Examining 3,4-methylenedioxymethamphetamine (MDMA) Effects on Psychological, Relational and Hyperarousal-Related Neural Reactivity Mechanisms in Veterans With PTSD and Moral Injury - Trial NCT06394284

Timeline & Enrollment

Primary Outcome

PTSD,Oxytocin

Summary

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.

ICD-10 Classifications