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:
Participant gender:
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.