Ketamine for Combined Depression and Alcohol Use Disorder
Recruiting now · Phase 1/Phase 2
Conditions studied: Depression, Alcohol Use Disorder
In brief
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.
Key facts
- Study ID
- NCT06090422
- Run by
- University Hospital of North Norway
- People needed
- 34
- Starts
- 2025-01-20
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-06-23
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Department of Addiction, University Hospital of North Norway — Tromsø, Norway (enrolling)
Full record on ClinicalTrials.gov
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