Inpatient Single Dose Interventions for Alcohol Use Disorder

NCT04562779 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: 20-2008
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Alcohol Use Disorder, Severe

Outcome Measures

Primary Outcomes (3)

• 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.

• Feasibility - Recruitment Rate (# Per Month)

  Number of participants recruited per month during the enrollment period

  The enrollment period is 12 months

• Feasibility - Follow-up Rate (%)

  Percentage of patients who presented to follow-up appointment within 14 days

  14 days

Secondary Outcomes (1)

• Rate (%) of 30-day Emergency Department Visit

  Within 30 days of index hospital discharge. The enrollment period is 12 months.

Study Arms (3)

XR Naltrexone

EXPERIMENTAL

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.

Drug: Naltrexone 380 MG; Behavioral: Enhanced linkage

IV Ketamine

EXPERIMENTAL

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.

Drug: Ketamine Hydrochloride; Behavioral: Enhanced linkage

Linkage

ACTIVE COMPARATOR

Participants will receive no single-dose addiction medication prior to hospital discharge, but will receive enhanced linkage to follow-up addiction care.

Behavioral: Enhanced linkage

Interventions

Naltrexone 380 MG DRUG

XR naltrexone to be given once prior to hospital discharge

XR Naltrexone

Ketamine Hydrochloride DRUG

IV ketamine infusion to be given once prior to hospital discharge

IV Ketamine

Enhanced linkage BEHAVIORAL

Includes in-hospital intake at outpatient addiction clinic plus contingency management related to follow-up

IV Ketamine; Linkage; XR Naltrexone

Eligibility Criteria

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

You may qualify if:

• Age 18-65
• + alcohol-related\* admission(s) or emergency department visit(s) in past 12 mo.
• Has insurance (public or private)
• Seen by inpatient addiction consult service

You may not qualify if:

• 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)

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Related Publications (1)

• Terasaki D, Loh R, Cornell A, Taub J, Thurstone C. Single-dose intravenous ketamine or intramuscular naltrexone for high-utilization inpatients with alcohol use disorder: pilot trial feasibility and readmission rates. Addict Sci Clin Pract. 2022 Nov 22;17(1):64. doi: 10.1186/s13722-022-00345-y.

  PMID: 36419181 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Naltrexone; Ketamine

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Dale Terasaki
• Organization: Denver Health & Hospital Authority

dale.terasaki@dhha.org

303-602-6922

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 24, 2020
• Study Start: January 19, 2021
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: May 2, 2024
• Results First Posted: May 2, 2024

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)