This multi-site, open-label, Phase II lead-in study (n=38) assesses safety and efficacy of three sessions of MDMA-assisted therapy (flexible MDMA dosing 80–120 mg with optional supplemental half-dose) in participants with at least severe PTSD.
Multi-site, open-label, single-group Phase II study evaluating three preparatory psychotherapy sessions, three MDMA-assisted experimental sessions, and integrative psychotherapy following each MDMA session in adults with severe PTSD (n=38).
MDMA dosing per experimental session is flexible (initial 80–120 mg with a 40–60 mg supplemental dose 1.5–2 hours later; total per session 80–180 mg). Primary outcome is change in CAPS-5 from baseline to primary endpoint; safety assessed via AEs, vitals and laboratory measures.
Three sessions of MDMA-assisted therapy with flexible MDMA dosing (80–120 mg with optional supplemental half-dose).
Initial 80–120 mg with 40–60 mg supplemental 1.5–2 h later; total per session 80–180 mg.
Manualized non-directive psychotherapy provided during preparatory, experimental and integrative sessions.
In an exploratory analysis of 32 participants from a Phase 2 open‑label trial of manualised MDMA‑assisted therapy for PTSD, 84% reported chronic pain and 75% reported pain‑related disability. MDMA‑AT was associated with significant reductions in pain intensity, disability and overall Chronic Pain Grade Scale severity in the high‑pain subgroup and reduced pain intensity in the medium‑pain subgroup, supporting further investigation of MDMA‑AT for comorbid chronic pain.