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NOT YET RECRUITING

NCT07247370

PHASE1/PHASE2

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

Sponsor: South West Sydney Local Health District

View on ClinicalTrials.gov

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.

Official title: An Open-label Pilot Evaluation of Ketamine-Enhanced Psychotherapy in Individuals With Alcohol Use Disorder (AUD) and Co-morbid Major Depressive Disorder (MDD)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-12-10

Completion Date

2027-12-10

Last Updated

2025-11-25

Healthy Volunteers

Conditions

Alcohol Use Disorder (AUD)Major Depressive Disorder (MDD)Comorbidities and Coexisting Conditions

Interventions

DRUG

Ketamine

Subcutaneous administration of of Ketamine across 3 dosing sessions (at week 2, 4 and 6). Dosing adjustments are permitted based on tolerability, with a minimum dose of 0.7mg/kg and a potential maximum of 1.2 mg/kg, at the discretion of the principal investigator (previous studies have found efficacy at 0.8mg/kg for AUD).

BEHAVIORAL

Cognitive Behavioural Therapy

This study uses a manualized CBT program adapted for ketamine-assisted context. It integrates evidence-based CBT for substance use and depression with principles of psychedelic-assisted therapy, including "set and setting." considerations central to psychedelic-assisted therapy. The therapist manual includes guidance on psychological preparation, intention-setting, integration, and therapeutic framing of ketamine experiences. Participants receive six 90-minute sessions over six weeks, delivered by trained health professionals (e.g., psychologists, mental health nurses, social workers) with specific training in the adapted CBT protocol and psychedelic-assisted therapy. Sessions include: Preparation (Week 1): Review of alcohol use, treatment goals, and ketamine orientation. Integration (Weeks 2, 4, 6): Post-dose processing and linking experience to recovery goals occurring 24-48 hours post dose. Continued CBT (Weeks 3, 5): Coping strategies, goal setting, and relapse prevention.

Inclusion Criteria: 1. Moderate to severe AUD according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V) criteria 2. Presence of current Major Depressive Disorder (MDD), according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V) criteria 3. Expressed motivation to reduce or cease alcohol consumption. 4. 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 5. Age 18-70 6. Adequate cognition and English language skills to give valid consent and complete research interviews 7. Stable housing 8. Willingness to give written informed consent. 9. Willingness to comply with study procedures and attend scheduled visits. Exclusion Criteria: 1. DSM-5 diagnosis of current or past psychotic disorder, bipolar I disorder, or substance-induced psychosis. 2. 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. 3. DSM-5 diagnosis of current or past moderate-to-severe ketamine or other dissociative drug use disorder. 4. Use of ketamine (prescribed or non-prescribed) in the previous 4 weeks. 5. Enrolment in another interventional clinical trial that may interfere with safety, data quality, or trial participation. 6. Pregnant or breastfeeding, or planning to become pregnant during the course of the study. 7. 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 8. Clinically significant alcohol withdrawal at screening (e.g., CIWA-Ar ≥10, history of delirium tremens). 9. History of heightened intracranial pressure, seizures, or diagnosed seizure disorder (except childhood febrile seizures). 10. Known hypersensitivity to ketamine or any excipients. 11. Concurrent use of psychotropic medications (other than stable-dose antidepressants ≥4 weeks). 12. 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). 13. Inability or unwillingness to comply with study procedures, judged by the principal investigator. 14. 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.

Locations (1)

Drug Health Services, Royal Prince Alfred Hospital

Sydney, New South Wales, Australia