MDMA-assisted Massed Prolonged Exposure for PTSD
Randomized, quadruple-blind Phase III parallel pilot (n=20) evaluating MDMA-assisted Massed Prolonged Exposure (one MDMA medicine session plus 12 90-minute PE sessions) in US veterans with PTSD; doses randomized (exact doses not disclosed).
Details
This randomized pilot evaluates the VASDHS-adapted Emory MDMA-PE protocol in veterans with PTSD using a parallel design with two active dose arms; one MDMA medicine session is paired with a massed PE course of twelve 90-minute sessions spanning roughly three weeks.
Primary outcome is change in clinician-rated PTSD symptoms (CAPS-5); secondary assessments include safety, tolerability, acceptability, SUDS during imaginal exposure, and remote CAPS-5 follow-ups at 1 week, 2 months, and 4 months. An optional fMRI substudy will be offered pre- and post-treatment.
Preparatory and integration sessions are included (one preparatory session prior to MDMA and at least one integration session after); optional additional MDMA/integration sessions may be offered after unblinding at 2-month follow-up.