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

This intervention trial (n=60) will evaluate the effects of MDMA-Assisted Therapy (MDMA-AT) versus Somatic Experiential Acceptance Intensive Trauma-based therapy (SEA-IT) on psychological, relational, and hyperarousal-related neural reactivity mechanisms in male Veterans with PTSD and Moral Injury.

Sixty male veterans from the Israeli military, aged 18 or above, with military-based PTSD lasting at least six months, will be randomly assigned to receive either MDMA-AT or SEA-IT. The study will consist of three preparation sessions followed by three long (8-hour) sessions, each with three integration sessions.

The primary outcome measures include changes in hyperarousal studied using EEG and cortisol responsivity, as well as measures of PTSD symptoms and emotion regulation abilities. The study aims to understand the effects of MDMA treatment on veterans with PTSD and Moral Injury and compare it with an intensive non-MDMA treatment.

The study, conducted at the Metiv Israel Psychotrauma Center, Herzog Medical Center, Jerusalem, Israel, began on February 18, 2024, and is estimated to be completed by December 31, 2028.

Compound MDMA

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