figure 1. Theoretical Framework 
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Summary. Rates of opioid use, disorder, and overdose have skyrocketed over the past decade. 
Injection drug use continues to be an important risk factor for HIV transmission. The majority of 
Americans with OUD remain out-of-treatment. Syringe exchange services are increasingly 
offered in areas with high rates of OUD. Pilot programs offering BMT at SEPs support feasibility, 
but effectiveness, safety, and cost-effectiveness of onsite treatment is unknown. Addressing the 
opioid epidemic will require increased access to and uptake of OUD treatments. Onsite BMT at 
SEPs holds promise in reaching a high-risk out-of-treatment population.  
III. Research Design and Methods
Overview of study approach. In a 24 week RCT based in a large urban area with high rates of 
OUD and HIV, we will recruit 250 out-of-treatment opioid users from SEPs and randomize 1:1 to 
onsite BMT initiation (O-BMT) or enhanced referral. Over two weeks, participants in the O-BMT 
arm will see a buprenorphine provider twice, receive prescriptions of medication, and then their 
care will be transferred to a community health center (CHC) for maintenance BMT. In the control 
arm, participants will receive enhanced referral to a CHC for initiation and maintenance BMT. 
We will assess participants with urine drug tests, questionnaires, and medical record review 
studying treatment engagement, treatment outcomes (opioid use, HIV risk behaviors) and 
programmatic service utilization in order to establish effectiveness and costs. We will also 
assess buprenorphine diversion using electronic monitors, urine drug testing, and sequential 
surveys.
Setting. A. New York Harm Reduction Educators (NYRHE) is the largest harm reduction 
agency in New York City with over 35 staff members and serving over 5000 clients annually. At 
two community-based offices and 11 street-side locations, NYHRE provides participants with 
syringe exchange; referral for medical, dental and addiction treatment; and other supportive 
services. The majority of NYHRE’s clients are Hispanic or black, male, 40-49 years old, and 
PWID. Diverse staff members (case managers, outreach workers, and syringe exchange staff) 
have received training on BMT. O-BMT will be offered at community-based offices only.
B. Washington Heights CORNER Project (WHCP) is another harm reduction agency 
situated in an area highly affected by OUD and HIV. At its community-based office, WHCP 
provides clients with syringe exchange; referrals for medical, dental, or addiction treatment; and 
other supportive services. WHCP serves over 1500 clients annually with similar characteristics 
as NYHRE. WHCP staff members have received training on BMT.
C. BOOM!Health Is a harm reduction agency located in the South Bronx that now 
delivers a full range of prevention, syringe access, health coordination, behavioral health, 
housing, legal, advocacy and wellness services to over 8,000 of the hardest to reach 
communities in the Bronx, New York. BOOM!Health strengthens efforts to remove barriers to 
accessing medical care, with particular emphasis on HIV and viral hepatitis prevention and care 
services. BOOM!Health has private space for medical assessment and staff have experience 
with referrals to buprenorphine treatment.
Montefiore’s Community Health Center (CHC) will serve as a referral source for the 
study. The CHC offers primary and specialty care to over 15,000 adult patients annually and 
has worked closely with SEPs to facilitate referral of clients with HIV, HCV, or OUD.10 The CHC 
has provided BMT to more than 1000 patients since 2006 and has been used extensively for 
BMT research.65-70 There are 11 general internists who are waivered to provide buprenorphine 
and a clinical pharmacist coordinator who receives referrals. The CHC has assisted in 
recruitment and retention of study subjects, and electronic medical records can easily be 
extracted to ascertain study outcomes. The CHC is representative of those serving low-income 
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urban neighborhoods; over 65% of patients have public insurance and most live in the 
surrounding neighborhoods, which are 57% Hispanic and 39% non-Hispanic Black, and remain 
devastated by drug use and HIV.71 
Participants. Eligibility criteria: 1) age ≥ 18 years; 2) opioid use disorder by DSM-V criteria; 3) 
interest in BMT; 4) motivation for OUD treatment; and 5) willingness to accept CHC referral. 
Exclusions: 1) receiving opioid agonist treatment in the past 30 days (confirmed by NY 
Prescription Drug Monitoring Program); 2.) inability to provide informed consent; 3) unstable 
mental illness (e.g., suicidality, psychosis, etc.); 4) severe alcohol use disorder or 
benzodiazipine use disorder by DSM-V criteria; 5) hypersensitivity to buprenorphine or 
naloxone; or 6) pregnancy (confirmed via urine testing). In our BMT program,65 transaminase 
elevation (5X upper limit of normal) limited buprenorphine treatment in <1% of patients, 
therefore we will not draw blood to assess liver function prior to study enrollment. 
Recruitment. Staff members at the SEPs will receive training on BMT (buprenorphine 
education and referral to the CHC).14 Active recruitment will occur by staff members discussing 
BMT with participants and contacting a research assistant (RA). Passive recruitment will occur 
by posting study flyers at study sites and asking study partcipants to recommend other 
acquantainces for the study. 
Screening procedures: The RAs will screen all participants for exclusion and inclusion criteria. 
A diagnosis of opioid use disorder and exclusions (unstable mental illness, alcohol use disorder, 
benzodiazepine use disorder) will be established by applying the Mini International 
Neuropsychiatric Interview (MINI), a widely used psychiatric structured diagnostic interview 
instrument for unstable mental illness and Post Traumatic Stress Disorder and the DSM-V 
checklist for opioid, alcohol and benzodiazepine use disorder.  For this assessment (for both 
alcohol and benzodiazepines), there are 11 questions asked, if the participant answers with 
a  Yes to 2-3 of these questions, their use severity will be assessed as Mild, if they score a 4 or 
5, their severity use will be assessed as moderate if they score 6 or greater, their severity will be 
considered Severe. Interest in BMT and motivation for treatment will be established with 
previously published measures.12,73 In addition, the PCL-5, PTSD Checklist for DSM-5 and the 
Life Events Checklist for DSM-5 will be conducted.  Women of childbearing age will be screened 
with a urine pregnancy test.
Randomization: An RA will meet with eligible participants at the SEPs to describe the 
study. At enrollment, written informed consent including a consent quiz to monitor 
comprehension will be obtained, including a release for medical records. Randomization will be 
stratified by site (A, B or C, occur in blocks of 4-8, with 1:1 allocation of O-BMT vs. referral.  
Participant tracking: To facilitate tracking participants over the 24 week follow-up period, 
we will use procedures that we developed to retain people who use drugs in our previous 
research studies, in which we have had an 84% retention rate over 6-month follow-up.74 Locator 
Forms will list information about: 1) participants’ address and phone number; 2) contact 
information of participants’ family members, friends, case managers, physician, pharmacy, and 
drug treatment program; and 3) locations where participants hang out.
Protocol for O-BMT. This study will build off of this infrastructure at the SEPs for clinical care 
by adding a trained, buprenorphine-waivered physician or physician’s assistant to initiate BMT 
during two 
Table 1. Description of study arms
O-BMT
Waitlist
Site of initiation
SEP
CHC
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O-BMT
0
12
24
Figure 2: Study arms
Time (weeks)
2
Enhanced 
referral
Maintenance BMT at CHC
Maintenance BMT at CHC
X
X
X
X
X
X
1
4
6
8
X
X
Study 
visits
Site of 
maintenance
CHC
CHC
Type of referral
Staff-facilitated
Staff-facilitated
Primary 
Outcome
Engagement
Engagement
Assessment for 
diversion
 Wisepill 
Technologies 
medication 
adherence +
Urine Tests + 
Questionnaires
 Wisepill 
Technologies 
medication 
adherence + 
Urine Tests + 
Questionnaires
Onsite program 
service utilization
Provider + 
Transfer
Enhanced 
Referral
SEP = syringe exchange program; CHC = 
community health center
half-day sessions weekly. Participants will be 
registered as CHC patients to ensure continuity of 
care. For example, the provider will document 
encounters in the CHC’s electronic health record 
via a web-based portal and patients will be able to 
access medical advice during off-hours through the 
CHC (see Human Subjects). Participants will be 
prescribed BMT from the SEP and then staff 
members will facilitate transfer a CHC for 
maintenance treatment. Details are presented 
below and in Table 1.
Initiation. Over two weeks, participants will see the study provider twice onsite at the SEP. The first visit will 
include: assessment of opioid use disorder, contraindicactions to BMT, and co-morbidities; instructions for 
initiating treatment; prescription for one week of medication (buprenorphine-naloxone provided by prescription 
and transferred by patient to a Wisepill Technologies Medication Adherence Tracker); and planning for one 
week follow-up. Participants will start taking medication at home, which is safe, effective, and a standard 
practice.75-78 Participants will be prescribed 4-16 mg of buprenorphine daily based on their withdrawal 
symptoms following a standard algorithm. After one week, the study provider will make dose adjustments, 
provide another prescription for one week of medication (second prescription), and arrange for linkage to the 
CHC for maintenance BMT. The SEP staff will provide psychosocial support between visits and facilitate 
transfer of care to a CHC as specified in pre-intervention training.. Participants who do not pick up their second 
prescription within 14 days will not be eligible to repeat O-BMT procedures, but they still may be referred to the 
CHC for maintenance BMT.
Maintenance. After two onsite visits with the study provider, BMT will be transferred to a CHC via enhanced 
referral. The CHC will guarantee access to a BMT provider within one week (see Letters of Support) and 
research staff will assist with scheduling appointments. Physicians at the CHC are experienced treating OUD 
and will provide standard BMT (weekly visits at initiation, change to monthly visits with clinical stability, urine 
drug testing, psychosocial counseling) according to a written protocol (see appendix 1.). Participants will 
receive reminder calls the day before their appointment.
     Risk mitigation strategy for participants who take sedatives: Clinical decisions regarding BMT dosing, 
treatment continuation, and referral for additional psychosocial treatments will be based on the clinical 
judgement of BMT providers (i.e., buprenorphine-waivered physicians). Consistent with FDA-guidance, 
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physicians will provide the following aspects of care to participants who are taking benzodiazepines or other 
sedatives (including alcohol):    
• Education about the serious risks of combined use, including overdose and death, that can occur with CNS 
depressants even when used as prescribed, as well as when used illicitly. 
• Developing strategies to manage the use of prescribed or illicit benzodiazepines or other CNS depressants 
when starting BMT. 
• Tapering the benzodiazepine or CNS depressant to discontinuation if possible. 
• Verifying the diagnosis if a patient is receiving prescribed benzodiazepines or other CNS depressants for 
anxiety or insomnia, and considering other treatment options for these conditions. 
• Recognizing that patients may require BMT indefinitely and their use should continue for as long as patients 
are benefiting and their use contributes to the intended treatment goals. 
• Coordinating care to ensure other prescribers are aware of the patient’s buprenorphine treatment. 
• Monitoring for illicit drug use, including urine screening  
If the risks of BMT outweigh the clinical benefits, participants will be referred to an opioid treatment program for 
care and treatment.108
Rationale for 2 week intervention. The goal of this intervention is to encourage BMT engagement, which we 
expect to increase from initiating pharmacotherapy. Drop out from BMT is most pronounced in the first week of 
treatment, but SEP staff will be available for psychosocial support throughout this time.75,79 Starting treatment 
at home does not increase dropout from treatment.67,77 After BMT initiation, linkage from community-based 
settings to primary care is feasible.80 We considered continuing BMT onsite for longer than two weeks to 
accommodate participants who are comfortable with SEP staff but uncomfortable in traditional medical 
settings;3,4 however, there are potential benefits to transfering care. Maintance BMT at SEPs could expose 
participants to cues of drug use, which may trigger opioid craving;81 transfer to a CHC may improve access to 
medical services (mental health counseling, HIV treatment, etc.);82 and segregating care of PWID outside of 
the traditional health care system risks entrenching “separate and unequal” care.33
Assessment of buprenorphine diversion. We will assess buprenorphine diversion in three ways. For the first 
two weeks of treatment in both study arms, electronic monitors will be used enabling us to monitor medication 
adherence in real time. Participants will be incentivized to return electronic monitors, thereby strengthening the 
assertion that they did not sell or give away an entire pack. We will ask participants directly about selling their 
buprenorphine through sequential surveys. Audio computer-assisted self-interview technology through 
REDcap (see below) may reduce social desirability bias in reporting stigmatized behaviors, and prior studies of 
medical marijuana diversion have detected high rates of diversion through self-report.83-85 Additionally,all 
participants will have urine samples tested to confirm presence of prescribed buprenorphine. 
Control: Enhanced referral to BMT. The control condition will be enhanced referral to a CHC for initiation of 
BMT and maintenance treatment. Similar to O-BMT, the research staff will facilitate linkage to care. 
Participants will receive an expedited appointment within 1 week of the referral and a reminder phone call the 
day before their appointment. If participants do not attend their first appointment at the CHC, enhanced referral  
procedures will be repeated as long as the request occurs within two weeks of study enrollment (in parallel with 
the timing of O-BMT). We will assess fidelity to these referral procedures (see below). Buprenorphine providers 
at the CHC will follow the same procedures for BMT initiation as provided in O-BMT: assessment for OUD and 
co-morbidities, instruction on starting treatment at home, weekly electronic medical adherence monitors for two 
weeks with 4-16 mg of buprenorphine, dose adjustment after one week, and then monthly visits. Providers at 
the CHC will receive instruction on study procedures before commencing the trial, and procedures will be 
reviewed at monthly buprenorphine provider meetings at the CHC (see Letters of Support).    
Training the SEP staff. Referral to addiction treatment and psychosocial support are standard services 
provided by the SEPs. Prior to enrolling participants, we will enhance services by providing 3 hours of training 
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on BMT eligibility and procedures for making appointments and reminder phone calls. We have provided these 
trainings to SEP staff and peer mentors with good acceptability and fidelity to procedures.14 
Methods common to all aims. We will assess for BMT engagement (at 30 days), treatment outcomes (illicit 
opioid use and treatment retention), HIV risk behaviors, buprenorphine diversion, programmatic costs and 
service utilization, and participant attitudes over the study period. 
Research Visits: An RA will meet with all participants at enrollment and after 1, 2, 4, 6, 8, 12, and 24 weeks 
have elapsed. Research visits will occur in private at the SEP office or CHC and participants will receive a $10 
Clincard payment (weeks 1, 6) or a $25 Clincard payment (weeks 0, 2, 4,  8, 12, 24) compensation. Interviews 
and urine samples will be collected at each study visit. Medical records will be extracted at the completion of 
the study.
Data sources and measures: A complete list of measures is presented in Table 2. 
Medical Records: We will extract medical record data from the CHC, including prescription and visit 
information to assess treatment engagement and retention in care. Prescription data will include information 
both from the electronic medical record (prescriptions) and the NY Prescription Drug Monitoring Program 
(medications dispensed). As mandated by law, the later source includes all controlled substances dispensed 
by all pharmacies in New York State. Prescription data will include medication name, strength, directions, 
number of pills, number of refills, date of prescription, prescriber, and date medication was filled. Visit data will 
include date of visit, and provider. If participants request referral to a different site for BMT or are transferred to 
an alternative form of OUD treatment (e.g., methadone maintenance), we will request medical records using 
the signed, HIPAA-compliant release for medical records.
Urine Drug Testing: All research visits will include  urine collection, which will be tested for buprenorphine, 
opiates, oxycodone, methadone, cocaine, methamphetamine and benzodiazepines. 
Table 2.  Timing and delivery of intervention and study measures
Assessment Period (week)
Measure
Study Instrument
0
1
2
4
6
8
1
2
2
4
Urine Drug Tests
Opioid use
Urine Drug Testing
x
x
x
x
x
x
x
x
Questionnaires
Sociodemographic information
BHIVES Study66
x
HIV Risk Behaviors
RBS86
x
x
x
x
Self-reported drug use
Addiction Severity 
Index87
x
x
x
x
x
Depressive Symptoms
CES-D88
x
x
x
x
Self-efficacy
DTCQ-889
x
x
x
x
Quality of Life
EQ-5D90
x
x
x
x
x
x
Patient satisfaction
PCBSS91
x
x
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Motivation for treatment
SOCRATES73
x
x
x
Stigma and Discrimination
Ahern et al.92
x
x
x
Buprenorphine Diversion
MGH Medication 
Questionnaire
x
x
x
x
x
Non-study resource utilization
Non-Study Resources 
Form
x
x
x
x
Criminal justice resource utilization
Criminal and Legal 
Activities Form
x
x
x
x
PTSD symptoms
PCL-5
X
X
X
X
Traumatic reexposure
LEC-5
X
X
X
X
Medical Record Review
Treatment engagement
-
30 days
Retention in care
-
3 month, 6 month
RBS = HIV Risk Behavior Survey; CES-D = Center for Epidemiologic Studies Depression Scale; 
DTCQ-8 = Drug-Taking Confidence Questionnaire, 8 item version; EQ-5D = EuroQol 5D-5L; 
PCBSS = Primary Care Buprenorphine Satisfaction Scale; SOCRATES = The Stages of Change 
Readiness and Treatment Eagerness Scale
Questionnaires: Using the survey feature on REDcap which plays an audio recording of questions as it 
displays the question on a computer screen, will be used by the RA to administer questionnaires. Interviews 
will assess for sociodemographic information, motivation for treatment, HIV risk behaviors, buprenorphine 
diversion, and other variables (see below). Interviews will last 45-60 minutes.
Electronic medication adherence monitors: Wisepill electronic monitors will be used allowing us to monitor 
if and when medication is taken. Participants will receive a prescription for buprenorphine. After receiving the 
prescription, research staff will supervise the patient as they place their medication into the Wisepill Medication 
adherence monitors.  Each time the device is opened it sends a signal to a password protected database. 
Fidelity of referral: The SEP staff will follow identical procedures for referral or transfer of care to a CHC. 
We will not be able to blind participants or staff to study allocation. Therefore, we will record the number of 
appointments and reminder phone calls performed in each arm to ensure that SEP staff members are not 
providing differential effort in facilitating referral to a CHC.
Main outcome variables: Aim 1: Primary outcome (efficacy): we will use a dichotomous measure (yes/no) 
of BMT engagement defined as having an active buprenorphine prescription at 30 days after randomization.30 
Secondary outcome measures assessed at 24 weeks will include: proportion who filled a prescription for BMT, 
total weeks prescribed BMT, and time to BMT initiation (all continuous measures).
Aim 1: Secondary outcomes (efficacy): a.) Illicit opioid use: We will check urine drug testing at each 
research visit and use the Addiction Severity Index (ASI) to assess self-reported substance use.87 We have 
adapted the ASI to also assess use of illicit buprenorphine.13 We will report the following continuous measures 
in each study arm: the percentage of urine drug tests that are positive for illicit opioids (opiates, oxycodone, 
methadone, illicit buprenorphine), self-reported days of illicit opioid use, and percent of participants achieving 
opioid abstinence, defined as no illicit opioid use based on self-report and urine drug testing.    
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b.) Retention in treatment: For participants initiating BMT, we will determine whether they are retained in 
treatment at three and six months following initiation (dichotomous measure). We will define retention as 
having a medical visit and active buprenorphine prescription each month after BMT initiation. We will also 
determine the proportion of days following BMT initiation that participants had an active prescription in order to 
detect lapses in treatment (continuous measure).   
c.) HIV risk behaviors: We will determine changes in drug-related HIV risks using the HIV Risk Behavior 
Survey – a validated, well-studied instrument that documents injection and sexual behaviors over the previous 
30 days. This instrument has been studied among out-of-treatment PWID and BMT patients.86,93  As previously 
reported, we will create a dichotomous measure (yes/no) of injecting risk based on self-report of at least one 
risk behavior (sharing syringes, not using bleach to clean syringes, sharing cookers, or front/back loading of 
syringes).93 Individual risk behaviors will be explored individually.
Aim 2: Primary outcome (safety): We will use a dichotomous measure (yes/no) of buprenorphine 
diversion for all participants to determine how many sell or give away prescribed medication. We will define 
diversion as having at least one problem behavior over the 24 weeks: non-adherence to prescribed medication 
on electronic monitoring, self-reported diversion, or a urine sample consistent with diversion. Adherence will be 
determined weekly with Wisepill adherence for one week equaling X/7Y, where X = number of openings in one 
week and Y = number of doses prescribed per day. For the composite measure, non-adherence will be 
considered < 90% adherence. We will adapt the MGH Medication Questionnaire, which assesses misuse of 
prescribed medications, including selling medication, letting others take prescribed medication, or taking 
medication to get “high”. For the composite measure, self-reported diversion will be defined as an affirmative 
response to the question, “In the past 2 weeks , have you sold your buprenorphine to others?” We will also test 
each urine sample for buprenorphine, and if absent among participants prescribed BMT, the urine sample will 
be considered consistent with diversion. Each behavior will also be explored individually.
Aim 2: Secondary outcomes (safety): We will also report illicit buprenorphine use (i.e., buprenorphine 
detected in urine samples of participants who are not prescribed BMT), and determine changes in illicit 
buprenorphine use from baseline to study completion among participants in each study arm. 
Aim 3: Primary outcome (incremental cost-effectiveness ratio, ICER): The ICER will be calculated by 
dividing the incremental mean cost of the O-BMT arm relative to the control arm by the incremental mean 
effectiveness of the O-BMT arm relative to the control arm (instruments used to measure costs and 
effectiveness are described in detail below). The primary economic effectiveness outcome will be the quality-
adjusted life-year (QALY), a measure that incorporates both duration and health-related quality-of-life and is 
recommended as the primary economic effectiveness measure.94 The QALY captures a wider range of 
consequences than other clinical effectiveness measures, and permits comparisons across disorders and 
interventions, allowing for broader economic interpretation. Also, generally accepted value thresholds have 
been established for QALYs, but not for clinical measures.95 
Aim 3: Secondary outcomes (ICER, clinical) We will also calculate ICERs using the clinically meaningful 
effectiveness measure of duration of opioid abstinence, which will be operationalized as the proportion of the 
year the participant was abstinent from opioids (the abstinent year). The calculation of cost-per abstinent-year 
enables comparisons with existing economic evaluations that have utilized similar effectiveness measures.96 
Health-related quality of life: will be measured using the EuroQol 5D-5L (EQ-5D).90,97 Preference weights 
obtained from the EQ-5D will be used to calculate QALYs. The EQ-5D is the most widely used generic, 
preference-based health-related quality of life instrument in prospective cost-effectiveness analyses.98
Criminal and legal activities: will be self-reported using Timeline Followback, and measured using  the 
Criminal and Legal Activities Form. The following measures will be obtained: days involved in criminal activity; 
average number of crimes/day on days when illegal activity occurred; days incarcerated in any facility; specific 
crimes committed, and charges and convictions for those crimes; visits to parole/probation officer; and 
parole/probation violations.
Non-study resources: Non-study medical resources (e.g., medications, and use of inpatient, outpatient and 
emergency services) will be self-reported using Timeline Followback and collected using the Non-Study 
Resources Form. Use of non-medical resources (e.g., travel time to medical care) will also be self-reported and 
collected by the Non-Study Resources Form.
Intervention Resource Utilization and Costs: The resource utilization and resulting cost of implementing 
and administering the O-BMT intervention will be estimated using a tailored version of the Drug Abuse 
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Treatment Cost Analysis Program (DATCAP) instrument.99,100 The DATCAP is a standardized, customizable 
tool used to estimate costs of addiction treatment programs in diverse settings. 
Other covariates: We will measure factors that may be associated with BMT outcomes, including 
sociodemographic characteristics, insurance status, depressive symptoms, motivation for treatment, and prior 
buprenorphine exposure. We will also measure other outcomes that are important for clinical care, including 
self-efficacy,  perceived discrimination in medical care, and treatment satisfaction.
Data management. Urine drug tests will be conducted at the syringe exchange program or CHC and will be 
entered onto a paper Case Report Form and then entered into a password protected database. The entry will 
be verified by another staff member. Interviews using REDcap surveys allow for direct data entry by study 
participants. To ensure confidentiality, participant identifiers will not be recorded on interviews or other data 
forms. Instead, participants will be assigned a unique study ID that will be used on all data documents and in 
databases. Participant’s names and consent forms will be stored separately from research data in locked file 
cabinets. Electronic data will be stored in a password-protected server, which will be back up daily and can 
only be accessed by the research team. Because we will be collecting data on buprenorphine diversion, we 
also received a Certificate of Confidentiality from NIDA to provide additional protection of confidentiality (see 
Human Subjects for details).
Analysis: All primary analyses will be intention to treat, including participants who are lost to follow-up. In 
secondary analyses, we will conduct per-protocol analyses to ascertain outcomes among participants who 
actually initiate BMT at the SEP or CHC. We will conduct additional exploratory analyses on a per-protocol 
basis to further assess outcomes (e.g., satisfaction with buprenorphine treatment) 
Preliminary analyses. We will first review and summarize data using descriptive summaries and graphical 
analyses to ensure that reported values are within appropriate ranges, to check for the presence of outliers and 
abnormal values, and to verify that the distributions of measures meet the assumptions of the statistical tests 
that are planned as described below. 
Missing data. For missing categorical data, we will use multivariate multiple imputation using the fully 
conditional specification method.101 We will repeat imputations 20 times, and then we will compare statistical 
results using datasets that include imputed values and the dataset that drops missing values. This will guide 
our interpretation of our assessment of the impact of missing data on our study findings, as well as our 
interpretation of overall results.
Aim 1: To test the effectiveness of O-BMT. H1: more participants randomized to O-BMT (vs. control) will be 
engaged in BMT at 30 days. Our primary analysis will determine the effect of the intervention (O-BMT). We will 
use a chi square test comparing the proportion of participants in each study arm who have an active 
buprenorphine prescription 30 days after enrollment. We will also conduct a multivariable logistic regression 
adjusting for mental illness, polysubstance use, and addiction severity.  
H2: Reductions in opioid use will be greater among participants randomized to O-BMT (vs. control) over 24 
weeks. We will use generalized estimating equations to compare changes in opioid use between study arms 
over the 24 week study period. One model will use results from urine drug tests at 1, 2, 4, 6, 8, 12, and 24 
weeks. A second model will compare the mean number of days (of the prior 30 days) with self-reported opioid 
use at 4, 8, 12, and 24 weeks. 
H3: Reductions in HIV risk behaviors will be greater among participants randomized to O-BMT (vs. referral) 
over 24 weeks of follow-up. We will use generalized estimating equations to compare changes in injecting risk 
at 2, 12, and 24 weeks. 
Aim 2: To test the safety of onsite buprenorphine treatment at syringe exchange programs.  
H4: Diversion of buprenorphine will not be significantly greater among participants randomized to O-BMT (vs. 
control). By definition, participants who are not prescribed buprenorphine will not have an opportunity to divert 
their medication, but we will use an intention to treat approach to maintain randomization. The risk difference 
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threshold margin for non-inferiority will be 5%. We will construct Wald 95% confidence intervals (CIs) for a 
difference in diversion rates between the two arms and examine if the lower bound of the 95% CI is greater 
than the threshold margin. If potential confounding factors are unbalanced and require adjustment, we will 
apply logistic regression and estimate the Odds Ratio (OR) and its CI, examining if the lower bound of the OR 
is greater than the OR converted from the risk difference. 
Aim 3: To determine the cost effectiveness of O-BMT by comparing costs and health service utilization 
between study arms. H5: We hypothesize that O-BMT will be cost-effective according to commonly accepted 
thresholds. Our comprehensive economic evaluation will follow well-established guidelines and, in accordance 
with recently revised guidelines, be conducted from both the perspective of the healthcare system and the 
broader societal perspective.94,102,103  Both of these perspectives represent the viewpoint of the public, because 
city or state governments are the primary funder of SEPs and we expect that SEP participants will be publically 
insured or uninsured.13 The healthcare system perspective will include costs associated with OUD treatment 
and other healthcare services received by this population. The societal perspective includes additional non-
healthcare system costs (e.g., criminal justice resources) attributed to participants regardless of who shares 
the burden of these costs (e.g., healthcare system costs, time costs to the patient, criminal justice costs, and 
productivity costs). Effective OUD treatment can lead to savings in non-healthcare system costs, so ignoring 
these costs would underestimate the intervention’s true benefit to society.
First, we will estimate the service utilization and resulting costs associated with implementing and 
sustaining the O-BMT intervention in the SEPs. Second, we will estimate the relative economic value of the 
intervention, including extrapolating the downstream savings resulting from reduced opioid misuse and 
injecting risk behaviors relative to the control condition (e.g., reduced utilization of high-cost healthcare 
services and criminal-justice resources). The outcome of the cost-effectiveness analysis will be the ICER. We 
will also calculate “net monetary benefit,” a measure of cost-benefit, by applying a generally accepted 
willingness-to-pay threshold range of $100,000/QALY - $200,000/QALY.94,95
Next, we will estimate participant-level costs using the resource costing method, in which we determine a 
price weight for each resource unit consumed and multiplying price weights by units of service utilized.94,102,103 
Unit costs will be derived from various sources reflecting “real-world” costs faced by the stakeholders 
considered here (i.e., the healthcare system and society). All values will be adjusted for inflation. Since no 
follow-up measurements will be obtained beyond 24 weeks following baseline, discounting for time preference 
will not be required.103,104 We will model the person period monthly during the first 12-weeks of intervention. 
Given the differences in mechanisms to generate data, separate multivariable generalized-linear models 
(GLMs) will be estimated to predict the mean cost associated with each resource category at each time point. 
GLMs permit us to choose the most appropriate mean and variance functions according to the fit of the data.103 
A multivariable GLM will also be used to predict health-related quality of life preference weights and days 
abstinent for each participant at each time point. QALYs gained and days abstinent for the intervention will 
then be estimated by using the area under the curve methodology.103-5 The method of recycled predictions will 
be used to obtain the final predicted mean values for each resource category and outcome, by study arm, 
which will then be summed and tested according to the relevant perspective.103 To account for sampling 
uncertainty in point estimates, both the p-values and standard errors, as well as the confidence intervals for the 
ICER, will be estimated using nonparametric bootstrapping techniques within the multivariable framework. 
Parametric methods based on parameters obtained from bootstrapping will be used to estimate acceptability 
curves, which illustrate the probability that the intervention is a good value for different willingness-to-pay 
thresholds. Sensitivity analyses will be performed to account for uncertain precision in assumptions and 
parameter estimates applied in the analysis.104
D.10 Power analysis. To estimate the effect size for the O-BMT intervention, we drew from prior pilots of 
onsite treatment. Stancliff et al.42 offered BMT to SEP participants (N = 100) and 68% were engaged in BMT at 
3 months (30 day engagement was not reported). Tringale et al.43 offered BMT to SEP participants (N=9) over 
15 days and then transferred care to treatment program. Following onsite initiation, 33% ultimately engaged in 
BMT. Daniels et al.80 offered BMT at a community-based recovery center (N = 78) and 49% were transitioned 
to primary care site to continue treatment. For enhanced referral, we estimated rates of engagement in BMT 
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from our own pilot data and several studies that referred SEP 
participants to MMT. Engagement after passive referral may be 
as low as 0%,14 while referral to MMT has resulted in 9-16% of 
SEP participants engaging in treatment.37-39 Therefore, we will 
recruit a sample of 250, which allowing for up to 20% attrition 
(n=200), giving us at least 80% power for the primary outcome 
(BMT engagement) in all proposed scenario.
For Aim 2, we chose the intention to treat analysis as the 
primary outcome. With a sample size of 250 and an expect rate 
of diversion of 10-25%, we will only have 80% power to declare 
that diversion rate in the O-BMT arm is non-inferior to the 
referral arm if the inferiority margin of the risk difference is 10-
14%. Though this is larger than  tolerable margins for non-inferiority, we will have good estimates of the 
frequency of diversion in the O-BMT arm, which will provide important safety data for onsite treatment.  
For Aim 3, assumptions are based on differences in cost and effect, standard deviations of cost and effect, 
the correlation of the difference in cost and effect, desired confidence and power levels, and the maximum 
willingness-to-pay value.106,107 We estimated the power for the primary outcomes of our economic analysis 
(cost-per QALY and cost-per abstinent year) using the target sample size of 250 (125 per group), and a range 
of values for the aforementioned assumptions, based on prior economic evaluations of substance use disorder 
interventions. We estimate at least 90% power to be 95% confident that an intervention is acceptable at the 
commonly cited willingness-to-pay threshold of $100,000 per QALY.95 
PROTECTION OF HUMAN SUBJECTS
Human subjects involvement and characteristics: We will enroll 250 participants from syringe exchange 
programs (SEPs) with opioid use disorder (OUD) who are interested in buprenorphine maintenance treatment 
(BMT) and are motivated for treatment. 
 Eligibility criteria include:
1) age ≥ 18 years 
2) opioid use disorder by DSM-V criteria 
3) interest in BMT
4) motivation for OUD treatment, based on SOCRATES 
5) willingness to accept CHC referral
Exclusion criteria include: 
1) receiving opioid agonist treatment in the past 30 days (confirmed by NY Prescription Drug Monitoring 
Program); 
2) inability to provide informed consent
3) unstable mental illness (e.g., suicidality, psychosis, etc.) 
4) severe alcohol use disorder or benzodiazepine use disorder by DSM-V criteria 
5) hypersensitivity to buprenorphine or naloxone.
6) pregnancy (confirmed via urine testing)
Rationale for inclusion/exclusion criteria: Study participants will include out-of-treatment SEP participants 
with OUD. We will only include participants who are interested in BMT, motivated for OUD treatment, and 
willing to accept referral to a CHC for treatment, because our goal is to increase engagement in 
comprehensive BMT. Providing BMT onsite at SEPs could attract participants who are unready to stop illicit 
opioid use and only want buprenorphine temporarily to reduce withdrawal symptoms or because they do not 
have access to their illicit opioid of choice. There may be benefits to this type of symptom treatment, but our 
study is not designed to evaluate these benefits. We will exclude those with clinical contraindications to BMT, 
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such as severe alcohol or benzodiazepine use disorders, in order to ensure participant safety. In our treatment 
program, transaminase elevation (5X upper limit of normal) limited buprenorphine treatment in <1% of patients, 
therefore, we will not assess liver function prior to study enrollment, but all participants who continue BMT at 
the community health center will have liver function tests monitored as clinically warranted. We will exclude 
adolescents < 18 years old, because the CHC where we will be referring participants only offers BMT to adults. 
We will exclude pregnant women because initiation of BMT would require them to experience opioid 
withdrawal, and our practice is to refer pregnant women to initiate methadone maintenance treatment, which 
does not require a period of withdrawal.
Recruitment: Staff members at the SEPs will receive training on BMT (buprenorphine education and 
referral to a CHC). Active recruitment will occur by staff members discussing BMT with participants and 
contacting a research assistant (RA). Passive recruitment will occur by posting study flyers at study sites and 
asking study participants to recommend other acquaintances for the study.
Participant tracking: We will use tracking procedures that we developed to retain drug users in previous 
research studies where there has been 84% retention rate. On locator forms, we will record information about: 
1) participants’ address and phone number; 2) contact information of participants’ family members, friends, 
case manager, physician, and pharmacy; and 3) locations where participants hang out.
Characteristics of participants: The SEPs are located in neighborhoods made up of mostly racial/ethnic 
minority groups; therefore, we expect to have no trouble recruiting minority groups. In prior studies at the two 
SEPs proposed as study sites, participants with OUD had the following characteristics: 70% were male, 60% 
were Hispanic, 21% were non-Hispanic black, and 16% were non-Hispanic white. We will attempt to limit the 
ratio of male to female participants to 2:1. Specifically, we anticipate the following characteristics of the 250 
participants we will enroll: 83 women and 167 men; 150 Hispanics, 53 non-Hispanic blacks, 40 non-Hispanic 
whites, and 7 participants with another race/ethnicity. 
Participant compensation: Brief visits (weeks 1, 6) where only urine is collected will include a $10 Clincard 
payment. Longer visits (weeks 0, 2, 4, 8, 12, 24) where urine and interviews will be collected will include a $25 
Clincard payment. We will compensate a $20 Clincard payment to incentivize return of Wisepill medication 
adherence devices.
Sources of materials. We will collect interview data, urine samples for drug testing, and we will extract 
electronic medical records. 
Urine Drug Testing: All research visits will include urine collection, which will be tested for buprenorphine, 
opiates, oxycodone, methadone, cocaine, methamphetamine and benzodiazepines. Results will be recorded 
on paper forms and entered into a web-based data base. Forms will contain only participant study ID (no 
identifying information).
Computerized interviews: At enrollment, the RA will administer interviews using REDcap survey (which is a 
self interview) technology where the participant is given headphones and the survey question is read aloud by 
the computer, the participant will then select the answer  to collect descriptive data and baseline measures. 
Interview data will be directly entered on a lap top computer or tablet, which will be password protected, and 
will contain only participant study ID (no identifying information). 
Medical record data: will be electronically extracting from Montefiore’s centralized clinical database, and 
will include data on buprenorphine prescriptions and clinical visits. The electronic file will be created by 
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Montefiore health technology staff, emailed to the PI in a password protected file, and saved on a password 
protected computer. We will also collect prescription data from the NY Prescription Drug Monitoring Program 
(medications dispensed). As mandated by law, the later source includes all controlled substances dispensed 
by all pharmacies in New York State. Prescription data will include medication name, strength, directions, 
number of pills, number of refills, date of prescription, prescriber, and date medication was filled.  For those 
participants who receive community treatment not at a Montefiore site, a medical records release form will be 
signed by the participant and data on their visit dates and medication dispensed will be given to research staff 
following the institutions policies.  
Electronic adherence data:  Wisepill electronic adherence monitors will be used allowing us to monitor if 
and when medication is taken. Electronic signal is sent to a password protected database when the device is 
opened and this data will be used to calculate adherence (or non-adherence) to prescribed medication. 
Adherence data will be downloaded and saved on a password protected computer.
Vulnerable population. SEP participants with OUD could be vulnerable to undue influence, because of 
physical dependence to opioids and challenges engaging in BMT. We will also be collecting sensitive 
information on diversion of buprenorphine, which is a controlled substance. In the following sections, we 
discuss the risks of enrolling SEP participants and procedures to minimize these risks. 
Potential risks. The primary risks of this study are: (1) breach of confidentiality leading to embarrassment, 
dismissal from SEP, or legal consequences; (2) inconvenience and discomfort associated with interviews; (3) 
fear that refusal to participate will affect care at the SEP; (4) diversion of prescribed BMT; (5) induced 
withdrawal after initiating BMT; (6) polysubstance use
Confidentiality issues: We will collect personal information from participants to facilitate tracking, and we 
will be asking personal questions including substance use and HIV risk behaviors.  We have outlined our 
procedures to maintain confidentiality below. 
Inconvenience and discomfort associated with interviews: Participants will be asked about substance use 
and opioid use disorder treatment.  It is possible that such questions could produce anxiety in participants.  
Participants will be instructed that they may withdraw from the study if this occurs. Dr. Fox (a board-certified 
general internist) will be involved with all study activities and will assess for severe discomfort or other severe 
community health center or emergency department. 
Fear that refusal to participate will affect care or services: Participants may use services at the SEP, such 
as housing assistance or mental health counseling. In the informed consent process, they will be clearly 
instructed that refusal to participate will in no way affect their care at the affiliated SEP. 
     Diversion of prescribed BMT: For the first two weeks after initiating treatment, prescribed buprenorphine will 
be provided in electronic adherence monitors to monitor adherence. This should dissuade diversion of 
buprenorphine. However, if participants do sell or give away their medication, there could be legal 
consequences or disciplinary action at the SEP. After initiating BMT, participants will be asked about whether 
they divert their medication, and we will also check urine drug tests with the expectation that participants who 
are prescribed buprenorphine will have detectable buprenorphine in their urine.
     Induced withdrawal after initiating BMT: Participants will start taking their medication at home, so they are 
subject to induced withdrawal if they take the buprenorphine before fully experiencing opioid withdrawal. This 
could include diarrhea, nausea, vomiting, musculoskeletal pain, sweating, and anxiety. Standard protocols for 
home inductions will be followed with similar procedures in the O-BMT and enhanced referral arms. The risk of 
induced withdrawal will not be increased from routine clinical practice. 
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Polysubstance use: Though buprenorphine has pharmacologic properties that make it safer than other 
opioid agonists (e.g., ceiling effect, partial agonist, co-formulation with naloxone), it does lead to some 
sedation, and overdoses are possible if taken with other sedating substances. If SEP participants are using 
multiple illicit substances, initiating BMT could add to their risk of overdose. 
Adequacy of protection against risks
Recruitment and informed consent: We will obtain informed consent for all participants of the RCT prior to 
collecting any information with personal identifiers (e.g. locator form or medical record release forms), 
administering the baseline REDcap interview, and randomization to an intervention arm. Informed consent will 
be obtained by the RA.
Protection against risk:  We will institute the following processes to ensure confidentiality is maintained: 
1.
We will create a system that prevents linking sensitive material to participants’ personal identifiers.  We will 
have a “name-based” system and “ID-based” system that will remain separate.  In the name-based system, 
all documents that have patient identifiers will be filed together.  Some of these documents will have 
participants’ signatures (e.g. consent forms) and others will have personal information (e.g. locator forms).  
In the ID-based system, all documents that do not include identifying information or signatures will use 
participants’ IDs (rather than names), and will be filed together. All forms will contain either participants’ 
names or their study IDs, but not both. We will maintain one electronic document that links participants’ 
names and study IDs, which will be stored on a password-protected file located on Montefiore Box.   
2.
We obtained a Certificate of Confidentiality to protect participants’ sensitive information. 
3.
Letters and/or phone messages that are left for participants (to schedule research visits or referrals to the 
CHC) will not include any personal identifying information, and will not mention buprenorphine treatment.
4.
Study records will be kept in locked files and/or within limited access, password-protected computer files, 
available only to the investigators and study personnel.  
5.
Publication or presentation of study results will not identify subjects by name.  
Inconvenience, discomfort, and distress: Dr. Fox will be contacted by cell phone if any study participants 
become overly distressed. Participants may be referred for individual medical or psychiatric attention at 
Montefiore’s community health center or the emergency department (depending on severity). 
Diversion of prescribed BMT: Risks to the public and risks to study participants from diversion are different. 
Risks to the public from diversion will be managed by taking steps to minimize risk of diversion. During the trial, 
we will have monthly meetings with SEP staff to discuss whether they are noticing buprenorphine diversion 
onsite. If the SEP staff reports concerns about increased buprenorphine diversion onsite after implementation 
of O-BMT, we will take measures to increase monitoring of prescribed medication (e.g., more frequent visits). 
Use of electronic adherence monitoring may reduce the risk of buprenorphine diversion. We will also perform 
interim analyses to detect diversion in aggregate, and if we detect higher levels of diversion than have 
previously been reported (> 30%), we will stop the trial and implement measures to reduce diversion with 
assistance from the SEP staff. Importantly, if there is diversion, there are also risks to study participants in self-
reporting illegal activity or if diversion is detected from electronic monitoring or urine tests. We will keep this 
data confidential during the study. Urine results will not be reported in the electronic medical record, so it will 
not be available to treatment providers. Interim analyses to detect diversion will only be performed in 
aggregate. We obtained a Certificate of Confidentiality from NIDA to reduce the chances of this data being 
obtained without participant consent. 
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Induced withdrawal after initiating BMT: We have produced patient-centered home induction materials that 
instruct the reader on estimating severity of withdrawal by counting the number of withdrawal symptoms (e.g., 
piloerection, yawning, rhinorrhea, etc.). Our research group and others have published clinical data 
demonstrating that home inductions are safe and induced withdrawal is rare. Also, study clinicians will be 
available by phone if participants have complications after initiating BMT or have questions about side effects. 
Even though O-BMT participants will see the study clinicians at the SEP, they will be registered as patients of 
the CHC, so additional medical advice is available 24 hours a day from an on-call physician. In an emergency, 
participants would be able to reach an on-call physician through the CHC, and the physician would be able to 
see their medical intake and assessment in the electronic medical record.
Polysubstance use: All BMT providers will follow national guidelines for patient selection and clinical 
monitoring. Participants will be screened for alcohol or benzodiazepine use disorder prior to study enrollment 
or being prescribed buprenorphine. A buprenorphine-waivered clinician will assess all study participants for 
other clinical contraindications before they are prescribed buprenorphine. Participants will only be prescribed a 
small supply of medication when they initiate BMT. The study clinicians will use clinical judgment about 
discontinuing BMT at the second onsite clinical visit, if they have concerns about polysubstance use. According 
to a safety announcement released by the FDA on September 20, 2017, “Based on our additional review, the 
U.S. Food and Drug Administration (FDA) is advising that the opioid addiction medications buprenorphine and 
methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the 
central nervous system (CNS). The combined use of these drugs increases the risk of serious side effects; 
however, the harm caused by untreated opioid addiction can outweigh these risks.” 108
Potential benefits. If effective, O-BMT could increase engagement in BMT, which could reduce opioid use, 
HIV risk behaviors, and opioid overdose. Additionally, O-BMT could have public health benefit by reducing HIV 
transmission or opioid overdose.
Risk/benefit ratio. The O-BMT intervention has the potential to improve engagement in BMT among out-of-
treatment opioid users, but it will require testing for safety and effectiveness. Given the steps that we will take 
to ensure that participants meet clinical criteria for BMT, minimize the chances of breach of confidentiality, and 
monitor for BMT diversion, study participation presents risks that are commensurate to risks of standard office-
based buprenorphine treatment and the risk/benefit ratio is favorable.
Importance of study findings. Our intervention will encourage OUD treatment in a high-risk out-of-treatment 
group of opioid users. The United States is in the midst of an opioid overdose epidemic, yet 80% of opioid 
users remain out-of-treatment. Effective interventions are needed to encourage treatment engagement.   
1.
Center for Behavioral Health Statistics and Quality. Behavioral Trends in the United States: Results 
from the 2014. National Survey on Drug Use and Health (HHS Publication No. [SMA] 15-4927.) Rockville, MD: 
Substance Abuse and Mental Health Services Administration, 2015. Available at: 
http://www.samhsa.gov/data/sites/default/files/NSDUH-FRR1-2014/NSDUH-FRR1-2014.pdf 
[accessed Jan 7, 2017].
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Center for Behavioral Health Statistics and Quality. Treatment Episode Dataset (TEDS): 2003-2013. 
National Admissions to Substance Abuse Treatment Services (HHS Publication No. [SMA] 12-4729.) Rockville, 
MD: Substance Abuse and Mental Health Services Administration, 2015. Available at: 
http://www.samhsa.gov/data/sites/default/files/2003_2013_TEDS_National/2003_2013_Treatment_Episode_D
ata_Set_National.pdf  [accessed Jan 7, 2017].
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towards patients with substance use disorders and its consequences for healthcare delivery: systematic 
review. Drug Alcohol Depend 2013;131:23-35.
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Sohler NL, Weiss L, Egan JE, et al. Consumer attitudes about opioid addiction treatment: a focus group 
study in New York City. Journal of opioid management 2013;9:111-9.
6.
Barry CL, Huskamp HA. Moving beyond parity--mental health and addiction care under the ACA. The 
New England journal of medicine 2011;365:973-5.
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Booth RE, Kwiatkowski C, Iguchi MY, Pinto F, John D. Facilitating treatment entry among out-of-
treatment injection drug users. Public health reports 1998;113 Suppl 1:116-28.
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Cunningham JA, Sobell LC, Chow VM. What's in a label? The effects of substance types and labels on 
treatment considerations and stigma. J Stud Alcohol 1993;54:693-9.
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Saloner B, Karthikeyan S. Changes in Substance Abuse Treatment Use Among Individuals With Opioid 
Use Disorders in the United States, 2004-2013. JAMA : the journal of the American Medical Association 
2015;314:1515-7.
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Mund PA, Heller D, Meissner P, Matthews DW, Hill M, Cunningham CO. Delivering care out of the box: 
the evolution of an HIV harm reduction medical program. J Health Care Poor Underserved 2008;19:944-51.
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Shah PA, Sohler NL, Lopez C, Fox AD, Cunningham CO. Awareness of, experience with, and attitudes 
toward buprenorphine among opioid users visiting a New York City syringe exchange program. Journal of 
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Fox AD, Shah PA, Sohler NL, Lopez CM, Starrels JL, Cunningham CO. I heard about it from a friend: 
assessing interest in buprenorphine treatment. Substance abuse 2014;35:74-9.
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Fox AD, Chamberlain A, Sohler NL, Frost T, Cunningham CO. Illicit buprenorphine use, interest in and 
access to buprenorphine treatment among syringe exchange participants. Journal of substance abuse 
treatment 2015;48:112-6.
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Fox AD, Sohler NL, Frost T, Lopez C, Cunningham CO. Development and evaluation of a community-
based buprenorphine treatment intervention. Harm Reduction Journal. UNDER REVIEW
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Appendix 1.
CHCC BUPRENORPHINE MAINTENANCE TREATMENT (BMT) PROTOCOL
1.
Intake
a.
On the first visit, gather the H&P w attention to the substance use history, set expectations, 
check LFTs and utox 
b.
Use smart phrase to gather complete substance use history
c.
Use smart phrase to generate BMT Patient Agreement
2.
Induction
a.
Second visit, the patient will receive Bupe induction instructions and COW scale. 
i.
Tips: Start with 8 mg tabs/films and ask patient to break in 1/2 or even 1/4. Also 
prescribe clonidine, loperamide, and ibuprofen for withdrawal symptoms. 
ii.
Induction can be done at home or in the office
1.
Home induction has been tolerated and successful at CHCC
3.
Induction and Stabilization
a.
See the patient for follow-up in 1 week, then again 1-2 weeks later until the patient is on a stable 
dose
b.
Doses can be adjusted based on symptoms of withdrawal and cravings. Sometimes this can be 
challenging as anxiety can mimic withdrawal symptoms.
c.
Total daily dose: The usual dose is 16 mg total daily (the vast majority range between 8-24mg 
daily) and doses can be increased by 4 mg/day. 
d.
Frequency: Can be dosed daily or bid, adjust according to symptoms, often pts like to split their 
doses, which is fine
4.
Maintenance
a.
Once dose is stable, can space out visits to monthly 
b.
Check urine drug testing at every follow-up visit
c.
 Assess for use of other substances (cocaine, alcohol, benzodiazepines, etc.) at each follow-up 
visit
d.
Adopt an uniform approach about cocaine, alcohol, or benzodiazepine use
i.
Refer to social worker for psychosocial counseling
ii.
Counsel all patients to minimize use of alcohol, benzodiazepines, and other sedatives
iii.
Refer to an opioid treatment program if polysubstance use makes risks of continuing 
buprenorphine treatment greater than benefits 
5.
Discharge from Treatment
a.
If patients are hostile to staff or adulterate urine they will be given an administrative warning. 
These expectations should be made clear from day 1.
b.
Repeat offenders should be discharged from the practice and referred to an opioid treatment 
program 
6.
Lost to Follow Up:
a.
Track patients who have ever been evaluated for Bupe at your clinic, and periodically review 
with program coordinator and community outreach worker about outreach/retention efforts for 
loss to follow up patients.
IRB NUMBER: 2017-7484
IRB APPROVAL DATE: 07/06/2020
IRB NUMBER: 2017-7484
IRB APPROVAL DATE: 07/06/2020
IRB NUMBER: 2017-7484
IRB APPROVAL DATE: 07/06/2020
IRB NUMBER: 2017-7484
IRB APPROVAL DATE: 07/06/2020
IRB NUMBER: 2017-7484
IRB APPROVAL DATE: 07/06/2020
IRB NUMBER: 2017-7484
IRB APPROVAL DATE: 07/06/2020
IRB NUMBER: 2017-7484
IRB APPROVAL DATE: 07/06/2020
IRB NUMBER: 2017-7484
IRB APPROVAL DATE: 07/06/2020
IRB NUMBER: 2017-7484
IRB APPROVAL DATE: 07/06/2020
IRB NUMBER: 2017-7484
IRB APPROVAL DATE: 07/06/2020
IRB NUMBER: 2017-7484
IRB APPROVAL DATE: 07/06/2020
IRB NUMBER: 2017-7484
IRB APPROVAL DATE: 07/06/2020

ICF_001.pdf: 
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Page 1 of 7
ALBERT EINSTEIN COLLEGE OF MEDICINE 
MONTEFIORE MEDICAL CENTER
DOCUMENTATION OF INFORMED CONSENT AND HIPAA AUTHORIZATION
Introduction
You are being asked to participate in a research study called “Buprenorphine treatment at 
syringe exchanges to reduce opioid misuse and HIV risk”. Your participation is voluntary -- it is 
up to you whether you would like to participate. It is fine to say “no” now or at any time after you 
have started the study. If you say “no,” your decision will not affect any of your rights or benefits 
or your access to care.
The researcher in charge of this project is called the 
“Principal Investigator.” His name is Aaron Fox, MD. 
You can reach Dr. Fox at: 
Office Address: 3300 Kossuth Ave
Bronx, NY 10467
Telephone #: 718-920-7173
For questions about the research study, or if you 
believe you have an injury, contact the Principal 
Investigator or the IRB.
Support for this research study is provided by 
National Institute on Drug Abuse
The Institutional Review Board (IRB) of the 
Albert Einstein College of Medicine and 
Montefiore Medical Center has approved 
this research study. The IRB # is in the 
stamp in the upper right hand corner. If you 
have questions regarding your rights as a 
research subject you may contact the IRB 
office at 718-430-2253, by e-mail at 
irb@einsteinmed.edu, or by mail:
Einstein IRB 
Albert Einstein College of Medicine
1300 Morris Park Ave., Belfer Bldg #1002
Bronx, New York 10461
Why is this study being done? 
The goal of this study is to test whether starting buprenorphine treatment at syringe exchange 
programs is safe and effective. Nearly all participants of syringe exchange programs meet 
clinical criteria for opioid use disorder, but very few engage in buprenorphine treatment for 
opioid use disorder. We seek to test a new strategy of onsite treatment at the syringe exchange 
program in order to increase engagement in buprenorphine treatment. 
Buprenrophine-Naloxone is approved by the U.S. Food and Drug Administration (FDA) to treat 
opioid use disorder.
Why am I being asked to participate? 
You are being asked to participate in this study because you are a participant of one of the 
partnering syringe exchange programs. You may have seen one of our study flyers or a syringe 
exchange program staff member may have suggested you as a participant. We will enroll 250 
participants of two different syringe exchange programs in New York City.  We are looking for 
subjects who are: 18 years or older, diagnosed opioid use disorder, interested in buprenorphine 
treatment, and are willing to accept referral to a community health center.
However, you cannot be in this study if you have received similar opioid agonist treatment in the 
past 30 days, or have severe alcohol or benzodiazepine use disorder, unstable mental illness, 
or are pregnant.
IRB NUMBER: 2017-7484
IRB APPROVAL DATE: 04/10/2024
IRB EXPIRATION DATE: 04/09/2025


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What will happen if I participate in the study?  
We will be studying two strategies of buprenorphine treatment – onsite treatment or referral to a 
community health center. You will be assigned to one strategy based on random chance (like a 
flip of a coin). If you are assigned to the onsite treatment group, over 2 weeks, you will see a 
buprenorphine provider twice at the syringe exchange program. Each treatment visit will take 
45-60 minutes. At the first treatment visit, the provider will assess whether you meet the criteria 
for buprenorphine treatment and write a prescription for a one week supply of buprenorphine if 
appropriate. You will receive the medication from a community pharmacy. You will see the 
provider again after one week and receive a second prescription for another one week supply of 
buprenorphine. After these two treatment visits, the study team will assist you in transferring 
your care to a community health center to continue buprenorphine treatment. If you are 
assigned to the referral group, the study team will assist you in making an appointment at the 
community health center to start buprenorphine treatment. Regardless of assignment, all 
participants will also complete 8 study visits over 6 months. Study visits will take 30-45 minutes. 
At these visits, a study coordinator will collect a urine sample for drug testing. At each study 
visit, you will also complete a questionnaire, which will include questions about your illicit drug 
use, mental health, and any criminal background you may have. We will also collect your 
medical records to determine whether or not you have continued buprenorphine treatment at the 
community health center.  
A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by U.S. 
law. This Web site will not include information that can identify you. At most, the Web site will 
include a summary of the results. You can search this Web site at any time.
How many people will take part in the research study?
You will be one of about 250 people who will be participating in this study.  The study will be 
conducted at 3 locations outside of Montefiore Medical Center/Albert Einstein College of 
Medicine/North Bronx Health Network. 
Specimen Banking (Future Use and Storage)
No Specimens or Data is Stored
We will destroy the specimens and information about you when the study is complete. 
Information about you will be kept for 25 years as per institutional policy, but will not be 
used for future studies.
INITIAL YOUR CHOICE BELOW 
_______ I consent to be contacted in the future to learn about:
 _______ New research protocols that I may wish to join.
 _______ General information about research findings. 
_______ I do not want to be contacted at all. 
IRB NUMBER: 2017-7484
IRB APPROVAL DATE: 04/10/2024
IRB EXPIRATION DATE: 04/09/2025


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Will I be paid for being in this research study? 
You will receive a maximum of $170 in Clincard payments (like a Visa gift card) for 8 study 
visits. You will also receive compensation for a two-way transit pass at each study visit. If you 
start buprenorphine treatment, you will also be provided with $20 Clincard payment for returning 
electronic monitors. If you choose to withdraw from the study before all visits are completed, you 
will be paid only for the visits you completed. Payment for study visits at baseline, and 2, 4, 8, 
12, and 24 weeks after enrollment will be $25 in Clincard payments. Payment for study visits at 
1 and 6 weeks after enrollment will be $10 Clincard payments.  Payments may not be available 
for up to 48 hours.
Some researchers may develop tests, treatments or products that are worth money. You will not 
receive payment of any kind for your specimens and information or for any tests, treatments, 
products or other things of value that may result from the research.
Will it cost me anything to participate in this study? 
If you take part in this study, you or your insurance will pay for the buprenorphine medication 
that is prescribed by the provider. If you continue buprenorphine treatment at the community 
health center, you or your insurance will also pay for the medical visits provided there.  
What will happen if I am injured because I took part in this study?
If you are injured as a result of this research, only immediate, essential, short-term medical 
treatment as determined by the participating hospital,will be available for the injury without 
charge to you personally. 

No monetary compensation will be offered. 

You are not waiving any of your legal rights by signing this informed consent document. 

If additional treatment is required as a result of a physical injury related to the research, 
necessary medical treatment will be provided to you and billed to your insurance 
company or to you as part of your medical expenses. 
Immediately report any discomforts, problems or injuries you experience during the course of 
your participation in the study to Dr. Aaron Fox 718-920-7173.
What else do I have to do?

You must tell the research study doctor about any past and present diseases or allergies 
you are aware of and about all medications you are taking including “over-the-counter” 
remedies and nutritional supplements or herbs.

If you do not feel well at any time, call your doctor or the research study doctor 
immediately. 

If you think you have become pregnant, contact your research study doctor immediately. 

If any other doctor recommends that you take any medicine, please inform him/her that 
you are taking part in a research study. You should give the other doctor the research 
study doctor’s name and phone number.

You may carry out all your normal daily activities.
IRB NUMBER: 2017-7484
IRB APPROVAL DATE: 04/10/2024
IRB EXPIRATION DATE: 04/09/2025


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Confidentiality
We will keep your information confidential. Your research records will be kept confidential and 
your name will not be used in any written or verbal reports. Your information will be given a code 
number and separated from your name or any other information that could identify you. The 
form that links your name to the code number will be kept in a secure manner and only the 
investigator and study staff will have access to the file. All information will be kept in a secure 
manner and computer records will be password protected. Your study information will be kept 
as long as they are useful for this research.
Information collected during study visits (for example, questionnaires and urine drug tests) will 
not be entered into your Montefiore electronic medical record. However, if you start 
buprenorphine treatment, the medical information that you tell the provider will be entered into 
your Montefiore electronic medical record and will be available to clinicians and other staff at 
Montefiore who provide care to you.
The only people who can see your research records are:

the research team and staff who work with them

the organization that funded the research

organizations and institutions involved in this research: OnPoint NYC, BOOM!Health

groups that review research (the Einstein IRB, and the Office for Human Research 
Protections
These people who receive your health information, may not be required by privacy laws to 
protect it and may share your information with others without your permission, if permitted by 
laws governing them.  All of these groups have been asked to keep your information 
confidential.
Are there any times we will not keep my data confidential? 
If you give us information that suggests that your child or any other child is being abused, we 
are required by law to report that information to the Administration for Children’s Services 
(ACS). Reporting this information may put you, your family, or others who are involved at risk of 
questioning and legal action by the authorities. 
If you give us information that you may hurt yourself, we will break confidentiality to make a 
referral to an appropriate clinical provider (e.g., calling 911).
If you give us information that you may hurt someone else, we will report this information to the 
authorities. 
Certificate of Confidentiality
As a way to protect your privacy, we have obtained a Certificate of Confidentiality from the 
National Institutes of Health, which is funding this study.  If information from this study was 
requested or subpoenaed by government agencies or the courts, we will use the Certificate to 
attempt to legally refuse to provide it.  This is rare – in only a few cases did researchers have to 
use the Certificate, and it was honored most of the time, but not every time. There are several 
kinds of situations that the Certificate does not apply. For example, we are still required to report 
child abuse and some diseases, and we must make data available to the government for a 
review or evaluation of our research. The Certificate does not prevent you or a member of your 
IRB NUMBER: 2017-7484
IRB APPROVAL DATE: 04/10/2024
IRB EXPIRATION DATE: 04/09/2025


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family from voluntarily sharing information. Similarly, if an insurer, employer, or other person 
obtains your written consent to receive research information, then the researchers may not use 
the Certificate to withhold that information.
Are there any risks to me? 
The risks related to participating in this research study are the same as what would be expected 
from routine clinical care when someone starts buprenorphine treatment. 
The main side effects of buprenorphine are constipation, insomnia, irritability, and sedation. 
There is also the risk of “induced withdrawal.” Opioids remain in your system for 24-48 hours, 
and if you take the buprenorphine when you have other opioids in your system, it can cause 
opioid withdrawal. This could include diarrhea, nausea, vomiting, musculoskeletal pain, 
sweating, and anxiety. The study provider will provide careful instructions on how to take the 
medication properly, but you will start taking your medication at home.
Buprenorphine is an opioid and overdoses are possible if you take buprenorphine with other 
sedating substances like alcohol or benzodiazepines.  
Taking opioid pain medication (as used in this study) along with benzodiazepines (Xanax, 
Valium, Ativan) and/or alcohol can cause serious side effects including respiratory depression 
(slow and ineffective breathing which could be life threatening and cause death). These drugs 
should only be taken together under a physician’s supervision. You should avoid drinking 
alcohol while taking buprenorphine. You agree to let the study team know all medications that 
you currently take or that are prescribed for you during the study. 
 
The medications that you may receive during this study may cause drowsiness or sedation. You 
should not drive after receiving these medications.
An additional risk of taking part in this study is the possibility of a loss of confidentiality or 
privacy. Loss of privacy means having your personal information shared with someone who is 
not on the study team and was not supposed to see or know about your information. The study 
team plans to protect your privacy – see the Confidentiality section above for details.
Questionnaire
You may feel uncomfortable answering questions about drug use and sexual behaviors. You 
can choose not to answer questions that make you feel uncomfortable.
New Findings
If we learn any significant new findings during the study that might influence your decision to 
participate, we will contact you and explain them.
Are there possible benefits to me? 
If you initiate buprenorphine treatment, participating in treatment can reduce opioid use, HIV 
risk, and opioid overdose. If you do not initiate buprenorphine treatment, the study will still 
generate important information about how to design programs for syringe exchange 
participants. 
IRB NUMBER: 2017-7484
IRB APPROVAL DATE: 04/10/2024
IRB EXPIRATION DATE: 04/09/2025


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What choices do I have other than participating in this study?
You can refuse to participate in the study. If you decide not to participate, the staff at the syringe 
exchange program will still give you all of the standard care and services that are appropriate for 
you. 
Your other choices are to start buprenorphine treatment or methadone maintenance treatment 
at a program of your choice.
Are there any consequences to me if I decide to stop participating in this study?
No. If you decide to take part, you are free to stop participating at any time without giving a 
reason. This will not affect your care and you will continue to be treated at this syringe exchange 
program. However, some of the information may have already been entered into the study and 
that will not be removed. The researchers and the sponsor may continue to use and share the 
information they have already collected.
To revoke (take back) your consent and authorization, you must contact the Principal 
Investigator in writing at the address on page 1 of this form. However, you may first call or 
speak to the Principal Investigator and he will stop collecting new information about you.  If you 
take back your consent and authorization, you will not be allowed to continue to participate in 
this research study. 
Can the study end my participation early?
Your participation will end if the investigator or study sponsor stops the study earlier than 
expected.
 
IRB NUMBER: 2017-7484
IRB APPROVAL DATE: 04/10/2024
IRB EXPIRATION DATE: 04/09/2025


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CONSENT TO PARTICIPATE
I have read the consent form and I understand that it is up to me whether or not I participate. I 
know enough about the purpose, methods, risks and benefits of the research study to decide 
that I want to take part in it. I understand that I am not waiving any of my legal rights by signing 
this informed consent document. I will be given a signed copy of this consent form.
Printed name of participant
Signature of participant
Date
Time
Printed name of the person 
conducting the consent 
process
Signature
Date
Time
IRB NUMBER: 2017-7484
IRB APPROVAL DATE: 04/10/2024
IRB EXPIRATION DATE: 04/09/2025