Clinical trial NCT04562779: Inpatient Single Dose Interventions for Alcohol Use Disorder
Official title: Single-dose Interventions to Reduce Re-admissions for Hospitalized Patients With Refractory Alcohol Use Disorder: A Randomized Pilot Feasibility Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Alcohol Use Disorder, Severe
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

1. 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.
2. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate (%) of 30-day Hospital Re-admission
timeFrame: Within 30 days of index hospital discharge. The enrollment period is 12 months.
measure: Feasibility - Recruitment Rate (# Per Month)
timeFrame: The enrollment period is 12 months
measure: Feasibility - Follow-up Rate (%)
timeFrame: 14 days
Secondary outcomes:
measure: Rate (%) of 30-day Emergency Department Visit
timeFrame: Within 30 days of index hospital discharge. The enrollment period is 12 months.
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
References: