A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD
This multi-site open-label study assesses the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in participants who were enrolled in a parent study for the treatment of posttraumatic stress disorder (PTSD).
Details
Open-label, single-group extension enrolling participants from parent Phase 3 MDMA-assisted psychotherapy trials (those who received placebo or were unable to complete parent study); participants receive three preparatory non-drug therapy sessions, three MDMA-assisted Experimental Sessions (~1 month apart), and three integrative non-drug therapy sessions following each Experimental Session.
Experimental Sessions use an initial dose of midomafetamine HCl (80 or 120 mg) followed 1.5–2 hours later by a supplemental dose (40 or 60 mg) when tolerated (total per session 80–180 mg); overnight stay is required for most participants.
Primary endpoint: change from baseline in PCL-5 PTSD Checklist scores. Safety and tolerability will be monitored throughout; the study is conducted across multiple US, Canadian and Israeli sites.