The ABC’s Dr Norman Swan discusses what you need to know about an emerging Australian approach to using MDMA and psilocybin in conjunction with specialised psychotherapy for treatment resistant post-traumatic stress disorder (PTSD) and treatment resistant depression available from 1 July 2023.
Psychedelic assisted therapy now available in Australia
“If you’ve got treatment resistant depression or treatment resistant post-traumatic stress disorder, from July of this year (2023), what’s called psychedelics assisted therapy is now an option,” Dr Swan says.
The psychedelics in the spotlight are the synthetic compound 3,4-methylenedioxymethamphetamine (MDMA, or ecstasy) and psilocybin, which occurs naturally in some species of mushrooms often referred to as ‘magic mushrooms’. While the use of psychedelics in medicine has been studied on an off for decades, the decision from the Therapeutic Goods Administration (TGA) decision to make them available in a limited way surprised some experts.1-2
“The decision is quite complex,” Dr Swan explains. “Only authorised psychiatrists who’ve had training and received permission from a Human Research Ethics Committee with be allowed to prescribe these drugs in association with psychotherapy. It’s psilocybin for treatment resistant depression and MDMA for treatment resistant post-traumatic stress disorder for people who’ve failed [standard] available therapies.”
How will prescription psychedelics be used for treatment?
While guidelines are still being developed, prescription MDMA and psilocybin will only be administered to patients for the purpose of undergoing a talk therapy session with an authorised psychiatrist in a therapeutic setting.1-2
“This is psychedelic assisted therapy which means the psychedelic is intended to make psychotherapy more effective,” Dr Swan says. “So it’s combined medication and psychotherapy, it’s not prescribe and walk away. It has to go with properly monitored care and the authorised psychiatrists will have to report on their patients on a regular basis.”
Does psychedelic assisted therapy work?
“The available evidence is stronger for MDMA and PTSD than psilocybin for depression but is still thinner than some researchers would prefer – even those who are enthusiastic about the therapies’ potential. Safety issues may not have been fully explored and it’s not clear that psilocybin is better than existing treatments. This should be clarified when trials underway are analysed and reported,” said Dr Swan.
Who can prescribe psychedelics in Australia?
“Authorised psychiatrists have to have undergone training,” Dr Swan says. “They also have to get approval from a human research ethics committee to be allowed to do the therapy. They also have to report on all cases every six months.”
These safeguards are designed to protect patients however much is still unknown about how standardised the therapy will.
Researchers have recently raised concerns about the potential for variations in therapy quality leading to the risk of patient harm. One recently commented on the ABC’s Health Report stating: “Therapy using psychedelic drugs is generally safe yet a review of its use found that adverse events were not properly assessed or not reported.”3
Are psychedelic drugs legal in Australia?
Not for recreational use. The TGA’s February 2023 decision means psilocybin and MDMA will be listed as Schedule 8 drugs for tightly controlled medical use in a very small, highly specific patient population when prescribed by an authorised psychiatrist from July 2023.1-2
Legally, this change puts psilocybin and MDMA in the same category as controlled drugs like prescription stimulants such as dexamphetamine for attention deficit hyperactivity disorder (ADHD). But it doesn’t alter the two psychedelics’ legal status for non-therapeutic purposes where they remain listed as Schedule 9 prohibited substances.
How are prescription psychedelics different to illegal MDMA/ecstasy and magic mushrooms?
“These are exactly the same drugs available on the illicit market,” Dr Swan says. “The difference is that you know what you’re getting in the tablet since they’re specially manufactured hopefully to a high quality.”
How can I get treatment with psychedelic drugs in Australia?
The change in scheduling recognises that some people with these chronic mental health conditions don’t respond to standard treatment. Introducing psilocybin and MDMA for therapeutic use with therapy in Australia could be great news for mental health care where new approaches to treatment are relatively rare.
“Most experts in the field feel that it’s premature, so you’ve just got to be careful. The evidence is looking promising, but the data’s not in yet,” Dr Swan says.
How much will prescription psychedelics cost?
As yet, there are no government subsidies for which cover the whole process of psychedelic assisted therapy and it is unclear what the response of private health insurers will be.
“The problem is that this is probably going to be expensive,” Dr Swan says. “The costs may be large. Some psychiatrists have quoted fees of $20,000 or more.” (NEEDS REFERENCING)
How will psychedelic treatment take place in Australia if there are no approved medicines yet?
As the TGA explains, “There are currently no approved products containing psilocybin or MDMA that the TGA has evaluated for quality, safety and efficacy. However, this amendment will allow authorised psychiatrists to access and legally supply a specified ‘unapproved’ medicine containing these substances to patients under their care for these specific uses.”
This isn’t particularly unusual since medicines regarded as ‘unapproved’ by the TGA are routinely used in Australian clinical trials and during some medications shortages via the organisation’s Special Access Scheme (SAS).
How are MDMA and psylocibin used in mental health treatment?
The TGA explains, “Psilocybin and MDMA are psychedelic substances that show promise in the treatment of treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD), respectively, in patients for whom other therapies have been ineffective. The evidence shows that there may be benefit when used in combination with psychotherapy under a strictly controlled treatment protocol.”
That precise protocol is yet to be formally announced but the TGA is very clear on how psychedelic therapy in Australia should occur and it will require strict medical supervision to manage potential risks such as side effects: “Under this authorisation, the substances will only be permitted to be administered to patients in a controlled medical setting, for example in combination with psychotherapy by appropriately qualified and trained healthcare professionals.”1-2
Who can get access to psilocybin and MDMA treatment in Australia?
You must have tried all the standard traditional treatments for PTSD and depression without improvement before you can be considered for one of the new psychedelic therapies.
“It’s worth checking with your GP, and maybe a psychologist or psychiatrist, whether you truly have treatment-resistant depression and if all options have been tried,” Dr Swan says.
If you do meet the guidelines, the next step is to be referred to a psychiatrist who is authorised to prescribe psilocybin and MDMA treatments in Australia.
“Your regular general practitioner can advise and refer you to a suitable psychiatrist if they consider that psilocybin or MDMA may be an appropriate treatment option for you,” the TGA says.
REFERENCES
[1] Australian Government Department of Health and Aged Care Therapeutic Goods Administration. Change to classification of psilocybin and MDMA to enable prescribing by authorised psychiatrists [Internet]. 2023. [Cited 2023 June 30]. Available from https://www.tga.gov.au/news/media-releases/change-classification-psilocybin-and-mdma-enable-prescribing-authorised-psychiatrists
[2] Australian Government Department of Health and Aged Care Therapeutic Goods Administration. Re-scheduling of psilocybin and MDMA in the Poisons Standard: questions and answers. [Internet]. 2023. [cited 2023 June 30]. Available from https://www.tga.gov.au/resources/publication/scheduling-decisions-final/notice-final-decision-amend-or-not-amend-current-poisons-standard-june-2022-acms-38-psilocybine-and-mdma/re-scheduling-psilocybin-and-mdma-poisons-standard-questions-and-answers
[3] ABC. Health report: The therapy in psychedelic-assisted therapy may be causing harm [Internet]. 2023 [cited 2023 June 30]. Available from https://www.abc.net.au/radionational/programs/healthreport/therapy-in-psychedelic-assisted-therapy-may-cause-harm/102484500
