NCT06394284

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
Herzog Hospital·Phase 3·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov
Study focus
Drug/Device/Intervention
MDMA-AT
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Herzog Hospital
Location
Jerusalem, Israel
Timeline & enrollment
Phase
Phase 3
Start date
Feb 18, 2024
End date
Dec 31, 2028
Enrollment
60 participants
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
Post-traumatic stress disorderPersonal history of psychological trauma, not elsewhere classifiedPsychological abusePersonal history of other physical traumaOther specified mental disorders due to brain damage and dysfunction and to physical disease
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06394284
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06394284 through Pure Global AI's free database. This Phase 3 trial is sponsored by Herzog Hospital and is currently Recruiting. The study focuses on PTSD, Post Traumatic Stress Disorder,Moral Injury. Target enrollment is 60 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.