Ketamine for Combined Depression and Alcohol Use Disorder (NCT06090422) | Clinical Trial Compass
RecruitingPhase 1/2
Ketamine for Combined Depression and Alcohol Use Disorder
Norway34 participantsStarted 2025-01-20
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 breastfeed…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Depression
Timeframe: Within 3 days after final treatment session