Ketamine for Depression in people with Alcohol Use Disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase study enrolls adults with at least moderate depression and alcohol dependence who are admitted for inpatient addiction treatment. Participants are randomized to receive ketamine or a placebo (midazolam) alongside standard therapy, with safety, depressive symptoms, and alcohol use monitored during treatment and for 6 months afterward. The trial aims to determine safety and potential effects on depression and alcohol-related outcomes, informing future research in dual-diagnosis care. Ketamine administration occurs under medical supervision as part of the inpatient program at the Department of Addiction, University Hospital of North Norway, with collaboration from the University of Exeter.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Andreas W Blomkvist, M.D. — University Hospital of North Norway
• Study coordinator: Andreas W Blomkvist, M.D.
• Email: andreas.wahl.blomkvist@unn.no
• Phone: 41694637

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Computer-based therapy for anxiety and alcohol use disorders

  This study is testing a computer-based therapy for people with both anxiety and alcohol use disorders to see if it helps them feel better compared to standard treatment.

  Recruiting University of Minnesota · Minneapolis, Minnesota · NCT05117255

• Smartphone-supported single-session psychotherapy for postpartum depression

  A single online therapy session plus four weeks of app-based support is being tested to see if it reduces depressive symptoms in postpartum women compared with a waitlist.

  Recruiting University of Sao Paulo · São Paulo, São Paulo · NCT07925762

• Emotional Reactivity in Severe Alcohol Use Disorder and Depression Using Eye-Tracking and Physiological Measures

  This study tests how people with severe alcohol use disorder, major depressive disorder, both conditions, or neither, recognize and react to emotions using eye-tracking and physiological data.

  Recruiting Université Catholique de Louvain · Brussels, Belgium · NCT07925281

• Mindful Smartphone Use: A Mindfulness-Based Program for Teens with Sleep and Mood Challenges

  This study tests Mindwire, a mindfulness-based program, to see if it helps teens with problematic phone use who also have depression or anxiety.

  Recruiting Brown University · Providence, Rhode Island · NCT07892807

• Tele-based wellbeing centres for women's mental health in Bangladesh

  A randomized trial tests whether tele-counselling for depression and anxiety in Bangladeshi women is as effective as in-person counselling.

  Recruiting at 2 sites International Centre for Diarrhoeal Disease Research, Bangladesh · Chāndpur, Matlab Dakshin and 1 other locations · NCT07890896

• Remote monitoring for adults with depression using ThIA Suivi

  This study tests whether adding the ThIA Suivi remote monitoring tool to usual psychiatric care helps adults with depression feel more improved after 3 months compared with standard care alone.

  Recruiting at 3 sites Phase 1 ThIA Santé Mentale · Bron and 2 other locations · NCT07878754

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.