NCT06090422 Ketamine for Combined Depression and Alcohol Use Disorder
| NCT ID | NCT06090422 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University Hospital of North Norway |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2025-01-20 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 34 participants in total. It began in 2025-01-20 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Ole K Grønli, Assoc Prof
STUDY DIRECTOR
University Hospital of North Norway
Frequently Asked Questions
Who can join the NCT06090422 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06090422 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06090422 currently recruiting?
Yes, NCT06090422 is actively recruiting participants. Contact the research team at andreas.wahl.blomkvist@unn.no for enrollment information.
Where is the NCT06090422 trial being conducted?
This trial is being conducted at Tromsø, Norway.
Who is sponsoring the NCT06090422 clinical trial?
NCT06090422 is sponsored by University Hospital of North Norway. The principal investigator is Ole K Grønli, Assoc Prof at University Hospital of North Norway. The trial plans to enroll 34 participants.
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