Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Inpatient Single Dose Interventions for Alcohol Use Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04562779
Recruitment Status : Not yet recruiting
First Posted : September 24, 2020
Last Update Posted : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
Denver Health and Hospital Authority

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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder, Severe Drug: Naltrexone 380 MG Drug: Ketamine Hydrochloride Behavioral: Enhanced linkage Early Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-dose Interventions to Reduce Re-admissions for Hospitalized Patients With Refractory Alcohol Use Disorder: A Randomized Pilot Feasibility Study.
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Naltrexone 380 MG
XR naltrexone 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

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.
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

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.
Behavioral: Enhanced linkage
Includes in-hospital intake at outpatient addiction clinic plus contingency management related to follow-up




Primary Outcome Measures :
  1. 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)

  2. Feasibility - recruitment rate (# per month) [ Time Frame: The enrollment period is 5 months ]
    Number of participants recruited per month during the enrollment period

  3. Feasibility - follow-up rate (%) [ Time Frame: The enrollment period is 5 months ]
    Percentage of patients who presented to 1 week follow-up appointment


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04562779


Contacts
Layout table for location contacts
Contact: Dale Terasaki, MD 303-602-6922 dale.terasaki@cuanschutz.edu
Contact: Anastasia Cornell, MPH Anastasia.Cornell@rmpds.org

Sponsors and Collaborators
Denver Health and Hospital Authority
Layout table for additonal information
Responsible Party: Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT04562779    
Other Study ID Numbers: 20-2008
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Alcohol Deterrents
Narcotic Antagonists