Emergency Department Initiated Oral Naltrexone for Patients With Moderate to Severe Alcohol Use Disorder: A Pilot Feasibility Study
Phase: PHASE1
Conditions: Alcohol Use Disorder
Sponsor: Icahn School of Medicine at Mount Sinai

PROTOCOL 
Emergency Department Initiated Oral Naltrexone for 
Patients with Moderate to Severe Alcohol Use 
Disorder: A Pilot Feasibility Study 
Principal Investigator: Ethan Cowan, MD, MS 
NCT04817410 
March 9, 2021 

Table of Contents 
1.0 LIST OF ABBREVIATIONS ...................................................................................................................6 
2.0 STUDY SYNOPSIS ............................................................................................................................... 7
2.1 Study Design ........................................................................................................................................... 7
3.0 INTRODUCTION......................................................................................................................................7 
3.1 Background and Rationale ...................................................................................................................... 7
3.2 Innovation ............................................................................................................................................... 8
3.3 Public Health Impact............................................................................................................................... 8
4.0 SPECIFIC AIMS AND HYPOTHESIS: .................................................................................................8 
5.0 STUDY DESIGN ........................................................................................................................................9 
5.1 Study Timeline ........................................................................................................................................ 9
6.0 STUDY SETTING .....................................................................................................................................9 
6.1 ED Characteristics .................................................................................................................................. 9
6.2 Physical Space ...................................................................................................................................... 10
6.3 Clinical Services – Mount Sinai Beth Israel ......................................................................................... 10
7.0 IMPLEMENTATION COMPONENT ..................................................................................................10 
7.1 Primary Aim: ........................................................................................................................................ 10
7.2 Secondary Aim: .................................................................................................................................... 10
8.0 PATIENTS AND METHODS ................................................................................................................11 
8.1 Patient Population ................................................................................................................................. 11
8.2 Inclusion / Exclusion Criteria ............................................................................................................... 11
8.3 Number of Study Subjects .................................................................................................................... 12
9.0 STUDY DESIGN AND PROCEDURES ...............................................................................................12 
9.1 Screening and Recruitment ................................................................................................................... 12
9.2 Informed Consent Procedures ............................................................................................................... 13
9.2.1 Consent for records matching: ....................................................................................................... 13 
9.3 Study Procedures .................................................................................................................................. 14
9.4 Daily Assessments ................................................................................................................................ 14
9.5 Follow-up .............................................................................................................................................. 14
9.6 Compensation ....................................................................................................................................... 15
9.7 Standard Intervention for all Participants: SBIRT ................................................................................ 15
10. STUDY ASSESSMENTS ........................................................................................................................16 
10.1 Overview: ............................................................................................................................................ 16
10.2 Table: Schedule of Study Activities and Assessments by Study Time Period ................................... 17
10.3 Pre-Enrollment (Screening) Assessment Phase .................................................................................. 18
10.3.1 ED Health Quiz ............................................................................................................................ 18 
10.3.2 Assessment of AUD: Questionnaire Based on DSM-533 ............................................................. 18 
10.3.3 Urine Drug Screen (Toxicology Testing) .................................................................................... 18 
10.3.4 Patient Eligibility and Inclusion/Exclusion ................................................................................. 18 
10.3.5 Informed Consent and Research Authorization (HIPAA) Forms ................................................ 18 
10.4 Enrollment Assessments ..................................................................................................................... 18
10.4.1 Demographics .............................................................................................................................. 18 
10.4.2 Locator Information Form ........................................................................................................... 18 
10.4.3 Other Substance Use .................................................................................................................... 19 

10.4.4 Cannabis Assessment (Appendix 24) .......................................................................................... 19 
10.4.5 Timeline Follow-Back (TLFB) .................................................................................................... 19 
10.4.6 Health Service Utilization Inpatient and Outpatient Health Services Utilization35 ..................... 19 
10.4.7 Health Status ................................................................................................................................ 19 
10.4.8 Stigma Scale................................................................................................................................. 19 
10.4.9 Health-Related Quality of Life (HRQol) ..................................................................................... 19 
10.4.10 Crime and Criminal Justice ........................................................................................................ 20 
10.4.11 Alcohol Craving ......................................................................................................................... 20 
10.4.12 Daily Alcohol Intake .................................................................................................................. 20 
10.4.13 Satisfaction Scale ....................................................................................................................... 20 
10.4.14 Healthcare Visits Logistics ........................................................................................................ 20 
10.4.15 ED Visits and Hospitalizations .................................................................................................. 20 
10.5 Outcome Data ..................................................................................................................................... 20
10.5.1 Engagement in Treatment Survey (Primary Outcome) ............................................................... 20 
10.5.2 Process Outcome .......................................................................................................................... 20 
11.0 FEASIBILITY COMPONENT ............................................................................................................21 
11.1 Study Procedures and Assessments .................................................................................................... 21
11.1.1 Rationale for study component .................................................................................................... 21 
11.1.2 Overview of feasibility component .............................................................................................. 21 
11.2 Primary Aim........................................................................................................................................ 21
11.2.1 Hypothesis.................................................................................................................................... 22 
11.3 Secondary Aims .................................................................................................................................. 22
11.4 Study Population ................................................................................................................................. 22
11.5 Study Procedures ................................................................................................................................ 22
11.5.1 Pre Enrollment Assessments ........................................................................................................ 22 
11.5.2 Enrollment Assessments .............................................................................................................. 22 
11.5.3 Outcome Assessments ................................................................................................................. 22 
11.6 Intervention ......................................................................................................................................... 23
11.7 Medication Packaging / Handling / Storage / Accountability ............................................................ 24
11.7.1 Study Medication Management ................................................................................................... 24 
11.7.2 Dispensing Study Medication ...................................................................................................... 24 
11.7.3 Study Medication Storage ............................................................................................................ 24 
12.0 DATA MANAGEMENT AND STATISTICAL ANALYSES ...........................................................24 
12.1 Statistical Analysis .............................................................................................................................. 24
12.1.1 General approach ......................................................................................................................... 24 
12.1.2 Analysis of Primary and Secondary Outcomes ........................................................................... 24 
12.1.3 Sample Size .................................................................................................................................. 25 
12.2 Data Management ............................................................................................................................... 25
13.0 REGULATORY COMPLIANCE, ETHICS, AND REPORTING ...................................................25 
13.1 Institutional Review Board (IRB) and Regulations ............................................................................ 26
13.2 Subject Information and Informed Consent ........................................................................................ 26
13.3 Confidentiality .................................................................................................................................... 27
13.4 Privacy Protections ............................................................................................................................. 27
13.5 Data Safety Monitoring....................................................................................................................... 27
13.6 Potential Risks .................................................................................................................................... 27
13.7 Potential Benefits ................................................................................................................................ 28
13.8 Alternatives ......................................................................................................................................... 28

13.9 Inclusion of Women and Minorities ................................................................................................... 28
13.10 Pregnant and Breastfeeding Women ................................................................................................. 28
13.11 Records Retention ............................................................................................................................. 28
13.12 Safety Monitoring ............................................................................................................................. 28
13.13 Data and Safety Monitoring Board (DSMB) .................................................................................... 28
14.0 ADVERSE EVENT REPORTING AND PROCEDURES ................................................................29 
14.1 Definition of Adverse Events and Serious Adverse Events ................................................................ 29
14.2 Definition of Expectedness ................................................................................................................. 29
14.3 Medical and Psychiatric History ......................................................................................................... 29
14.4 Adverse Event Reporting .................................................................................................................... 29
14.5 PIs Role in Assessing Severity and Causality of Adverse Events ...................................................... 30
14.6 Guidelines for Assessing Severity ...................................................................................................... 30
14.7 Guidelines for Determining Causality ................................................................................................ 30
14.8 Site’s Role in Monitoring Adverse Events ......................................................................................... 30
14.9 Participant Withdrawal ....................................................................................................................... 30
Bibliography ...................................................................................................................................................31 
APPENDIX .....................................................................................................................................................34 
Appendix 1: Patient Eligibility Summary ................................................................................................... 34
Appendix 2: Locator Form.......................................................................................................................... 35
Appendix 3: Stigma Scale (PDDS) ............................................................................................................. 39
Appendix 4: Crime and Justice Assessment ............................................................................................... 39
Appendix 5: Daily Substance Use .............................................................................................................. 40
Appendix 6: Health Services Utilization Report ........................................................................................ 41
Appendix 7: Health Status Report .............................................................................................................. 44
Appendix 8: HIV Risk Behaviors ............................................................................................................... 45
Appendix 9: PROMIS 29+2 Profile (PROPr) ............................................................................................. 55
Appendix 10: Patient Satisfaction and Attitudes Scale............................................................................... 57
Appendix 11: Alcohol Craving Scale ......................................................................................................... 58
Appendix 12: Generalized Anxiety Disorder Screener (GAD-7) ............................................................... 59
Appendix 13: ED Health Quiz (EHQ) ........................................................................................................ 59
Appendix 14: DSM-5 Alcohol Use Disorder.............................................................................................. 60
Appendix 15: Patient Health Questionnaire (PHQ-9) ................................................................................ 62 
Appendix 16: Healthix Authorization and Information Sheet .................................................................... 63 
Appendix 17: ED Visit Review .................................................................................................................. 65
Appendix 18: Treatment Facility Survey .................................................................................................... 65
Appendix 19: Release Authorization Form ................................................................................................ 67
Appendix 20: Importance of Change Scale ................................................................................................ 68
Appendix 21: Confidence Scale.................................................................................................................. 68
Appendix 22: Readiness to Change Scale .................................................................................................. 69
Appendix 23: ASSIST-Lite......................................................................................................................... 70
Appendix 24: Cannabis Assessment ........................................................................................................... 71
Appendix 25: HRQol .................................................................................................................................. 72
Appendix 26: GRIP Adherence and Pill Counts Measure .......................................................................... 74
Appendix 27: Adverse Event Report (AD1) and Severe Adverse Event Report (AD2) ............................ 74
Appendix 28: Protocol Deviation ............................................................................................................... 76
Appendix 29: Contact Logs ........................................................................................................................ 79
Appendix 30: Study Completion ................................................................................................................ 79 

Appendix 31: PRISE………………………………………………………………………………………80

 
 
1.0 LIST OF ABBREVIATIONS 
 
Abbreviation 
Definition 
AE 
Adverse Event 
AUD 
Alcohol Use Disorder 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
DSMB 
Data Safety Monitoring Board 
DSM-5 
Diagnostic and Statistical Manual of Mental Disorders, 5th Edition 
ED 
Emergency Department 
EHR 
Electronic Health Record 
GAD-7 
Generalized Anxiety Disorder Screener 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability Act 
HSP 
Human Subjects Protection 
IRB 
Institutional Review Board 
MAT 
Medication Assisted Treatment 
MSBI 
Mount Sinai Beth Israel 
OUD 
Opioid Use Disorder 
PDDS 
Perceived Devaluation Discrimination Scale 
PHQ-9 
Patient Health Questionnaire 
PI 
Principal Investigator 
PROMIs 
Patient-Reported Outcome Measurement Information System 
QA 
Quality Assurance 
RN 
Registered Nurse 
SAE 
Serious Adverse Event 
SBIRT 
Screening, Brief Intervention and Referral for Treatment 
TLFB 
Time-Line Follow-Back 
VAS 
Visual Analogue Scale 
WHO 
World Health Organization 
 
 
 

 
 
2.0 STUDY SYNOPSIS 
 
This study will recruit Emergency Department (ED) patients with moderate to severe alcohol use disorder 
(AUD) who are interested in initiating medication assisted treatment (MAT). The study is split into two 
phases. The first phase (N=10) will use implementation science strategies to strengthen existing non-
targeted ED based AUD screening program and optimize feasibility, acceptability, and linkage pathways. 
The second phase (N=20) will incorporate lessons learned from phase 1 to initiate ED patients on MAT for 
AUD in the form of oral naltrexone. The primary outcome for both phase 1 and phase 2 is engagement in 
comprehensive addiction treatment at 14 and 30 days post enrollment. 
2.1 Study Design 
 
Overview 
 
The study will be comprised of two components outlined below: 
 
1) Site Implementation Component 
 
In this component implementation science strategies will be used to strengthen existing non-targeted 
ED based AUD screening program and optimize feasibility, acceptability and linkage pathways. Three 
specific aims are to, 1) optimize registered nurse (RN) driven non-targeted alcohol use screening 
supplemented with secondary screening using DSM-5 criteria for AUD and an SBIRT (screening, brief 
intervention and referral to treatment) intervention administered by trained staff. 2) During a 3-month 
period, use continuous quality improvement methods to decrease the time for completion of AUD 
screening to an interval that is acceptable to ED patients and ED providers and 3) Assess willingness to 
initiate oral naltrexone among ED patients with moderate to severe AUD.  Ten (10) patients will be 
enrolled in phase 1.  
 
2) Oral Naltrexone Feasibility Component 
 
In this component we aim to assess the feasibility of initiating treatment in ED patients with moderate to 
severe AUD on oral naltrexone, an evidence based and accepted standard of care treatment for AUD. 
Specifically, 1) over an 8-month period we aim to identify 20 patients with moderate to severe AUD 
eligible and interested in immediate initiation of oral naltrexone. Consenting patients will be receive a 
standard SBIRT intervention and be provided with immediate oral naltrexone initiation in the ED with a 
14-day starter pack at the time of ED discharge. All participants will receive facilitated linkage to 
comprehensive out-patient care. 2) We will evaluate the impact of immediate ED initiated oral 
naltrexone with the primary outcome being engagement in comprehensive addiction care at 14 and 30 
days post enrollment. Secondary outcomes include medication adherence, changes in daily alcohol 
consumption, number of heavy drinking days, hospital admissions and ED utilization, transition to long-
acting injectable naltrexone and alcohol craving. 3) Lastly, we will collect data on recruitment and 
attrition rates, as well as means and standard deviations for key measures that will be needed to plan a 
definitive randomized controlled trial of ED-initiated oral naltrexone.    
 
3.0 INTRODUCTION 
3.1 Background and Rationale 
 
 
Alcohol use disorder (AUD) is the most common disorder of addiction in the United States (US) 
affecting more than 14 million individuals in 2019.1 The physical, psychological and health costs of alcohol 
use disorder and heavy alcohol use (binge drinking on 5 or more days in the past 30) are unparalleled. 

 
 
From 2006 to 2010 alcohol associated deaths in the US approached 88,000 or 9.8% of all US deaths.2 
Costs to the US healthcare system in 2010 from alcohol related conditions were $249 billion.2 While the 
physical, mental and psychological impacts of AUD have recently been overshadowed by increased rates 
of opioid use disorder (OUD) and opioid related deaths, AUD remains the largest and most costly 
substance use disorder by several orders of magnitude. 
 
Despite the availability of medication assisted treatment (MAT) for AUD, fewer than 9% of eligible 
patients are prescribed one of the four FDA approved medications for AUD treatment (oral and long-acting 
naltrexone, disulfiram and acamprosate).2 Numerous barriers to the expansion of MAT for AUD to the out-
patient setting have been identified including AUD pharmacotherapy complexity, limited experience and 
knowledge with AUD MAT and negative attitudes towards patients with AUD.3, 4 These barriers mirror those 
for out-patient medication initiation for patients with OUD.5, 6 EDs have become a major site of expansion 
for medication initiation in patients with OUD and there is good reason to believe that, having demonstrated 
the operational capacity and experience with pathways and medications relevant to treatment 
implementation for OUD, that EDs could successfully implement medication treatment for AUD.7-12 Of the 
four medications for AUD, oral naltrexone is a prime target for initiation in the ED for several reasons: 1) 
Oral naltrexone it is relatively safe, having a serious adverse event rate similar to placebo in multiple 
clinical trials.13 2) It is easy to administer. 3) It does not require a period of abstinence prior to initiation and 
4) can used to bridge to the long acting injectable formulation.  
 
