Emergency Department Initiated Extended-Release Naltrexone and Case Management for the Treatment of Alcohol Use Disorder
Condition: Alcohol Use Disorder; Substance Use; Alcohol Abuse or Dependence
MeSH terms: Emergencies; Substance-Related Disorders; Alcoholism; Alcohol Drinking
Intervention: Vivitrol (Extended Release Naltrexone)
Intervention description: Monthly Injections of 380mg Extended-Release Naltrexone, case management services as needed tailored to the individual participant
Intervention MeSH terms: Naltrexone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 179.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Emergency Department; Naltrexone

Summary:

      This is a phase 4, open-label, feasibility study of extended release naltrexone (Vivitrol,
      Alkermes Pharmaceutical) and case management for treatment of alcohol use disorders in the
      ED.

      Excess alcohol use is a major cause of morbidity and mortality and contributes to a large
      number of emergency department (ED) visits. The rate of alcohol-related ED visits is
      increasing, and 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. 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.

      ED patients with alcohol use disorders frequently 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.

      Regardless of comorbidity, limited access to substance use and mental health services is a
      significant barrier to receiving treatment, and large disparities exist in access based on
      income level. Facilitated referrals, where a healthcare worker communicates with the patient
      and service providers and assists the patient with obtaining follow up, have been used
      effectively to improve access to specialty care after ED discharge. Case managers are
      familiar with community treatment resources and are well versed in providing facilitated
      referrals.

      The primary hypothesis is that implementing this multimodal treatment will be feasible in an
      ED setting and will reduce alcohol use. Feasibility measures (recruitment, retention,
      continuation of treatment after the trial) are the primary outcomes. The intent of the
      intervention is to change drinking behavior in a way that benefits participants' health and
      quality of life. As such, we will conduct a limited efficacy assessment. Treatment efficacy
      will be assessed by comparing alcohol consumption, quality of life, and life consequences
      related to alcohol use before and after the intervention.

      The primary efficacy outcome is change in total alcohol consumption measured by a 2 week
      timeline follow back. Change from baseline will be assessed after the 3 month intervention
      period, and at the conclusion of the study follow up period for all outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active alcohol use by self-report

          -  Known alcohol use disorder or suspected alcohol use disorder and Alcohol Use Disorders
             Identification Test (AUDIT) score ≥ 8 or AUDIT-C score > 4, or frequent emergency
             department visits and hazardous drinking 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 or AUDIT-C score > 4

        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