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Study on Ketamine and Midazolam for Adults with Depression and Alcohol Use Disorder

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of ketamine on individuals who have both depression and alcohol use disorder. The trial will use a medication called Ketalar, which contains the active ingredient ketamine. Another medication involved in the study is Midazolam Accord, which contains midazolam hydrochloride. The purpose of the study is to evaluate how effective ketamine is in treating depression in adults who are also dealing with alcohol use disorder and are receiving therapy for addiction.

Participants in the study will receive treatments through intravenous infusion, which means the medication is given directly into a vein. The study will compare the effects of ketamine with those of a placebo to see if there is a significant difference in how well the depression symptoms improve. The trial will also look at changes in alcohol cravings and consumption, as well as any side effects that may occur during the treatment sessions.

The study will take place over a period of time, with participants being monitored for changes in their symptoms and overall health. The goal is to gather information on how ketamine can help people with both depression and alcohol use disorder, and to understand its impact on their mental health and alcohol consumption habits. This research aims to provide valuable insights into potential new treatment options for individuals facing these challenges.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age (18-65 years), presence of moderate depression without psychotic features, and alcohol dependence as the primary substance use disorder.
Admission to the hospital for inpatient addiction therapy is required.
Step 2
Treatment sessions
The treatment involves the administration of two medications: midazolam hydrochloride and ketamine.
Both medications are given as a solution for injection or infusion through a vein (intravenous infusion).
The specific dosage and frequency of administration are determined by the study protocol.
Step 3
Monitoring and assessment
The primary outcome is measured by the change in depression symptoms using the MADRS scale from the start of the study to within three days after the final treatment session.
Secondary outcomes include changes in alcohol craving, alcohol consumption, and neurocognitive function, as well as the frequency and severity of any adverse reactions.
Step 4
Post-treatment follow-up
Follow-up assessments are conducted to evaluate changes in alcohol consumption from three months before admission to six months after treatment.
Tolerability of the treatment is assessed through reports from both participants and physicians.

Who can join the trial?

4 criteria

Must be between 18 and 65 years old.
Must have at least moderate depression without any psychotic features. Depression is a mental health condition that affects mood and can cause feelings of sadness and loss of interest.
Must have alcohol dependence as their main substance use disorder. Alcohol dependence means having a strong need to drink alcohol and difficulty controlling its use.
Must be admitted to the hospital for inpatient addiction therapy at one of the inpatient units at University Hospital of North Norway. Inpatient therapy means staying in the hospital to receive treatment.

Who cannot join the trial?

5 criteria

Individuals who are not diagnosed with both depression and alcohol use disorder cannot participate. Depression is a condition that affects mood and can cause feelings of sadness, while alcohol use disorder is a pattern of alcohol use that involves problems controlling drinking.
Participants must be admitted for addiction therapy, meaning they are receiving treatment for their alcohol use disorder.
Individuals who do not fall within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Both males and females are eligible, so gender is not a reason for exclusion.
Individuals who are considered part of a vulnerable population are not eligible. A vulnerable population includes groups who may have limited ability to protect their own interests.

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Verified sites

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Sykehuset Oestfold HF Kalnes
Responsive
Graalum, Norway
Universitetssykehuset Nord-Norge HF
Responsive
Tromsø, Norway

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Investigated drugs

Ketamine is being studied for its potential to help with depression in adults who also have an alcohol use disorder. The trial aims to see if ketamine can effectively reduce symptoms of depression in these individuals while they are receiving treatment for addiction.

What is already known about the treatment

Ketamine – Ketamine is administered intravenously or intranasally and is currently being studied for its potential benefits in treating depression and alcohol use disorder. It is gaining attention in medical literature for its rapid-acting antidepressant effects, especially in cases where traditional treatments have failed. The main therapeutic indications include depression and alcohol use disorder. At the molecular level, ketamine works by blocking NMDA receptors in the brain, which are involved in mood regulation and synaptic plasticity. It is classified pharmacologically as an anesthetic and is also known for its off-label use in mental health conditions.

Investigated diseases

Depression
Depression is a mental health disorder characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. It can affect how a person thinks, feels, and handles daily activities. Symptoms may include changes in appetite, sleep disturbances, fatigue, and difficulty concentrating. The condition can vary in severity and duration, with some individuals experiencing recurrent episodes. Depression can impact relationships and work performance, and it often requires a comprehensive approach to management.
Alcohol Use Disorder
Alcohol Use Disorder (AUD) is a chronic condition characterized by an inability to control or stop alcohol consumption despite negative consequences. It involves a pattern of alcohol use that leads to significant impairment or distress. Individuals with AUD may experience cravings, increased tolerance, and withdrawal symptoms when not drinking. The disorder can lead to problems in personal, social, and occupational areas of life. Over time, excessive alcohol use can cause physical and mental health issues. AUD often requires long-term strategies to manage and reduce alcohol intake.