Emergency Department Initiated Extended-Release Naltrexone and Case Management for the Treatment of Alcohol Use Disorder

NCT04094584 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 18-26090
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder; Substance Use; Alcohol Abuse or Dependence

Keywords

Emergency Department; Naltrexone

Outcome Measures

Primary Outcomes (4)

• Participants Retained in Study at 3 Months

  Percentage of enrolled participants who attend final study visit at the end of the intervention period

  3 months

• Retention at 12 Months

  Percentage of enrolled participants who complete final study visit at the end of the follow up periods

  12 months

• Change in Daily Total Alcohol Consumption From Baseline at 3 Months

  Self-reported total daily alcohol consumption at 3 months, compared to baseline

  3 months after enrollment

• Change in Total Alcohol Consumption at 12 Months

  Change in self-reported total daily alcohol consumption from baseline

  12 months after enrollment

Secondary Outcomes (1)

• Change in Quality of Life Score at 3 Months

  3 months after enrollment

Other Outcomes (7)

• Substance Use Treatment Utilization

  12 months

• Recruitment

  12 months

• Continued Naltrexone Use After Intervention Period

  3 months

Study Arms (1)

Multimodal Intervention

EXPERIMENTAL

The intervention is multimodal and consists of: 1. Intramuscular injections of 380mg extended-release Naltrexone, given once monthly for 3 months. 2. Case Management services

Drug: Vivitrol (Extended Release Naltrexone)

Interventions

Vivitrol (Extended Release Naltrexone) DRUG

Monthly Injections of 380mg Extended-Release Naltrexone, case management services as needed tailored to the individual participant

Also known as: Case Management, SBIRT

Multimodal Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Carestar Foundation: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94122, United States

Location

Related Publications (1)

• Murphy CE 4th, Coralic Z, Wang RC, Montoy JCC, Ramirez B, Raven MC. Extended-Release Naltrexone and Case Management for Treatment of Alcohol Use Disorder in the Emergency Department. Ann Emerg Med. 2023 Apr;81(4):440-449. doi: 10.1016/j.annemergmed.2022.08.453. Epub 2022 Oct 31.

  PMID: 36328851 DERIVED

MeSH Terms

Conditions

Alcoholism; Substance-Related Disorders; Emergencies

Interventions

vivitrol; Case Management

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Ralph Wang
• Organization: University of California, San Francisco

ralph.wang@ucsf.edu

(415) 353-4890

Study Officials

• Maria Raven, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Charles E Murphy IV, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 19, 2019
• Study Start: August 14, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: June 22, 2023
• Results First Posted: June 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)