From July 1 psychiatrists in Australia will be able to prescribe MDMA and psilocybin for controlled clinical use. Australia’s medicines regulator, the Therapeutic Goods Administration, announced the change in February.
MDMA – 3,4-methylenedioxy-methamphetamine, commonly known as ecstasy – will be used for the treatment of post-traumatic stress disorder. Psilocybin, a psychedelic that forms the active compound in magic mushrooms, will be able to be prescribed for treatment-resistant depression.
The two drugs will be down-scheduled from the strictest controlled category, schedule 9 (prohibited substances), to schedule 8 (controlled drugs), but only for medical use in psychedelic-assisted psychotherapy.
The change makes Australia the first country in the world to down-schedule psilocybin and MDMA for clinical treatments, though some other countries make these drugs available through different regulatory pathways.
What effects do these drugs have on the brain?
PTSD and depression together affect around 2 million Australians. Dr Mike Musker, a mental health researcher at the University of South Australia, described the regulatory change enabling psychedelic use to treat these conditions as “one of the biggest evolutions in psychiatry in the last 70 years”.
MDMA induces the release of the neurotransmitter serotonin in the brain, and also has effects on brain pathways involving oxytocin, which facilitates connection and empathy with others. Research has shown that MDMA-assisted therapy is more effective than psychotherapy alone in treating patients with severe PTSD.
Psilocybin is converted to psilocin in the body, which also acts on the brain’s serotonin receptors. “It has a major effect on depression for up to three months, just after one singular [25mg] dose,” Musker said in a media briefing.
Who will be able to access the drugs?
The drugs can only be prescribed by psychiatrists with pre-approval via the TGA’s authorised prescriber scheme, for the treatment of PTSD or treatment-resistant depression.
“Psychiatrists will need to provide a clinical justification for why they believe these substances are appropriate for the patient group they’re proposing to treat,” said Associate Prof Daniel Perkins, co-executive director of the Pychae Institute in Melbourne.
“Patients will be able to access these only in supervised clinical settings. There’s no dispensing for home use.”
Prescribers will be required to provide a proposed treatment protocol which includes dosing information and the number of therapy sessions. The TGA “would expect protocols which are similar to clinical trial protocols that have been used in Australia and overseas,” Perkins said. That protocol also has to be approved by a human research ethics committee.
The treatment will likely be expensive: Perkins estimates that a round of psychedelic-assisted sessions may cost between $15,000 and $25,000.
Scott Kelly, co-founder of Goodmind Therapeutics, a clinic that offers psychedelic-assisted therapy, said there would be rigorous assessments in place to determine eligibility. People with a previous history of psychosis, or a heart condition or other serious illness, for example, would likely be excluded.
He expects a huge discrepancy “between what we anticipate the demand will be and clinicians who are appropriately trained to facilitate the work”.
“I think it will probably be at least 12 months before it’s really … up and running,” Kelly said.
How will the drugs be administered?
“The access will involve a small number of administrations – probably one to three full-day, high-dose sessions with pre- and post-psychotherapeutic support,” Perkins said.
“There will be no access to any other patient groups, no off-label prescribing, and there’ll be no change in the regulation of MDMA and psilocybin in all other circumstances.”
Kelly said: “The model in the clinical trials has been a therapist dyad model, so two therapists for every one client … One of those therapists needs to be medically trained and is usually a psychiatrist.”
People undergoing the treatment would set their intention for the day’s session and receive their dose of the drug in the morning. “Six to eight hours later, the client should have returned to normal consciousness again. When the therapist team assesses that they’re … ready to go home, then they’ll be picked up by a support person who has agreed to stay with them for the next 24 hours,” Kelly said.
Are MDMA and psilocybin overhyped as treatment options?
“We see consistently positive outcomes in clinical trials,” Perkins said. “In these studies, we’re seeing very large effect sizes for benefit and a very low signal for adverse effects.”
However, he warned that the trial data was preliminary and remained limited. “We don’t exactly know how well it’s going to translate to the real world settings.”
While the long-term outcomes looked “encouraging”, there was “very little data to actually back that up at this stage,” Perkins added.
Researchers warn against self-administration. “People are desperate for treatment,” Musker said, “There is a risk that we don’t provide this treatment soon enough at an effective cost. There is a risk that people will try and treat themselves.”
There is a lack of consistent evidence suggesting that microdosing psychedelics has any beneficial effects.
