Study of Psilocybin and Midazolam Effects on Brain Plasticity and Emotional Wellbeing in Adults

What this Trial Is About

Researchers are investigating how inducing neuroplasticity, which is the brains ability to adapt and change, affects the behavioral impact of psilocybin in adults who have experienced a mild decline in emotional wellbeing. This Phase 1 study compares different doses of psilocybin combined with either midazolam or a placebo to understand which dose may increase wellbeing. Participants will be randomly assigned to one of four groups receiving either 25 mg or 1 mg of psilocybin combined with intravenous midazolam or saline placebo. Midazolam is used to induce amnesia of the psychedelic experience without over-sedation. During the study, participants will receive these medication combinations under controlled conditions. Throughout the trial, participants will undergo MRI scans, transcranial magnetic stimulation TMS, and EEG assessments. They will complete questionnaires measuring wellbeing and psychological responses at baseline and up to 28 days after dosing. The primary outcomes include changes in mental wellbeing, experiential avoidance, learning tasks, and brain activity from baseline to 7 days post-dose. Safety and behavioral effects will be monitored, with the total participation lasting several weeks.

The RECAP2 Study: Midazolam and Psilocybin