Psychiatrists in Australia can now prescribe MDMA and psilocybin for controlled clinical use.

MDMA, commonly known as ecstasy, will be prescribed for post-traumatic stress disorder (PTSD), while psilocybin, the active compound in magic mushrooms, will be used to treat treatment-resistant depression.

These drugs will be down-scheduled from the strictest controlled category to a controlled drug category specifically for medical use in psychedelic-assisted psychotherapy. 

Australia is the first country to down-schedule psilocybin and MDMA for clinical treatments, although other countries have made these drugs available through different regulatory pathways.

Dr Mike Musker from the University of South Australia has described this regulatory change as “one of the biggest evolutions in psychiatry in the last 70 years”.

MDMA induces the release of serotonin and affects brain pathways involving oxytocin, facilitating connection and empathy. 

Research has shown that MDMA-assisted therapy is more effective than psychotherapy alone in treating severe PTSD.

Psilocybin, converted to psilocin in the body, acts on the brain's serotonin receptors and has a significant effect on depression for up to three months after a single dose. However, experts say there is a strong need for caution and further research.

Access to these drugs will be limited to psychiatrists with pre-approval through the Therapeutic Goods Administration's authorised prescriber scheme, specifically for PTSD or treatment-resistant depression. 

Patients can only access these drugs in supervised clinical settings, and there will be no dispensing for home use.

The treatment is expected to be expensive, with estimates ranging from $15,000 to $25,000 for a round of psychedelic-assisted sessions. 

Eligibility will be rigorously assessed, with individuals with a history of psychosis, heart conditions, or serious illnesses likely to be excluded.

During the sessions, patients will receive a dose of the drug and undergo pre- and post-psychotherapeutic support. The treatment protocol will be similar to clinical trial protocols, with the aim of ensuring safety and efficacy.

Critics argue that the evidence supporting the broad-scale implementation of psychedelic drug use is insufficient. 

Neuropsychologists and psychiatrists have raised concerns about the decision, suggesting that the influence of lobby groups played a role. 

They believe that further research is necessary to determine the long-term safety profile of the drugs and to establish appropriate care alongside psychedelic dosing.

The Royal Australian and New Zealand College of Psychiatrists has released guidance documents calling for a “safety first” approach for psychiatrists using psychedelic-assisted therapy. 

While the decision has opened the door to clinical use earlier than usual, the potential benefits for patients with treatment-resistant mental illnesses have been acknowledged by the Therapeutic Goods Administration.