Wellcome Leap Psilocybin for OUD
Triple-blind, randomised, parallel-group Phase II trial (n=36) testing a single 25 mg vs 1 mg PEX010 psilocybin dose (2:1) in individuals on MAT for opioid use disorder to assess neural and clinical outcomes including urine drug screens and MAT adherence.
Details
This randomised, triple-blind, parallel-group study will allocate 36 participants on medication-assisted treatment for opioid use disorder to a single 25 mg or 1 mg oral dose of PEX010 (psilocybin) in a 2:1 ratio to evaluate neural correlates of cognitive flexibility and clinical outcomes.
Participants undergo brain and behavioural testing before dosing (24–48 hours) and follow-up assessments including one-week and quarterly research follow-ups to one year; urine drug screens and MAT adherence are collected twice weekly during a post-randomisation period.
Primary aims are to determine whether PEX010-25 improves neurocognitive flexibility and related executive functions and whether these changes relate to improved OUD clinical outcomes (reduced opioid use, fewer relapses, and better MAT adherence).