Clinical TrialPTSDMDMARecruiting
An Open-Label Feasibility Study to Assess the Safety and Effect of Manualised MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder among Four Australians
Open-label feasibility single-group study (n=4) of MAPS manualised MDMA-assisted psychotherapy for treatment-refractory PTSD with three MDMA-assisted sessions (initial 80 mg; supplemental half-dose at 1.5–2 h; sessions 2–3 may use 80–120 mg).
Target Enrollment
4 participants
Study Type
Phase I/II interventional
Design
Non-randomized
Registry
Detailed Description
Open-label feasibility (n=4) assessing delivery of MAPS manualised MDMA-assisted psychotherapy for severe PTSD in Australia; treatment includes three MDMA-assisted sessions plus preparatory and integrative psychotherapy totalling 15 therapy sessions over ~12 weeks.
Each MDMA session is ~8 hours with an initial oral dose (80 mg first session; 80 or 120 mg for later sessions depending on response) and a supplemental half-dose 1.5–2 hours later; therapy delivered by a male/female co-therapy team per MAPS protocol.
Study Protocol
Preparation
3 sessions
90 min each
Dosing
3 sessions
480 min each
Integration
9 sessions
90 min each
Therapeutic Protocol
existential humanistic
Study Arms & Interventions
MDMA-assisted psychotherapy
experimentalOpen-label single-group MAPS manualised MDMA-assisted psychotherapy with three dosing sessions and integrated preparatory/integrative therapy.
Interventions
- MDMA80 - 120 mgvia Oral• three sessions• 3 doses total
Each MDMA session includes an initial dose (80 mg first session; 80 or 120 mg for sessions 2–3 depending on response) with a supplemental half-dose 1.5–2 h later (40 mg or 60 mg). Drug delivered in capsules.
Participants
Ages
18 – 99
Sexes
Male & Female
BMI
-
Psychosis History
-
Inclusion Criteria
- 1. A diagnosis of current PTSD for more than 6 months.
- 2. Have PTSD symptoms in the last month based on PCL-5 total score of 35 or greater.
- 3. Are fluent in speaking and reading the predominantly used or recognised language of the study site.
- 4. Are able to swallow pills.
- 5. Agree to the study visits being video recorded, including MDMA Sessions, Independent Rater assessments and non-drug psychotherapy sessions.
- 6. If of childbearing potential, must have a negative pregnancy test at study entry and prior to each MDMA Session, and must agree to use adequate birth control through 10 days after the last MDMA Session. Not of childbearing potential is defined as permanent sterilisation, postmenopausal, or assigned male at birth.
- 7. Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to MDMA Sessions, not participate in any other interventional clinical trials during the duration of the study, remain overnight at the study site after each MDMA Session and be driven home after, and commit to medication dosing, therapy, and study procedures.
- 8. Have attempted to engage in at least one evidence-based psychotherapy for PTSD and trialled one medication.
Exclusion Criteria
- 1. Is unable to give adequate informed consent.
- 2. Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders.
- 3. Are likely, in the investigator’s opinion and via observation during the Preparatory Period, to be re-exposed to their index trauma or other significant trauma, lack social support, or lack a stable living situation.
- 4. Have used Ecstasy (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the first MDMA Session; or have previously participated in a MAPS-funded MDMA clinical trial.
- 5. Have any current problem which, in the opinion of the investigator or Medical Monitors, might interfere with participation.
- 6. Are prescribed a psychotropic medication that could adversely interact with MDMA.
- 7. Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrolment.
- 8. Have a history of, or a current primary psychotic disorder, bipolar affective disorder type 1 assessed via MINI or dissociative identity disorder.
- 9. Have a current eating disorder with active purging.
- 10. Have current major depressive disorder with psychotic features.
- 11. Have an active substance use disorder for any substance other than caffeine or nicotine in the past 60 days.
- 12. Have a Personality Disorders.
- 13. Is presenting current serious acute suicide risk.
- 14. Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist.
- 15. Require ongoing concomitant therapy with a psychiatric medication that could adversely interact with MDMA.
- 16. Have evidence or history of significant (controlled or uncontrolled) haematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the investigator to significantly increase the risk of MDMA administration or be likely to produce significant symptoms that during the study could interfere with participation or be confused with side effects of MDMA (participants with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded). Note: if participants present with a history of glaucoma, enrolment would be allowed only with the approval of their ophthalmologist.
- 17. Have uncontrolled hypertension using the standard criteria of the American Heart Association (values of 140/90 millimetres of Mercury [mmHg] or higher assessed on three separate occasions).
- 18. Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds corrected by Bazett’s formula).
- 19. Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome).
- 20. Have symptomatic liver disease.
- 21. Have history of hyponatremia or hyperthermia.
- 22. Weigh less than 48 kilograms.
- 23. Are pregnant or breastfeeding, or are of childbearing potential and are not practising an effective means of birth control.