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WithdrawnPhase 2

Ketamine for the Treatment for Alcohol Use Disorder in the ED

NCT05661669 · Brigham and Women's Hospital

Closed to entry
Status
Not accepting participants
Phase 2
Phase
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The investigators' approach is to conduct a pilot double-blind, placebo-controlled randomized clinical trial with individuals with alcohol use disorder (AUD) seeking inpatient alcohol detoxification in the emergency department (ED) to receive either intravenous ketamine or saline placebo. The primary aim is to evaluate the intervention's safety. The secondary aim is to evaluate the preliminary efficacy of alcohol-related outcomes.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Safety of administering ketamine in the emergency department (ED) for alcohol use disorder (AUD) patients seeking detoxification

    Measured over Outcomes will be assessed throughout the inpatient admission, on average 3-5 days and throughout duration of study.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * English speaking adults aged 18 and above * Diagnosed with DSM5 alcohol use disorder, severe * Admitted to BWF inpatient withdrawal management unit (Addiction Recovery Program) Exclusion Criteria: * Any psychotic disorder, bipolar disorder, active suicidality or homicidality * Inability to perform consent due to impaired mental status * Clinical Institute Withdrawal Assessment (CIWA) score \> 20 at any point in the ED * Alcohol withdrawal seizure prior to or during the ED visit * Systolic blood pressure persistently elevated above 180mmHg, or heart rate \>130bmp, in the ED * History of hypersensitivity to ketamine, or experience of emergence reaction * History of any illicit or recreational use of ketamine * Receipt of ketamine treatment for depression in the past 3 months * History of DSM5 hallucinogen use disorder, intracranial mass or bleed, porphyria, thyrotoxicosis, seizure disorder other than from alcohol withdrawal, liver cirrhosis, renal failure, obstructive lung disease, or sleep apnea * History within 6 months of head trauma, stroke, or myocardial infarction * Liver dysfunction with LFTs \>3x upper normal limit * Current use of medications with known drug-drug interactions with ketamine (i.e., St. John's Wort, theophylline, opioid analgesics, CNS depressants other than benzodiazepines or phenobarbital) * Pregnant

Where

1 study site

FacilityCityRegionCountry
Brigham and Women's Faulkner HospitalBostonMassachusettsUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05661669 on ClinicalTrials.gov →

Last updated in the registry 2025-01-08. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits