Single-dose Interventions to Reduce Re-admissions for Hospitalized Patients With Refractory Alcohol Use Disorder: A Randomized Pilot Feasibility Study.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Feasibility - Recruitment Rate (# Per Month)
研究概览
简要总结
Every year, alcohol use disorder (AUD) generates millions of emergency department (ED) visits and hospital admissions, costing the U.S. health sector over $90 billion. These hospital admissions are critical opportunities to start patients on addiction pharmacotherapy, but factors like medication non-adherence and post-discharge relapse contribute to frequent re-admissions. Two single-dose interventions are well suited to facilitate treatment retention and prevent re-admissions due to their prolonged, adherence-independent effects: extended-release (XR) naltrexone injection and intravenous (IV) ketamine infusion. These have not been thoroughly investigated in the hospital setting among high-utilizer, safety-net populations. Therefore, the investigators aim to:
- Test the feasibility of randomizing hospitalized patients (n=45-60, age 18-65) with multiple AUD-related admissions to treatment with either extended-release (XR) naltrexone, intravenous (IV) ketamine, or no single-dose medication, all with enhanced linkage to care. Feasibility outcomes such as recruitment rate, patient acceptability, post-discharge follow-up rate, and adverse events will help to identify key lessons for a future comparative effectiveness study.
- Estimate the 30-day re-admission rate for patients randomized to treatment with XR naltrexone, with IV ketamine, or no single-dose medication, all with enhanced linkage to care. The investigators hypothesize that the re-admission rate will be lower for each of the two single-dose medication groups than for the "linkage-alone" group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65
- •1+ alcohol-related* admission(s) or emergency department visit(s) in past 12 mo.
- •Has insurance (public or private)
- •Seen by inpatient addiction consult service
排除标准
- •Known or suspected active COVID-19 infection
- •Hepatic: AST/ALT >5x upper-limit of normal, decompensated liver failure
- •Renal: Glomerular filtration rate <30ml/min
- •Cardiovascular: History of acute coronary syndrome, cerebrovascular event, hypertensive crisis, known cardiomyopathy
- •Known elevated intracranial pressure
- •Thrombocytopenia (<50/microliter)
- •Active moderate/severe withdrawal (based on hospital withdrawal protocol)
- •Active delirium (alcohol-related or otherwise)
- •Already enrolled in study
- •XR naltrexone or IV ketamine in last 30 days
- •Known intolerance to naltrexone or ketamine
- •Other active severe substance use disorder (tobacco, cannabis excluded)
- •Pregnant or breast-feeding, or planning.
- •Opioids: chronic, recent (<24h), or anticipated
- •Unstable psychiatric illness (active psychosis, active suicidality)
- •Moving from region within 30-days of discharge
- •Discharge to acute/residential treatment
- •Involuntary hold
研究组 & 干预措施
XR Naltrexone
Participants will receive a single dose of extended-release, injectable naltrexone prior to hospital discharge, in addition to enhanced linkage to follow-up addiction care.
干预措施: Naltrexone 380 MG (Drug)
XR Naltrexone
Participants will receive a single dose of extended-release, injectable naltrexone prior to hospital discharge, in addition to enhanced linkage to follow-up addiction care.
干预措施: Enhanced linkage (Behavioral)
IV Ketamine
Participants will receive a single dose of intravenous ketamine (0.5mg/kg over 40 minutes) prior to hospital discharge, in addition to enhanced linkage to follow-up addiction care.
干预措施: Ketamine Hydrochloride (Drug)
IV Ketamine
Participants will receive a single dose of intravenous ketamine (0.5mg/kg over 40 minutes) prior to hospital discharge, in addition to enhanced linkage to follow-up addiction care.
干预措施: Enhanced linkage (Behavioral)
Linkage
Participants will receive no single-dose addiction medication prior to hospital discharge, but will receive enhanced linkage to follow-up addiction care.
干预措施: Enhanced linkage (Behavioral)
结局指标
主要结局
Feasibility - Recruitment Rate (# Per Month)
时间窗: The enrollment period is 12 months
Number of participants recruited per month during the enrollment period
Feasibility - Follow-up Rate (%)
时间窗: 14 days
Percentage of patients who presented to follow-up appointment within 14 days
Rate (%) of 30-day Hospital Re-admission
时间窗: Within 30 days of index hospital discharge. The enrollment period is 12 months.
Binary outcome: any all-cause hospitalization ascertained by chart review (our EHR includes records from several local hospitals). Note that it is not dependent on study completion, so it is analyzed by intent to treat.
次要结局
- Rate (%) of 30-day Emergency Department Visit(Within 30 days of index hospital discharge. The enrollment period is 12 months.)