Effectiveness Of Psychedelic Therapy for Post Traumatic Stress Disorder (PTSD)
This interventional trial (n=30) will assess the efficacy and safety of MDMA-assisted psychotherapy for PTSD with 2–3 oral MDMA medicine days (120 mg + 60 mg top-up typical) alongside preparatory and integration psychotherapy.
Detailed Description
Open-label, non-randomised, single-group study of MDMA-assisted psychotherapy for PTSD. Participants receive three preparatory 1‑hour sessions, 2–3 medicine days (6–7 hours each) with supportive, client-centred psychotherapy during dosing, and sets of integration sessions after each medicine day.
MDMA is administered orally in capsules by the treating psychiatrist; typical dosing follows MAPS protocols (120 mg with 60 mg top-up at ~2 hours; 80 mg + 40 mg top-up if needed). Adverse events are recorded and reported to HREC and the TGA; psychometric measures administered pre- and post-treatment.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
MDMA therapy
experimentalOpen-label, single-group MDMA-assisted psychotherapy with 2–3 medicine days interspersed with preparation and integration sessions.
Interventions
- MDMA120 mgvia Oral• single dose per medicine day• 3 doses total
Typical regimen 120 mg with 60 mg top-up at ~2 hours; lower option 80 mg + 40 mg top-up if not tolerated; dosing tailored by treating psychiatrist.
Participants
Inclusion Criteria
- Must suffer from: Post Traumatic Stress Disorder
Exclusion Criteria
- (1) Is not able to give adequate informed consent, or is under 18 or over 65 years old.
- (2) Has uncontrolled hypertension or unstable diabetes.
- (3) Has a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms corrected by Bazett's formula).
- (4) Has a history of additional risk factors for Torsade de pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome).
- (5) Has evidence or history of significant medical disorders e.g. epilepsy, stroke, unstable cardiovascular disease.
- (6) Has symptomatic liver disease.
- (7) Has a history of hyponatremia or hyperthermia.
- (8) Weighs less than 48 kg.
- (9) Is pregnant or nursing or is of childbearing age and is not practicing an effective means of birth control.
- (10) Is currently abusing illegal drugs