Inpatient Single Dose Interventions for Alcohol Use Disorder
Primary Purpose
Alcohol Use Disorder, Severe
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Naltrexone 380 MG
Ketamine Hydrochloride
Enhanced linkage
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder, Severe
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
Sites / Locations
- Denver Health Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
XR Naltrexone
IV Ketamine
Linkage
Arm Description
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.
Outcomes
Primary Outcome Measures
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)
Feasibility - recruitment rate (# per month)
Number of participants recruited per month during the enrollment period
Feasibility - follow-up rate (%)
Percentage of patients who presented to 1 week follow-up appointment
Secondary Outcome Measures
Average within-subject difference in readiness-to-change (SOCRATES-8A score)
Within-subject differences in readiness to change between inpatient enrollment and outpatient follow-up.
Rate (%) of 30-day emergency department visit
Binary outcome: any all-cause ED visit ascertained by chart review
Rate (%) of urine Ethyl Glucuronide (EtG) at follow-up
Obtained by urine EtG at outpatient follow-up
Rate (%) of self-reported binge drinking since discharge
Self reported at outpatient follow-up, ascertained by Timeline Follow-Back Method.
Full Information
NCT ID
NCT04562779
First Posted
September 14, 2020
Last Updated
February 2, 2022
Sponsor
Denver Health and Hospital Authority
1. Study Identification
Unique Protocol Identification Number
NCT04562779
Brief Title
Inpatient Single Dose Interventions for Alcohol Use Disorder
Official Title
Single-dose Interventions to Reduce Re-admissions for Hospitalized Patients With Refractory Alcohol Use Disorder: A Randomized Pilot Feasibility Study.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 19, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
February 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Denver Health and Hospital Authority
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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:
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Severe
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XR Naltrexone
Arm Type
Experimental
Arm Description
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.
Arm Title
IV Ketamine
Arm Type
Experimental
Arm Description
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.
Arm Title
Linkage
Arm Type
Active Comparator
Arm Description
Participants will receive no single-dose addiction medication prior to hospital discharge, but will receive enhanced linkage to follow-up addiction care.
Intervention Type
Drug
Intervention Name(s)
Naltrexone 380 MG
Intervention Description
XR naltrexone to be given once prior to hospital discharge
Intervention Type
Drug
Intervention Name(s)
Ketamine Hydrochloride
Intervention Description
IV ketamine infusion to be given once prior to hospital discharge
Intervention Type
Behavioral
Intervention Name(s)
Enhanced linkage
Intervention Description
Includes in-hospital intake at outpatient addiction clinic plus contingency management related to follow-up
Primary Outcome Measure Information:
Title
Rate (%) of 30-day hospital re-admission
Description
Binary outcome: any all-cause hospitalization ascertained by chart review (our EHR includes records from several local hospitals)
Time Frame
Within 30 days of index hospital discharge. The enrollment period is 12 months.
Title
Feasibility - recruitment rate (# per month)
Description
Number of participants recruited per month during the enrollment period
Time Frame
The enrollment period is 12 months
Title
Feasibility - follow-up rate (%)
Description
Percentage of patients who presented to 1 week follow-up appointment
Time Frame
The enrollment period is 12 months
Secondary Outcome Measure Information:
Title
Average within-subject difference in readiness-to-change (SOCRATES-8A score)
Description
Within-subject differences in readiness to change between inpatient enrollment and outpatient follow-up.
Time Frame
Follow-up planned to be within one week of discharge
Title
Rate (%) of 30-day emergency department visit
Description
Binary outcome: any all-cause ED visit ascertained by chart review
Time Frame
Within 30 days of index hospital discharge. The enrollment period is 12 months.
Title
Rate (%) of urine Ethyl Glucuronide (EtG) at follow-up
Description
Obtained by urine EtG at outpatient follow-up
Time Frame
Follow-up planned to be within one week of discharge. The enrollment period is 12 months.
Title
Rate (%) of self-reported binge drinking since discharge
Description
Self reported at outpatient follow-up, ascertained by Timeline Follow-Back Method.
Time Frame
Follow-up planned to be within one week of discharge. The enrollment period is 12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Inpatient Single Dose Interventions for Alcohol Use Disorder
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