Ketamine for the treatment for alcohol use disorder in the emergency department: A pilot double-blind, placebo-controlled randomized clinical trial - Project Summary Abstract
An estimated 15 million Americans have an alcohol use disorder (AUD), resulting annually in 95,000 deaths from
alcohol-related causes and 250 billion dollars in economic burden. Yet, epidemiologic studies have consistently
found that the vast majority of those with AUD are not receiving any evidence-based treatments. One of the
consequences of an untreated AUD is the need for medical treatment to address the acute and chronic effects
of heavy drinking, which has resulted in the number of alcohol-related emergency department (ED) visits to
increase by 61.6% from 3.1 million to 5.0 million. This makes the ED an important and timely setting to engage
individuals with AUD to enter addiction treatment as evidenced by the success of behavioral interventions like
Screening, Brief Intervention and Referral to Treatment (SBIRT). However, SBIRT has not been as impactful for
those with severe AUD, and it has been difficult for many EDs to successfully implement and sustain brief
interventions. As such, more effective strategies that can be implemented in the ED setting to address AUD are
critically needed. Ketamine has emerged as a potential treatment option for AUD. Ketamine has garnered
interest due to its potential in treating psychiatric disorders, rapidly diminishing depressive and suicidal symptoms
among individuals with treatment-resistant depression. Sub-anesthetic doses of ketamine administered in either
single or multiple sessions in conjunction with psychotherapy has shown beneficial effects for patients with
alcohol, opioid, and cocaine use disorders. A major advantage of ketamine is that it is already an accepted
pharmacotherapy used routinely in the ED for procedural sedation, agitation, and acute pain. If ketamine could
be used as an effective pharmacotherapy for AUD in the ED, the approach would be consistent with Screening,
Treatment Initiation, and Referral (STIR) which may be more beneficial for patients with severe AUD than the
traditional SBIRT approach. However there remains a significant gap in understanding the safety of ED-initiated
ketamine in improving AUD-related outcomes for those who seek detoxification. To fill this need, we propose to
conduct a pilot double-blind placebo-controlled randomized clinical trial with the primary aim of assessing the
safety of administering ketamine in the ED to AUD patients seeking admission to an inpatient detoxification unit.
All participants will receive the hospital’s standard detoxification treatment which also includes intensive
psychosocial support. Participant selection will focus on ensuring the exclusion of those with potential medical
and psychiatric co-morbidities that pose a risk when administered ketamine. Eligible participants will be randomly
assigned to receive either a single infusion of ketamine or saline placebo in the ED. Vital signs, adverse effects,
alcohol withdrawal, and craving for alcohol and ketamine will be monitored closely throughout the trial. As an
exploratory aim, we will assess alcohol-related outcomes as well as mechanisms of behavior change. If
successful, this line of research will help establish the safety of ketamine administration for AUD in the ED, and
facilitate the design of an adequately powered efficacy trial.
