Actively Recruiting
Examining 3,4-methylenedioxymethamphetamine (MDMA) Effects on Psychological, Relational and Hyperarousal-Related Neural Reactivity Mechanisms in Veterans With PTSD and Moral Injury
Led by Herzog Hospital · Updated on 2024-05-01
60
Participants Needed
1
Research Sites
254 weeks
Total Duration
On this page
Sponsors
H
Herzog Hospital
Lead Sponsor
M
Metiv Israel Psychotrauma Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Examining 3,4-methylenedioxymethamphetamine (MDMA) Effects on Psychological, Relational and Hyperarousal-Related Neural Reactivity Mechanisms in Veterans With PTSD and Moral Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Assigned male sex at birth and currently identify as male (not transgender or on hormone therapy)
- Veterans of the Israeli military
- At least 18 years old
- Fluent in Hebrew speaking and reading
- Able to swallow pills
- Agree to have EEG and salivary monitoring during study sessions
- Agree to have study visits recorded
- Provide a contact person reachable if participant becomes unwell or unreachable
- Agree to inform investigators within 48 hours of any medical conditions or procedures
- Agree to lifestyle requirements including fasting and medication restrictions before sessions, overnight stay after sessions, and commitment to therapy and study procedures
- Meet DSM-5 criteria for military-based PTSD with symptoms lasting 6 months or longer and prior psychiatric or psychological treatment attempt
- Have a PCL-5 total score of 33 or higher and CAPS-5 diagnosis of PTSD with severity score of 28 or higher
- Body weight at least 45 kilograms; if 45 to 48 kg, BMI between 18 and 30 kg/m2
- Capable of giving signed informed consent
You will not qualify if you...
- Alanine transaminase (ALT) or aspartate transaminase (AST) above 2 times upper limit of normal
- Total bilirubin above 1.5 times upper limit of normal unless fractionated direct bilirubin is less than 35%
- Current unstable liver or biliary disease
- Recent history of significant hyponatremia or hyperthermia
- QTcF interval above 450 ms on repeated ECGs
- History of medical conditions making sympathomimetic drugs harmful, including myocardial infarction, stroke, heart failure, severe coronary artery disease, or aneurysm
- Uncontrolled hypertension with repeated blood pressure readings ≥140/90 mmHg
- History of ventricular arrhythmia except occasional premature ventricular contractions without ischemic heart disease
- Wolff-Parkinson-White syndrome or untreated accessory pathways
- History of arrhythmia within 12 months unless successfully treated with ablation and no recurrence for one year
- Additional risk factors for Torsade de pointes
- New psychiatric or mental health care within 12 weeks including ECT or ketamine therapy
- Likely re-exposure to trauma during study
- Moderate or severe alcohol or cannabis use disorder in past 12 months
- Active illicit or prescription drug use disorder except cannabis
- Current serious suicide risk or recent suicidal behaviors
- Unable or unwilling to taper prohibited psychiatric medications
- Use of medications that prolong QT interval during experimental sessions
- Excessive prior use of Ecstasy (more than 10 times in 10 years or any use within 6 months)
- Current enrollment in other clinical studies without approval
- Current personality disorders, eating disorders with compensatory behaviors, major depressive disorder with psychotic features, psychotic disorders, bipolar I disorder, or dissociative identity disorder
- Sensitivity or allergy to study interventions
- Engaged in compensation litigation related to psychiatric disorders
- Lack of social support or stable living situation
- Prior participation in MAPS-sponsored MDMA trials
- Employees or immediate family of MAPS or related organizations
- Conditions that might interfere with study participation
- Security risks related to ongoing war conditions as defined by study protocol including residence in safe, permanent housing and no recent operational military involvement or relatives in war zones
AI-Screening
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Trial Site Locations
Total: 1 location
1
METIV Israel Psychotrauma Center, Herzog Medical Center
Jerusalem, Israel, 3090844
Actively Recruiting
Research Team
M
Moriya Rahmani, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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