Examining 3,4-methylenedioxymethamphetamine... — Clinical Trial Details

This randomised parallel treatment trial will examine whether MDMA‑Assisted Therapy enhances the window of tolerance for PTSD therapy by reducing hyperarousal and improving connection to self and others, compared with an intensity‑matched somatic experiential therapy (SEA‑IT).

Outcomes include neural measures of hyperarousal via EEG event‑related responses, cortisol responsivity, PTSD symptom measures (PCL‑5, CAPS‑5), emotion regulation measures, oxytocin responsivity, and interpersonal/connection questionnaires; procedures include three preparation sessions, three 8‑hour experimental sessions with overnight stay, and three integration sessions.

Participants

Ages

18 – 99

Sexes

male

BMI

Psychosis History

Inclusion Criteria

Inclusion Criteria:
1. Were assigned male sex at birth and currently identify as a male (e.g. are not transgender nor taking hormone replacement therapy)
2. Are veterans of the Israeli military
3. Are at least 18 years old
4. Are fluent in speaking and reading Hebrew
5. Are able to swallow pills
6. Agree to have EEG (three times) and salivary monitoring (during experimental sessions) at multiple occasions throughout the study
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
9. Must agree to inform the investigators within 48 hours of any medical conditions and procedures
10. Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to experimental sessions, not enroll in any other interventional clinical trials during the duration of the study, remain overnight at the study site after each experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures
Medical History:
11. At Screening, meet DSM-5 criteria 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
12. 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
13. Have a body weight of at least 45 kilograms (participants 45–48 kg must also have BMI 18–30)
14. Capable of giving signed informed consent

Exclusion Criteria

Exclusion Criteria (selected highlights):
Medical:
ALT/AST >2x ULN; total bilirubin >1.5x ULN (with specified exceptions); current unstable liver or biliary disease
Recent clinically significant hyponatraemia or hyperthermia
Marked baseline QTcF >450 ms on repeated ECGs (with procedures for reassessment if due to concomitant meds)
History of medical conditions making sympathomimetic use hazardous (e.g., recent MI, stroke, heart failure, severe coronary disease, aneurysm)
Uncontrolled hypertension (repeated ≥140/90 mmHg)
History of ventricular arrhythmia (exceptions noted)
Psychiatric:
New form of psychiatric care within 12 weeks (including ECT, ketamine-assisted therapy)
Likely re-exposure to index trauma during study
Current moderate/severe alcohol or cannabis use disorder within 12 months (exceptions for mild or early remission described)
Active illicit drug (other than cannabis) or prescription drug substance use disorder within 12 months
Current serious suicide risk (see suicidality exclusions)
Current primary psychotic disorder, bipolar I, dissociative identity disorder
Other:
Unable/unwilling to safely taper prohibited psychiatric medication
Concomitant medications that could prolong QT interval during sessions
Ecstasy use >10 times in last 10 years or any use within 6 months prior to first experimental session
Current enrolment in another interventional clinical study (unless approved)
Prior participation in a MAPS-sponsored MDMA clinical trial
Employees/close relations of MAPS organizations or the site investigator
Lack of social support or unstable living situation
Security-specific exclusions:
Long sessions will not occur when there is high risk of rocket attack or recent sirens; participants must not have participated operationally in war in prior 3 months; must not have first-degree relatives/partner actively serving in a war zone; must live in a permanent safe place

Company

Product

Legal

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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

MDMA-AT

Interventions

SEA-IT

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators