Clinical trial NCT04094584: Emergency Department Initiated Extended-Release Naltrexone and Case Management for the Treatment of Alcohol Use Disorder
Official title: Feasibility of Emergency Department Initiated Extended-Release Naltrexone and Case Management Services for the Treatment of Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Alcohol Use Disorder
Substance Use
Alcohol Abuse or Dependence
Keywords: Emergency Department
Naltrexone
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Carestar Foundation
First posted: 2019-09-19
Enrollment: 179
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Participants Retained in Study at 3 Months
timeFrame: 3 months
measure: Retention at 12 Months
timeFrame: 12 months
measure: Change in Daily Total Alcohol Consumption From Baseline at 3 Months
timeFrame: 3 months after enrollment
measure: Change in Total Alcohol Consumption at 12 Months
timeFrame: 12 months after enrollment
Secondary outcomes:
measure: Change in Quality of Life Score at 3 Months
timeFrame: 3 months after enrollment
Other outcomes:
measure: Substance Use Treatment Utilization
timeFrame: 12 months
measure: Recruitment
timeFrame: 12 months
measure: Continued Naltrexone Use After Intervention Period
timeFrame: 3 months
measure: Change in ED Utilization
timeFrame: 12 months before and after enrollment
measure: Change in WHO Drinking Risk Level
timeFrame: 3 months after enrollment
measure: Change in Alcohol Related Life Consequences (Short Inventory of Problems Scale, Version 2R: SIP-2R)
timeFrame: 3 months after enrollment
measure: Receipt of All Study Naltrexone Injections
timeFrame: 3 months
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Maria Raven, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Charles E Murphy IV, MD
role: PRINCIPAL_INVESTIGATOR
References: