Inpatient Single Dose Interventions for Alcohol Use Disorder

NCT ID: NCT04562779

Last Updated: 2024-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-19
• Study Completion Date: 2022-02-01

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.

Conditions

Alcohol Use Disorder, Severe

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Naltrexone 380 MG

Intervention Type: DRUG

XR naltrexone to be given once prior to hospital discharge

Enhanced linkage

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Ketamine Hydrochloride

Intervention Type: DRUG

IV ketamine infusion to be given once prior to hospital discharge

Enhanced linkage

Intervention Type: BEHAVIORAL

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

Linkage

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

Group Type: ACTIVE_COMPARATOR

Enhanced linkage

Intervention Type: BEHAVIORAL

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

Interventions

Naltrexone 380 MG

XR naltrexone to be given once prior to hospital discharge

Intervention Type: DRUG

Ketamine Hydrochloride

IV ketamine infusion to be given once prior to hospital discharge

Intervention Type: DRUG

Enhanced linkage

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Denver Health and Hospital Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Denver Health Medical Center

Denver, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36419181 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

20-2008

Identifier Type: -

Identifier Source: org_study_id