RecruitingPhase 3interventionalRules rewrite

Phase 3: testing MDMA-AT for PTSD, Post Traumatic Stress Disorder

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.

Official registry: https://clinicaltrials.gov/study/NCT06394284 · Herzog Hospital · enrollment listed as 60

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are MDMA-AT, or SEA-IT. The registry lists allocation as randomized. 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.

They plan to enroll about 60 people at Jerusalem. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.

Official title (unrewritten)

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

Interventions: MDMA-AT, SEA-IT

Primary outcome (registry wording): PTSD

Who it is for (from inclusion criteria)

Men only
7\. Agree to have study visits recorded, including Experimental Sessions, Independent Rater assessments, and non-drug therapy sessions
8\. Must provide a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming unwell or unreachable
8\. Must agree to inform the investigators within 48 hours of any medical conditions and procedures
10\. At Screening, meet diagnostic criteria (Diagnostic Statisticians Manual, 5th version, DSM-5) for current military-based PTSD with a symptom duration of 6 months or longer with a history of at least one attempt at psychiatric or psychological treatment
11\. At Screening, have a PCL-5 total score of 33 or greater and at Screening/Baseline a confirmed diagnosis of PTSD per CAPS-5 and a total severity score of 28 or greater
12\. Have a body weight of at least 45 kilograms. Participants with a body weight of 45 to 48 kg must also have a body mass index (body-mass index (BMI)) within the range of 18 to 30 kg/m2

Who the registry excludes

\- Medical Conditions
Alanine transaminase (ALT) \[or aspartate transaminase (AST)\]higher than 2 x upper limit of normal (ULN)
Total bilirubin higher than 1.5 x ULN (isolated bilirubin higher than; 1.5 x ULN is acceptable if total bilirubin is fractionated and direct bilirubin less than; 35%)
Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis
Have a recent history of clinically significant hyponatremia or hyperthermia
Note: The QTcF is the QT interval corrected for heart rate according to Fridericia's formula. It is either machine-read or manually over-read
Have a diagnosis of uncontrolled hypertension, defined as repeated blood pressure readings of ≥140 mmHg systolic or ≥90 mmHg diastolic. The diagnosis may be confirmed by repeated clinic measurements or home blood pressure monitoring if clinically indicated

Public study contact (from the registry)

Sharon Bar Dov

009225952234

Sharonb@metiv.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

METIV Israel Psychotrauma Center, Herzog Medical Center — Jerusalem, Jerusalem, Israel (recruiting)

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseChicago, Illinois

Not a traditional drug phase: real iTBS for Mild Traumatic Brain Injury

This study will determine (i) the magnitude of immediate and sustained effects of a current clinical standard interactive computer attention processing training (APT) when combined with intermittent theta burst stimulation (iTBS), a type of repetitive transcranial magnetic stimulation and (ii) determine how APT + iTBS changes the neurocognitive system of attention in individuals with persistent attention deficits related to mTBI +/- PTSD.

NCT03819608 · Official ClinicalTrials.gov record · Northwestern University

RecruitingNot a traditional drug phaseLondon, Ontario

Not a traditional drug phase: Deep Brain Reorienting (DBR) for PTSD

This study will measure the how well it works of a therapeutic treatment, Deep Brain Reorienting (DBR), for PTSD (Post-traumatic Stress Disorder). you would be randomly assigned to either the DBR treatment, or wait-list condition.

NCT04317820 · Official ClinicalTrials.gov record · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

RecruitingNot a traditional drug phaseRichmond, Virginia

Not a traditional drug phase: Antioxidant for Peripheral Vascular Diseases

The purpose of this research study is to examine the role oxidants, substances produced in the blood that can damage blood vessel function, may play in blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and/or generalized anxiety disorder (GAD)).

NCT04916327 · Official ClinicalTrials.gov record · Virginia Commonwealth University

FAQ about this NCT record

Is NCT06394284 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06394284?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06394284?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary