Inpatient Single Dose Interventions for Alcohol Use Disorder

Alcohol Use Disorder, Severe Clinical Trial

Official title:

Single-dose Interventions to Reduce Re-admissions for Hospitalized Patients With Refractory Alcohol Use Disorder: A Randomized Pilot Feasibility Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04562779
• Other study ID #: 20-2008
• Status: Completed
• Phase: Early Phase 1
• Start date: January 19, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: November 2022
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder, Severe
• Alcoholism

Intervention

Drug:
• Naltrexone 380 MG
XR naltrexone to be given once prior to hospital discharge
• Ketamine Hydrochloride
IV ketamine infusion to be given once prior to hospital discharge

Behavioral:
• Enhanced linkage
Includes in-hospital intake at outpatient addiction clinic plus contingency management related to follow-up

Locations

Country	Name	City	State
United States	Denver Health Medical Center	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate (%) of 30-day Hospital Re-admission	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.	Within 30 days of index hospital discharge. The enrollment period is 12 months.
Primary	Feasibility - Recruitment Rate (# Per Month)	Number of participants recruited per month during the enrollment period	The enrollment period is 12 months
Primary	Feasibility - Follow-up Rate (%)	Percentage of patients who presented to follow-up appointment within 14 days	14 days
Secondary	Rate (%) of 30-day Emergency Department Visit	Binary outcome: any all-cause ED visit ascertained by chart review	Within 30 days of index hospital discharge. The enrollment period is 12 months.