Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD With Optional fMRI Sub-Study
This open-label, lead-in Phase II study is intended to gather supportive data on the safety and effectiveness of manualized MDMA-assisted psychotherapy as a treatment for PTSD, with two open-label MDMA-assisted therapy sessions per participant (flexible dosing 80–180 mg per session).
Details
Multi-site, open-label Phase 2 lead-in study in participants with at least severe PTSD assessing safety and efficacy of two manualized MDMA-assisted psychotherapy sessions, preceded by three preparatory sessions and followed by three integrative sessions after each experimental session.
Dosing per experimental session is flexible: initial 80 mg or 120 mg MDMA HCl followed 1.5–2 hours later by a supplemental half-dose (40 mg or 60 mg), for total per session of 80–180 mg. Primary endpoint is change in CAPS-5 from baseline to 13 weeks post-baseline; select sites optional fMRI sub-study.