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Examining 3,4-methylenedioxymethamphetamine (MDMA) Effects on Psychological, Relational and Hyperarousal-Related Neural Reactivity Mechanisms in Veterans With PTSD and Moral Injury

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Randomised, parallel-group trial (n=60) comparing MDMA-Assisted Therapy (three 8‑hour MDMA sessions with preparatory/integration therapy) versus an intensive somatic experiential therapy (SEA-IT) in male veterans with PTSD and moral injury.

Details

This randomised parallel treatment trial will examine whether MDMA‑Assisted Therapy enhances the window of tolerance for PTSD therapy by reducing hyperarousal and improving connection to self and others, compared with an intensity‑matched somatic experiential therapy (SEA‑IT).

Outcomes include neural measures of hyperarousal via EEG event‑related responses, cortisol responsivity, PTSD symptom measures (PCL‑5, CAPS‑5), emotion regulation measures, oxytocin responsivity, and interpersonal/connection questionnaires; procedures include three preparation sessions, three 8‑hour experimental sessions with overnight stay, and three integration sessions.

Topics:PTSD

Registry

Registry linkNCT06394284