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Ketamine therapy shows promise for alcohol and depression in early trial

NCT ID NCT07247370

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 70 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Drug Health Services, Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.