Ketamine for Combined Depression and Alcohol Use Disorder

• Status: Not yet recruiting
• Trial end date: 2027-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital of North Norway
• Collaborator: University of Exeter
• Treatments: Ketamine; Midazolam

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