Status:
COMPLETED
ED Initiated Oral Naltrexone for AUD
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 i...
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 no...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04817410
Start Date
September 28 2021
End Date
November 2 2023
Last Update
August 26 2025
Active Locations (1)
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1
Mount Sinai Beth Israel
New York, New York, United States, 10003