A new module in the drug development process: preclinical multi-center randomized controlled trial of R-ketamine on alcohol relapse.
Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology May 1, 2025 Marcus W Meinhardt, Ivan Skorodumov, Jérôme Jeanblanc et al. 8 citations
A new approach in psychiatric drug development, the preclinical randomized controlled trial (preRCT), was tested across three European centers using a rat model of alcohol relapse. Ketamine (20 mg/kg) reduced relapse, while R-ketamine worked only in females at the same dose; a higher dose (40 mg/kg) was effective in males. The sex-dependent effects were linked to plasma R-ketamine levels, which were twice as high in females. R-ketamine produced a lasting reduction in alcohol consumption without adverse effects. The findings support moving to a clinical trial that accounts for sex differences.