Randomized, Double-blind, Controlled of MDMA-assisted Psychotherapy in 12 Subjects With PTSD
Randomized, double-blind, placebo-controlled Phase II study (n=6) comparing MDMA-assisted therapy (125 mg initial + 62.5 mg supplemental per experimental session, two blinded sessions) versus placebo with therapy in adults with chronic, treatment-resistant PTSD.
Details
This randomized, double-blind, placebo-controlled study randomizes participants to MDMA-assisted therapy or placebo with therapy during two blinded experimental sessions spaced three to five weeks apart; primary outcome assessed by CAPS-IV.
Each experimental session uses split dosing (125 mg MDMA HCl initial dose followed by 62.5 mg supplemental dose). Participants receive preparatory psychotherapy sessions prior to dosing and integration sessions after dosing; safety and secondary clinical measures are assessed throughout.
After unblinding, participants originally assigned to MDMA may receive an open-label third MDMA-assisted session; participants assigned to placebo may have the option to enter Stage 2 to explore titrated MDMA dosing.