NUTS AND BOLTS OF MDMA-ASSISTED PSYCHOTHERAPY
This programme has been approved by the ACT Health Human Research and Ethics Committee, as well as the Therapeutic Goods Administration.
Introduction
MDMA-assisted Psychotherapy is a psychotherapy programme that is facilitated by MDMA. MDMA is not a magic pill and will not provoke any cure or recovery by itself. Individuals who fully engage in the psychotherapeutic process will likely have a better outcome. Such involves the application of skills and insights learnt in the therapy in one’s every day life. Recovery will require a lot of practise outside of the clinic to form new neural pathways.
Medication: MDMA
Dosage: MDMA: 120 mg with an additional optional 60 mg.
The dose range in MDMA studies in PTSD has varied between 75 mg and 180 mg. The dosage utilised during sessions will be 120 mg with an additional 60 mg optional top-up dose.
MDMA is colloquially known as Ecstasy or Molly, amognst other names. The medication will be supplied by a GMP supplier and is manufactured to meet Therapeutic Goods (Standard of MDMA) (TGO 112) Order 2024 to ensure purity and potency.
MDMA for treatment of PTSD is not approved outside of Australia for medical treatment of PTSD. Within Australia, following the rescheduling of MDMA on 1 July 2023, registered psychiatrists with approval as an Authorised Prescriber, will be permitted to prescribe MDMA for treatment-resistant PTSD as an unapproved good.
Toxicology
3,4‑Methylenedioxymethamphetamine (MDMA) is a synthetic psychoactive compound structurally related to amphetamines and mescaline, known to promote the acute release and inhibit the reuptake of serotonin, norepinephrine, and dopamine. It also elevates neurohormones such as oxytocin and prolactin, which may support therapeutic processes. MDMA is rapidly absorbed when administered orally, reaching peak plasma concentrations within 1.5 to 3 hours. The elimination half-life is approximately 7 to 9 hours, with psychoactive effects typically lasting 4 to 6 hours and excretion is primarily by the kidneys, with urinary pH affecting clearance.
Therapeutic dosing consists of 120 mg orally, with an optional supplemental dose of 60 mg administered 1 to 1.5 hours after the initial dose. In clinical settings, adverse effects are generally mild and transient, including minor elevations in blood pressure, heart rate, and body temperature (<1°C), as well as jaw clenching, muscle tension, dizziness, insomnia, and transient anxiety.
Serious adverse events such as hyponatraemia, serotonin syndrome, or hyperthermia are rare and typically associated with uncontrolled or high-dose recreational use. Such outcomes have not been observed in modern clinical trials at therapeutic doses in screened participants.
No neurocognitive decline has been identified with limited, medically supervised use. Preclinical animal studies have demonstrated serotonergic neurotoxicity only at supra-therapeutic doses and recreational data are confounded by polydrug use and uncontrolled dosing. There is no evidence of carcinogenicity or mutagenicity in preclinical studies. However, MDMA is contraindicated during pregnancy and lactation, and effective contraception is required for participants of reproductive potential to participate in this program.
A robust safety monitoring framework is in place and includes comprehensive pre-treatment medical and cardiovascular screening, with exclusion criteria such as psychotic disorders, Bipolar I disorder, uncontrolled hypertension, significant cardiovascular disease, pregnancy, and active substance use disorder. Dosing will be conducted under continuous clinical supervision with emergency equipment (e.g., defibrillator, blood pressure monitor) and rescue medications available on site. The Authorised Prescriber, Dr Bench, will always be physically present on site for every dosing session. Structured follow-up and integration are provided, and only pharmaceutical-grade MDMA compliant with TGO 112 (2024) will be used.
MDMA-Assisted Psychotherapy Programme
The programme may be completed in a minimum of 12 weeks, with further time allowed between dosing sessions where the prescriber deems appropriate. Patients will have the option of additional preparation and integration sessions before, after and between dosing, if clinically indicated. The below is an example only of how the therapy may unfold. The final programme will be tailored by the needs of the patient and often can not be predicted prior to the commencement of therapy.
Week 1 Preparation session 1
Week 2 Preparation session 2
Week 3 Preparation session 3
Week 4 Dosing 1
First Integration Session is the day after dosing
Week 5 Integration session 2
Week 6 Integration session 3
Week 7 Dosing 2
Integration session the day after dosing session 2
Week 8 Integration
Week 9 Integration
Week 10 Dosing 3
Integration session the day after dosing session 3
Week 11 Integration
Week 12 Integration & discharge
The first integration session after each dosing day will occur on the day following the dosing day.
Follow-up, check-in contact post-treatment and outcome measures will be provided.
Clinical staff will be available between sessions for support if needed.
The psychotherapy sessions are informed by MAPS MDMA Assisted Therapy Manual (Mithoefer, 2015). The therapist team will be delivered by experienced therapists (psychiatrists, nurses, psychologists or clinical psychologists, indigenous therapists, counsellors) with training in psychedelic-assisted therapies.
Patients may be referred to other mental health supports during treatment where necessary as add-ons to this core MDMA assisted therapy program above.
What monitoring is required, how it will be done, and the interval and duration of monitoring?
Psychometrics will be administered throughout the program along with regular reviews by the authorised prescriber. Suicide risk will be assessed in the therapy sessions and throughout the program.
During dosing sessions:
Vital sign monitoring along with medical staff on site during the dosing sessions. Clients will be monitored and reviewed for safety to depart the premises with a support person at the end of dosing.
During psychotherapy sessions:
Mental state exams at each therapy session and clinical interview/assessment of client progression in the treatment.
A member of the clinical team will be available if for support if needed between sessions.