Traditionally, EDs have provided ‘safety net’ care for those who do not receive care elsewhere.14-16 
These “hidden populations” consist of individuals who are not engaged in primary care, are underserved, 
uninsured, and belong to minority groups.16-18 Expanding the AUD treatment initiation options for these 
populations in the ED could have a major contribution to population health. The investigators have already 
developed a successful program for buprenorphine initiation in ED patients with OUD and will leverage the 
lessons learned from that program in this proposal. Given the need to expand access to and engagement 
in AUD treatment, the promise of using EDs as an initiation and linkage platform to successfully reach 
otherwise difficult to reach at risk persons, and ED patients’ willingness to start medications for AUD, our 
Aims are to:  
3.2 Innovation 
 
While MAT for AUD with oral naltrexone has long been established as an effective treatment for patients 
with moderate to severe AUD, uptake has been poor. This study is innovative in that it evaluates the 
feasibility of expanding the pool of potentially eligible patients for MAT with oral naltrexone by identifying 
the patients in the ED and initiating treatment. This pathway builds upon a plethora of recent research with 
OUD demonstrating that ED initiated treatment increases the likelihood of patient remaining engaged in 
comprehensive addiction care at 30 days post-ED visit and beyond.  
3.3 Public Health Impact 
 
Traditionally, EDs have provided ‘safety net’ care for those who do not receive care elsewhere.15-17 These 
“hidden populations” consist of individuals who are not engaged in primary care, are underserved, 
uninsured, and belong to minority groups.17-19 Expanding the AUD treatment initiation options for these 
populations in the ED could have a major contribution to population health.  
 
 
4.0 SPECIFIC AIMS AND HYPOTHESIS:  
 
Aim 1: Implementation Aim 1: Strengthen existing non-targeted ED based AUD screening program and 
optimize feasibility, acceptability and linkage pathways.  
 

 
 
1a. Optimize registered nurse (RN) driven non-targeted alcohol use screening supplemented with
 
secondary screening using DSM-5 criteria for AUD and an SBIRT intervention administered by
 
trained staff. 
1b. During a 3-month period, use continuous quality improvement methods to decrease the time for 
completion of AUD screening in 10 ED patients to an interval that is acceptable to ED patients and 
ED providers. 
1c. Assess willingness to initiate oral naltrexone among ED patients with moderate to severe AUD. 
 
Aim 2: Feasibility Aim 1: Over an 8-month period we aim to identify 20 patients with moderate to severe
 
AUD eligible and interested in immediate initiation of oral naltrexone. Consenting patients will be 
 
receive a standard SBIRT intervention and be provided with immediate oral naltrexone initiation in the
 
ED with a 14 day starter pack at the time of ED discharge. All participants will receive facilitated linkage
 
to comprehensive out-patient care. 
2a. Evaluate the impact of immediate ED initiated oral naltrexone with the primary outcome being
 
engagement in comprehensive addiction care at 14 and 30 days post enrollment. Secondary
 
outcomes include medication adherence, changes in daily alcohol consumption, number of heavy
 
drinking days, hospital admissions and ED utilization, transition to long-acting injectable naltrexone
 
and alcohol craving.  
2b. Collect data on recruitment and attrition rates, as well as means and standard deviations for key
 
measures that will be needed to plan a definitive randomized controlled trial of ED-initiated oral
 
naltrexone.    
 
5.0 STUDY DESIGN 
5.1 Study Timeline 
 
 
 
6.0 STUDY SETTING  
6.1 ED Characteristics 
  
This is a single site study taking place in the Emergency Department of Mount Sinai Beth Israel Medical 
Center.  
 
The Beth Israel Department of Emergency Medicine was established an independent academic ED in 
1989. After the merger with the Mount Sinai Health System in 2013 the ED was integrated into the larger 
Mount Sinai Health System and is today known as the Mount Sinai Beth Israel (MSBI) Department of 
Emergency Medicine.  There are 29 full-time core faculty actively engaged at the local, state, national and 
international levels as clinical, educational, administrative, and research experts in emergency medicine. 

 
 
MSBI is the second most active Emergency Department in respect to research activities in the health 
system after MSH. 
6.2 Physical Space 
 
The Emergency Department at MSBI is comprised of 3 main divisions: Pediatric Emergency Service, Adult 
Acute Care, FastTrack for lower acuity patients; all located in adjacent areas on the first floor of the Dazian 
Pavilion at the corner of 1st avenue and 16th street in Manhattan, New York. The Department also runs a 
separate Urgent Care Facility at 10 Union Square, part of the Mount Sinai Downtown out-patient clinic 
system. With more than 30 medical practices this center Is a “hospital without beds” where patients care 
receive both primary and specialty care. The academic offices of the Department of Emergency Medicine 
are located in the adjacent Silver building. The Research division also has dedicated space in the 
Emergency Department for the research coordinators. All members of the research team who are housed 
in this area are outfitted with a workstation or laptop with network access to all MSBI computing services.  
6.3 Clinical Services – Mount Sinai Beth Israel  
 
An 856-bed teaching hospital founded in 1889 on Manhattan’s East Side, Mount Sinai Beth Israel (MSBI) is 
notable for its unique approach to combining medical excellence with clinical innovation. The hospital also 
has significantly advanced its commitment to community-based ambulatory care and expanding patient 
access to primary and specialty care. Built in 2010, the MSBI ED has approximately 90,000 annual patient 
visits. ED demographics are as follows: 51% male, 26% white, 18% African American, 20% Latino, 5% 
Asian, and 31% more than one race. The payer mix is 36% Medicaid, 11% uninsured, 26% Medicare and 
the remainder with private or other governmental plans. 
 
7.0 IMPLEMENTATION COMPONENT 
7.1 Primary Aim: 
 
To strengthen existing non-targeted ED based AUD screening program and optimize feasibility, 
acceptability, and linkage pathways. 
7.2 Secondary Aim: 
 
To assess willingness to initiate oral naltrexone among ED patients with moderate to severe AUD. 
 
ED items for implementation aim received from quality improvement: 
 
1) Number of ED visits for patients with an ICD10 code related to alcohol abuse who have a 
completed RN alcohol screen 
2) Number of ED visits for patients with an ICD10 code related to alcohol abuse who have a 
completed AUDIT-C  
3) Number of ED visits for patients with an ICD10 code related to alcohol abuse who receive a 
referral for outpatient treatment 
 
ED items for implementation aim received from potential study participants: 
 
1) Number of ED patients approached for study participation 
2) Percentage of those approached who agree to study screening 
3) Percentage of ED patients who complete behavioral screen (DSM-5) 
 

 
 
ED items for implementation aim received from enrolled participants: 
 
1) Percentage of enrolled participants who complete medical screening 
2) Length of time to complete medical screening procedures 
3) Percentage of participants who meet both behavioral and medical criteria for MAT 
4) Percentage of patients that indicate a willingness to initiate MAT for AUD 
5) Percentage of enrolled participants who accept referral for out-patient treatment 
6) Percentage of enrolled participants engaged in formal addiction care at 14-days post index visit 
7) Satisfaction with the screening program 
 
8.0 PATIENTS AND METHODS 
8.1 Patient Population  
 
The target population will be the lower Manhattan community that Mount Sinai Beth Israel (MSBI) services.  
This community is predominantly made up of the Lower East Side, East Village, Two Bridges, Chinatown 
and Stuyvesant Town/Peter Cooper Village.19 The collective population of these neighborhoods is over 
185,000.  Within this geographic area, the community living between Bowery and the East river to the west 
and east respectively and 14th street and the Brooklyn Bridge to the north and south, has some of the 
oldest and poorest residents in New York City.20 Based on census data almost 35% of the population is 
foreign born with 65% of those emigrating from Asia, 26% emigrating from Latin America, and 11% from 
Europe.20 Median household incomes in these neighborhoods remain substantially lower than the rest of 
NYC with some communities, such as Two Bridges, where the median household income is more than 
60% below the NYC median.20  
8.2 Inclusion / Exclusion Criteria 
 
INCLUSION CRITERIA 
1) Emergency Department patients 18 years of age or older 
2) Treated in the ED during screening hours 
3) Moderate to severe AUD as determined by DSM-5 criteria 
4) Able to speak and understand English 
5) Medically stable for an interview as determined by their primary ED provider 
6) Willing and able to consent to study participation 
7) Two points of contact available for follow-up 
 
EXCLUSION CRITERIA 
1) ED patients younger than 18 years of age 
2) Medically or psychiatrically unstable as determined by the ED provider 
3) Unable to speak or understand English 
4) Unable to provide consent for study participation 
5) Past year opioid dependence 
6) Urine drug screen positive for opioids 
7) Current or anticipated need for opioid medications for pain 
8) Anticipated surgical procedure within 14-day of ED visit 
9) Serologic evidence of liver disease (LFTs 3X normal) within 7 days of enrollment 
10) Cirrhosis either by PMH or self-report  
11) Pregnant or breastfeeding  
12) Lacking contact information for follow-up 
13) Requiring in-patient admission for medical or psychiatric reasons 
14) Patient receiving a sexual assault forensics exam (SAFE) 

 
 
15) Patient suspected of having COVID-19 
16) Patient is actively suicidal or homicidal 
17) Previously enrolled in either the implementation or feasibility phase of the study 
18) Be a prisoner or in police custody at the time of the index ED visit 
19) Be currently (anytime within the last 14 days) enrolled in formal addiction treatment, including by 
court order. 
20) In the investigators opinion patient would be unable to comply with study directions and follow-
up 
21) Patient being admitted for inpatient detox 
22) Patient in CPEP 
8.3 Number of Study Subjects 
 
In 2020, the Mount Sinai Beth Israel Emergency Department recorded 4,384 patient visits with a discharge 
diagnosis (ICD10 code) related to alcohol abuse. A single health educator (HE), working 8-hour shifts, 5-
days a week will be able to screen 10-15 patients a day. This is approximately 2.5-5% of the daily adult ED 
volume. Given the number of ED visits related to alcohol use disorder we believe we can easily recruit 30 
patients (10 in the implementation phase and 20 in the feasibility phase) to complete the study in 1 year.  
 
9.0 STUDY DESIGN AND PROCEDURES 
9.1 Screening and Recruitment 
 
The study team will use both targeted and non-targeted recruitment methods.  
 
Patients will only be recruited while they are in the ED. Research Assistants (RAs) assigned to the study 
will work various shifts including, days, evenings and weekends to ensure success with enrollment. The RA 
will identify patients seen in the ED by reviewing the EHR track boards and by provider referral.  
 
Study staff will review the ED tracking board to identify patients with chief complaints that might indicate 
eligibility. This would include patients presenting to the ED for complaints related to alcohol use including 
intoxication or seeking alcohol use treatment or detoxification. For track board screening, study personnel 
will have to view the following identifiable information: 
 
• 
Date of Birth 
• 
Age 
• 
Chief Complaint 
 
A HIPAA waiver request will be submitted to review this limited information for screening purposes only. 
This information will not be recorded.  
 
The RA will keep a log of all patients screening and excluded and the reasons for exclusion.   
 
If a patient is deemed potentially eligible based on tracking board review, study staff will approach the 
patient's ED provider to ascertain if the patient is medically and psychiatrically stable to be approached for 
potential study participation. Only after obtaining permission from the patient's ED provider will the patient 
be approached for study participation. 
 
Study staff will approach the patient, introduce themselves, and ask for verbal consent to complete a set of 
screening assessments that includes questions about alcohol use embedded in a general health screener 
that also includes questions about safety, tobacco and opioid use in the last 30 days.21, 22 Embedded 

 
 
questions have been noted by the World Health Organization (WHO) to improve the reliability of self-
reported behavior.  As part of the verbal consent process patients will be informed that the screening 
questions are to assess their eligibility for a study on oral naltrexone for patients with moderate to severe 
alcohol use disorder. Patients will be told they are free to decline screening and can opt-out at any time. 
They will also be informed that none of the screening information collected could be used to identify them 
and that their answers to the screening questions are anonymous. We will not be collecting any identifiable 
information until the patient is found to meet eligibility criteria and signs written informed consent. We will 
ask for a modification of written consent for screening purposes.  
 
If alcohol use is reported in response to the general health screener the RA will perform a structured 
diagnostic interview with questions based on the DSM-5 criteria to evaluate for the presence of 
moderate/severe AUD. Potential study patients who do not meet criteria for moderate/severe AUD will not 
be asked to participate but will be given referrals as per existing ED protocols. Those who meet criteria for 
moderate/severe AUD will be informed that they may qualify for the study. They will then be asked to 
provide a urine sample to check for opioids. If the urine test is negative for any opioid and the patient 
indicates he/she is able to provide contact information for 2 separate reliable contacts (in addition to their 
own) and the patient meets all eligibility criteria on the Patient Eligibility Summary form (Appendix 1), 
patients will be offered participation and informed consent will be obtained. Of note, we will not be asking 
the patients specific information about their contacts, only if they have them.  Only after written informed 
consent for study participation will participants be asked to provide the specific contact information. 
Patients whose point of care urine test strips are positive for fentanyl only, which are not approved for 
clinical use will not be considered eligible for study participation. Women of childbearing age will have a 
pregnancy test performed on this urine sample to assess for study eligibility. 
9.2 Informed Consent Procedures 
 
We will use the Icahn School of Medicine PPHS as the IRB of record for this study and will comply with all 
necessary informed consent requirements. Only IRB-approved Informed Consent documents and HIPAA 
disclosure allowing study access to protected health information in the patient’s ED medical record will be 
used.  
 
In addition, potential participants will be instructed concerning the importance of full and accurate 
disclosure. Initial screening questions will be asked with verbal consent however, all eligible study patients 
will be asked for written consent to participate using the IRB-approved forms.   
 
As part of the consent process we will also ask for consent for health records matching. 
9.2.1 Consent for records matching: 
 
As part of standard clinical care all patients presenting to any of Mount Sinai’s Emergency Departments are 
asked to provide authorization for Mount Sinai health care providers to access their medical records via the 
health information exchange or HEALTHIX. This authorization will continue to be collected by clinical staff 
as per the standard operating protocols of the Emergency Department.  
 
Individuals will be able to participate in the study whether or not they consent to HEALTHIX matching.  
 
In order to minimize the possibility of undue influence, potential subjects will be informed that participation 
is voluntary, refusal to participate will not involve penalty or loss of benefits to which the subject is 
otherwise entitled, and that the subject may cease participation at any point. 

 
 
9.3 Study Procedures 
 
After signing written informed consent study participants will undergo phlebotomy to assess the medical 
eligibility criteria for oral naltrexone initiation. This includes a measurement of Liver Function Tests (LFTs). 
Patients with LFTs 3X normal will not be eligible for ED naloxone initiation but will continue in the study. 
 
Enrolled participants will also be asked to complete a number of validated and study team developed 
measures including:  
 
1) Locator form with additional demographics (Appendix 2) 
2) Stigma scale (Appendix 3) 
3) Crime and justice assessment (Appendix 4) 
4) Daily substance use report (timeline follow-back methodology) (Appendix 5) 
5) Health services utilization report (Appendix 6) 
6) Health status report (Appendix 7) 
7) HIV risk behaviors report (Appendix 8) 
8) PROMIS 29+2 Profile (PROPr) (Appendix 9) 
9) Patient satisfaction (Appendix 10) 
10) Craving scale (Appendix 11) 
11) Generalized Anxiety Disorder Screener (GAD-7) (Appendix 12) 
12) ED Health Quiz (Appendix 13) 
13) DSM-5 for AUD (Appendix 14)  
14) Patient Health Questionnaire (PHQ-9) (Appendix 15) 
15) Healthix authorization (Appendix 16) 
 
The RA will then complete the ED Visit Review (Appendix 17).  
9.4 Daily Assessments 
 
On a daily basis (excluding the 14 and 30 day follow-up assessment visits) the patient will be asked to 
complete a craving scale and daily substance use report. These scales will be completed using a Qualtrics 
survey sent to the patient’s electronic device (phone, computer). For patients without a device capable of 
receiving and completing electronic surveys these daily assessments will be performed over the phone. 
9.5 Follow-up 
 
All patients will be given follow-up referrals at the Addiction Institute of Mount Sinai (AIMS) within 14 days 
of their ED visits. Follow-up study assessments will occur at 14 and 30 days post ED visit. As much as 
possible study assessment visits will be scheduled to correspond with clinical addiction medicine visits. For 
patients that have a clinical addiction medicine visit at 14 and/or 30 days post study enrollment the RA will 
meet the patient at their clinic visit to complete the follow-up study assessments. For patients that do not 
have a clinical addiction medicine visit coinciding with the 14 and/or 30 day follow-up assessments those 
assessments will be performed over the phone.  
 
Follow-up assessments will include: 
1) Crime and justice assessment 
2) Daily substance use report (timeline follow-back methodology) 
3) Health services utilization report 
4) Health status report 
5) HIV Risk Behaviors Report 
6) PROMIS 29+2 Profile (PROPr) 

 
 
7) Patient satisfaction 
8) Craving scale 
9) Generalized Anxiety Disorder Screener (GAD-7) 
10) Patient Health Questionnaire (PHQ-9) 
 
Assessment of engagement in formal addiction treatment on days 14 and 30 will be based on direct 
contact with the treatment provider/program provided by the participants and will be documented on the 
treatment facility survey (Appendix 18). If the facility if outside of the Mount Sinai Health System, a signed 
release authorization form (Appendix 19) will be sent. Study participants will be provided with a “study card” 
indicating their participation in the study and their use of oral naltrexone.  The study card will also list the 
study teams contact information. Printed reminders for the follow-up will be given to the study participant 
prior to discharge. In addition the RA will send a reminder in the mail/text/email or social media (based on 
the study participant’s preference) about 7 days prior to the scheduled follow-up assessment with an 
additional reminder phone call the day before the scheduled follow-up assessment.  
9.6 Compensation 
 
Because of the expected difficulty of maintaining high follow-up rates in the study population, adequate 
compensation for time and inconvenience is critical. Compensation of a $50 gift card will be distributed in-
person for completing the enrollment process at the initial ED visit. This card will be reloaded with an 
additional $50 after successful completion at each of the follow-up assessments at 14 and 30 days post-
enrollment visits.   
 
For each daily assessment completed participants will receive $5 which will be uploaded to their gift-card at 
each follow-up assessment time-point (14 and 30 days). If the participant completes all daily assessments 
(days 1-13 and 15-29) the total additional amount they could receive would be $140. Participants 
completing enrollment, both 14 and 30 day follow-ups, and all daily assessments would receive total 
compensation of $290.   
9.7 Standard Intervention for all Participants: SBIRT 
 
Screening, Brief Intervention, and Referral to Treatment (SBIRT) is an evidence-based public health 
approach to identify patients who use alcohol and/or drugs at risky levels and referring them to substance 
use disorder treatment. SBIRT begins with screening all patients for substance use disorders.23, 24 This 
screening is currently mandated by NYS public health law (Part 405.9 of Title 10).25, 26 At MSBI the 
regulatory requirement for screening is accomplished using the two question screener developed by Smith, 
et als. built into the Epic RN primary assessment which is reproduced below.27, 28  
 
The nurse will complete a primary assessment for each patient by asking the following questions: 
1. How many times in the past year have you had 4-5 or more drinks in a day?  
2. How many times in the past year have you used an illegal drug or used a prescription medication 
for non-medical reasons? 
 
An answer of 1 or greater for either question is considered as a positive screen. For patients with AUD 
study staff will then complete additional screening using DSM5 criteria for AUD to determine if the patient 
has AUD and the level of severity. After a patient is screened and determined to have AUD, study staff will 
initiate a brief intervention where the patient is told their screening score and they have a discussion with 
the patient about how important the patient views changing their alcohol use to be (Appendix 20), how 
confident they are that they can change their behaviors (Appendix 21), and their readiness to change those 
behaviors (Appendix 22). The brief intervention is a good time to ask the patient about their goals so you 

 
 
can offer referrals that will help them best reach their stated goals. Finally the patient will be offered a 
referral to treatment which could include inpatient or out-patient services.29  
 
 
10. STUDY ASSESSMENTS 
10.1 Overview: 
 
The baseline and follow-up assessments for this study attempt to balance the benefits of comprehensive 
data collection against the feasibility of collecting data in often chaotic and pressured environment of the 
Emergency Department.30 A cumbersome assessment process is also likely to impede the successful 
completion of the study through an adverse effect on recruitment nor would it model real-world clinical 
practice. If this intervention is to be successful it must not only be shown to be effective but also feasible 
and pragmatic. Excluding collection of a study patient participant characteristics and locator information, 
the patient’s baseline data will include a brief assessment of health status, healthcare utilization, past 7-day 
alcohol and drug using Time-line Follow-Back (TLFB) method,31 use of other substances the HRQol32 and 
other data necessary to measure costs. The total expected time burden for the screening assessments is 
30 minutes. Assessments collected at 14 and 30 days post study enrollment will be similar. Daily 
assessments should take no longer than 4 minutes.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
10.2 Table: Schedule of Study Activities and Assessments by Study Time Period 
Instrument/Activity 
 
 
Tim
e 
Done 
by 
Study Assessments 
Screenin
g 
Enrollme
nt 
Day 1-13 
Assessment 
14-Day 
Assessment 
Day 15-29 
assessment 
30-Day 
Assessment 
(Index ED Visit, Day 
0) 
Qualtrics or 
phone 
Phone 
Qualtrics or 
phone 
Phone 
ED Health Quiz 
2' 
RA 
X 
  
  
  
  
  
DSM-5 
5' 
RA 
X 
  
  
  
  
  
Urine Drug Screen 
5' 
RA 
X 
  
  
  
  
  
Patient Eligbility  
Summary 
2' 
RA 
X 
  
  
  
  
  
Written Informed  
Consents 
10' 
RA 
  
X 
  
  
  
  
Demographics 
5' 
RA 
  
X 
  
  
  
  
Locator  
 Form 
5' 
RA 
  
X 
  
X 
  
  
Other Substance 
Use 
1' 
RA 
  
X 
  
X 
  
X 
Cannabis 
Assessment 
2' 
RA 
  
X 
  
  
  
  
Timeline Follow-
Back (TLFB) 
10' 
RA 
  
X 
  
X 
  
X 
Health Services  
Utlization 
(Inpatient and 
Outpatient) 
6' 
RA 
  
X 
  
X 
  
X 
PHQ-9 
3’ 
RA 
 
 
X 
 
X 
 
X 
GAD-7 
1’ 
RA 
 
X 
 
X 
 
x 
Health Status 
Report 
2’ 
RA 
 
X 
 
 
 
 
HIV Risk Behavior 
5’ 
RA 
 
X 
 
 
 
 
Stigma Scale 
3' 
RA 
  
X 
  
 
  
 
Health-Related 
Quality of 
 Life (HRQol) 
2' 
RA 
  
X 
  
X 
  
X 
Crime and Criminal  
Justice 
1' 
RA 
  
X 
  
 
  
 
PRISE (Appendix 
31) 
3’ 
RA 
 
 
 
X 
 
 
Alcohol Craving 
2' 
RA/Part
icipant 
  
X 
X 
X 
X 
X 
Daily Alcohol 
Intake 
2' 
Particip
ant 
  
  
X 
  
X 
  
Satisfaction Scale 
3' 
RA 
  
X 
  
X 
  
X 
Total Duration in Minutes 
14' 
58' 
  
  
  
  
Healthcare Visits  
Logistics 
3' 
RA 
  
  
  
  
  
X 
Total Duration in Minutes 
  
  
5' 
33' 
5' 
26' 
RA/PI Assessments 
ED Visits and 
 Hospitalizations 
  
RA 
  
  
  
  
  
X   
Engagement in  
Treatment Survey 
  
RA 
  
  
  
  
  
X   
Process Outcome 
  
RA 
  
  
  
  
  
X   

 
 
Serious Adverse  
Event (Death) 
X 
Protocol Deviations 
X 
 
10.3 Pre-Enrollment (Screening) Assessment Phase 
10.3.1 ED Health Quiz 
 
Individuals will meet with an RA to be evaluated for study eligibility. This assessment will be conducted 
after verbal consent, and before enrollment into the study. It will include questions about alcohol and opioid 
use in the past 30 days embedded in a general health and substance use screening. 
10.3.2 Assessment of AUD: Questionnaire Based on DSM-533 
 
The DSM-5 criteria are assessed during the screening period to determine a current diagnosis of moderate 
or severe alcohol use disorder. The assessment will be completed electronically and will be automatically 
scored.  
10.3.3 Urine Drug Screen (Toxicology Testing) 
 
Urine testing will be performed for the presence of the following drugs: opioids, oxycodone, 
benzodiazepines, cocaine, methamphetamine, amphetamine, ecstasy (MDMA), marijuana (THC), 
barbiturate, methadone, buprenorphine and fentanyl. The urine drug screen is collected during the 
screening phase of the initial ED visit. The fentanyl point of care test strip is being used for research 
purposes only. Urine testing supplies will be purchased for this study and kept separate from the general 
ED stock.  
10.3.4 Patient Eligibility and Inclusion/Exclusion 
 
The Patient Eligibility and Inclusion/Exclusion form collects information regarding eligibility during the 
screening phase, before written informed consent is obtained. This includes an initial discussion about the 
availability of two alternate contacts in addition to the participant. Prior to signing consent patients will only 
be asked if they have two points of additional contact and not the specific information for those contacts.  
10.3.5 Informed Consent and Research Authorization (HIPAA) Forms 
 
Only patients who continue to meet study eligibility criteria will be allowed to continue to the enrollment 
phase.  
10.4 Enrollment Assessments 
10.4.1 Demographics 
 
The demographics forms collect information about demographic characteristics of the study participant, 
including age, gender, cultural/ethnic group, education level, marital status, and type of insurance. This 
form is completed at enrollment only.  
10.4.2 Locator Information Form 
 

 
 
A locator form is used to obtain information to assist in finding study participants during the 14 and 30 day 
assessment period. The form collects contact information including the participant’s current address, email 
address, and phone number. In an effort to facilitate locating participants if direct contact efforts are 
unsuccessful, address and phone number of family/friends who may know how to reach the participant are 
also collected. This information will be collected at enrollment and updated at each follow-up visit. Locator 
information will not be used in data analysis.   
10.4.3 Other Substance Use 
 
Select questions from the ASSIST-lite (Appendix 23) will be used to assess severity of drug use problems 
over the last 3 months and will be asked at enrollment only. Questions related to alcohol use have been 
eliminated to avoid duplication.  
10.4.4 Cannabis Assessment (Appendix 24) 
 
This questionnaire is an 8-item measure that is used to assess cannabis use in the past 12-months. This 
questionnaire is collected at enrollment only. 
10.4.5 Timeline Follow-Back (TLFB) 
 
The Timeline Follow-back procedure will be used to elicit the participant’s self-reported use of alcohol and 
other substances.31, 34 At enrollment, substance use is reported by the participants for the 7-day period 
prior to the index ED-visit. At 14 and 30 day follow-up assessments, substance use is again reported for 
the 7 days prior to the visit.  
10.4.6 Health Service Utilization Inpatient and Outpatient Health Services Utilization35 
 
A brief, structure interview regarding health care utilization will be used, which collects information on the 
type and amount of services received. This includes ED visits, hospitalizations and primary medical care 
visits. This form is collected at enrollment, 14 and 30 days post-enrollment. 
10.4.7 Health Status 
 
We will collect information on HIV and Hepatitis C status, HIV risk, and psychological health (PHQ-9).36 The 
Data Harmonization Measure is an HIV Risk Behavior Scale. The PHQ-9 is used to assess depressive 
symptoms including suicidal ideation. If the participant responds to “Thoughts that you would be better off 
dead, or of hurting yourself in some way” other than “Not at all”, it will prompt a clinician assessment for 
suicide risk. Also included in the health assessment will be the GAD-737, a brief 7-question survey to 
assess the degree of the participant’s anxiety. All health status scales are collected at enrollment, 14 and 
30 days post enrollment. 
10.4.8 Stigma Scale 
 
The 12-item Perceived Devaluation Discrimination Scale (Link, 1982; Link et al., 1991) will be used to 
assess the extent to which a person believes that other people will devalue or discriminate against 
someone with a mental illness. This is collected at enrollment, 14 and 30 days post enrollment.  
10.4.9 Health-Related Quality of Life (HRQol) 
 
The HRQoL (Appendix 25) will be measured using the Patient –Reported Outcomes Measurement 
Information System (PROMIS).32 PROMIS domains include Cognitive Function – Abilities, Depression, 

 
 
Fatigue, Pain, Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles 
and Activities. Levels for each domain range from no problems over light, moderate and severe problems 
to extreme problems. This is collected at enrollment, 14 and 30 days post enrollment.  
10.4.10 Crime and Criminal Justice 
 
This form captures data on incarceration, recent crimes, and recent contact with the law and is collected at 
enrollment, 14 and 30 days post-study enrollment.  
10.4.11 Alcohol Craving 
 
We will use a standardized craving scale to assess craving to use alcohol. This will be asked daily for days 
0-30 via Qualtrics or phone.38, 39  
10.4.12 Daily Alcohol Intake 
 
Daily alcohol intake will be assed with a short survey. This will be asked daily on days 2-13 and 15-29 via 
Qualtrics or phone.  
10.4.13 Satisfaction Scale 
 
A short 3uestion satisfaction scale will be used to measure satisfaction with the screening and linkage 
process. This will be asked at enrollment, 14 and 30 days post enrollment. 
10.4.14 Healthcare Visits Logistics 
 
The Healthcare Visit Logistics form asks cost data at 30 days post study enrollment as well as barriers to 
care. 
10.4.15 ED Visits and Hospitalizations 
 
The ED Visits and Hospitalization form collects information about the index ED visit and any visits or 
hospitalization between the index and 30-day follow-up. Data is acquired for this form by patient report, 
EHR query and records matching (if patient consents to such matching).  
10.5 Outcome Data 
10.5.1 Engagement in Treatment Survey (Primary Outcome) 
 
At 14 and 30 days post enrollment, participants will be asked to report AUD treatment received on their 7th 
and 30th day post enrollment target date (Day 30, with the ED enrollment visit being Day 0). The services 
reported by the patient will be confirmed with the addiction treatment provider. The Engagement in 
Treatment-Facility survey includes the type of treatment the participant is receiving (MAT, intensive 
therapy, detoxification, residential or inpatient treatment). Date of admission is recorded as well as the level 
of treatment received according to ASAM Levels of care, such as Level 1: Outpatient Treatment; Level II: 
Intensive outpatient treatment (including partial hospitalization); Level II: Residential/Inpatient Treatment; 
Level IV: Medically managed intensive treatment.  
10.5.2 Process Outcome 
 

 
 
The process outcome will be assessed using standardized Epic reports and billing data that are currently 
received as a standard part of monthly quality improvement. The process data elements include the 
monthly aggregate number of:  
 
1) ED visits for patients with an ICD10 discharge or admission diagnostic code related to alcohol 
abuse 
2) ED visits for patients with an ICD10 code related to alcohol abuse who have a completed RN 
alcohol screen 
3) Number of ED visits for patients with an ICD10 code related to alcohol abuse who have a 
completed AUDIT-C 
4) Number of ED visits for patients with an ICD10 code related to alcohol abuse who receive a referral 
for outpatient treatment 
 
As noted these reports are currently used as part of MSBI EDs monthly QI data reporting. The reports are 
stripped of all identifiers and reported as aggregate numbers. These reports will be viewed monthly to 
assess compliance with quality metrics for patients with AUD.  
 
11.0 FEASIBILITY COMPONENT 
11.1 Study Procedures and Assessments 
11.1.1 Rationale for study component 
 
Initiation of patients with AUD onto MAT is common clinical practice but has typically been reserved for the 
out-patient setting. Unfortunately, many patients with AUD remain “hidden”, infrequently seeking care or 
interacting with out-patient healthcare resources. Not infrequently, however, these same individuals do 
seek care in the Emergency Department setting often as a result of circumstances related to their alcohol 
use. Expanding evidence based AUD treatment initiation options for these populations in the ED could 
have a major contribution to population health.  
11.1.2 Overview of feasibility component 
 
We will conduct a case series, n=20, of inductions of oral naltrexone in Emergency Department patients 
with moderate or severe alcohol use disorder. This study will be performed in a single ED by an 
investigator with extensive experience in ED initiated treatment with buprenorphine for patients with OUD 
and PrEP initiation for patient with activities that put them at high risk for acquiring HIV. Patients will be 
initiated on oral naltrexone and assessed for one hour post ingestion to monitor for any adverse medication 
effects. Daily craving and alcohol use will then be measured over 30 days as well as engagement in formal 
addiction treatment (primary outcome).  
11.2 Primary Aim 
 
The primary feasibility Aim 1 is to, over an 8-month period, identify 20 patients with moderate to severe 
AUD eligible and interested in immediate initiation of oral naltrexone. Consenting patients will be provided 
with immediate oral naltrexone initiation in the ED with a 14-day starter pack at the time of ED discharge. 
All participants will receive facilitated linkage to comprehensive out-patient care.  
 
The primary outcome aim is to determine engagement in comprehensive addiction care at 14 and 30 days 
post enrollment. 

 
 
11.2.1 Hypothesis 
 
We can identify 20 ED patients interested in immediate initiation of oral naltrexone for AUD. We further 
hypothesize that a higher percentage of patients initiated on oral naltrexone in the ED will be engaged in 
comprehensive addiction care at 14 and 30 days post enrollment then patients who received SBIRT alone.  
11.3 Secondary Aims 
 
1) Medication adherence 
2) Medication side-effects 
3) Daily alcohol consumption 
4) Desire to use – Craving Scale 
5) Patient satisfaction 
6) Health care utilization 
7) Transition to long acting injectable naltrexone 
11.4 Study Population 
 
The study population, inclusion criteria, exclusion criteria, screening procedures, eligibility determination, 
informed consent procedures and compensation are identical to phase 1.   
11.5 Study Procedures 
 
Study procedures are identical to phase 1 with the following exceptions. In addition to all the measures and 
assessments detailed for phase 1, phase 2 study participants will also complete the following additional 
measures: 
11.5.1 Pre Enrollment Assessments 
 
No additional measures from phase 1. 
11.5.2 Enrollment Assessments 
  
No additional measures from phase 1. 
11.5.3 Outcome Assessments 
 
In addition to all the measures cited above for phase 1 we will also complete the following measures for 
phase 2 participants: 
 
Medication adherence measures – Medication adherence will be measured by pill counts at 14 days post-
enrollment. Patients having an in-person follow-up assessment at day 14 will be asked to bring their 
unused pills to their appointment.  Patients having a remote follow-up at 14-days will be asked to show 
their pills to the RA if a visual platform is used or count the number of pills and report that to the RA. We 
will also use the single question GRIP measures (Appendix 26), a validated instrument to assess 
medication compliance.  
 
Patient related inventory of side effects (PRISE) is a 7 item patient self-reported measure used to qualify 
side effects by identifying and evaluating the tolerability of each symptoms. Normally used for depression 

 
 
related mediations but can be used to describe general side effects to any medication. This will be 
completed at the 14 day assessment only as that is the duration of the naloxone starter pack.  
 
Adverse Events (AEs) and Serious Adverse Events (SAEs) – Adverse events will be captured and reported 
through the Adverse Event (AE) reporting mechanism described in Section 14 Given the small sample size 
and the fact that the medication being used is standard practice AEs and SAEs are expected to be low. 
 
 
 
Protocol Deviation Form (Appendix 27) – This form will be used to capture protocol deviations, should they 
occur. The form will document a description of the deviation, how it occurred, the corrective action taken to 
resolve the specific deviation, as well as a description of the plan implemented to prevent further 
occurrences of similar deviations.  
11.6 Intervention 
 
Enrolled participants will all receive the same SBIRT intervention delivered to patients in phase 1. 
Participants in phase two will receive their first dose of oral naltrexone (50mg) while in the ED once their 

 
 
liver function tests are completed and within the acceptable range (less than 3X upper limit of normal). 
Participants will be observed for 1 hour after medication administration to monitor for any side-effects.  
11.7 Medication Packaging / Handling / Storage / Accountability 
 
Oral naltrexone will be provided by the research pharmacy.  
11.7.1 Study Medication Management 
 
Research staff will be responsible for monitoring the medication supply to ensure that adequate unexpired 
medications are available for the study. 
11.7.2 Dispensing Study Medication 
 
All study medications will be prepared by the research pharmacy and dispensed by a pharmacist or 
licensed medical practitioner appropriately trained and authorized to dispense study medications per local 
regulations.  
11.7.3 Study Medication Storage 
 
Study medications will be stored in compliance with federal, state, and local laws and institutional policies.  
Study medications will be stored in a secured location under the conditions specified by the research 
pharmacy.  
 
12.0 DATA MANAGEMENT AND STATISTICAL ANALYSES 
12.1 Statistical Analysis 
12.1.1 General approach 
 
Nominal and ordinal categorical variables will be summarized as frequencies and percentages. Continuous 
variables will be summarized with the following descriptive statistics: N, mean, standard deviation, median, 
minimum, maximum, interquartile range, and range. 
 
No imputation of missing data will be performed for any of the analysis given the pilot nature of the study 
and small sample size. 
 
12.1.2 Analysis of Primary and Secondary Outcomes 
 
For this pilot study we are most interested in feasibility and engagement in comprehensive addiction care 
14 and 30 days post enrollment. In statistical analyses, participants will be included to the date of their last 
active follow-up visit. The primary outcome, engagement in comprehensive addiction care, will be reported 
using descriptive statistics including which includes the number/percentage engaged in care at 14 and 30 
days.  
 
Secondary outcomes: Multiple secondary outcomes will be assessed at 14 and 30 post oral naltrexone 
initiation including daily alcohol consumption assessed using timeline follow-back methodology, medication 
adherence assessed by self-report and pill counts, hospital admissions and ED utilization and degree of 
daily alcohol craving assessed using a validated craving measure. Adherence will be calculated at pre-

 
 
specified study time points for each participant. No a-priori comparisons are planned given the small 
sample size and pilot nature of the study. Secondary outcomes will be summarized using descriptive data.  
12.1.3 Sample Size 
 
This pilot study is meant to demonstrate the feasibility of ED initiated MAT for AUD. Sample size is based 
on projected ability to recruit within the proposed timeframe. Pilot data will be used to determine 
recruitment and attrition rates, as well as means and standard deviations for key measures that will be 
needed to plan a definitive trial of ED-initiated oral naltrexone for patients with moderate to severe AUD.   
12.2 Data Management 
 
With the exception of patient reported daily data captured in Qualtrics, data will be entered directly into 
REDCAP. The data stored in REDCAP will be password protected and access will be restricted to study 
staff. Data from REDCAP will be exported to STATA for analysis. Data stored in REDCAP will include 
participants’ first and last name and contact information, in order to conduct follow-up contacts. Identifiers 
such as date of birth and Medicaid identification number will also be stored in REDCAP. Each participant 
will be assigned a unique identification code in REDCAP, which will be used in lieu of first and last name 
for analysis in STATA.  
 
Data for analysis and records matching will be stored separately in a secure folder on the Mount Sinai 
server accessible only to the Principal Investigator (PI). Analytic datasets will not include participants’ first 
and last name, contact information, date of birth, or any other identifying information. 
 
Data from daily Qualtics surveys will be downloaded and stored in a secured folder. Data will be matched 
back to the participant and entered into the corresponding REDCAP profile by a member of the research 
staff.  Hard-copy consent forms will be scanned and stored electronically in REDCAP and in a secure 
folder on the Mount Sinai server. Paper copies of signed Informed Consent Forms will be stored in a locked 
file cabinet that will only be accessible to the PI and study staff.  
 
The PI will review all original consent forms that have been scanned into REDCAP and place a copy in a 
secure folder on the Mount Sinai server. All study documents will be stored for a period of six years after 
the study as per IRB policy.  
 
All program and study staff who work with human subjects and/or data will undergo training on 
confidentiality and data management protocols in order to ensure data is collected, stored, and analyzed in 
a confidential manner.  
 
There is no planned data sharing. 
 
 
13.0 REGULATORY COMPLIANCE, ETHICS, AND REPORTING 
 
This trial will be conducted in according with the current version of the protocol, in full conformity with the 
ethical principles outlined in the Declaration of Helsinki, the Protection of Human Subjects described in the 
International Council for Harmonization Good Clinical Practice (GCP) Guidelines, applicable United States 
(US) Code of Federal Regulations (CFR) and all other applicable state, local and federal regulatory 
requirements. The Lead Investigator will assure that no deviations from, or changes to the protocol will take 
place without prior agreement from the Institutional Review Board (IRB), except where necessary to 
eliminate an immediate hazard to the trial participants. 

 
 
13.1 Institutional Review Board (IRB) and Regulations 
 
Prior to initiating the study, the PI will obtain written approval from the Icahn Mount Sinai School of 
Medicine IRB. If changes to the study protocol become necessary, protocol amendments will be submitted 
in writing by the investigators for IRB approval prior to implementation. In addition, IRBs will approve all 
consent forms, recruitment materials, and any materials given to the participants, and any changes made 
to these documents throughout study implementation. Approval of both the protocol and the consent form 
must be obtained before any participant is consented. If changes to the consent form are needed, a 
decision will be made regarding whether previously consented participants need to be re-consented. IRB 
continuing review will be performed annually. Unanticipated problems involving risk to study participants 
will be promptly reported to and reviewed by the IRB of record, according to usual practices.  
13.2 Subject Information and Informed Consent 
 
A HIPAA waiver will be requested for track board screening (no patient interaction 
 
An alteration of informed consent and waiver of written documentation will be requested for the screening 
questions (Health Quiz and DSM).  
 
Patient found to be study eligible based on screening will be offered study participation and will be asked to 
sign full, written informed consent.  
 
We believe the alteration and waiver of written documentation for screening is in accordance with 
applicable federal regulations.  
 
• 
The screening questions involves no more than minimal risk to the subjects; 
• 
The screening could not practicably be carried out without the requested waiver or alternation; 
• 
The waiver or alteration will not adversely affect the rights and welfare of the subjects; 
• 
Whenever appropriate, the subjects or legally authorized representatives will be provided with 
additional pertinent information after participation. 
 
The study does not preempt any applicable federal, state, or local laws which require additional information 
to be disclosed in order for informed consent to be legally effective.  It is in conformance with 42 CFR 2.52, 
which allows for research-related provisions with regard to the disclosure of substance use disorder patient 
identifying information in the absence of the informed consent process and HIPAA authorization. 
 
The informed consent form is a means of providing information regarding the study to a prospective patient 
participant and allows for an informed decision about participation in the study. Given the well-established 
safety and efficacy or oral naltrexone for AUD, we do not view the proposed study as high risk. However, 
given that oral naltrexone is being initiated in a different setting than usual we have taken precautions to 
minimize the risk of any adverse events. This includes ensuring that all inclusion criteria have been 
satisfied and no exclusion criteria are present prior to giving the first dose of oral naltrexone. We have also 
build in a 1-hour post medication administration observation period to monitor for any adverse effects. 
While this observation is not deemed necessary in clinical practice we thought that participant safety would 
be increased by being observed in a monitored setting.  
 
Once eligibility is determined, the RA, who is knowledgeable about the study, will explain the significant 
elements of the study to the potential participant. Included in the consent will be language allowing the RA 
to contact community-based providers and programs to determine the patient’s engagement in formal 
addiction treatment after trial enrollment. If the patient chooses to sign consent for study participation a 
copy of the consent will be provided to the participant. All persons obtaining consent will have completed 

 
 
appropriate training in human subjects research. The participant will be informed that their participation is 
voluntary, and they may withdraw from the study at any time, for any reason without penalty. Individuals 
who refuse to participate of who withdraw from the study will be treated without prejudice.   
 
The informed consent form must be updated or revised whenever important new safety information is 
available, or whenever the protocol is amended in a way that may affect participants’ participation in the 
study.   
13.3 Confidentiality 
 
As described in the section on data management all necessary precautions will be taken to guard against 
breaches of confidentiality. All program and study staff who work with human subjects and/or data will 
undergo training on confidentiality and data management protocols in order to ensure data is collected, 
stored, and analyzed in a confidential manner. 
13.4 Privacy Protections 
 
The protection of subjects’ privacy is a primary concern. To insure that all staff members are aware of the 
sensitivity of data to be collected, all staff will receive confidentiality training. The training will outline strict 
confidentiality protocols and the penalties involved for breaching protocol. Each person must be 
continuously aware of the responsibility to safeguard the privacy of all the participating individuals. Names 
or any other information about Program or Program Evaluation participants should never be divulged. Staff 
are to refrain from discussion about participants which might be overheard by non-study staff.  
 
Participants’ names and contact information will be collected in order to conduct follow-up encounters as 
part of the study. Participants will also be asked to provide the names and contact information of friends 
and family members, as additional contacts, should research staff be unable to reach them for follow-up. 
Only individual names and their contact information that the program participants offer to share will be 
tracked, and consents will be signed allowing research staff to communicate with them. 
 
For issues that participants may deem sensitive or private, program and evaluation staff will remind 
participants that their information will be kept confidential and that they may choose to skip any questions 
that they prefer not to answer, and suffer no consequences with regard to participation the study.   
13.5 Data Safety Monitoring 
 
There will be no external data and safety monitoring committee for this study. This study involves no 
clinical or psychological intervention and as such there are no anticipated adverse events expected as part 
of study participation. Study outcomes will be tracked and monitored by the PI. 
13.6 Potential Risks 
 
Risks to participants in this study are not expected to be greater than minimal. Both the SBIRT intervention 
used in phases 1 and 2 as well as oral naltrexone as MAT for AUD are proven effective clinical 
interventions to decrease alcohol use in patients with AUD. The only change from standard practice is the 
setting in which oral naltrexone is being initiated. We have been using SBIRT for patients with AUD for the 
last year so this is not a change from standard ED practice. However, in regard to oral naltrexone initiation, 
standard practice has been for ED patients to be referred to care for outpatient initiation of MAT for AUD. 
This study moves that initiation step into the ED. We do not believe this change of venue for oral 
naltrexone initiation increases the risk above what would normally be considered standard practice. 

 
 
However, given that we are initiating medication as part of this study and that medication has the potential 
for side-effects, patients will be informed of such effects in the informed consent document.  
 
Other risks include loss of confidentiality. Participants are asked questions about illicit drug use and 
overdose, which may present social, legal, or economic risk if divulged to outside parties. As a result, the 
study team will take great care to protect confidential information.  
 
All study interactions will be done one-on-one by phone, or in private or semi-private locations. Follow-up 
evaluations will be conducted by phone whenever possible. Participants can opt out of answering any 
question at any time.  
13.7 Potential Benefits 
 
There are potential direct benefits to participants in both phase 1 and phase 2 of the study. In phase 1 
participants may benefit from the SBIRT intervention and referral to out-patient addiction care. In phase 2, 
in addition to the potential direct benefits of the SBIRT intervention participants craving for alcohol use and 
daily alcohol consumption could decrease with the initiation of oral naltrexone. 
13.8 Alternatives 
 
The only alternative to study participation is not to participate. Patients presenting with AUD typically 
receive a referral for out-patient addiction services.  
13.9 Inclusion of Women and Minorities 
 
We aim to enroll a diverse study population. There are no plans to exclude any gender, racial and/or ethnic 
group from study participation.  
13.10 Pregnant and Breastfeeding Women 
 
Pregnant and breastfeeding women are excluded from study participation. Oral naltrexone is not 
recommended in pregnancy as there is limited date on fetal effects. There is also limited data on the effects 
of oral naltrexone on breastfeeding infants. 
13.11 Records Retention 
 
Research records for all study participants (case report forms, source documents, signed consent forms 
and regulatory files) are to be maintained for 6 years as per IRB policy.   
13.12 Safety Monitoring 
 
The PI will review and provide consultation for each Adverse Event (AE) and Serious Adverse Event (SAE) 
as needed. These reviews will include an assessment of the possible relatedness of the event to the study 
intervention or other study procedures.  
13.13 Data and Safety Monitoring Board (DSMB) 
 
Given that the interventions being used in this study are part of standard clinical practice and considered 
no greater than minimal risk no DSMB is being used. The PI will be responsible for monitoring the safety of 
study participants.  
 

 
 
14.0 ADVERSE EVENT REPORTING AND PROCEDURES 
14.1 Definition of Adverse Events and Serious Adverse Events 
 
An adverse event (AE) is any untoward medical occurrence in humans, whether or not considered study 
medication related which occurs during the conduct of the clinical trial. Any change from baseline in clinical 
status, ECGs, lab results, x-rays, physical examination, etc., that is considered clinically significant by the 
PI are considered AEs.  
 
Suspected adverse reaction is any adverse event for which there is a reasonable possibility that the 
study medication caused the adverse event. A reasonable possibility implies that there is evidence that the 
study medication caused the event. 
 
Adverse reaction is any adverse event caused by the study medication. 
 
An adverse event, suspected adverse reaction, or adverse reaction is considered “serious” if, in the 
view of the PI it: 
 
1) Results in a death 
2) Is life-threatening 
3) Requires inpatient hospitalization or prolongation of existing hospitalization 
4) Results in persistent or significant incapacity of substantial disruption of the ability to conduct 
normal life functions 
5) Is an important medical event that may not result in one of the above outcomes, but may jeopardize 
the health of the study participant or require medical or surgical intervention to prevent one of the 
outcomes listed in the above definition of serious event. 
14.2 Definition of Expectedness 
 
Any adverse event is considered “unexpected” if it is not listed in the package insert or is not listed at the 
specificity or severity that has been observed. 
14.3 Medical and Psychiatric History 
 
A thorough review of the participant’s medical and psychiatric history of any chronic, acute, or intermittent 
preexisting or current illness, diseases, symptoms, or laboratory signs should be undertaken to avoid 
reporting pre-existing conditions as new AEs and to assist in the assessment of worsening in intensity or 
severity of these conditions that would indicate an AE. Stable chronic conditions which are present prior to 
clinical trial entry and do not worsen are not considered AEs.  
14.4 Adverse Event Reporting 
 
Appropriately qualified and trained personnel will elicit participant reporting of AEs and SAEs (Appendix 28) 
at each study visit. Study personnel will obtain as much information as possible about the reported AE/SAE 
to complete the AE/SAE forms and will consult with the PI as necessary. 
 
Standard reporting, within 7 days of the site becoming aware of the event, will be required for all AEs.  
Expedited reporting (within 24 hours of their occurrence and/or site’s knowledge of the event) is required 
for reportable SAEs.   
 
Reportable adverse events will be followed until resolution, stabilization or study end. 

 
 
14.5 PIs Role in Assessing Severity and Causality of Adverse Events 
 
The PI will conduct an initial assessment of the serious, severity and causality when eliciting participant 
reporting of adverse events.   
14.6 Guidelines for Assessing Severity 
 
The severity of an adverse event refers to the intensity of the event defined by CDISC SDTM Severity 
Intensity Scale for Adverse Event: 
 
14.7 Guidelines for Determining Causality 
 
The PI will use the following question when assessing causality of an adverse event to study medication 
where an affirmative answer designates the event as a suspected adverse reaction: 
 
Is there a reasonable possibility that the study medication caused the event? 
14.8 Site’s Role in Monitoring Adverse Events 
 
Staff education, re-training, or appropriate corrective action plan will be implemented as needed in 
response to reported AEs and SAEs. 
14.9 Participant Withdrawal 
 
The PI will apply his/her judgement to determine whether or not an adverse event is of sufficient severity to 
require that the participant be withdrawn from further study medication. A participant may also voluntarily 
withdraw from treatment due to what he/she perceives as an intolerable adverse event or for any other 
reason. If voluntary withdrawal is requested, the participant will be asked to complete an end-of-study 
medication visit to return unused medication and document end-of-medication outcomes.  

 
 
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APPENDIX 
Appendix 1: Patient Eligibility Summary 
Patient Eligibility Summary  
Date:  
In order to meet eligibility, ALL inclusion answers must be “Yes.” 
1. Is the participant 18 years of age or older? 
2. Is the participant being treated in the ED during screening hours? 
3. Does the participant have a moderate to severe AUD as determined by DSM-5 criteria?  
4. Is the participant able to speak and understand English? 
5. Is the participant medically stable for an interview as determined by their primary ED provider? 
6. Is the participant willing and able to consent to study participation? 
7. Does the participant have two points of contact available for follow up? 
In order to meet eligibility, ALL exclusion answers must be “no.”  
1. Is the participant psychiatrically unstable as determined by their primary ED provider? 
2. Has the participant had an opioid dependence in the past year? 
3. Does the participant have a urine toxicology test that is positive for opioids?  
4. Is there a current or anticipated need for opioid medications for pain? 
5. Is there an anticipated surgical procedure within 14 days of ED visit? 
6. Does the participant have cirrhosis either from their medical history or self-report? 
7. Is the participant pregnant or breastfeeding?  
8. Does the participant require inpatient admission for medical or psychiatric issues? 
9. Is the participant receiving a sexual assault forensics exam (SAFE)? 
10. Is the participant suspected of having COVID-19? 
11. Is the participant actively suicidal or homicidal? 
12. Was the participant previously enrolled in either the implementation or feasibility phase of the 
study? 
13. Is the participant on parole, in police custody or incarcerated at the time of the initial ED visit? 
14. Is the participant currently or any time within the last 14 days enrolled in a formal addiction 
treatment, including by court order? 
15. In the investigators opinion, is the participant unable to comply with study directions and follow-up?  
16. Is the patient being admitted for inpatient alcohol detox? 
Eligibility for Enrollment 
1. Is the participant eligible for the study? 
2. Did the participant provide informed consent?  
a. If yes, date: 
3. Did the participant sign the medical release form? 
a. If yes, date: 
Comments:  
 

 
 
Appendix 2: Locator Form 
We are going to ask you now to give us your name, address and phone number, if you have one, and the 
names and addresses of at least 2 people who know you.  We will use this information to contact 
you after you leave the emergency department.  This information can only be seen by the study 
staff working on the PrEPPED study.   
 
We will always try to reach you first by your preferred method of contact.  
If you give us permission we will communicate with you via email or text 
If we are not able to reach you directly, and you give us permission, we will contact the people who know 
you whose information you have given to us.  We will contact them by telephone.  
If you give us permission to contact someone other than you we will only tell those people to give you a 
message to call us.   
You may refuse to answer any question on this form.   
 
Remember that all of this information is confidential. 
Entered by:  __________________________ 
Date:  _____/_____/20_____ 

 
 
1...................... Name: _____________________________   ____ __________________________ 
 
 ......................................................................................................  
 
First 
 
 
 
       MI  
 ................................................................................................ Last 
 
 ............................................................................... Nick Name (s):
 .......... _______________________________________________ 
 
2. 
Age:  _____ ...................................................................................  
 
Date of Birth:  
______/______/_______ 
 
3. 
MRN:_________________________ ............................................  
 
 
4. 
Where do you currently live? 
 
Address____________________________________________________ 
 
 ...................................................................................................... 
 ____________________________________________________Apt No.: ___________ 
 
 ................................................................................................ City
 ........................................ ________________________________State  ___________ Zip Code: 
__________ 
Type of dwelling: _______________________________________________________ 
Whose place is it?  ______________________________________________________ 
 
 ......................................................................................................  
 
 
 
 
Name  
 
 
 ...................................................................................................... Relationship 
 
5. 
Is this the best address where we can send you information? 
 
Address.......... _________________________________________ 
 
 ...................................................................................................... 
 ____________________________________________________Apt No.: ___________ 
 
 ................................................................................................ City
 ........................................ ________________________________State  ___________ Zip Code: 
__________ 
 
6. 
What is the best way we should contact you by? ...........................  
 
 
 ......................................................................... ❑   Regular mail 
 
❑   Email 
 
❑   
Phone ............................................................................................ ❑   Text 
7. 
Primary phone number:  (______)______________________❑  Cell      ❑  Work      ❑  Home 
 
Share phone?  ❑  No  .................................................................. ❑  Yes  With whom?  
______________________________ 
 
If we leave a message for you, what can we say?OK to text?   ❑ Yes      ❑ No 
 
Mount Sinai BI   ❑ .........................................................................  
 
Hospital   ❑ 
 
 ................................................................................. Navigator   ❑ 
 
Other:   ❑  _________________________________________________________________ 
 
OK to text primary number?   ❑ Yes      ❑ No 
 
Alternative phone number:  (______)______________________❑  Cell      ❑  Work      ❑  Home 
If we leave a message for you, what can we say? .....................................  
Mount Sinai BI   ❑ .....................................................................................  
 
Hospital   ❑ 
 
 ................................................................................. Navigator   ❑ 
Other:   ❑  _________________________________________________________________ 
 
  OK to text alternative number?   ❑ Yes      ❑ No 
Yes  ❑   (skip to Q6) 
No   ❑   (complete address below) 

 
 
 
Email address:  __ 
____________________________________________________________ 
 
 
12. Which of the above is the best way to reach you quickly, if necessary? 
Specify:  _______________________________________________ 
13. May we contact you at work?  ............................. ❑  Yes  ❑  No 
 
❑  Not 
working 
Name of employer:   ____________________________________________________ 
 
Work Address:  ________________________________________________________ 
 
City:  ___________________________  State:  ______   Zip:  _________ 
 
 ..................... Phone:  ___________________________________ 
 
 ...................................... Can we leave a message at this number? 
 
❑  Yes  ❑  No 
 
 ................................................................ If yes, what can we say? 
 
 ......................................................................... Mount Sinai BI   ❑ 
 
 
Hospital   ❑ 
 
 ................................................................................. Navigator   ❑ 
 
Other:   ❑  ______________________________________________________________ 
 
14.     OK to text work number?   ❑ Yes      ❑ No 
 
SECONDARY CONTACT INFORMATION: Parent, sister/brother, other relative, good friend, neighbor, 
case worker/social worker or counselor.  If not in contact with the person within the last month, 
ask for another contact.  
 
CONTACT #1 
    Name: ................ ___________________________________________    
Address:__________________________________________________________________ 
 
Phone:  ......................... (______)__________________________ 
 
What is your relationship to this person? ........................................  
 ................................................____________________________ 
 
If we leave a message with them for you, what can we say? 
 
Mount Sinai BI   ❑ .........................................................................  
 
Hospital   ❑ 
 
 ................................................................................. Navigator   ❑ 
 
Other:   ❑  _________________________________________________________________ 
 
CONTACT #2 
   Name: ................. ___________________________________________     
Address:__________________________________________________________________ 
 
Phone:  ......................... (______)__________________________ 
 
What is your relationship to this person? ........................................  
 ................................................____________________________ 
 
If we leave a message with them for you, what can we say? 
 
Mount Sinai BI   ❑ .........................................................................  
 
Hospital   ❑ 
 
 ................................................................................. Navigator   ❑ 
 
Other:❑  _____________________________________________________________ 
 
 

 
 
Appendix 3: Stigma Scale (PDDS) 
Stigma Scale 
Perceived Devaluation/Discrimination Scale (PDDS) 
Please answer the following questions as either “Strong Disagree,” “Disagree,” “Agree,” or “Strongly Agree.”  
1. Most people believe that people who formerly had an alcohol problem cannot be trusted. 
2. Most people would not want to marry someone who has had an alcohol problem.  
3. Most people believe that a person who has been hospitalized for an alcohol problem is dangerous. 
4. Most people will think less of a person who has been hospitalized for an alcohol problem.  
5. Most people look down on people who have been hospitalized for an alcohol problem.  
6. Most people think that patients with an alcohol problem are just as intelligent as the average person. 
7. Most employers will not hire a person who has been hospitalized for an alcohol problem.  
8. Many people are afraid of people who have been hospitalized for an alcohol problem.   
Appendix 4: Crime and Justice Assessment 
 
Crime and Criminal Justice Assessment  
1. Have you been incarcerated in the past 12 months?   ☐ Yes   ☐  No 
a. If Yes, how many days? 
2. Have you been incarcerated in the past 30 days? 
a. If Yes, how many days? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4. How many days in the last 30 days have you been in contact (either initiated by you or by the legal 
system) with the court, criminal justice system, or probation/parole office? 
a. Court: 
3. How many times in the 
past 14 days have you 
committed the following 
crimes?  
 
# of 
Times 
a. If greater 
than “0” 
were you 
charged 
for it? 
 
Dealing Narcotics 
 
☐ Yes   ☐  No 
Vandalism 
 
☐ Yes   ☐  No 
Stolen property 
 
☐ Yes   ☐  No 
Forgery/counterfeiting 
 
☐ Yes   ☐  No 
Fraud 
 
☐ Yes   ☐  No 
Larceny/theft 
 
☐ Yes   ☐  No 
Household burglary 
 
☐ Yes   ☐  No 
Robbery 
 
☐ Yes   ☐  No 
Rape/sexual assault 
 
☐ Yes   ☐  No 
Homicide 
 
☐ Yes   ☐  No 
Aggravated assault 
 
☐ Yes   ☐  No 
Motor vehicle theft 
 
☐ Yes   ☐  No 
Arson 
 
☐ Yes   ☐  No 
Embezzlement 
 
☐ Yes   ☐  No 

 
 
b. Criminal justice system: 
c. Probation/parole officer:  
Appendix 5: Daily Substance Use 
Daily alcohol use 
 
Have you used alcohol in the past 24 hours?    ☐ Yes ☐ No 
 
If “yes,” continue to the following questions. 
In the past 24 hours did you drink beer?           ☐ Yes ☐ No 
 
If “yes”: A standard serving of beer is 12 ounces for a regular beer (about 5% alcohol). How many beers 
have you had in the past 24 hours?  
In the past 24 hours did you drink wine?          ☐ Yes ☐ No 
 
If “yes:” A standard glass of wine is 5 ounces and there are 5 glasses in a bottle of wine. How many glasses 
of wine have you had in the past 24 hours? 
In the past 24 hours did you drink liquor?         ☐ Yes ☐ No 
 
If “yes:” A standard serving of liquor is a 1.5 ounce shot. There are approximately 17 shots in a 750ml 
bottle of liquor (also called a “fifth.”) How many shots of liquor have you had in the past 24 hours?  
 
 
 

 
 
Appendix 6: Health Services Utilization Report 
Health Services Utilization - Baseline 
Inpatient 
Now I would like to review in detail any facilities in which you have been hospitalized overnight for any reason 
(physical, emotional, or substance use) during the last 7 days. Please include residential detoxification facilities, 
but do not include sober houses or halfway house stays.  
Were any inpatient services used in the last 7 days?  ☐ Yes    ☐ No 
If “Yes”, how many inpatient facilities were utilized in the last 7 days? 
Answer the following questions for each facility that was utilized in the last 7 days.  
1. What type of facility did you stay at? 
a. Medical hospital 
b. Psychiatric hospital 
c. Inpatient substance use treatment (residential) 
d. Skilled nursing/extended care facility 
e. Other inpatient facility:  
2. Service type:  
a. Medical/surgical 
b. Psychiatric (non-substance use) 
c. Substance use 
d. Psychiatric and substance use 
3. What was the reason for the hospitalization?  
4. Number of nights stayed in this visit: 
5. Number of admissions to this facility in the last 7 days: 
6. Visit paid for by: 
a. Insurance 
b. Self-pay 
c. No-cost 
Outpatient 
Next, I want to ask you about any time(s) you were an outpatient during the last 7 days. Please include regular 
doctor visits, visits to Emergency Departments/Rooms (ED), not including this ED enrollment visit, and any 
treatment centers (e.g., methadone maintenance centers). Let’s review, in detail, each practitioner or community 
service you received as an outpatient for any reason (physical, emotion, or substance use) during the last 7 days.  
Were any outpatient services used in the last 7 days?  ☐ Yes    ☐ No 
If “Yes”, how many outpatient facilities were utilized in the last 7 days? 
Answer the following questions for each facility that was utilized in the last 7 days.  
1. What type of facility did you go to? 
a. Hospital-based clinic 
b. Federally-qualified (community) health center 
c. Private doctor’s office 
d. Emergency department 
e. Urgent care center/walk-in facility 
f. Other:  
2. Service type: 
a. Medical/surgical 
b. Psychiatric (non-substance use) 
c. Substance use 

 
 
d. Psychiatric and substance use 
3. Provider type: 
a. Doctor 
b. Nurse 
c. Nurse Practitioner 
d. Physician’s Assistant (PA) 
e. Chiropractor 
f. Other: 
g. I don’t know 
4. Number of visits to this facility in the last 7 days?  
5. Average minutes per visit: 
6. Visit(s) paid for by: 
a. Insurance 
b. Self-pay 
c. No-cost 
7. Medications received/amount in the past 7 days: 
a. Naltrexone  ☐ Yes    ☐ No 
i. Oral ☐ Yes    ☐ No 
1. Milligrams prescribed per day: 
2. Number of days prescribed: 
ii. Injectable ☐ Yes    ☐ No 
1. Injection date: 
2. Date of second injection: 
3. Milligrams prescribed per day: 
iii. Other: ☐ Yes    ☐ No 
b. Other medication: 
Health Services Utilization – Follow Up 
Inpatient 
Now I would like to review in detail any facilities in which you have been hospitalized overnight for any reason 
(physical, emotional, or substance use) during the last 14 days (or number of days since last follow up). Please 
include residential detoxification facilities, but do not include sober houses or halfway house stays.  
Were any inpatient services used in the past 14 days? (Since your ED visit/since the last follow up call) ☐ Yes    
☐ No 
If “Yes”, how many inpatient facilities were utilized in the last 7 days? 
Answer the following questions for each facility that was utilized in the last 7 days?  
1. What type of facility did you stay at? 
a. Medical hospital 
b. Psychiatric hospital 
c. Inpatient substance use treatment (residential) 
d. Skilled nursing/extended care facility 
e. Other inpatient facility:  
2. Service type:  
a. Medical/surgical 
b. Psychiatric (non-substance use) 
c. Substance use 

