Recruiting

Ketamine for Combined Depression and Alcohol Use Disorder

ClinicalTrials.gov IDNCT06090422

PhasePHASE1, PHASE2

Enrollment34

SponsorUniversity Hospital of North Norway

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Depression, Alcohol Use Disorder

About this study

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.

Interventions

Drug: Ketamine Hydrochloride — Four single-doses, given two times per week for two weeks Dose: 0,8 mg/kg body weight Route of administration: intravenous infusions over 40 minutes
Drug: Midazolam Hydrochloride — Four single-doses, given two times per week for two weeks Dose: 0,02 mg/kg body weight Route of administration: intravenous infusions over 40 minutes

Primary outcomes

Depression (Within 3 days after final treatment session)

Eligibility information

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

Study locations

Department of Addiction, University Hospital of North Norway, Tromsø, Norway

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-29.