RecruitingPhase 2

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

Switzerland75 participantsStarted 2025-06-01

Plain-language summary

The goal of this clinical trial is to learn about the effects of the combination of ketamine and realtime functional magnetic resonance imaging (fMRI) neurofeedback training on the treatment of individuals with alcohol use disorder (AUD). The main questions the investigators aim to answer are: * Can the investigators observe a positive, significant therapeutic effect by comparing changes in alcohol use via i) mean alcohol use per day, ii) heavy drinking days one month after the last treatment intervention? * Are changes in glutamatergic neurotransmission in the nucleus accumbens related to cue-induced cravings in individuals with AUD? * Is there a significant, ketamine-dependent change in glutamate levels in the nucleus accumbens? Participants will be given ketamine or placebo and real-time fMRI neurofeedback (rt-fMRI NFT) or sham rt-fMRI NFT. The investigators will compare three intervention groups to investigate the effects of the stand-alone effects as well as potential synergies between the combination of pharmacological and non-pharmacological intervention.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 tr…

What they're measuring

Change in mean alcohol use per day

Timeframe: Starting immediately after the intervention visit 2 and ending 4 weeks later (integration visit).

Change in heavy drinking days

Timeframe: Starting immediately after the intervention visit 2 and ending 4 weeks later (integration visit).

Trial details

NCT IDNCT06969937

SponsorDr. med. Marcus Herdener

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Marcus Herdener, PD Dr. med.

+41583845810 marcus.herdener@bli.uzh.ch