Ketamine therapy shows promise for alcohol and depression in early trial
NCT ID NCT07247370
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This small pilot study will test whether adding ketamine to cognitive behavioral therapy (CBT) is safe and feasible for people with both alcohol use disorder and major depression. Twenty participants will receive three ketamine injections over six weeks along with CBT sessions. The main goals are to see if people stay in the study and to monitor side effects, not yet to prove the treatment works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ketamine
- What this could lead to
- If this works, it could point toward a new treatment approach for people struggling with both alcohol dependence and depression.
- What could go wrong
- This is a very early, small pilot study with only 20 participants. It is designed mainly to check safety and feasibility, not to prove effectiveness. Results may not apply to broader populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Drug Health Services, Royal Prince Alfred Hospital
Sydney, New South Wales, 2050, Australia
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