Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394284
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-07
Brief Title:
Examining 34-methylenedioxymethamphetamine MDMA Effects on Psychological Relational and Hyperarousal-Related Neural Reactivity Mechanisms in Veterans With PTSD and Moral Injury
Sponsor:
Herzog Hospital
Organization:
Herzog Hospital
Study Overview
Official Title:
IISPT2 Examining 34-methylenedioxymethamphetamine MDMA Effects on Psychological Relational and Hyperarousal-Related Neural Reactivity Mechanisms in Veterans With PTSD and MI
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 13 of veterans recover using traditional treatments In recent years 34-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
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
Detailed Description:
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 recent years 34-methylenedioxymethamphetamine MDMA has demonstrated a significant treatment potential for severe and treatment resistant PTSD though not specifically in a veteran population The current study proposes to address the major gaps in the theoretical literature by examining the proposed mechanisms by which MDMA Assisted Therapy MDMA-AT 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-AT is more successful in reducing PTSD in veterans compared to a matched somatic experiential PTSD treatment SEA-IT Sixty male veterans suffering from military-related PTSD who have participated in at least one attempt at treatment previously will be randomly assigned non-blinded to receive MDMA-AT or somatic-based therapy All participants will undergo 3 preparation sessions and then three long 8hour sessions each followed by 3 integration sessions Hyperarousal will be studied using EEG electroencephalogram to detect significant changes in event-related neural responses and cortisol responsivity to treatment Additionally measures of PTSD symptoms of hyperarousal and a specific measure of emotion regulation abilities will be studied Connection will be studied as both mediated by oxytocin responsivity to treatment and as subjective outcome measures of treatment response namely using psychological measures of connection to others and self via interoceptive sensitivity It is predicted that by using longitudinal modeling and specifically the analysis of mediators of treatment response the current study will enable both the understanding of the promising effects of MDMA treatment and the refinement of the key contribution of MDMA-AT compared to an intensive similarly somatic and experimentally based non-MDMA treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None