Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD
This multi-site, open-label, Phase II, lead-in study assesses the safety and effect of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in participants diagnosed with at least severe posttraumatic stress disorder (PTSD).
Details
This open-label Phase II lead-in trial tests whether three sessions of MDMA-assisted psychotherapy reduce PTSD symptoms in participants with at least severe PTSD; therapy teams are being trained for planned Phase III studies.
Participants receive three preparatory non-drug sessions, three experimental MDMA-assisted therapy sessions (flexible MDMA dosing 100–125 mg with optional supplemental half-dose 1.5–2 hours later; total per session 100–187.5 mg), and three integrative non-drug sessions after each Experimental Session; primary outcome is change in CAPS-5 from baseline to Visit 19.