MDMA-assisted Therapy in People With Anxiety Related to Advanced Stage Cancer
Pilot randomised, triple-blind Phase II study testing MDMA-assisted psychotherapy in people with advanced-stage cancer and anxiety; Stage 1 randomised (full vs low MDMA doses) with optional Stage 2 open-label extension.
Details
Randomised, triple-blind, parallel Phase II pilot examining MDMA-assisted psychotherapy for anxiety related to advanced-stage cancer; Stage 1 randomised to low versus near-full MDMA doses, with a Stage 2 open-label extension for low-dose participants.
Dosing in Stage 1: Session 1 initial 83.3 mg with optional 41.7 mg supplement (total 125 mg); Session 2 125 mg with optional 62.5 mg (total 187.5 mg). Low-dose arm: 25 mg with optional 12.5 mg (total 37.5 mg) per session. Two MDMA-assisted sessions per stage.
All participants receive six one-hour preparatory psychotherapy sessions and MDMA-assisted sessions lasting six to eight hours with an overnight stay; psychotherapy is conducted by the same therapists across sessions.
Outcomes include anxiety and quality-of-life measures at baseline, pre- and post-sessions, 1-week post-MDMA, and final study visit (~84 days), plus diaries of medication use and pain; medical examinations performed during follow-up.