Binary outcome: any all-cause hospitalization ascertained by chart review (our EHR includes records from several local hospitals)
Inpatient Single Dose Interventions for Alcohol Use Disorder
Naltrexone 380 MG (DRUG)XR naltrexone to be given once prior to hospital discharge
Ketamine Hydrochloride (DRUG)IV ketamine infusion to be given once prior to hospital discharge
Enhanced linkage (BEHAVIORAL)Includes in-hospital intake at outpatient addiction clinic plus contingency management related to follow-up
Condition or Disease
- Alcohol Use Disorder, Severe
|Study results:||No Results Available|
|Age:||18 Years to 65 Years|
Clinical Trial Dates
|Start date:||Jan 19, 2021||ACTUAL|
|Primary Completion:||Jan 01, 2022||ACTUAL|
|Completion Date:||Feb 01, 2022||ACTUAL|
|Study First Posted:||Sep 24, 2020||ACTUAL|
|Last Updated:||Feb 02, 2022|
Sponsors / Collaborators
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.
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.
Participants will receive no single-dose addiction medication prior to hospital discharge, but will receive enhanced linkage to follow-up addiction care.
|Age Groups:||Adult / Older Adult|
* 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
* 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
Number of participants recruited per month during the enrollment period
Percentage of patients who presented to 1 week follow-up appointment
Within-subject differences in readiness to change between inpatient enrollment and outpatient follow-up.
Binary outcome: any all-cause ED visit ascertained by chart review
Obtained by urine EtG at outpatient follow-up
Self reported at outpatient follow-up, ascertained by Timeline Follow-Back Method.