Investigation of the Combined Effect of Ketamine and Neurofeedback Training in the Treatment of Alcohol Use Disorder
Summary description of the study
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)
Intervention under investigation
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)
Disease under investigation
Alcohol Use Disorder
(BASEC)
• DSM-IV diagnosis of alcohol use disorder (mild to severe) • Motivation to reduce or stop alcohol consumption • Good physical health without unstable medical conditions (BASEC)
Exclusion criteria
• History of severe substance use disorder according to DSM-IV (except alcohol, excluding caffeine or nicotine) within two months prior to participation, as well as any opioid use disorder within two months prior to participation. • Life history of bipolar disorder or schizophrenia/schizoaffective disorder/psychosis (BASEC)
Trial sites
Zurich
(BASEC)
Sponsor
Dr. Marcus Herdener
(BASEC)
Contact
Contact Person Switzerland
Patricia Dürler
+41583843324
patricia.duerler@clutterbli.uzh.chUniversity of Zurich
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
11.04.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Phase II, randomised, placebo-controlled, double blind, parallel group, single centre study investigating ketamine and neurofeedback as combined therapeutic interventions to target glutamatergic neurotransmission in alcohol use disorder. (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
not available
Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
not available
Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
not available