Trial intelligence / Profile preview

Ketamine-Enhanced Psychotherapy for AUD and MDD

NCT07247370Phase 2

Key facts

Status: Not yet recruiting
Start: Dec 2025
Primary completion: Apr 2027
Countries: 1
Sponsor: South Western Sydney Local Health District
Modality: Small Molecules

Drugs: ketamine
Conditions: alcohol use disorder (AUD)major depressive disorder (MDD)

Overview

Phase 2, open-label trial of ketamine in alcohol use disorder (AUD) and major depressive disorder (MDD), sponsored by South Western Sydney Local Health District. Primary endpoints: Feasibility (Recruitment, Retention, Attendance) at 22 weeks and Safety (Adverse Events) at 22 weeks. Planned start Dec 2025; status: not yet recruiting.

Design

Study design: Non-randomizedOpen-labelSingle group

Who it enrols

Adults aged 18-70 with moderate to severe Alcohol Use Disorder and comorbid Major Depressive Disorder, motivated to reduce alcohol use. Excludes those with psychotic disorders, acute suicidality, recent ketamine use, severe medical conditions, or active other substance use disorders.

Endpoints

Primary

Feasibility (Recruitment, Retention, Attendance)22 weeks
Safety (Adverse Events)22 weeks

Secondary

Number of Heavy Drinking Days per week22 weeks
Total Alcohol Consumption22 weeks
Montgomery-Åsberg Depression Rating Scale22 weeks
Depression Anxiety Stress Scales-2122 weeks
Columbia Suicide Severity Rating Scale22 weeks
Positive and Negative Mood StatesWeek 6

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