 
 
d. Psychiatric and substance use 
3. What was the reason for the hospitalization?  
4. Number of nights stayed in this visit: 
5. Number of admissions to this facility in the last 7 days: 
Note: if a patient was hospitalized continuously since ED visit there would have been no admissions in 
the 14/30 days since initial ED visit.  
6. Visit paid for by: 
a. Insurance 
b. Self-pay 
c. No-cost 
Outpatient 
Next, I want to ask you about any time(s) you were an outpatient during the last 14 days (from your enrollment 
visit in the ED OR since the last follow up). Please include regular doctor visits, visits to Emergency 
Departments/Rooms (ED), not including this ED enrollment visit, and any treatment centers (e.g., methadone 
maintenance centers). Let’s review, in detail, each practitioner or community service you received as an 
outpatient for any reason (physical, emotion, or substance use) during the last 14 days.  
Were any outpatient services used in the last 14 days?  ☐ Yes    ☐ No 
If “Yes”, how many outpatient facilities were utilized in the last 14 days? 
Answer the following questions for each facility that was utilized in the last 14 days.  
1. What type of facility did you go to? 
a. Hospital-based clinic 
b. Federally-qualified (community) health center 
c. Private doctor’s office 
d. Emergency department 
e. Urgent care center/walk-in facility 
f. Other:  
2. Service type: 
a. Medical/surgical 
b. Psychiatric (non-substance use) 
c. Substance use 
d. Psychiatric and substance use 
3. Provider type: 
a. Doctor 
b. Nurse 
c. Nurse Practitioner 
d. Physician’s Assistant (PA) 
e. Chiropractor 
f. Other: 
g. I don’t know 
4. Number of visits to this facility in the last 14 days?  
5. Average minutes per visit: 
6. Visit(s) paid for by: 
a. Insurance 
b. Self-pay 
c. No-cost 
7. Medications received/amount in the past 7 days: 

 
 
a. Naltrexone  ☐ Yes    ☐ No 
i. Oral ☐ Yes    ☐ No 
1. Milligrams prescribed per day: 
2. Number of days prescribed: 
ii. Injectable ☐ Yes    ☐ No 
1. Injection date: 
2. Date of second injection: 
3. Milligrams prescribed per day: 
iii. Other: ☐ Yes    ☐ No 
b. Other medication: 
Appendix 7: Health Status Report 
Health Status Report 
1. Did you come to the Emergency Department today primarily to receive treatment for referral for your 
alcohol use?   ☐ Yes   ☐ No 
2. Do you have a medical care provider whom you usually see? ☐ Yes   ☐ No 
3. Where do you usually or most often go for medical care? 
a. Hospital-based clinic 
b. Federally qualified (community) health center 
c. Private doctor’s office  
d. Emergency department 
e. Urgent care center/walk in facility 
f. Other: 
4. Do you know your HIV status? ☐ Yes   ☐ No 
a. If “Yes,” what is your HIV status? 
i. Negative 
ii. Positive 
1. Undetectable 
2. Detectable 
5. Do you know your Hepatitis C status? ☐ Yes   ☐ No 
a. If “Yes,” what is your Hepatitis C status? 
i. Never been positive/antibody non-reactive 
ii. Viral load negative 
iii. Viral load positive 
Pain Section 
Please answer the following questions on a scale of 0 to 10.  
6. What number best describes your pain on average in the past week? 
a. 0 = no pain, 10 = pain as bad as you can imagine 
7. What number best describes how, during the past week, pain has interfered with your enjoyment of life? 
a. 0= pain has not interfered at all, 10=pain has interfered extremely 
8. What number best describes how, during the past week, pain has interfered with your general activity? 
a. 0= pain has not interfered at all, 10=pain has interfered extremely 
9. In your lifetime have you ever been related for any psychological or emotional problems in a hospital or 
inpatient setting? ☐ Yes   ☐ No 

 
 
10. In your lifetime, have you ever been treated for any psychological or emotional problems as an 
outpatient/private patient? ☐ Yes   ☐ No 
11. In the past 30 days, have you been treated for any psychotically or emotional problems with counseling 
or medication? ☐ Yes   ☐ No 
12. Over the last 2 weeks, how often have you been bothered by any of the following problems? Not at all, 
several days, more than half the days, or nearly every day. 
a. Little interest or pleasure in doing things 
b. Feeling down, depressed, or hopeless 
c. Trouble falling or staying asleep or sleeping too much 
d. Feeling tired or having little energy 
e. Poor appetite or overrating 
f. Feeling bad about yourself or that you are a failure or have let yourself or your family down 
g. Trouble concentrating on things, such as reading the newspaper or watching television 
h. Moving or speaking so slowly that other people could have noticed. Or the opposite – being so 
fidgety or restless that you have been moving around a lot more than usual 
i. Thoughts that you would be better off dead, or of hurting yourself in some way 
13. How difficult have these problems made it for you to do your work, take care of things at home, or get 
along with other people? 
a. Not difficult at all 
b. Somewhat difficult 
c. Very difficult 
d. Extremely difficult 
14. Any comments:  
Appendix 8: HIV Risk Behaviors 
HIV Risk Behaviors/Perception of Risks Questionnaire - Baseline 
READ::: This survey is going to ask you sensitive questions about your drug use, 
and sexual and HIV risk behaviors.  The information you provide is being used 
for research purposes only and will not be linked to your name. This information 
is strictly confidential. Please be as honest as possible. Thank you. 
 
Sexual Behaviors with Main Partner 
 
READ:  First, I want to ask you specific questions about your vaginal, oral, and/or anal (i.e., in the bum) 
sexual practices with a main or steady partner.  This could be a husband/wife, boyfriend/girlfriend, 
lover, or your live-in partner. 
 
Q1. 
In the past 30 days, has there been one person who you consider to be your main sexual partner? 
 
........................................................................................................................YES 1   
NO ......................................................................................................0   (SKIP TO Q12) 
 
........................................................................................................................DK/UNSURE 
9  

 
 
........................................................................................................................REFUSED  7  
 
 
Q2. How long have you been together? 
 
..................................................................................... YEARS 
|__|__|  
................................................................................. MONTHS 
|__|__| 
.................................................................................... WEEKS 
|__|__| 
 
 
 
DK/UNSURE ........................................................... 99 
 
REFUSED…………………………………………… 97 
 
Q3. Is this person a male or a female ? 
 
........................................................................................................................Male 2 
........................................................................................................................Female 1  
........................................................................................................................ 
........................................................................................................................DK/UNSURE 
9 
........................................................................................................................REFUSED 7 
 
Q4. 
Has your main partner ever been tested for HIV? 
 
 
YES ...........................................................................................................   1  
 
NO ………………………………………………………………………………..   0 (SKIP TOQ5)   
 
 
DK/UNSURE ............................................................................................... 9 
  
 
REFUSED .................................................................................................... 7 
  
 
Q4a. 
What were his/her test results? 
 
 
Results Were Positive ............................................................................... 1  
 
Results Were Negative .............................................................................. 2 
  
 
DK/UNSURE...................................................................................9 
 
 
REFUSED .................................................................................................... 7 
  
 
 
Q5. 
How likely do you think it is that your main sexual partner is having sex with someone else? Would you say he 
definitely is, probably is, probably is not or definitely is not? 
 
 
Definitely Is ............................................................................................... 1 
 
Probably Is ................................................................................................. 2  
 
Probably Not ............................................................................................. 3 
 
Definitely Not ............................................................................................ 4 
 
 
DK/UNSURE ............................................................................................... 9 
 
REFUSED .................................................................................................... 7 

 
 
 
 
[IF MSM, SKIP TO Q7] 
 
Q6. 
How many times in the last 30 days did you have vaginal sex with your main sexual partner (meaning a 
penis was inserted into her/your vagina)? 
 
............................................................................. # OF TIMES 
|__|__|__|     
 
 
DK/UNSURE ......................................................... 999    
 
REFUSED  ............................................................. 997    
 
 
 
 
Q6a. 
Of these ____ (TOTAL FROM Q7) times, how many times was a male or female condom used? 
 
 
# OF TIMES .................................................... |__|__|__| 
 
 
 
DK/UNSURE ................................................................. 999 
 
REFUSED  ..................................................................... 997 
 
Q7. 
How many times in the last 30 days did you have anal sex with your main sex partner (meaning a penis 
was inserted into your butt/bum/bottom? 
 
 
# OF TIMES .................................................... |__|__|__|     
 
 
DK/UNSURE ................................................................. 999    
 
REFUSED  ..................................................................... 997    
 
Q7a. 
Of these ____ (TOTAL FROM Q8) times, how many times was a condom (male or female condom used? 
 
 
# OF TIMES .................................................... |__|__|__| 
 
 
 
DK/UNSURE ................................................................. 999 
 
REFUSED  ..................................................................... 997 
 
Q8. 
During the past 30 days, did you use alcohol just before or during sex with your main sexual partner? 
 
 
YES  ............................................................................................................ 1 
 
NO ............................................................................................................. 0 (SKIP TO Q10) 
 
 
DK/UNSURE ............................................................................................... 9 
  
 
REFUSED  ................................................................................................... 7 
  
 

 
 
Q9. 
Have you ever had sex to receive money, alcohol, drugs, or other things from your main partner? 
 
 
YES ............................................................................................................. 1 
 
NO ............................................................................................................. 0 
 
 
DK/UNSURE ............................................................................................... 9 
 
REFUSED .................................................................................................... 7 
 
Q10. 
Have you ever given money, alcohol, drugs, or other things to your main partner for sex? 
 
 
YES ............................................................................................................. 1 
 
NO ............................................................................................................. 0 
 
 
DK/UNSURE ............................................................................................... 9 
 
REFUSED .................................................................................................... 7 
 
 
Sexual Behaviors with Casual Partners 
 
READ:  Next I’m going to ask you about casual sex partners.  These are sex partners who were not main, 
steady partners or sex trading partners, but may be casual friends, or one-night stands.   
 
Q11. 
In the past 30 days, did you have vaginal or anal sex with a casual partner?  
 
YES..........................................................................1 
 
NO.......................................................................... 0 (SKIP TO Q17)  
 
DK/UNSURE .............................................................. 9 
 
REFUSED ................................................................... 7 
 
Q12. 
How many different casual partners did you have in the past 30 days? 
 
 
# OF CASUAL PARTNERS ............................... |__|__|__| 
 
 
 
DK/UNSURE ................................................................. 999 
 
REFUSED  ..................................................................... 997 
 
 
Q13. 
The last time you had sex with a casual partner did you use a male or female condom? 
  
YES ............................................................................................................... 1   
NO ............................................................................................................... 0     
DK/UNSURE ................................................................................................. 9 
 
REFUSED ...................................................................................................... 7 
 
 
 
Q14.    How many times in the last 30 days did you have vaginal sex with a casual partner? 

 
 
 
 
# OF TIMES .................................................... |__|__|__| 
[IF “0” SKIP TO Q15] 
 
 
DK/UNSURE ................................................................. 999  
 
REFUSED  ..................................................................... 997   
 
Q14a. Of these times that you had vaginal sex with a casual partner, how many times was a male or female 
condom used? 
 
 
# OF TIMES .................................................... |__|__|__| 
 
 
 
DK/UNSURE ................................................................. 999 
 
REFUSED  ..................................................................... 997 
 
Q15. 
How many times in the last 30 days when you had sex with casual partners, did any of your partners 
put their penis into your anus? 
 
 
# OF TIMES .................................................... |__|__|__| 
[IF “0” SKIP TO Q16] 
 
 
DK/UNSURE ................................................................. 999  
 
REFUSED  ..................................................................... 997   
 
Q15a.   Of these times that you had anal sex with a casual partner, how many times was a male or female 
condom used? 
 
 
# OF TIMES .................................................... |__|__|__| 
 
 
DK/UNSURE ................................................................. 999 
 
REFUSED  ..................................................................... 997 
  
 
 
Alcohol, Drug Use, and Sex 
 
Q16. During the past 30 days, did you use alcohol just before or during sex with a casual partner?   
 
 
YES ............................................................................................................. 1 
 
NO ............................................................................................................. 0  (SKIP TO Q18) 
 
 
DK/UNSURE ............................................................................................... 9 
 
 
REFUSED .................................................................................................... 7 
 
 
Sexual Behaviors with Trading Partners 
 
READ:   
Next I’m going to ask you about sex with a trading partner, not including your main partner or a main 
sexual partner, that might have given you money, drugs, clothes, food, transport, or a place to stay in 
exchange for sex. 

 
 
 
Q17. 
Have you ever traded sex for drugs, money, food, clothing, shelter, or any other goods?  
 
........................................................................................................................YES  
1 
........................................................................................................................NO 0   
........................................................................................................................DK/UNSURE  9  
........................................................................................................................REFUSED 7  
 
 
Q18. 
During sex with any partner over the past 30 days, did you experience any problems with condoms (i.e. 
breakage, slippage, removal, or only put on half way)? 
 
 
YES ............................................................................................................. 1 
 
NO ............................................................................................................. 0 
 
 
DK/UNSURE ............................................................................................... 9 
 
REFUSED .................................................................................................... 7 
 
HIV Risk Behaviors/Perception of Risks Questionnaire – Follow Up 
READ::: This survey is going to ask you sensitive questions about your drug use, 
and sexual and  HIV risk behaviors.  The information you provide is being used 
for research purposes only and will not be linked to your name. This information 
is strictly confidential. Please be as  honest as possible. Thank you. 
 
 
Sexual Behaviors with Main Partner 
 
READ:  First, I want to ask you specific questions about your vaginal, oral, and/or anal (i.e., in the bum) 
sexual practices with a main or steady partner.  This could be a husband/wife, boyfriend/girlfriend, 
lover, or your live-in partner. 
 
Q1. 
In the past 14 days, has there been one person who you consider to be your main sexual partner? 
 
........................................................................................................................YES 1   
NO ......................................................................................................0   (SKIP TO Q12) 
 
........................................................................................................................DK/UNSURE 
9  
........................................................................................................................REFUSED  7  
 
 
Q2. How long have you been together? 
 

 
 
..................................................................................... YEARS 
|__|__|  
................................................................................. MONTHS 
|__|__| 
.................................................................................... WEEKS 
|__|__| 
 
 
 
DK/UNSURE ........................................................... 99 
 
REFUSED…………………………………………… 97 
 
Q3. Is this person a male or a female ? 
 
........................................................................................................................Male 2 
........................................................................................................................Female 1  
........................................................................................................................ 
........................................................................................................................DK/UNSURE 
9 
........................................................................................................................REFUSED 7 
 
Q4. 
Has your main partner ever been tested for HIV? 
 
 
YES ...........................................................................................................   1  
 
NO ………………………………………………………………………………..   0 (SKIP TOQ5)   
 
 
DK/UNSURE ............................................................................................... 9 
  
 
REFUSED .................................................................................................... 7 
  
 
Q4a. 
What were his/her test results? 
 
 
Results Were Positive ............................................................................... 1  
 
Results Were Negative .............................................................................. 2 
  
 
DK/UNSURE...................................................................................9 
 
 
REFUSED .................................................................................................... 7 
  
 
 
Q5. 
How likely do you think it is that your main sexual partner is having sex with someone else? Would you say he 
definitely is, probably is, probably is not or definitely is not? 
 
 
Definitely Is ............................................................................................... 1 
 
Probably Is ................................................................................................. 2  
 
Probably Not ............................................................................................. 3 
 
Definitely Not ............................................................................................ 4 
 
 
DK/UNSURE ............................................................................................... 9 
 
REFUSED .................................................................................................... 7 
 

 
 
 
[IF MSM, SKIP TO Q7] 
 
Q6. 
How many times in the last 30 days did you have vaginal sex with your main sexual partner (meaning a 
penis was inserted into her/your vagina)? 
 
............................................................................. # OF TIMES 
|__|__|__|     
 
 
DK/UNSURE ......................................................... 999    
 
REFUSED  ............................................................. 997    
 
 
 
 
Q6a. 
Of these ____ (TOTAL FROM Q7) times, how many times was a male or female condom used? 
 
 
# OF TIMES .................................................... |__|__|__| 
 
 
 
DK/UNSURE ................................................................. 999 
 
REFUSED  ..................................................................... 997 
 
Q7. 
How many times in the last 14 days did you have anal sex with your main sex partner (meaning a penis 
was inserted into your butt/bum/bottom? 
 
 
# OF TIMES .................................................... |__|__|__|     
 
 
DK/UNSURE ................................................................. 999    
 
REFUSED  ..................................................................... 997    
 
Q7a. 
Of these ____ (TOTAL FROM Q8) times, how many times was a condom (male or female condom used? 
 
 
# OF TIMES .................................................... |__|__|__| 
 
 
 
DK/UNSURE ................................................................. 999 
 
REFUSED  ..................................................................... 997 
 
Q8. 
During the past 14 days, did you use alcohol just before or during sex with your main sexual partner? 
 
 
YES  ............................................................................................................ 1 
 
NO ............................................................................................................. 0 (SKIP TO Q10) 
 
 
DK/UNSURE ............................................................................................... 9 
  
 
REFUSED  ................................................................................................... 7 
  
 

 
 
Q9. 
Have you ever had sex to receive money, alcohol, drugs, or other things from your main partner? 
 
