This open-label, Phase I trial (n=20) will study the safety and tolerability of psilocybin in individuals with chronic stroke. Participants will receive either a single 25 mg dose of psilocybin or a divided dose (12.5 mg followed by another 12.5 mg two hours later), to assess whether the compound is safe to use in this population. Secondary outcomes will explore psilocybin’s potential to aid motor recovery following stroke.
The trial is sponsored by Johns Hopkins University and is led by Steven Zeiler, M.D., Ph.D. It is grounded in recent neuroscientific findings suggesting that psychedelics like psilocybin, MDMA, and LSD may reopen “critical periods” in the brain—time windows during which the brain is more malleable and receptive to learning and adaptation. These periods are typically limited to early development but could, if reopened, improve rehabilitation outcomes in adults with neurological injury.
Participants must be over 18 and have experienced a confirmed ischaemic or haemorrhagic stroke at least 12 months prior. The study will include comprehensive safety screening, especially around blood pressure and cardiac function, to ensure psilocybin can be administered safely. Participants will be monitored closely for blood pressure stability and other vital signs for up to 24 hours after dosing. The research team hopes that if psilocybin proves safe in this population, it may eventually be used as an adjunct therapy to enhance rehabilitation efforts in stroke survivors with long-term disabilities.
Trial Details
Trial Number
Sponsors & Collaborators
Johns Hopkins UniversityJohns Hopkins University (Medicine) is host to the Center for Psychedelic and Consciousness Research, which is one of the leading research institutes into psychedelics. The center is led by Roland Griffiths and Matthew Johnson.