Ketamine-Enhanced Therapy for Individuals With Alcohol Use Disorder and Depression: A Pilot Study (KET-DUAL)

Prior treatment

• Use of ketamine (prescribed or non-prescribed) in the previous 4 weeks.
• Concurrent use of psychotropic medications (other than stable-dose antidepressants ≥4 weeks).

Other illness

• DSM-5 diagnosis of current or past psychotic disorder, bipolar I disorder, or substance-induced psychosis.
• DSM-5 diagnosis of current or past moderate-to-severe ketamine or other dissociative drug use disorder.
• Significant uncontrolled medical conditions, including but not limited to:
  • Severe or poorly controlled hypertension (\>160/100 mmHg)
  • Severe cardiovascular disease (e.g., heart failure, recent myocardial infarction, dysrhythmia)
  • History of stroke, cerebral trauma, or intracranial mass/haemorrhage
  • Severe hepatic impairment (e.g., MELD ≥10) or end-stage liver disease, bladder or kidney disease
• Clinically significant alcohol withdrawal at screening (e.g., CIWA-Ar ≥10, history of delirium tremens).
• History of heightened intracranial pressure, seizures, or diagnosed seizure disorder (except childhood febrile seizures).
• Known hypersensitivity to ketamine or any excipients.
• Active substance use disorder (moderate or severe) other than nicotine or caffeine; stable opioid use disorder permitted if on maintenance therapy (with strict stability criteria).
• Any clinically significant medical or psychiatric condition that, in the judgment of the Principal Investigator, poses a safety risk or could confound study results or hinder protocol adherence.

Other

• 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.
• Enrolment in another interventional clinical trial that may interfere with safety, data quality, or trial participation.
• Pregnant or breastfeeding, or planning to become pregnant during the course of the study.
• Inability or unwillingness to comply with study procedures, judged by the principal investigator.

• 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
• Age 18-70
• Adequate cognition and English language skills to give valid consent and complete research interviews
• Stable housing
• Willingness to give written informed consent.
• Willingness to comply with study procedures and attend scheduled visits.