Investigation of the Combined Effect of Ketamine and Neurofeedback Training in the Treatment of Alcohol Use Disorder

Zusammenfassung der Studie

In this study, we investigate the effects of combining ketamine and neurofeedback training for the treatment of alcohol use disorder. Participants will be randomly assigned – like a coin toss – to one of three groups: ketamine with neurofeedback, placebo (an inactive substance) with neurofeedback, or ketamine with 'sham' neurofeedback (which provides no real feedback). Neither the participants nor the researchers will know which treatment they receive, ensuring unbiased results. The goal is to examine whether ketamine and neurofeedback, individually or in combination, can help reduce alcohol cravings and support treatment.

(BASEC)

Untersuchte Intervention

This clinical study aims to investigate the effects of combining ketamine infusions with neurofeedback training for the treatment of alcohol use disorder. Participants will be randomly assigned to one of three groups, each undergoing a specific investigation that is part of the clinical study. The groups and their respective interventions are as follows:

1. Ketamine + Neurofeedback Training

Participants in this group will receive an intravenous infusion of ketamine at a dose of 0.8 mg/kg, administered over approximately 40 minutes. After the infusion, they will participate in neurofeedback training sessions. These sessions target specific brain regions associated with alcohol cravings and self-regulation, helping participants gain better control over their responses to alcohol-related triggers. The neurofeedback training sessions (each lasting 25 minutes) will take place on two different days, aiming to examine whether the combination of ketamine and neurofeedback training reduces alcohol cravings more effectively than other approaches.

2. Placebo + Neurofeedback Training

This group will receive an intravenous infusion of a placebo (saline solution), administered over approximately 40 minutes, mimicking the experience of ketamine administration without the active ingredient. Subsequently, participants will engage in the same neurofeedback training as the ketamine + neurofeedback group. This group serves as a control group to investigate the influence of neurofeedback training alone on reducing alcohol use disorder symptoms.

3. Ketamine + Sham Neurofeedback

In this group, participants will receive ketamine at the same dose (0.8 mg/kg) and duration as in the ketamine + neurofeedback group. Instead of real neurofeedback training, they will participate in sham neurofeedback training, where they receive feedback that does not reflect their actual brain activity. This approach allows researchers to examine the effects of ketamine independently of active neurofeedback training and determine whether ketamine alone has an impact on outcomes related to alcohol use disorder.

These three interventions will help us investigate the individual and combined effects of ketamine and neurofeedback training on reducing alcohol cravings and supporting the long-term treatment of alcohol use disorder.

(BASEC)

Untersuchte Krankheit(en)

Alcohol Use Disorder

(BASEC)

Sponsor

Dr. Marcus Herdener

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Zürich

(BASEC)

Datum der Bewilligung durch die Ethikkommission

11.04.2025

(BASEC)

Ergebnisse der Studie