To assess the safety, feasibility and preliminary efficacy of ketamine-enhanced therapy (KET) for alcohol use disorder (AUD) and comorbid major depressive disorder (MDD) in an open-label, single arm, pilot clinical trial.
Moderate to severe AUD according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V) criteria
Presence of current Major Depressive Disorder (MDD), according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V) criteria
Expressed motivation to reduce or cease alcohol consumption.
Consumed at least 21 standard drinks per week or 2 HDD per week (≥5 standard drinks/day for men; ≥4 for women) in the month prior to screening
DSM-5 diagnosis of current or past psychotic disorder, bipolar I disorder, or substance-induced psychosis.
Current acute suicidality, defined as high risk by the Columbia Suicide Severity Rating Scale (C-SSRS) or clinical judgment or attempts in the past 6 months.
DSM-5 diagnosis of current or past moderate-to-severe ketamine or other dissociative drug use disorder.
Use of ketamine (prescribed or non-prescribed) in the previous 4 weeks.
South West Sydney Local Health District
Lead sponsor
University of Sydney
Collaborator