Mindfulness-based Psilocybin Therapy for PTSD
Phase II, assessor-blinded, randomised controlled trial (n=30) of a single 25 mg oral synthetic psilocybin dose given with either standard psychological support or psychological support plus MBCT in adults with PTSD.
Details
This study evaluates whether adding Mindfulness-based Cognitive Therapy (MBCT) to standard psychedelic-assisted therapy (PAT) with a single 25 mg oral psilocybin dose improves PTSD symptoms, neurophysiology and neuroplasticity versus psilocybin with non-directive support.
Design: initial open-label pilot of 10 participants receiving psilocybin + MBCT to refine the intervention, followed by a randomised, assessor-blinded parallel comparison of 20 participants (psilocybin + MBCT vs psilocybin + support). Assessments at baseline, Day 2 and Day 28 include EEG/EMG, fMRI/DWI, CAPS-5, MADRS, C-SSRS and self-report measures.
Safety measures and medication restrictions (e.g., no recent MAOI, specific ECG and lab criteria) are used to reduce risk; contraceptive requirements apply for participants of childbearing potential.