Feasibility, Clinical Effects, and Safety of Psilocybin-assisted Psychotherapy for Treatment-resistant OCD (PAP-OCD)
Open-label, single-group feasibility study (n=10) of two 25 mg psilocybin sessions given two weeks apart with supportive psychotherapy for treatment-resistant OCD.
Details
Proof-of-concept, open-label single-group trial of 10 adults with treatment-resistant OCD receiving two 25 mg oral psilocybin sessions two weeks apart with psychological support; primary aims are safety and feasibility with Y-BOCS change at Week 3 as a key clinical outcome.
Dosing sessions occur in CAMH’s psychedelic treatment suite, last approximately 5–6 hours, and are supported by two trained therapists; psilocybin is encapsulated (HPMC, PEX010) and participants are discharged with a caregiver after safety evaluation.
Screening includes SCID-5, labs and medication tapering as needed; assessments include Y-BOCS, C-SSRS, AE monitoring, fMRI and neurophysiological measures with follow-ups through 12 weeks after second dosing.