ED Initiated Oral Naltrexone for AUD

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
Overview The study will be comprised of two components outlined below: 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. Oral Naltrexone Feasibility Component In this component the study team aims 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 the study team aims 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) The study team aims 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, the study team 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.

Official Title
-----------------
Emergency Department Initiated Oral Naltrexone for Patients With Moderate to Severe Alcohol Use Disorder: A Pilot Feasibility Study

Conditions
-----------------
Alcohol Use Disorder

Intervention / Treatment
-----------------
* Drug: Emergency Department Initiated Oral Naltrexone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Emergency Department patients 18 years of age or older Treated in the ED during screening hours Moderate to severe AUD as determined by DSM-5 criteria Able to speak and understand English Medically stable for an interview as determined by their primary ED provider Willing and able to consent to study participation Two points of contact available for follow-up Exclusion Criteria: ED patients younger than 18 years of age Medically or psychiatrically unstable as determined by the ED provider Unable to speak or understand English Unable to provide consent for study participation Past year opioid dependence Urine drug screen positive for opioids Current or anticipated need for opioid medications for pain Anticipated surgical procedure within 14-day of ED visit Serologic evidence of liver disease (LFTs 3X normal) within 7 days of enrollment Cirrhosis either by PMH or self-report Pregnant or breastfeeding Lacking contact information for follow-up Requiring in-patient admission for medical or psychiatric reasons Patient receiving a sexual assault forensics exam (SAFE) Patient suspected of having COVID-19 Patient is actively suicidal or homicidal Previously enrolled in either the implementation or feasibility phase of the study Be a prisoner or in police custody at the time of the index ED visit Be currently (anytime within the last 14 days) enrolled in formal addiction treatment, including by court order.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Naloxone<br>Oral Naltrexone initiation | Drug: Emergency Department Initiated Oral Naltrexone<br>* Emergency Department Initiated Oral Naltrexone<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants enrolled and receiving formal addiction treatment at day 14 | Number of participant enrolled with engagement in care of comprehensive addiction treatment | Day 14 | 
| Number of participants enrolled and receiving formal addiction treatment at day 30 | Number of participant enrolled with engagement in care of comprehensive addiction treatment | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Guidelines Regimen Information Program (GRIP) guide at day 14 | Adherence to daily oral naltrexone measured using GRIP guide - GRIP guide is a self-report to assess adherence, with 6 categorical items: excellent, very good, good, fair, poor, and very poor. | Day 14 | 
| Guidelines Regimen Information Program (GRIP) guide at day 30 | Adherence to daily oral naltrexone measured using GRIP guide - GRIP guide is a self-report to assess adherence, with 6 categorical items: excellent, very good, good, fair, poor, and very poor. | Day 30 | 
| Number of pills in bottle at day 14 | Adherence to daily oral naltrexone measured using pill counts. | Day 14 | 
| Number of pills in bottle at day 30 | Adherence to daily oral naltrexone measured using pill counts. | Day 30 | 
| Number of drinks | Daily alcohol intake self reported via a text-messaging application | up to 30 days | 
| Number of Heavy Drinking Days | Number of heavy drinking days defined as 4 or more drinks for a woman or 5 or more drinks for a man on the same occasion in a 24 hour period. | up to 30 days | 
| Health Services Utilization Survey | A brief, structured measure (not scored) regarding health care utilization (inpatient and outpatient) will be used, which collects information on the type and amount of services received. This includes ED visits, hospitalizations, primary medical care visits. | Day 30 | 
| Number of participants who Transition to LA Injectable | Number of participants who transition from oral to long acting injectable naloxone. | Day 30 | 
| Health Related Quality of Life (HRQoL) | HRQoL - full scale score ranges from 0 to 100, higher score indicates better health outcomes | Day 30 | 
| The Patient Rated Inventory of Side Effects (PRISE) survey | Medication side effects of oral naltrexone measured using PRISE survey - is a patient self-report measure used to identify and evaluate the tolerability of side effect symptom. This scale is a 7 item assessment of the side effects in the following symptom areas; gastrointestinal, heart, skin, nervous system, eyes/ears, genital/urinary, sleep, sexual functioning, and other. Each domain has multiple symptoms and for each domain the patient rates whether these symptoms are tolerable or distressing. Higher score represents more side-effects. | Day 30 | 
| Daily alcohol craving scale | Daily alcohol craving scale using Qualtrics - Full scale from 0 to 36, higher score represents more severity. | up to 30 days | 
| AUD Program Satisfaction Survey | Satisfaction with the naloxone initiation program measured using Satisfaction survey - full scale from 0 to 36 higher score represents more satisfaction. | Day 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Naltrexone, Medication Assisted Treatment, Emergency Department