Randomised, double-blind, placebo-controlled Phase II trial (n=90) testing a single 25 mg dose of psilocybin plus psychological support versus placebo in treatment-seeking adults (20–70 yrs) with alcohol use disorder.
This single-centre, randomised, double-blinded, placebo-controlled 1:1 parallel-group trial will compare a single 25 mg dose of psilocybin plus psychological support with placebo plus psychological support in 90 patients with alcohol use disorder.
Primary outcome is reduction in percentage of heavy drinking days from baseline to 12 weeks. Key secondary outcomes include phosphatidyl-ethanol as an objective biomarker, plasma psilocin levels, and acute subjective drug experience; fMRI one week post dosing will explore neurobiological mechanisms.
Patients receive psychological support before, during and after dosing with outcome assessments at weeks 1, 4, 8 and 12.
Single administration of 25 mg psilocybin given with psychological support before, during and after dosing.
Given within a protocol of psychological support
Single administration of placebo (maltodextrin) given with psychological support before, during and after dosing.
Maltodextrin (placebo)