Ketamine-Enhanced Therapy for Individuals With Alcohol Use Disorder and Depression: A Pilot Study… (NCT07247370) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Ketamine-Enhanced Therapy for Individuals With Alcohol Use Disorder and Depression: A Pilot Study (KET-DUAL)
Australia20 participantsStarted 2025-12-10
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Feasibility will be assessed through recruitment rates, retention to follow-up, session attendance, and treatment adherence.
Timeframe: 22 weeks
2
Safety will be assessed through the frequency, severity, and relatedness of adverse events (AEs), including dissociation, affective destabilisation, and vital sign abnormalities.