Ketamine Combined With Talk Therapy for Alcohol Use Disorder and Depression
Tests ketamine with talk therapy in adults with alcohol use disorder and depression.
Plain-language title generated from the registry record
Registry title: Ketamine-Enhanced Therapy for Individuals With Alcohol Use Disorder and Depression: A Pilot Study (KET-DUAL)
Key facts
- Where
- Sydney, AustraliaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07247370, who can take part
Where in Australia
- Drug Health Services, Royal Prince Alfred HospitalSydney, AustraliaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- South West Sydney Local Health District
- Trial code
- NCT07247370
- Record updated
- 25 November 2025
- Original description
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.Read full original descriptionShow less
An Open-label Pilot Evaluation of Ketamine-Enhanced Psychotherapy in Individuals With Alcohol Use Disorder (AUD) and Co-morbid Major Depressive Disorder (MDD)
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.
Inclusion: 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.
Exclusion: Use of ketamine (prescribed or non-prescribed) in the previous 4 weeks; Concurrent use of psychotropic medications (other than stable-dose antidepressants ≥4 weeks); 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; 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.