Randomized, open-label, active-comparator controlled trial (n=20) comparing psilocybin-assisted psychotherapy (25 mg oral) vs ketamine-assisted psychotherapy (200 mg oral) in males with moderate or severe alcohol use disorder.
Parallel-group randomised trial comparing a single 25 mg oral psilocybin administration plus integrative psychotherapy to a single 200 mg oral ketamine administration plus integrative psychotherapy; each participant receives four psychotherapy sessions (two preparatory, one dosing, two integration).
Assessments include baseline and post-treatment MRI scans, weekly follow-up for four weeks, and final assessment at week 8; ketamine participants are offered an open-label psilocybin session with two integration visits and additional follow-up in an extension.
Primary outcomes focus on preliminary efficacy signals on alcohol use; safety monitoring includes drug screens, vitals, adverse events and medical/psychiatric assessments.
25 mg oral psilocybin with integrative psychotherapy (4 sessions).
Single 25 mg oral dose paired with psychotherapy sessions.
200 mg oral ketamine with integrative psychotherapy (4 sessions).
Single 200 mg oral dose paired with psychotherapy sessions; ketamine arm offered open-label psilocybin and integration in extension.