Psilocybin on Brain Mechanisms of Motivation in OUD
Randomised, quadruple-masked Phase II trial (n=24) comparing single low (1 mg) vs high (25 mg) PEX010 psilocybin doses to study motivation/reward and cognitive flexibility circuits in people with opioid use disorder.
Details
This parallel, randomized study will assign 24 participants with opioid use disorder to a single oral low (1 mg) or high (25 mg) dose of PEX010 (psilocybin, Filament) to probe addiction-related brain circuitry and cognitive flexibility using fMRI.
Participants will undergo screening assessments, be resident in a treatment facility for the psilocybin phases (~two weeks), and attend approximately seven study visits including preparation therapy, baseline neuropsychological testing, dosing, post-dose therapy visits, and follow-up assessments.
Primary outcomes focus on fMRI measures of motivation/reward and inhibition circuits; secondary measures include cognitive flexibility and clinical assessments relevant to relapse risk.