Clinical trial NCT04817410: ED Initiated Oral Naltrexone for AUD
Official title: Emergency Department Initiated Oral Naltrexone for Patients With Moderate to Severe Alcohol Use Disorder: A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcohol Use Disorder
Keywords: Medication Assisted Treatment
Emergency Department
Naltrexone
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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:

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 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.

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.

Primary outcomes:
measure: Number of participants enrolled and receiving formal addiction treatment at day 14
timeFrame: Day 14
measure: Number of participants enrolled and receiving formal addiction treatment at day 30
timeFrame: Day 30
Secondary outcomes:
measure: Guidelines Regimen Information Program (GRIP) guide at day 14
timeFrame: Day 14
measure: Guidelines Regimen Information Program (GRIP) guide at day 30
timeFrame: Day 30
measure: Number of pills in bottle at day 14
timeFrame: Day 14
measure: Number of pills in bottle at day 30
timeFrame: Day 30
measure: Number of drinks
timeFrame: up to 30 days
measure: Number of Heavy Drinking Days
timeFrame: up to 30 days
measure: Health Services Utilization Survey
timeFrame: Day 30
measure: Number of participants who Transition to LA Injectable
timeFrame: Day 30
measure: Health Related Quality of Life (HRQoL)
timeFrame: Day 30
measure: The Patient Rated Inventory of Side Effects (PRISE) survey
timeFrame: Day 30
measure: Daily alcohol craving scale
timeFrame: up to 30 days
measure: AUD Program Satisfaction Survey
timeFrame: Day 30
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Ethan Cowan, MD
role: PRINCIPAL_INVESTIGATOR
References: