Ketamine for the Treatment for Alcohol Use Disorder in the ED

This pilot double-blind, placebo-controlled randomized clinical trial (n=50) aims to assess the safety and preliminary efficacy of ketamine as a treatment for individuals with alcohol use disorder (AUD) seeking inpatient alcohol detoxification in the emergency department (ED).

Conducted at Brigham and Women’s Faulkner Hospital in Boston, MA, the study will administer either intravenous ketamine or saline placebo to participants. The intervention involves a single infusion of ketamine at a dose of 0.8mg/kg over 40 minutes. Participants will also receive standard detoxification treatment, intensive psychosocial support, and referral to outpatient treatment.

The primary aim is to evaluate the safety of the intervention, focusing on the incidence of severe adverse events such as hypertensive urgency or tachycardia. Secondary aims include assessing the preliminary efficacy of ketamine on alcohol-related outcomes, such as proportion of abstinent days, days to relapse, proportion of heavy drinking days, and engagement with addiction treatment. The study hypothesizes that ketamine will show adequate safety and better drinking outcomes compared to the placebo group.

Eligible participants include English-speaking adults aged 18 and above diagnosed with DSM 5 alcohol use disorder, severe, and admitted to the hospital’s inpatient withdrawal management unit. Exclusion criteria include various medical and psychiatric conditions, as well as pregnancy.

The study is scheduled to start in October 2023 and is estimated to complete in August 2024. It is a phase II interventional trial with a randomized allocation conducted under triple masking (participant, investigator, outcomes assessor).

Trial Details

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.

NCT Number

Data attribution

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