 
YES ............................................................................................................. 1 
 
NO ............................................................................................................. 0 
 
 
DK/UNSURE ............................................................................................... 9 
 
REFUSED .................................................................................................... 7 
 
Q10. 
Have you ever given money, alcohol, drugs, or other things to your main partner for sex? 
 
 
YES ............................................................................................................. 1 
 
NO ............................................................................................................. 0 
 
 
DK/UNSURE ............................................................................................... 9 
 
REFUSED .................................................................................................... 7 
 
 
Sexual Behaviors with Casual Partners 
 
READ:  Next I’m going to ask you about casual sex partners.  These are sex partners who were not main, 
steady partners or sex trading partners, but may be casual friends, or one-night stands.   
 
Q11. 
In the past 14 days, did you have vaginal or anal sex with a casual partner?  
 
YES..........................................................................1 
 
NO.......................................................................... 0 (SKIP TO Q17)  
 
DK/UNSURE .............................................................. 9 
 
REFUSED ................................................................... 7 
 
Q12. 
How many different casual partners did you have in the past 14 days? 
 
 
# OF CASUAL PARTNERS ............................... |__|__|__| 
 
 
 
DK/UNSURE ................................................................. 999 
 
REFUSED  ..................................................................... 997 
 
 
Q13. 
The last time you had sex with a casual partner did you use a male or female condom? 
  
YES ............................................................................................................... 1   
NO ............................................................................................................... 0     
DK/UNSURE ................................................................................................. 9 
 
REFUSED ...................................................................................................... 7 
 
 
 
Q14.    How many times in the last 14 days did you have vaginal sex with a casual partner? 

 
 
 
 
# OF TIMES .................................................... |__|__|__| 
[IF “0” SKIP TO Q15] 
 
 
DK/UNSURE ................................................................. 999  
 
REFUSED  ..................................................................... 997   
 
Q14a. Of these times that you had vaginal sex with a casual partner, how many times was a male or female 
condom used? 
 
 
# OF TIMES .................................................... |__|__|__| 
 
 
 
DK/UNSURE ................................................................. 999 
 
REFUSED  ..................................................................... 997 
 
Q15. 
How many times in the last 14 days when you had sex with casual partners, did any of your partners 
put their penis into your anus? 
 
 
# OF TIMES .................................................... |__|__|__| 
[IF “0” SKIP TO Q16] 
 
 
DK/UNSURE ................................................................. 999  
 
REFUSED  ..................................................................... 997   
 
Q15a.   Of these times that you had anal sex with a casual partner, how many times was a male or female 
condom used? 
 
 
# OF TIMES .................................................... |__|__|__| 
 
 
DK/UNSURE ................................................................. 999 
 
REFUSED  ..................................................................... 997 
  
 
 
Alcohol, Drug Use, and Sex 
 
Q16. During the past 14 days, did you use alcohol just before or during sex with a casual partner?   
 
 
YES ............................................................................................................. 1 
 
NO ............................................................................................................. 0  (SKIP TO Q18) 
 
 
DK/UNSURE ............................................................................................... 9 
 
 
REFUSED .................................................................................................... 7 
 
 
Sexual Behaviors with Trading Partners 
 
READ:   
Next I’m going to ask you about sex with a trading partner, not including your main partner or a main 
sexual partner, that might have given you money, drugs, clothes, food, transport, or a place to stay in 
exchange for sex. 

 
 
 
Q17. 
Have you ever traded sex for drugs, money, food, clothing, shelter, or any other goods?  
 
........................................................................................................................YES  
1 
........................................................................................................................NO 0   
........................................................................................................................DK/UNSURE  9  
........................................................................................................................REFUSED 7  
 
 
Q18. 
During sex with any partner over the past 14 days, did you experience any problems with condoms (i.e. 
breakage, slippage, removal, or only put on half way)? 
 
 
YES ............................................................................................................. 1 
 
NO ............................................................................................................. 0 
 
 
DK/UNSURE ............................................................................................... 9 
 
REFUSED .................................................................................................... 7 
 
Appendix 9: PROMIS 29+2 Profile (PROPr) 
 
Physical Function 
Unable 
to Do 
(1) 
With 
much 
difficulty 
(2) 
With some 
difficulty 
(3) 
With  a 
little 
difficulty 
(4) 
Without any 
difficulty (5) 
Are you able to do chores such as 
vacuuming or yard work? 
 
 
 
 
 
Are you able to go up and down stairs at 
a normal pace? 
 
 
 
 
 
Are you able to go for a walk of at least 
15 minutes? 
 
 
 
 
 
Are you able to run errands and shop? 
 
 
 
 
 
Anxiety 
In the past 7 days… 
Never 
(1) 
Rarely 
(2) 
Sometimes 
(3) 
Often (4) Always (5) 
I felt fearful 
 
 
 
 
 
I found it hard to focus on anything other 
than my anxiety 
 
 
 
 
 
My worries overwhelmed me 
 
 
 
 
 
I felt uneasy 
 
 
 
 
 
Depression 
In the past 7 days… 
Never 
(1) 
Rarely 
(2) 
Sometimes 
(3) 
Often (4) Always (5) 
I felt worthless 
 
 
 
 
 
I felt helpless 
 
 
 
 
 
I felt depressed 
 
 
 
 
 
I felt hopeless 
 
 
 
 
 
Fatigue 
In the past 7 days… 
Not at 
all (1) 
A little 
bit (2) 
Somewhat 
(3) 
Quite a 
bit (4) 
Very much 
(5) 

 
 
I feel fatigued 
 
 
 
 
 
I have trouble starting things because I 
am tired 
 
 
 
 
 
How run-down did you feel on average? 
 
 
 
 
 
How fatigued were you on average?  
 
 
 
 
 
Sleep Disturbance 
In the past 7 days… 
Very 
good 
(1) 
Good (2) Fair (3) 
Poor (4) 
Very poor 
(5) 
My sleep quality was 
 
 
 
 
 
In the past 7 days… 
Not at 
all (1) 
A little 
bit (2) 
Somewhat 
(3) 
Quite a 
bit (4) 
Very much 
(5) 
My sleep was refreshing 
 
 
 
 
 
I had a problem with my sleep 
 
 
 
 
 
I had difficulty falling asleep 
 
 
 
 
 
Ability to Participate in Social Roles 
and Activities 
Never 
(1) 
Rarely 
(2) 
Sometimes 
(3) 
Often (4) Always (5) 
I have trouble doing all of my regular 
leisure activities with others 
 
 
 
 
 
I have trouble doing all of the family 
activities that I want to do 
 
 
 
 
 
I have trouble doing all of my usual work 
(including work at home) 
 
 
 
 
 
I have trouble doing all the activities with 
friends that I want to do 
 
 
 
 
 
Pain Interference 
In the past 7 days… 
Not at 
all (1) 
A little 
bit (2) 
Somewhat 
(3) 
Quite a 
bit (4) 
Very much 
(5) 
How much did pain interfere with your 
day to day activities? 
 
 
 
 
 
How much did pain interfere with work 
around the home? 
 
 
 
 
 
How much did pain interfere with your 
ability to participate in social activities? 
 
 
 
 
 
How much did pain interfere with your 
household chores? 
 
 
 
 
 
Cognitive Function Abilities 
In the past 7 days… 
Not at 
all (1) 
A little 
bit (2) 
Somewhat 
(3) 
Quite a 
bit (4) 
Very much 
(5) 
I have been able to concentrate 
 
 
 
 
 
I have been able to remember to do 
things, like take medicine or buy 
something I needed 
 
 
 
 
 
Pain 
Interference 
In the past 7 
days… 
0 (no 
pain) 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 (worst 
pain 
imaginable) 
How would you 
rate your pain 
on average? 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Appendix 10: Patient Satisfaction and Attitudes Scale 
Satisfaction and Acceptability Measures 
 
Overall satisfaction with the screening procedures 
 
How inconvenient did you find today’s screening procedures? 
 
Not 
Inconvenient 
0 
1 
2 
3 
4 
5 
Very 
Inconvenient 
6 
Prefer not 
to answer 
 
How difficulty did you find today’s screening procedures? 
 
Not at all 
difficult 
0 
1 
2 
3 
4 
5 
Very 
Difficult 
6 
Prefer not 
to answer 
 
How satisfied were you with today’s screening process? 
 
Very 
dissatisfied 
0 
1 
2 
3 
4 
5 
Very 
satisfied 
6 
Prefer not 
to answer 
 
Attitudes toward future Naltrexone usage 
 
What effect do you think being screened today in the Emergency Department will have on your future 
Naltrexone use? 
 
Less likely 
to start 
Naltrexone 
0 
1 
2 
No effect 
on future 
Naltrexone 
use  
3 
4 
5 
More 
Likely to 
start 
Naltrexone 
6 
Prefer not 
to answer 
 
Would you be interested in starting Naltrexone today if we were able to give you the medications in the 
Emergency Department? 
 
Would 
not be 
interested 
in 
starting 
today 
0 
1 
2 
3 
 
4 
5 
Would 
start 
medication 
today if 
available 
6 
Prefer not 
to answer 
 

 
 
 
Appendix 11: Alcohol Craving Scale 
Alcohol Craving Scale 
During enrollment these questions apply to the last week that you drank any alcohol. 
If this is a daily assessment or 14 and 30 day follow- up assessment, these questions apply to the time period 
between your last completed assessment and now. 
1. How often have you thought about drinking or about how good a drink would make you feel during this 
period? 
a. Never, that is, 0 times during this period of time = 0 
b. Rarely, that is, 1 or time times during this period of time = 1 
c. Occasionally, that is, 3 to 4 times during this period of time = 2 
d. Sometimes, that is 5 to 10 times during this period or 1 to 2 times a day = 3 
e. Often, that is, 11 to 20 times during this period or 2 to 3 times a day = 4 
f. Most of the time, that is 20 to 40 during this period, or 3-6 times a day = 5 
g. Nearly all of the time, that is, more than 40 times during this period or more than 6 times a day = 
6 
2. At its most severe point, how strong was your craving during this period? 
a. None at all = 0 
b. Slight, that is a very mild urge = 1 
c. Mild urge = 2 
d. Moderate urge = 3 
e. Strong urge, but easily controlled = 4 
f. Strong urge and difficult to control = 5 
g. Strong urge and would have drunk alcohol if it were available = 6 
3. How much time have you spent thinking about drinking or about how good a drink would make you feel 
during this period? 
a. None at all = 0 
b. Less than 20 minutes = 1 
c. 21-45 minutes = 2 
d. 46-90 minutes = 3 
e. 90 minutes-3 hours =4 
f. 3-6 hours = 5 
g. More than 6 hours = 6 
4. How difficult would it have been to resist taking a drink during this period of time if you had known a 
bottle were in your house? 
a. Not difficult at all = 0 
b. Very mildly difficult = 1 
c. Mildly difficult = 2 
d. Moderately difficult = 3 
e. Very difficult = 4 
f. Extremely difficult = 5 
g. Would not be able to resist = 6 
5. Keeping in mind your responses to the previous questions, please rate your overall average alcohol 
craving for the stated period of time? 
a. Never thought about drinking and never had the urge to drink = 0 

 
 
b. Rarely thought about drinking and rarely had the urge to drink = 1 
c. Occasionally thought about drinking and occasionally had the urge to drink = 2 
d. Sometimes thought about drinking and sometimes had the urge to drink = 3 
e. Often thought about drinking and often had the to urge to drink = 4 
f. Thought about drinking most of the time and had the urge to drink most of the time = 5 
g. Though about drinking nearly all the time and had the urge to drink nearly all of the time = 6 
 
Appendix 12: Generalized Anxiety Disorder Screener (GAD-7) 
Over the last two weeks, how often have you been bothered by the following problems? Answers are not at all 
(0), several days (1), more than half the days (2), or nearly every day (3).  
1. Feeling nervous, anxious, or on edge 
2. Not being able t ostop or control worrying 
3. Worrying too much about different things 
4. Trouble relaxing 
5. Being so resteless that is hard to sit still 
6. Beocming easily annoyed or irritable 
7. Feeling afraid, as if something awful might happen 
Scoring: 
0-4: minimal anxiety 
5-9: mild anxiety 
10-14: moderate anxiety 
15-21: severe anxiety  
 
If you chose that any of the above are problems, how difficult have they made it for you to do your work, take 
care of things at home, or get along with other people? 
 
Not difficult at all, somewhat difficult, very difficult, extremely difficult 
 
Appendix 13: ED Health Quiz (EHQ) 
ED Health Quiz (EHQ) 
1. Do you smoke cigarettes every day, some days, or not at all?  
Answers: Every day, Some days, Not at all 
2. Assigned male at birth: In the past year have you had 5 or more drinks in one day? 
Assigned female at birth: In the past year have you had 4 or more drinks in one day? 
 
Answers: Yes, No 
3. Are you in the ED today for treatment of an injury? 
Answers: Yes, No 
4. In the past 30 days have you used any alcohol? 
Answers: Yes, No 
5. How many drinks of alcohol did you have in the last 7 days?  
Answer: number of drinks in the last 7 days 
6. When was the most recent day/date you used alcohol?  
Answer: date 
7. How often did you use alcohol in the past 7 days? 

 
 
Answer: start with today and go back 7 days and document how many drinks were had on each of those 
days   
8. In the past 12 months, have you used any opioid for any reason? Opioids include prescription opioids 
like Oxycodone (OxyContin, Perococet) or Hydrocodone (Vicodin) as well as illicit opioids like heroin 
or fentanyl. 
Answers: Yes, No 
If “Yes”, complete the DAST-10 for opioid use. If the participant scores anything above a 0 they are not 
eligible for the study.   
 
Appendix 14: DSM-5 Alcohol Use Disorder 
 
DSM-5 Alcohol Use Disorder 
 
Date of assessment:  
1. Have you used alcohol in the past 12 months?      ☐ Yes             ☐ No 
In the past 12 months, have you: 
2. Had times when you ended up drinking more, or longer, than you intended?  ☐ Yes   ☐ No 
3. More than once wanted to cut down or stop drinking, or tried to, but couldn’t? ☐ Yes  ☐ No 

 
 
4. Spent a great deal of time in activities necessary to get alcohol, drink alcohol, or recover from its 
effects?    ☐ Yes   ☐ No 
5. Wanted a drink so badly you couldn’t think of anything else?    ☐ Yes   ☐ No 
6. Found that drinking – or being sick from drinking – often interfered with taking care of your home or 
family? Or caused job troubles or school troubles?   ☐ Yes   ☐ No 
7. Given up or cut back on activities that were important or interesting to you, or gave you pleasure, in 
order to drink?    ☐ Yes   ☐ No 
8. Continued to drink even though it was causing trouble with your family or friends? ☐ Yes  ☐ No 
9. More than once gotten into situations while or after drinking that increased your chances of getting hurt 
(such as driving, swimming, using machinery, walking in a dangerous area, or having unsafe sex)? ☐ 
Yes ☐ No 
10. Continued to drink even though it was making you feel depressed or anxious or adding to another health 
problem? Or after having had a memory blackout?   ☐ Yes   ☐ No 
11. Had to drink more than you once did to get the effect you want? Or found that your usual number of 
drinks had much less effect than before?   ☐ Yes   ☐ No 
12. Found that when the effects of alcohol were wearing off you had withdrawal symptoms, such as trouble 
sleeping, shakiness, restlessness, nausea, sweating, a racing heart, or a seizure? Or sensed things that 
were not there?   ☐ Yes   ☐ No  
 
To meet criteria for an alcohol use disorder (AUD), the participant must answer “Yes” to at least 2 of the 
symptoms above. 
• Mild disorder: 2-3 symptoms 
• Moderate: 4-5 symptoms 
• Severe: 6 or more symptoms 
 

 
 
Appendix 15: Patient Health Questionnaire (PHQ-9) 
 
 

 
 
Appendix 16: Healthix Authorization and Information Sheet 
 

 
 
 

 
 
Appendix 17: ED Visit Review 
ED Visit Review (EDR) 
Date of ED visit: 
1. How was this patient identified? 
a. Health Quiz by research staff 
b. Emergency Department (ED) staff referral based on clinical care 
c. Electronic Medical Record (EMR) Review 
d. Other:  
2. What was the chief complaint as written in the EMR?   ☐ Yes  ☐ No 
3. Did the patient come to the ED specifically for alcohol use treatment? ☐ Yes  ☐ No 
a. If “yes,” which of the following: 
i. Intoxication 
ii. Withdrawal 
iii. Detox Request 
iv. Other:  
4. What was the discharge diagnosis? 
5. What are the ICD 10 code(s) for the discharge diagnosis? 
6. What was the date of discharge?  
7. Were any of the following medications given in the ED, prescribed at discharge, and/or given a take 
home dose? (yes/no answers for each of these options) 
a. Opioids 
b. Benzodiazepines 
c. Naltrexone 
d. Naloxone 
8. Did the patient receive a referral to AUD treatment? ☐ Yes  ☐ No 
a. If yes, give site name:  
9. Did the patient receive a psychiatric evaluation during the ED visit? ☐ Yes  ☐ No 
10. Comments:  
Appendix 18: Treatment Facility Survey 
Treatment Facility Survey (ETF) 
Date of assessment: 
1. What type of provider/program is this? 
a. Office based provider 
b. Substance use treatment program 
c. Inpatient facility 
d. Other: 
2. Was this patient engaged in a program at your facility or being treated at your office for their alcohol use 
disorder? 
If “Yes”, please review and answer the following questions. 
3. What was the date of their admission into your program, or if office-based, when did their care begin?  
4. Indicate the type(s) of treatment they are receiving for their alcohol use disorder: 
a. Naltrexone treatment: 
i. Oral: 
ii. Injectable: 

 
 
b. Short-term detoxification 
c. Inpatient 
d. Other:   
5. How would you categorize the level of treatment received by this patient? 
a. No care received 
b. Level 1: Outpatient treatment 
c. Level 2: Intensive outpatient treatment (including partial hospitalization)  
d. Level 3: Clinically managed residential/inpatient treatment 
e. Level 4: Medically managed intensive inpatient treatment 
f. Other:  
 

 
 
Appendix 19: Release Authorization Form  
 

 
 
Appendix 20: Importance of Change Scale 
 
 
Appendix 21: Confidence Scale 
 
 
 
 
 

 
 
Appendix 22: Readiness to Change Scale 
 
 

 
 
Appendix 23: ASSIST-Lite 
 

 
 
 
Appendix 24: Cannabis Assessment  
Cannabis Assessment 
Instructions: When we use the term “marijuana/cannabis” we are referring to marijuana, cannabis concentrates, 
edibles, tinctures, and other inhaled or consumed products made with marijuana or cannabis. We are not 
referring to lotions, ointment, and CBD-only (e.g. hemp) products.  
1. How often in the past 12 months have you used marijuana/cannabis? 
a. Never                               [If Q1=Never, end assessment] 
b. Less than monthly 
c. Monthly 
d. Weekly  
e. Daily or almost daily 
2. When you used marijuana/cannabis during the past 12 mnoths, was it: 
a. For medical reasons 
b. For non-medical reasons 
c. For both medical and non-medical reasons 
3. During the past 12 months, have you used marijuana/cannabis to help you manage any of the following:  
Check all that apply 

 
 
a. Pain 
b. Muscle spasm 
c. Seizures 
d. Nausea or vomiting 
e. Sleep 
f. Appetite 
g. Worry or anxiety 
h. Depression or sadness 
i. Focus or concentration 
j. Other symptoms (please specify): 
k. None of the above 
4. During the past 12 months, did you use marijuana/cannabis to replace, reduce, or stop use of alcohol?    
Yes/No 
5. During the past 12 months, how did you use marijuana/cannabis? Please select all that apply.  
a. Smoked it (for example, in a joint, bong, blunt, spliff, or pipe) 
b. Vaporized it (for example, hash oil in an e-cigarette-like vaporizer, vape pen, or another 
vaporizing device)  
c. Ate it (for example, in brownies, cakes, cookies, or candy) 
d. Used it some other way (please list):  
These next questions ask you to consider all the ways you typically use marijuana/cannabis: 
6. How many days per week do you typically use any marijuana/cannabis? 
a. Less than 1 
b. 1 
c. 2 
d. 3 
e. 4 
f. 5 
g. 6 
h. 7 
7. On a typical day that you use marijuana/cannabis, how many times per day do you use it? 
a. Less than 1 
b. 1 
c. 2 
d. 3-4 
e. 5-9 
f. 10 or more 
8. How do you feel your marijuana use affects your life? 
VAS 
-100                                               0                               +100 
Definitely harmful                      Neutral                        Definitely beneficial  
 
Appendix 25: HRQol 
Health-Related Quality of Life (HRQol) 
1. Would you say that in general your health is: 

 
 
a. Excellent 
b. Very good 
c. Good  
d. Fair 
e. Poor 
f. Don’t know/Not sure 
g. Refused 
2. Now think about your physical health, which includes physical illness and injury, for how many days 
during the past 30 days was your physical health not good? 
a. Number of days: 
b. None 
c. Don’t know/Not sure 
d. Refused 
3. Now thinking about your mental health, which includes stress, depression, and problems with emotions, 
for how many days during the past 30 days was your mental health not good? 
a. Number of days: 
b. None (if both Q2 and Q3 are “None”, skip next question) 
c. Don’t know/Not sure 
d. Refused 
4. During the past 30 days, for about how many days did poor physical or mental health keep you from 
doing your usual activities, such as self-care, work, or recreation? 
a. Number of days: 
b. None 
c. Don’t know/not sure 
d. Refused 
Activity Limitations Section  
These next questions are about physical, mental, or emotional problems or limitations you may have in 
your daily life. 
1. Are you LIMITED in any way in any activities because of any impairment or health problem? 
a. Yes 
b. No (Skip the rest of this section) 
c. Don’t know/Not Sure (Skip the rest of this section) 
d. Refused  (Skip the rest of this section) 
2. What is the MAJOR impairment or health problem that limits your activities? Choose only one. 
a. Arthritis/rheumatism 
b. Back or neck problem 
c. Fractures, bone/joint injury 
d. Walking problem  
e. Lung/breathing problem 
f. Hearing problem 
g. Eye/vision problem 
h. Heart problem 
i. Stroke problem 
j. Hypertension/high blood pressure 
k. Diabetes 

 
 
l. Cancer 
m. Depression/anxiety/emotional problem 
n. Other impairment/problem 
o. Don’t know/Not sure 
p. Refused 
3. For HOW LONG have your activities been limited because of your major impairment or health 
problem? 
a. Days 
b. Weeks 
c. Months 
d. Year 
e. Don’t know/Not sure 
f. Refused 
4. Because of any impairment or health problem, do you need the help of other persons with your 
PERSONAL CARE needs, such as eating, bathing, dressing, or getting around the house? 
a. Yes 
b. No 
c. Don’t know/Not sure 
d. Refused 
5. Because of any impairment or health problem, do you need the help of other persons in handing your 
ROUTINE needs, such as everyday household chores, doing necessary business, shopping, or getting 
around for other purposes? 
a. Yes 
b. No 
c. Don’t know/Not sure 
d. Refused 
Healthy Days Symptoms Module 
1. During the past 30 days, for about how many days did PAIN make it hard for you to do your usual 
activities, such as self-care, work, or recreation? 
a. Number of days: 
b. None 
c. Don’t know/Not sure 
d. Refused 
2. During the past 30 days, for about how many days have you felt SAD, BLUE, or DEPRESSED? 
a. Number of days 
b. None 
c. Don’t know/Not sure 
d. Refused 
3. During the past 30 days, for about how many days have you felt WORRIED, TENSE, or ANXIOUS? 
a. Number of days: 
b. None 
c. Don’t know/Not sure 
d. Refused 
4. During the past 30 days, for about how many days have you felt you did NOT get ENOUGH REST or 
SLEEP? 

 
 
a. Number of days: 
b. None 
c. Don’t know/Not sure 
d. Refused 
5. During the past 30 days, for about how many days have you felt VERY HEALTHY and FULL OF 
ENERGY? 
a. Number of days: 
b. None 
c. Don’t know/Not sure 
d. Refused 
 
Appendix 26: GRIP Adherence and Pill Counts Measure 
 
 
Pill Counts Measure 
How many naltrexone pills do you have left?  
 
How was this reported to you? 
1. RA counted in person 
2. Participant reported via video conference and RA was able to visually see the pills 
3. Participant reported via phone call  
 
 
Appendix 27: Adverse Event Report (AD1) and Severe Adverse Event Report (AD2) 
 
Adverse Event Report (AD1) 
Adverse Event Onset Date: 
Sequence number:  
1. Adverse event name: 
2. Date site became aware of the event: 
3. Severity of event (pick one): 
a. Grade 1 – Mild 
b. Grade 2 – Moderate 
c. Grade 3 – Severe 
4. Is there a reasonable possibility that study medication caused the event?  ☐ Yes   ☐ No 
a. If “Yes”, action taken with study medication (select one): 
i. None 

 
 
ii. Decreased drug 
iii. Increased drug 
iv. Temporarily stopped drug 
v. Permanently stopped drug 
vi. Participant terminated from study 
5. If not caused by the study medication, alternative etiology (select one): 
a. None apparent 
b. Study disease 
c. Concomitant medication 
d. Other pre-existing disease or condition 
e. Accident, trauma, or external factors 
f. Concurrent illness/condition (not pre-existing) 
g. Study procedures 
h. Other:  
6. Outcome of event (select one): 
a. Recovering/resolving (skip question 7) 
b. Recovered/resolved 
c. Recovered/resolved with sequelae 
d. Not recovered/not resolved (skip question 7) 
e. Fatal (skip question 7) 
f. Unknown (skip question 7) 
7. Date of resolution or medically stable: 
A response of “Yes” to any of the following will designate this as a Serious Adverse Event (SAE). The 
Serious Adverse Event Summary (AD2) form should be completed for all Serious Adverse Events 
reported. 
8. Was this event associated with:  
If more than one option applies, select the most serious.  
a. Is the adverse event associated with a congenital anomaly or birth defect?  
b. Did the adverse event result in persistent or significant disability or incapacity? 
c. Did the adverse event result in death? 
i. If “Yes”, date of death: 
d. Did the adverse event result in initial or prolonged hospitalization for the participant? 
i. If “Yes”,  
1. Date of hospital admission: 
2. Date of hospital discharge: 
e. Is the adverse event life threatening? 
f. Is the adverse event an “Other serious” event (important medical event)? 
 
Comments: 
Study staff completing form:  
Date completed:  
 
Serious Adverse Event Summary (AD2) 
Adverse event onset date:  
Initial narrative description of serious adverse event:  

 
 
1. Relevant past medical history:   ☐ Yes   ☐ No  ☐  Unknown  
Allergies, pregnancy, smoking and alcohol use, hypertension, diabetes, epilepsy, depression, etc. 
Expand on relevant past medical history: 
 
2. Medications at the time of event:   ☐ Yes   ☐ No  ☐  Unknown 
Be sure to assess for dosage and date of last dose for the study medication, and any prior/concomitant 
medications as needed.  
Medication (Generic Name) 
Indication 
 
 
 
 
 
 
 
 
 
3. Treatments for the event:  ☐ Yes   ☐ No  ☐  Unknown 
Treatment 
Indication 
Date Treated (mm/dd/yyyy) 
 
 
 
 
 
 
 
 
 
 
4. Labs/tests performed in conjunction with this event: ☐ Yes   ☐ No  ☐  Unknown 
Lab/Test 
Findings 
Date of Test (mm/dd/yyyy) 
 
 
 
 
 
 
 
5. Follow-up:  
Include labs/test results as they became available, clinical changes, consultant diagnosis, etc.  
Comments: 
Study staff completing form: 
Date completed:  
 
Appendix 28: Protocol Deviation 
Protocol Deviation (PD) 
Date of Deviation:  
1. Is this deviation related to one or more participants?   ☐ Yes   ☐ No  
a. If “Yes”, how many participants?  
b. Please provide the associated participant IDs:  
2. Date deviation identified:  
3. Deviation type (select one): 
a. Informed consent/assent procedure 
i. No consent/assent obtained 
ii. Unauthorized assessments and/or procedures conducted prior to obtaining informed 
consent/assent 
iii. Other informed consent/assent procedures issues (specify): 
b. Inclusion/exclusion criteria 

 
 
i. Ineligible participant randomized/inclusion/exclusion criteria not met or eligibility not 
fully assessed prior to randomization 
ii. Other inclusion/exclusion criteria issues (specific):  
c. Laboratory assessments 
i. Other laboratory assessment issues – minor (specify): 
ii. Other laboratory assessments issues – major (specify):  
d. Study procedures/assessments 
i. Study assessment/procedures not followed in accordance with study protocol 
ii. Other study procedures/assessments issues (specific):  
e. Adverse event 
i. AE not reported 
ii. SAE not reported 
iii. AE/SAE reported out of protocol specified timeframe 
iv. AE/SAE not elicited, observed, and/or documented per protocol 
v. Safety assessment not conducted per protocol 
vi. Other adverse events issues (specify):  
f. Randomization procedures 
i. Stratification error 
ii. Other randomization procedures issues (specify): 
g. Study medication management 
i. Medication not dispensed/administered in accordance with the study protocol 
ii. Other study medication management issues (specify): 
h. Safety event 
i. Safety event assessment not conducted per protocol  
i. Other significant deviations 
i. Destruction of study materials without prior authorization from sponsor 
ii. Breach of confidentiality 
iii. Other significant deviations issues – minor (specify): 
iv. Other significant deviations issues – major (specify): 
4. Reason for the protocol deviation (selected all that apply):  
a. Research staff error 
b. Hospital error 
c. Laboratory error 
d. Pharmacy error 
e. Equipment/supply failure 
f. Issue with system down/glitch (e.g., EMR, REDCap) 
g. Participant unable to comply 
h. Participant refusal 
i. Investigator/study decision 
j. Other, specify: 
5. Is this deviation related to COVID-19?   ☐ Yes   ☐ No 
6. Brief description of what occurred:  
7. Was/will there be corrective action for this event?   ☐ Yes   ☐ No 
a. If “No”, describe why corrective action will not be taken: 
b. If “Yes”, which of the following corrective actions were/will be taken (select all that apply): 

 
 
i. Participant consent/re-consent was/will be obtained 
ii. Research staff corrected/will correct error(s) and/or completed/will complete document(s) 
iii. Participant corrected/will correct error(s) and/or completed/will complete document(s) 
iv. Document(s) was/will be moved to correct file location(s) 
v. Participant was/will be withdrawn from study 
vi. Study drug administration was/will be halted 
vii. Study assessment was/will be performed or repeated 
viii. Other, specify: 
c. As needed or requested, provide additional details about the corrective action plan: 
8. Brief description of the plan to prevent recurrence (select all that apply): 
a. Complete local retraining (specify):  
b. Revise local SOP(s) 
c. Recalibrate/fix or replace faulty equipment/supplies 
d. Remove and/or replace incorrect/outdated document(s) from file(s) 
e. No site action needed 
f. Other (specify): 
9. Is this deviation reportable to your IRB?   ☐ Yes   ☐ No 
a. If “Yes”, will the IRB be notified at the time of continuing review?   ☐ Yes   ☐ No 
i. If “Yes”, date of planned submission: 
ii. If “No”, date of actual submission:  
Comments: 
Completed by: 
Date completed: 
 
Appendix 29: Contact Logs 
Participant Contact Log 
Contact visit:   ☐ Day 14     ☐ Day 30  
Please record all participant contact or contact attempts following enrollment.  
Date: 
Time:  
Contact person:   ☐ Participant  ☐ Alternative Contact   ☐ Other: 
Contact type:  ☐ Phone  ☐  Email   ☐  Mail 
Result: ☐ Interview complete ☐ No answer   ☐ Line busy  ☐  Answering machine  ☐ Subject Refusal  ☐  
Contact Refusal ☐  Unable to Contact ☐ Other:  
Notes:  
RA completing attempt:  
 
Facility Contact Log 
Date: 
Time:  
Contact person (Name and Phone number/email/address):    
Contact type:  ☐ Phone  ☐  Email   ☐  Mail 
Result: ☐ Complete ☐ No answer   ☐ Line busy  ☐  Answering machine  ☐ Refusal, needs follow up  ☐  
Medical records release not accepted ☐  Unable to Contact ☐ Other:  
Notes:  

 
 
RA completing attempt:  
 
Appendix 30: Study Completion 
Study Completion (STC) 
Date completed: 
Study staff completing form:  
1. Did the participant complete the 30 day follow-up assessment visit? ☐ Yes (skip to question 2)   ☐ No 
a. If “No,” select the primary reason for study discontinuation? 
i. Participant deceased 
ii. Participant terminated for administrative issues 
iii. Participant was ineligible and should not have been enrolled in the study 
iv. Participant refused, non-specific 
v. Unable to contact participant 
vi. Participant terminated due to COVID-19 
vii. Participant terminated for other reason  
1. If “Participant terminated for administrative issues” or “Participant terminated for 
other reason”, specify: 
2. Date of last data collection with participant or date of withdrawn consent: 
3. Comments: 
 

 
 
 
Appendix 31: PRISE