RecruitingPhase 1 / Phase 2

Ketamine for Combined Depression and Alcohol Use Disorder

NCT06090422 · KeDA · University Hospital of North Norway

Recruiting

Status

Accepting participants

Phase 1 / Phase 2

Phase

Target enrolment

Study sites

Outside the US

What it is testing

Summary

The goal of this clinical trial is to investigate the effects of ketamine, in combination with standard inpatient addiction therapy, for adults with depression and alcohol use disorder. After screening and enrollment, participants will undergo baseline assessments of depression, measures of alcohol use and craving, as well as neurocognitive function. Participants will then be randomized to either ketamine (intervention) or midazolam (control). All participants will be admitted for standard inpatient addiction therapy while receiving ketamine or midazolam. Measures on safety, depression and alcohol use disorder will be repeatedly assessed during and after treatment. Final follow-up assessment is scheduled 6 months after baseline assessment.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Depression
Measured over Within 3 days after final treatment session

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years

Ages

All

Sex

Not accepted

Healthy volunteers

Please contact the project team for a full and detailed list of inclusion/exclusion criteria Inclusion Criteria: * Currently abstinent from alcohol * At least moderate depression without psychotic features * Minimum Montgomery-Åsberg Depression Rating Scale (MADRS) of 20 * Alcohol dependence * Admitted for inpatient addiction therapy at University Hospital of North Norway Exclusion Criteria: * Intoxicated or in significant withdrawal from alcohol or drug use * Not able to give adequate informed consent * Current or past history of schizophrenia, schizophreniform disorder, paranoid delusional disorder, schizoaffective disorder * Current or historical diagnosis of schizophrenia in a first degree relative * Cardiovascular conditions: recent stroke (\< 1 year from informed consent), recent myocardial infarction (\< 1 year from informed consent), uncontrolled hypertension (\>150/100 mm Hg) or recent arrhythmia (\< 1 year from informed consent; clinically significant arrhythmia requiring treatment at hospital) * Liver (Child-Pughs Class C) or kidney (Creatinin clearance \< 30 mL/min) failure * Heart failure (the New York Heart Association Functional Classification (NYHA) class III or IV) * Chronic respiratory failure (requiring long-term oxygen therapy (LTOT) and/or Global Initiative for Chronic Obstructive Lung Disease system (GOLD) stage 3 or higher) * Previous anaphylactic reaction to ketamine or midazolam * Illegal use of ketamine the last 6 months * Pregnancy or breastfeeding * Current or suspected increased intracranial pressure

Where

1 study site

Facility	City	Region	Country
Department of Addiction, University Hospital of North Norway	Tromsø	—	Norway

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06090422 on ClinicalTrials.gov →

Last updated in the registry 2026-06-23. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Ketamine

Indication