This randomised, controlled trial (n=86) will assess the safety, feasibility, and efficacy of PEX010 (psilocybin) for the treatment of stimulant use disorder in adults. Participants will receive either a 25 mg dose of PEX010 or a 1 mg active placebo in conjunction with cognitive behavioural therapy.
The study involves two preparation sessions, one PEX010 dosing session, one integration session, and seven follow-up visits. The primary outcome measure is the reduction in stimulant use, assessed via the Timeline Followback method and urine drug tests over three months. Secondary outcomes include monitoring adverse events and serious adverse events.
The trial, sponsored by Filament Health Corp., is expected to start in January 2025 and complete in July 2028.
Trial Details
Trial Number
Sponsors & Collaborators
University of British ColumbiaFilament Health
Filament Health is a global extraction and drug discovery company. The company have a deep natural psychedelics IP portfolio and are led by an accomplished botanical extraction management team.