CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 44 enrolled
Drug / intervention
Naltrexone 380 MG +2 moredrug
Likely dose
Naltrexone 380 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04562779
NCT04562779Early Ph 1Completed

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

Denver Health and Hospital Authority·interventional·Posted Sep 24, 2020·Updated May 2, 2024

In Brief

A Early Phase 1 clinical trial evaluating Naltrexone 380 MG, Ketamine Hydrochloride, and 1 other intervention for Alcohol Use Disorder, Severe. Completed, enrolled 44 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
202120222023202420252026
First PostedSep 24, 2020
Enrollment StartJan 19, 2021
Primary CompletionJan 1, 2022
Study CompletionFeb 1, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.8 years ago

Interventions

Naltrexone 380 MGdrug

XR naltrexone to be given once prior to hospital discharge

Ketamine Hydrochloridedrug

IV ketamine infusion to be given once prior to hospital discharge

Enhanced linkagebehavioral

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