Summary

for people ages 21 years and up (full criteria)
at San Francisco, California
study started
estimated completion
Maria Raven, MD

Description

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.

Official Title

Feasibility of Emergency Department Initiated Extended-Release Naltrexone, Tele-addiction Medicine Counseling, and Case Management Services for the Treatment of Alcohol Use Disorder

Keywords

Alcohol Use Disorder Substance Use Alcohol Abuse or Dependence Emergency Department Naltrexone Emergencies Alcoholism Alcohol Drinking Vivitrol (Extended Release Naltrexone)

Eligibility

You can join if…

Open to people ages 21 years and up

Active alcohol use by self-report or detectable blood ethanol level

Frequent emergency department visits for alcohol related complaints, defined as: At least 3 emergency department visits for alcohol related complaints in the past 12 months, including the index visit. Alcohol related complaints include acute alcohol intoxication, alcohol withdrawal, trauma while intoxicated, altered mental status ultimately attributed to alcohol, alcoholic hepatitis/gastritis/esophagitis/pancreatitis

You CAN'T join if...

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

Location

  • University of California, San Francisco not yet accepting patients
    San Francisco California 94143 United States

Lead Scientist

  • Maria Raven, MD
    Maria Raven, MD, MPH, MSc, a practicing emergency medicine physician and health services researcher, is an Associate Professor of Emergency Medicine and Chief of Emergency Medicine at UCSF as well as a Vice Chair of Emergency Medicine for the UCSF Department of Emergency Medicine.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04094584
Phase
Phase 4
Study Type
Interventional
Last Updated