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

This Phase II, randomised, placebo-controlled, double-blind trial (n=75) will assess the therapeutic effects of a single intravenous dose of ketamine (56mg/70kg) combined with real-time fMRI neurofeedback (rt-fMRI NFT) on alcohol use disorder (AUD).

Conducted at the Psychiatric University Hospital in Zurich and led by Dr. Marcus Herdener, the study will investigate whether modulating glutamatergic neurotransmission in the nucleus accumbens — a brain region involved in reward and craving — can reduce alcohol consumption and cravings. Participants will be randomly assigned to one of three intervention groups: ketamine with active rt-fMRI NFT, ketamine with sham NFT, or placebo with active NFT. The neurofeedback sessions will last 25 minutes, during which participants will learn to downregulate cravings in response to alcohol-related cues. Researchers aim to evaluate changes in alcohol use (measured daily and by the number of heavy drinking days), brain plasticity markers, and individual differences in ketamine metabolism.

The study addresses the limitations of previous research that showed variable responses to ketamine therapy and explores whether combining pharmacological (ketamine-induced neuroplasticity) and non-pharmacological (NFT) treatments offers superior outcomes. Eligible participants are adults aged 18–65 with a DSM-IV diagnosis of AUD, physically healthy, and motivated to reduce or stop drinking. The study is expected to run from May 2025 to December 2026.

Trial Details

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.

Trial Number NCT06969937

Data attribution

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