Emergency Department Initiated Extended-Release Naltrexone and Case Management for the Treatment of Alcohol Use Disorder
- Conditions
- Alcohol Use DisorderSubstance UseAlcohol Abuse or Dependence
- Interventions
- Registration Number
- NCT04094584
- Lead Sponsor
- University of California, San Francisco
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 179
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Multimodal Intervention Vivitrol (Extended Release Naltrexone) 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
- Primary Outcome Measures
Name Time Method Retention at 12 Months 12 months Percentage of enrolled participants who complete final study visit at the end of the follow up periods
Change in Daily Total Alcohol Consumption From Baseline at 3 Months 3 months after enrollment Self-reported total daily alcohol consumption at 3 months, compared to baseline
Change in Total Alcohol Consumption at 12 Months 12 months after enrollment Change in self-reported total daily alcohol consumption from baseline
Participants Retained in Study at 3 Months 3 months Percentage of enrolled participants who attend final study visit at the end of the intervention period
- Secondary Outcome Measures
Name Time Method Change in Quality of Life Score at 3 Months 3 months after enrollment Kemp Quality of Life score at 3 months compared to baseline. Score is 1-7 with higher scores indicating higher quality of life.
Trial Locations
- Locations (1)
University of California, San Francisco
🇺🇸San Francisco, California, United States