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.
Trial Details
Despite being exposed to a high level of potentially traumatic experiences due to exposure to combat, military veterans have poor response rates to traditional PTSD treatments, in some reports, just 1/3 of veterans recover using traditional treatments. In recent years 3,4-methylenedioxymethamphetamine (MDMA), a psychedelic drug has demonstrated a significant treatment potential for severe and treatment resistant PTSD though not specifically in a veteran population. Additionally, even in groups where participants receive a placebo, the effect of the psychedelic treatment formulation, intensive, focused and respectful structure, appears to have promising effects. Indeed, in the current psychedelic literature, the setting and mind with which participant approach psychedelic therapy, significantly contributes to the treatment effect. The current study proposes to address the major gaps in the theoretical literature by examining the proposed mechanisms by which MDMA enhances the "window of tolerance" for PTSD therapy, specifically in those with comorbid symptoms of moral injury; namely by reducing hyperarousal and enhancing connection (to self and others) and whether MDMA assisted therapy is more successful in reducing PTSD in veterans compared to a matched somatic experiential PTSD treatment, Somatic Experiental Acceptance Intensive Trauma-based therapy, (SEA-IT) which builds upon the promising placebo results, enhancing them with somatic and acceptance based treatment protocols.NCT Number NCT06394284