This randomised, quadruple-blind, placebo-controlled trial (n=40) will evaluate the safety, feasibility, and efficacy of psilocybin-assisted therapy in adults aged 18–65 with persistent post-concussion symptoms (PPCS). Participants will receive either a high dose (25mg) or a low dose (1mg) of psilocybin and undergo 5–6 weekly sessions of BrainACT, an adapted form of Acceptance and Commitment Therapy (ACT) for individuals with acquired brain injury.
A randomised, double-blind, parallel-group trial comparing a single 25 mg oral dose of PEX010 psilocybin with a 1 mg low-dose active comparator in adults with persistent post-concussion symptoms; participants receive preparatory psychoeducation and 5–6 weekly ACT sessions after dosing.
Primary outcomes assess safety and feasibility; efficacy outcomes include change in RPQ at 1 week, 4 weeks, 3 months and 6 months, plus secondary measures of headache, dizziness, mood, anxiety, PTSD symptoms, cognitive flexibility, emotional regulation, and quality of life.
Single oral 25 mg psilocybin (PEX010) administered 24 h prior to first ACT session.
PEX010; single dose administered 24 h prior to first ACT session.
Single oral 1 mg psilocybin (active control) administered 24 h prior to first ACT session.
PEX010 low-dose active control; single dose administered 24 h prior to first ACT session.