Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
Phase 2: testing methylenedioxymethamphetamine for Post Traumatic Stress Disorder
The overall objective of this study is to use standard clinical measures to explore the safety and preliminary effectiveness of open-label MDMA-assisted therapy with a flexible dose of methylenedioxymethamphetaminel, in participants with war-related Post traumatic Stress Disorder, in a hybrid individual and group treatment protocol. The overall safety objective is to assess the severity, incidence, and frequency of AEs, AEs of Special Interest (AESIs), and Serious side effects (SAEs), concomitant medication use, suicidal ideation and behavior and vital signs .
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
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 methylenedioxymethamphetamine. The registry lists allocation as randomized. The overall objective of this study is to use standard clinical measures to explore the safety and preliminary effectiveness of open-label MDMA-assisted therapy with a flexible dose of methylenedioxymethamphetaminel, in participants with war-related Post traumatic Stress Disorder, in a hybrid individual and group treatment protocol.
They plan to enroll about 60 people at Afula. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Preliminary Effectiveness of Hybrid Individual and Group MDMA-assisted Therapy for War-related PTSD
Interventions: methylenedioxymethamphetamine
Primary outcome (registry wording): Change from pre-treatment baseline to post-treatment in CAPS-5 total score
Who it is for (from inclusion criteria)
Ages 18 Years to any
Experienced war-related trauma
Fluent in speaking and reading Hebrew
Able to swallow capsules
Willing to have study visits, including MDMA experimental sessions and non-drug psychotherapy sessions, audio- and/or video-recorded as specified by the protocol
Able to identify a relative, spouse, close friend, or other support person who can be contacted by the investigators if the participant becomes suicidal or cannot be reached
Agrees to inform the investigators within 48 hours of relevant medical conditions or procedures
At screening, meets DSM-5 criteria for current PTSD of the protocol-specified minimum duration
Who the registry excludes
Use of Ecstasy or material represented as containing MDMA more than 10 times during the previous 10 years, or any such use within 6 months before the first experimental session
Previous participation in a MAPS-sponsored MDMA clinical trial
Any current medical, psychiatric, psychosocial, or other condition that, in the judgment of the investigator or study physician, could interfere with safe or effective participation
Known sensitivity or allergy to MDMA or another study intervention that, in the judgment of the sponsor-investigator or study clinician, contraindicates participation
Electroconvulsive therapy within 12 weeks before enrollment
Current or lifetime primary psychotic disorder
Current eating disorder involving active purging, as assessed by the MINI and clinical interview
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.
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.
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)).
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 NCT05732155?
Phase 2. 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 NCT05732155?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.