ED Initiated Oral Naltrexone for AUD

  • STATUS
    Recruiting
  • End date
    Mar 24, 2023
  • participants needed
    30
  • sponsor
    Icahn School of Medicine at Mount Sinai
Updated on 24 March 2022

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.

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.

Details
Condition Alcohol Use Disorder
Treatment Emergency Department Initiated Oral Naltrexone
Clinical Study IdentifierNCT04817410
SponsorIcahn School of Medicine at Mount Sinai
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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