This triple-blind, randomised, placebo-controlled trial (n=60) will study the role of neuroplasticity in the behavioural effects of psilocybin in individuals with mild declines in emotional wellbeing. Participants will receive one of four medication combinations, involving either 25 mg or 1 mg of psilocybin alongside intravenous (IV) midazolam or IV saline.
The study, sponsored by the University of Wisconsin, Madison, aims to assess whether psilocybin-induced neuroplasticity contributes to improved wellbeing.
Participants will undergo MRI scans, complete questionnaires, and receive transcranial magnetic stimulation (TMS) and EEG assessments. The primary outcomes include changes in cognitive flexibility, wellbeing, and experiential avoidance, with secondary measures evaluating psychological flexibility, emotional breakthroughs, and neural excitability. The trial is expected to begin in February 2025 and conclude in November 2027.
Trial Details
The goal of this clinical trial is to learn about the role that inducing neuroplasticity (the brain's ability to adapt and change) plays in the behavioral effects of psilocybin in people who have experienced a mild decline in emotional wellbeing. Researchers will compare different doses of psilocybin combined with midazolam or placebo to see what dose induces increased wellbeing. Participants will: -Receive one of four possible combinations of medications -Undergo an MRI -Complete questionnaires -Undergo transcranial magnetic stimulation (TMS) and EEGTrial Number NCT06692192
Sponsors & Collaborators
University of Wisconsin-MadisonThe Transdisciplinary Center for Research in Psychoactive Substances (TCRPS) was launched at the University of Wisconsin-Madison in 2021.