This randomised, controlled clinical trial (n=128) aims to investigate whether a single dose of psilocybin administered with motivational enhancement therapy (MET) can reduce heavy drinking in patients with alcohol use disorder (AUD).
Randomised, parallel-group Phase II trial (n=128) comparing a single oral high dose (25 mg) versus low dose (1 mg) of PEX010 (psilocybin) given 24 hours before a course of motivational enhancement therapy (MET) to reduce heavy drinking in patients with AUD.
All participants complete baseline clinical, behavioural and neuroimaging measures; dosing is followed by five weekly MET sessions starting 24 hours post-dose. Outcomes include percent heavy drinking days (TLFB) at 1, 4 and 12 weeks and repeat neuroimaging at 1 week.
PEX010 (Oral Psilocybin), 25mg; single dose administered 24hrs prior to first of 5 weekly MET sessions
PEX010 (25 mg)
PEX010 (Oral Psilocybin), 1mg; single dose administered 24hrs prior to first of 5 weekly MET sessions
PEX010 (1 mg)