Bridging ED to Outpatient AUD Therapy With Naltrexone

NCT05228418 | Unknown Phase 4 FDA Drug

• 1 other identifier: 2021-546
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Alcohol use disorder (AUD) is a treatable and common condition encountered in the emergency department, but unfortunately is rarely directly addressed in emergency departments nationwide. To our knowledge, initiation of medication assisted therapy (MAT) for AUD in the emergency department setting has not been widely adopted. Our project is novel for its scope to use a medication well-tested in the outpatient environment and bring it to the emergency department in order to more effectively link patients to outpatient alcohol use reduction therapy as part of a medication assisted therapy (MAT). The investigators are proposing a feasibility project to initiate oral naltrexone to eligible ED patients deemed to have alcohol use disorder and who are interested in cutting down their drinking. The investigators plan to connect these patients with outpatient follow-up in our own community practice center (CPC) for intramuscular (IM) Vivitrol injections under the supervision of the Einstein Toxicology Department. Through the CPC, patients can also be referred to other supporting services such as Alcoholics Anonymous for multidisciplinary care. The investigators are optimistic that this innovative warm hand off from the initial ED visit to outpatient follow-up will ultimately decrease problematic drinking, improve patient's health, and benefit the hospital. Our main objective is to establish a pathway to encourage patients who present to the emergency room with acute sequelae of alcohol use disorder to enter outpatient treatment. Our intervention will be the initiation of oral naltrexone with warm handoff to the Community Practice Center where patients will be transitioned to intramuscular (IM) Vivitrol for chronic maintenance therapy. Thus success will be measured by primarily: percentage of patients who make it to their first outpatient visit for the Vivitrol injection, percentage of patients who continue with treatment and continue to receive Vivitrol for their second injection.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• Successful referral and follow-up in MAT clinic

  The primary endpoint is percentage of patients who are successfully referred to outpatient MAT treatment in our hospital's outpatient clinic and percentage of people who stay in treatment at the intake and subsequent follow-up outpatient clinic visit. (i.e. % of patients who remain in treatment at the initial outpatient intake visit scheduled within 1 week of the initial index ED visit and the follow-up appointment 4 weeks after the intake visit)

  4 weeks

Secondary Outcomes (1)

• Alcohol use severity measures

  4 weeks

Study Arms (1)

Participant

EXPERIMENTAL

All participants who meet inclusion criteria will be offered oral naltrexone in the ED, a bridge prescription for oral naltrexone, and be referred to outpatient MAT clinic where participants will be offered monthly IM naltrexone injections.

Drug: Naltrexone Pill

Interventions

Naltrexone Pill DRUG

Naltrexone oral bridge to IM naltrexone maintenance therapy

Also known as: naltrexone IM 380mg

Participant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Presents to the ED with chief complaint of alcohol use or judged to have alcohol use as a significant contributing factor to their presentation to the emergency department
• Patients must be interested in reducing or stopping their alcohol use
• AUDIT score greater or equal to 16

You may not qualify if:

• Patients will be excluded if they previously participated in the study
• patients who will be admitted to the hospital
• Endorse dependence on opioid medications or opioid street drugs
• have an extended urine drug screen that is positive for opioids
• elevated liver transaminase (AST or ALT) that is greater than 5 times the upper limit of normal
• decompensated liver disease
• allergic reaction to naltrexone
• pregnant
• prisoners
• unable to provide consent
• subjects in police custody
• non-English speaking
• have no reliable means for future contact.

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Albert Einstein Medical Center Philadelphia

Philadelphia, Pennsylvania, 19141, United States

Location

Related Publications (3)

• Garbutt JC, Kranzler HR, O'Malley SS, Gastfriend DR, Pettinati HM, Silverman BL, Loewy JW, Ehrich EW; Vivitrex Study Group. Efficacy and tolerability of long-acting injectable naltrexone for alcohol dependence: a randomized controlled trial. JAMA. 2005 Apr 6;293(13):1617-25. doi: 10.1001/jama.293.13.1617.

  PMID: 15811981 BACKGROUND

• Anderson ES, Chamberlin M, Zuluaga M, Ullal M, Hawk K, McCormack R, D'Onofrio G, Herring AA. Implementation of Oral and Extended-Release Naltrexone for the Treatment of Emergency Department Patients With Moderate to Severe Alcohol Use Disorder: Feasibility and Initial Outcomes. Ann Emerg Med. 2021 Dec;78(6):752-758. doi: 10.1016/j.annemergmed.2021.05.013. Epub 2021 Aug 2.

  PMID: 34353648 BACKGROUND

• Bryson WC, McConnell J, Korthuis PT, McCarty D. Extended-release naltrexone for alcohol dependence: persistence and healthcare costs and utilization. Am J Manag Care. 2011 Jun;17 Suppl 8(Suppl 8):S222-34.

  PMID: 21761949 BACKGROUND

MeSH Terms

Conditions

Alcoholism

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• David Hui, MD

  Albert Einstein Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Hui, MD

CONTACT

510-371-5687; huidavid@einstein.edu

Serge Simpson, MD

CONTACT

215-456-6679; simpsose@einstein.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 8, 2022
• Study Start: March 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: July 1, 2025
• Last Updated: February 8, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)