A study to investigate the safety and feasibility of delivering MDMA-assisted psychotherapy to patients with posttraumatic stress disorder
Open-label, non-randomised interventional study (n=5) assessing safety and feasibility of three cycles of MDMA-assisted psychotherapy (87 mg initial dose + 43.5 mg supplemental) in patients with PTSD.
Details
Participants receive two preparatory sessions (~2 hours each), then three full-day treatment sessions (~8 hours each) over 12 weeks; each treatment session includes an initial 87 mg oral MDMA dose with a supplemental half-dose (43.5 mg) administered in-session unless contraindicated.
Each treatment session is followed by three integration sessions (24 hours; 3–14 days; 20–34 days post-session, ~1.5 hours each). Outcomes include safety/tolerability (adverse events) and change in PTSD symptoms measured by PCL-5; follow-up visits occur at 3, 6 and 12 months after final session.