About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Ketamine
- Real-time fMRI Neurofeedback Training
- Placebo
- Sham Neurofeedback Training/ Ketamine
Treatment groups
Sponsors and collaborators
Dr. med. Marcus Herdener
Lead sponsor
Psychiatric University Hospital, Zurich
Sponsor institution
University of Zurich
Collaborator