Psilocybin-Assisted vs Ketamine-Assisted Psychotherapy for Alcohol Use Disorder
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.
Details
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.