This Phase II, randomised, placebo-controlled, double-blind, parallel-group single-centre trial (n=75) will assess the effects of a single IV ketamine infusion (0.8 mg/kg) combined with real-time fMRI neurofeedback versus sham NFT and placebo in people with alcohol use disorder.
Randomised, placebo-controlled, double-blind, parallel-group Phase II single-centre study evaluating a single IV ketamine infusion (0.8 mg/kg) alone or combined with closed-loop rt-fMRI neurofeedback in adults with alcohol use disorder (n=75).
Primary mechanistic outcomes assess glutamatergic signalling in the nucleus accumbens and ketamine-dependent changes in glutamate; neuroplasticity markers (BDNF) and ketamine metabolism will also be measured.
Clinical endpoints include mean alcohol use per day and heavy drinking days one month after the last intervention; rt-fMRI NFT consists of a 25-minute closed-loop training to downregulate cue-induced cravings.
Real-time fMRI neurofeedback with single IV ketamine 0.8 mg/kg.
Closed-loop real-time fMRI neurofeedback (25 minutes) to downregulate cue-induced cravings.
Sham neurofeedback with single IV ketamine 0.8 mg/kg.
Sham neurofeedback based on control region activity.
Real-time fMRI neurofeedback with single placebo (0.9% NaCl) infusion.
0.9% NaCl infusion (placebo).
Closed-loop real-time fMRI neurofeedback (25 minutes).