Ketamine and Neurofeedback as Combined Therapeutic Interventions to Target Glutamatergic Neurotransmission in Alcohol Use Disorder

Launched by PSYCHIATRIC UNIVERSITY HOSPITAL, ZURICH · May 8, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring the combined effects of ketamine, a medication often used for pain and depression, and a special type of brain training called real-time functional magnetic resonance imaging (fMRI) neurofeedback, on people struggling with alcohol use disorder (AUD). The researchers want to find out if this combination can help reduce the amount of alcohol people consume and lessen their cravings when they see cues related to drinking. They will compare three different groups: some will receive ketamine with neurofeedback, others will get a placebo (a non-active treatment) with neurofeedback, and the last group will receive ketamine with a sham (fake) neurofeedback.

To participate in this trial, individuals should be between 18 and 65 years old and have a diagnosis of alcohol use disorder. They must be motivated to reduce their alcohol consumption and be in generally good health. The study will involve several visits where participants will receive treatments and answer questions about their drinking habits. It's important to note that participants should not have a history of certain severe mental health issues or other significant health problems. This trial is currently not recruiting participants, but it aims to provide valuable insights into potential new treatments for those dealing with alcohol dependence.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Informed Consent as documented by signature
• • In- and outpatients aged 18 to 65 years of all sexes.
• • DSM-IV diagnosis of alcohol use disorder (mild - severe).
• • Motivation to reduce or stop alcohol use
• • Normal level of language comprehension (German or Swiss-German)
• • Good physical health with no unstable medical conditions
• • Participants of childbearing potential must use an effective and established method of contraception for the entire study duration
• • Comply with the study protocol as explained by investigator
• Exclusion Criteria:
• • History of DSM-IV severe drug dependence other than alcohol (except for caffeine or nicotine) and any opiod use disorder within two months prior to enrolment.
• • Hallucinogen and ketamine use 3 months prior to study participation (including regular microdosing).
• • Alcohol withdrawal symptoms at any of the treatment visits (V2 and V3) (CIWA-Ar Scale \>9).
• • Current or lifetime psychotic disorders
• • History of severe substance-induced psychosis
• • Current or lifetime bipolar I or II disorders
• • Current suicidality
• • Previous suicide attempts during the last 2 years
• • High risk of adverse emotional and behavioral reactions
• • Unmedicated or unstable hypertension
• • Severe illness (e. g. myocardial ischemia or arrythmias, severe pulmonary secretions, glaucoma, congestive heart failure or angina, significant renal or hepatic impairment)
• • Acute infection (e. g. pulmonary or upper respiratory tract infection)
• • Insufficient treated or uncorrected hyperthyroidism
• • Severe central nervous system related traumas or disorders (e. g. stroke, cerebral trauma with loss of consciousness over more than 24h, epilepsy)
• • During the study, new use or dose changes of already existing concomitant medication without prior informing the investigators.
• • Taking medications that are known to modualte uridine diphosphate glucuronosyltransferase-enzyme
• • Medication directly affecting glutamate signaling (e. g. anticonvulsant medication)
• • Inhibitors of UGT1A9 and 1A10 should be discontinued at least five half-lives prior to the administration of ketamine.
• • Monoamine oxidase and aldehyde or alcohol dehydrogenase inhibitors should be discontinued at least 5 half-lives prior to the dose of ketamine.
• • Pregnancy or lactation
• • Women of childbearing potential with no use of medically accepted contraceptive (e. g. condoms, contraceptive diaphragm, birth control pill, hormone injection, intrauterine device)
• • BMI \< 17 or \> 35
• • Allergy, hypersensitivity, or other adverse reaction to previous use of ketamine
• • Contradictions to magnetic resonance imaging
• • Concurrent participation in other clinical study