Alcohol Use Disorder, SevereEarly Phase 1NCT04562779

Inpatient Single Dose Interventions for Alcohol Use Disorder

A Early Phase 1 study testing Naltrexone 380 MG, Ketamine Hydrochloride and Enhanced linkage in people with Alcohol Use Disorder, Severe, run by Denver Health and Hospital Authority at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Alcohol Use Disorder, Severe
What is being tested?: Naltrexone 380 MG, Ketamine Hydrochloride and Enhanced linkage
Type of treatment: Injection or infusion, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteUnited States
Study dates: 19 Jan 2021to 1 Feb 2022
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 18Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Denver Health Medical Center
Denver, Colorado, 80204

Other trials in United States

About this study

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

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.

Conditions: Alcohol Use Disorder, Severe
Being tested: Naltrexone 380 MG, Ketamine Hydrochloride, Enhanced linkage
Medical subject headings: Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04562779
Study group	Role	What they receive
XR Naltrexone	Experimental	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. Receives: Drug: Naltrexone 380 MG; Behavioral: Enhanced linkage
IV Ketamine	Experimental	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. Receives: Drug: Ketamine Hydrochloride; Behavioral: Enhanced linkage
Linkage	Active comparator	Participants will receive no single-dose addiction medication prior to hospital discharge, but will receive enhanced linkage to follow-up addiction care. Receives: Behavioral: Enhanced linkage

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Note that it is not dependent on study completion, so it is analyzed by intent to treat.
Measured: Within 30 days of index hospital discharge. The enrollment period is 12 months.
Feasibility - Recruitment Rate (# Per Month)
Number of participants recruited per month during the enrollment period
Measured: The enrollment period is 12 months
Feasibility - Follow-up Rate (%)
Percentage of patients who presented to follow-up appointment within 14 days
Measured: 14 days

Secondary outcomes (1)

Rate (%) of 30-day Emergency Department Visit
Binary outcome: any all-cause ED visit ascertained by chart review
Measured: Within 30 days of index hospital discharge. The enrollment period is 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jan 20211 Feb 2022

First posted24 Sep 2020
Study start19 Jan 2021
Primary completion1 Jan 2022
Study completion1 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Alcohol Use Disorder, SevereStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04562779
Sponsor's protocol ID: 20-2008
Status last verified: Nov 2022
First submitted: 14 Sep 2020
Last updated: 2 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Terasaki D, Loh R, Cornell A, Taub J, Thurstone C. Single-dose intravenous ketamine or intramuscular naltrexone for high-utilization inpatients with alcohol use disorder: pilot trial feasibility and readmission rates. Addict Sci Clin Pract. 2022 Nov 22;17(1):64. doi: 10.1186/s13722-022-00345-y.
PubMed 36419181

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alcohol Use Disorder, Severe trials

Study at a glance

From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-dose Interventions to Reduce Re-admissions for Hospitalized Patients With Refractory Alcohol Use Disorder: A Randomized Pilot Feasibility Study.
ClinicalTrials.gov ID: NCT04562779
Acronym / sponsor ID: 20-2008
Conditions: Alcohol Use Disorder, Severe
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Denver Health and Hospital AuthorityUniversity, hospital or other
Study start: 19 Jan 2021 (actual)
Primary completion: 1 Jan 2022 (actual)
Study completion: 1 Feb 2022 (actual)
First posted: 24 Sep 2020 (actual)
Results: Posted 2 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
XR Naltrexone	Experimental	Drug: Naltrexone 380 MG, Behavioral: Enhanced linkageParticipants will receive a single dose of extended-release, injectable naltrexone prior to hospital discharge, in addition to enhanced linkage to follow-up addiction care.
IV Ketamine	Experimental	Drug: Ketamine Hydrochloride, Behavioral: Enhanced linkageParticipants 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.
Linkage	Active comparator	Behavioral: Enhanced linkageParticipants will receive no single-dose addiction medication prior to hospital discharge, but will receive enhanced linkage to follow-up addiction care.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (18 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Naltrexone 380 MGXR naltrexone to be given once prior to hospital discharge	Drug	XR Naltrexone
Ketamine HydrochlorideIV ketamine infusion to be given once prior to hospital discharge	Drug	IV Ketamine
Enhanced linkageIncludes in-hospital intake at outpatient addiction clinic plus contingency management related to follow-up	Behavioural	IV Ketamine, Linkage, XR Naltrexone

Primary outcome

Rate (%) of 30-day Hospital Re-admission
Time frame: Within 30 days of index hospital discharge. The enrollment period is 12 months.
Binary outcome: any all-cause hospitalization ascertained by chart review (our EHR includes records from several local hospitals). Note that it is not dependent on study completion, so it is analyzed by intent to treat.
Feasibility - Recruitment Rate (# Per Month)
Time frame: The enrollment period is 12 months
Number of participants recruited per month during the enrollment period
Feasibility - Follow-up Rate (%)
Time frame: 14 days
Percentage of patients who presented to follow-up appointment within 14 days

1 secondary outcome

Rate (%) of 30-day Emergency Department Visit
Time frame: Within 30 days of index hospital discharge. The enrollment period is 12 months.

Results and safety

Results posted to the registry on 2 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
XR Naltrexone	14	5
IV Ketamine	13	6
Linkage	17	7

Primary outcome: Rate (%) of 30-day Hospital Re-admission

Time frame: Within 30 days of index hospital discharge. The enrollment period is 12 months.. Count of participants. Unit: Participants

Measure	XR Naltrexone n = 14	IV Ketamine n = 13	Linkage n = 17
Value	3	2	7

Primary outcome: Feasibility - Recruitment Rate (# Per Month)

Time frame: The enrollment period is 12 months. Mean (Standard Deviation). Unit: participants per month recruited

Measure	Full Trial Sample n = 44
Value	3.7 (2.8)

Primary outcome: Feasibility - Follow-up Rate (%)

Time frame: 14 days. Count of participants. Unit: Participants

Measure	XR Naltrexone n = 14	IV Ketamine n = 13	Linkage n = 17
Value	7	8	7

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Immediate effects of IM naltrexone or IV ketamine were assessed immediately after administration in the hospital. Adverse events by PRISE questionnaire were assessed at follow-up visit (targeted at 1 week post-discharge) for those who attended. Deaths and serious adverse events would be detected at any point within 30 days post-discharge from electronic health record alerts, direct patient communication with study team, or other staff communication.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
XR Naltrexone	0 of 14 (0%)	5 of 14 (35.7%)	0 of 14
IV Ketamine	0 of 13 (0%)	6 of 13 (46.2%)	0 of 13
Linkage	0 of 17 (0%)	6 of 17 (35.3%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36419181Terasaki D, Loh R, Cornell A, Taub J, Thurstone C. Single-dose intravenous ketamine or intramuscular naltrexone for high-utilization inpatients with alcohol use disorder: pilot trial feasibility and readmission rates. Addict Sci Clin Pract. 2022 Nov 22;17(1):64. doi: 10.1186/s13722-022-00345-y.
Individual participant dataSharing planned: No

Related trials for Alcohol Use Disorder, Severe

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate (%) of 30-day Hospital Re-admission (time frame: Within 30 days of index hospital discharge. The enrollment period is 12 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04562779, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.