NCT04562779

Inpatient Single Dose Interventions for Alcohol Use Disorder

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Denver Health and Hospital Authority · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Naltrexone 380 MG	XR naltrexone to be given once prior to hospital discharge
DRUG	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

Timeline

• Start date: 2021-01-19
• Primary completion: 2022-01-01
• Completion: 2022-02-01
• First posted: 2020-09-24
• Last updated: 2024-05-02
• Results posted: 2024-05-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study