PEX010-Assisted Therapy for Stimulant Use Disorder: A Safety, Feasibility and Efficacy Study (PATSUD)

This is a randomised, parallel-group, quadruple-blind Phase II trial evaluating the safety, feasibility and efficacy of a single 25 mg oral dose of PEX010 (psilocybin) versus a 1 mg active placebo in adults with moderate-severe stimulant use disorder; both arms receive cognitive behavioural therapy.

Participants undergo two preparation sessions, one dosing session and one integration session, with follow-up visits to assess stimulant use (self-report and urine screens), clinician interviews, safety labs and adverse events.