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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDr. med. Marcus Herdener

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

75 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Dr. med. Marcus Herdener

Lead sponsor

Psychiatric University Hospital, Zurich

Sponsor institution

University of Zurich

Collaborator