This double-blind, randomised, parallel Phase II trial (n=32) compares single-dose MDMA-assisted therapy (120 mg, optional 60 mg supplemental) versus methylphenidate-assisted therapy (20 mg, optional 10 mg supplemental) for depressive and anxiety symptoms in people with advanced-stage cancer.
Participants receive one 8-hour supervised medication-assisted therapy session (MAPS model) with two therapists; preparation comprises two 90-minute sessions and integration one 90-minute session.
MDMA arm: 120 mg oral dose with optional 60 mg supplemental at ~2 hours if safety and participant preference allow. Methylphenidate arm: 20 mg oral dose with optional 10 mg supplemental. Safety monitoring includes BP and pulse checks prior to supplemental dosing.
Primary outcomes include change from baseline in MADRS and IPOS at Day 28 (±3 days); study conducted in New Zealand with University of Otago sponsor.
Single supervised MDMA-assisted therapy session (MAPS model) with optional supplemental dose at 2 hours.
Optional supplemental 60 mg offered ~2 hours after initial dose if safety criteria met and participant agrees; 8-hour supervised session.
Single supervised methylphenidate-assisted therapy session with optional supplemental dose at 2 hours.
Optional supplemental 10 mg at ~2 hours if criteria met and participant agrees; therapy procedures mirror MDMA arm.