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Inpatient Single Dose Interventions for Alcohol Use Disorder

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ClinicalTrials.gov Identifier: NCT04562779
Recruitment Status : Not yet recruiting
First Posted : September 24, 2020
Last Update Posted : December 1, 2020
Sponsor:
Information provided by (Responsible Party):
Denver Health and Hospital Authority

Tracking Information
First Submitted Date  ICMJE September 14, 2020
First Posted Date  ICMJE September 24, 2020
Last Update Posted Date December 1, 2020
Estimated Study Start Date  ICMJE January 1, 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2020)
  • Rate (%) of 30-day hospital re-admission [ Time Frame: Within 30 days of index hospital discharge. The enrollment period is 5 months. ]
    Binary outcome: any all-cause hospitalization ascertained by chart review (our EHR includes records from several local hospitals)
  • Feasibility - recruitment rate (# per month) [ Time Frame: The enrollment period is 5 months ]
    Number of participants recruited per month during the enrollment period
  • Feasibility - follow-up rate (%) [ Time Frame: The enrollment period is 5 months ]
    Percentage of patients who presented to 1 week follow-up appointment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2020)
  • Average within-subject difference in readiness-to-change (SOCRATES-8A score) [ Time Frame: Follow-up planned to be within one week of discharge ]
    Within-subject differences in readiness to change between inpatient enrollment and outpatient follow-up.
  • Rate (%) of 30-day emergency department visit [ Time Frame: Within 30 days of index hospital discharge. The enrollment period is 5 months. ]
    Binary outcome: any all-cause ED visit ascertained by chart review
  • Rate (%) of urine Ethyl Glucuronide (EtG) at follow-up [ Time Frame: Follow-up planned to be within one week of discharge. The enrollment period is 5 months. ]
    Obtained by urine EtG at outpatient follow-up
  • Rate (%) of self-reported binge drinking since discharge [ Time Frame: Follow-up planned to be within one week of discharge. The enrollment period is 5 months. ]
    Self reported at outpatient follow-up, ascertained by Timeline Follow-Back Method.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inpatient Single Dose Interventions for Alcohol Use Disorder
Official Title  ICMJE Single-dose Interventions to Reduce Re-admissions for Hospitalized Patients With Refractory Alcohol Use Disorder: A Randomized Pilot Feasibility Study.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Use Disorder, Severe
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Drug: Naltrexone 380 MG
    • Behavioral: Enhanced linkage
  • Experimental: 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.
    Interventions:
    • Drug: Ketamine Hydrochloride
    • Behavioral: Enhanced linkage
  • Active Comparator: Linkage
    Participants will receive no single-dose addiction medication prior to hospital discharge, but will receive enhanced linkage to follow-up addiction care.
    Intervention: Behavioral: Enhanced linkage
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 18, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18-65
  • 1+ alcohol-related* admission(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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dale Terasaki, MD 303-602-6922 dale.terasaki@cuanschutz.edu
Contact: Anastasia Cornell, MPH Anastasia.Cornell@rmpds.org
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04562779
Other Study ID Numbers  ICMJE 20-2008
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Denver Health and Hospital Authority
Study Sponsor  ICMJE Denver Health and Hospital Authority
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Denver Health and Hospital Authority
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP