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A Study of Psilocybin for PTSD (PSI-3PO)

RecruitingRegisteredCTG

Randomized, parallel-group pilot (n=20) testing psilocybin therapy (25 mg initial; second dose conditional up to 40 mg) for adults with chronic PTSD on an SSRI, comparing trauma-focused psychotherapy versus standard psychological support.

Details

This randomized, parallel-group study at Johns Hopkins CPCR will evaluate feasibility, safety, and preliminary efficacy of psilocybin-assisted therapy in adults with chronic PTSD who remain on an SSRI.

Participants receive about 8 hours of preparatory meetings, two oral psilocybin sessions approximately two weeks apart (initial 25 mg; second session may remain 25 mg or be escalated to 40 mg based on MEQ30 score, clinician judgement, and participant preference), and multiple integration contacts after each session.

Outcomes include clinician- and participant-rated PTSD and mood measures, safety monitoring (vitals, ECG, labs, AEs), and measures of wellbeing and integration; trial compares trauma-focused psychotherapy plus psilocybin versus psilocybin with standard psychological support.

Topics:PTSD

Registry

Registry linkNCT06407635