Feasibility of Emergency Department Initiated Extended-Release Naltrexone for the Treatment of Alcohol Use Disorder

• Status: Recruiting
• Trial end date: 2022-08-14
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 4, open-label, feasibility study of extended release naltrexone (Vivitrol, Alkermes Pharmaceutical), case management and tele-addiction medicine services for treatment of alcohol use disorders in the ED.

Alcohol use contributes to a large number of emergency department (ED) visits and the rate of alcohol-related ED visits is increasing. There is evidence that this increase may be driven by a subset of patients who frequently visit the ED due to an underlying alcohol use disorder (AUD). The proposed study will assess the feasibility of implementing a multimodal treatment for AUD in the emergency department for 25 patients with AUD and frequent ED visits related to alcohol use. The rationale for including each component of the multimodal treatment is outlined below.

Pharmacotherapy is recommended as the standard of care for alcohol use disorders. Of the four drugs approved by the FDA for treatment of alcohol use disorder, extended release naltrexone has been found to be superior at reducing healthcare utilization, increasing detoxification facility use, and reducing total cost. Fewer than 1 in 4 patients with AUD currently receives treatment with an FDA approved agent and use of these drugs in EDs is virtually non-existent.

In addition to higher rates of alcohol and substance use, patients who frequently visit the ED often suffer from multiple medical, mental health, and social problems that influence their health. Providing such patients with case management services has shown promise in improving health related outcomes while curbing ED utilization and healthcare costs.

Limited access to substance use and mental health services is a significant barrier to receiving treatment, and large disparities exist in access to care based on income level. Telemedicine is the remote diagnosis and treatment of patients via interactive telecommunication equipment. It has been used effectively to improve access to mental health care in a variety of patient populations, including in the ED.

The primary hypothesis is that this multimodal treatment will reduce ED visits related to alcohol use. ED utilization in the 12 months before and after initiating treatment will be compared evaluate treatment efficacy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: CARESTAR Foundation; The CARESTAR Foundation
• Treatments: Naltrexone

Criteria

Inclusion Criteria:

• Active alcohol use by self-report

• Frequent emergency department visits and hazardous drinking or active alcohol use disorder, defined as: At least 3 emergency department visits in the past 12 months, including the index visit, and Alcohol Use Disorders Identification Test (AUDIT) score ≥ 8

Exclusion Criteria:

• Opioid use: currently receiving opioid analgesics, self-report of opioid use in past 7 days, current physiologic opioid dependence, patients in acute opioid withdrawal, urine toxicology screen positive for opiates including fentanyl

• History of hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose, or any other components of the diluent

• Liver function tests (AST, ALT) > 5x upper limit of normal or known cirrhosis

• Platelets less than 100,000 per cubic mm

• Acute condition at the time of enrollment that necessitates medical therapy with opioids

• Pregnant

• Incarcerated