RecruitingPhase 3NCT06394284

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

IISPT2: Examining 3,4-methylenedioxymethamphetamine (MDMA) Effects on Psychological, Relational and Hyperarousal-Related Neural Reactivity Mechanisms in Veterans With PTSD and MI


Sponsor

Herzog Hospital

Enrollment

60 participants

Start Date

Feb 18, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALE

Plain Language Summary

Simplified for easier understanding

This study examines how MDMA (commonly known as ecstasy) affects brain activity and psychological responses in Israeli male veterans who have PTSD and moral injury — emotional distress from experiencing events that violate one's moral code. **You may be eligible if...** - You are a male Israeli military veteran - You are at least 18 years old and fluent in Hebrew - You have been diagnosed with PTSD related to military service, lasting at least 6 months - You have previously tried at least one psychiatric or psychological treatment for PTSD - You have a support person (family member or close friend) who can be contacted in an emergency - You weigh at least 45 kg **You may NOT be eligible if...** - You have significant liver problems, heart conditions, or a history of serious high blood pressure - You have a personal or family history of psychosis or bipolar I disorder - You currently have active suicidal plans or have made a suicide attempt recently - You are taking certain medications that interact with MDMA (such as lithium or MAOIs) - You have a history of substance use disorder within the past year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMDMA-AT

As described above in arm description

BEHAVIORALSEA-IT

As described in arm description


Locations(1)

METIV Israel Psychotrauma Center, Herzog Medical Center

Jerusalem, Israel

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NCT06394284


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