ED Initiated Oral Naltrexone for AUD

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Treatments: Naltrexone

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.