This Phase II, assessor-blinded, randomised controlled trial (n=30) will study the effects of a single 25 mg oral dose of synthetic psilocybin, given with either standard psychological support or psychological support plus mindfulness-based cognitive therapy (MBCT), in adults with post-traumatic stress disorder (PTSD).
The trial, sponsored by Anthony P. King at Ohio State University, aims to explore how psilocybin-assisted therapy affects brain activity, connectivity, and microstructural neuroplasticity (changes in the brain’s wiring and adaptability). Researchers will use EEG (electroencephalography), EMG (electromyography) and advanced MRI scans to investigate these effects, as well as examine changes in PTSD and depression symptoms, cognitive function, and relevant biomarkers.
The study will begin with an open-label pilot phase involving 10 participants who receive psilocybin with both standard support and MBCT. The second phase will randomise 20 participants into two groups: one receiving psilocybin with standard support only, and the other with psilocybin plus MBCT. In both groups, support is provided before, during, and after dosing; those in the MBCT group will also attend bi-weekly therapy sessions and complete daily mindfulness homework.
Assessments will take place at baseline, 24 hours after dosing, and again at 28 days, using clinician-rated PTSD and depression scales (CAPS-5, MADRS), self-report questionnaires, and brain imaging. The aim is to determine whether combining psilocybin with MBCT can enhance therapeutic benefits beyond standard psychedelic-assisted therapy and to better understand the brain mechanisms behind these effects.
Trial Details
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Sponsors & Collaborators
Ohio State UniversityThe Center for Psychedelic Drug Research & Education (CPDRE) at the College of Social Work at Ohio State University aims to explore and advance the research about psychedelic drugs and their effects, and to disseminate the knowledge about psychedelics.