MDMA and psilocybin are now approved for medical use. Problem is, experts don’t know how to use them

Australia’s drug regulator bumping up the categorisation of MDMA and psilocybin for use in clinical settings as an assistant to psychotherapy has been hailed as a win for drug reform. But among advocates for psychotherapeutic uptake, there is collective concern this is a “cart before the horse” situation.

Psychiatrist and long-time advocate for psychedelic-assisted psychotherapy Dr Nigel Strauss said the science has unfinished business. The resources and medical infrastructure required for rollout (namely, trained professionals) are not ready to go, he said, and without adequate training, the drugs risk being dealt as just another antidepressant.

“Psychiatrists are used to writing prescriptions, but doing psychotherapy is a whole new paradigm,” he told Crikey. 

Conventional psychiatric medication suppresses symptoms by muting emotions, whereas psychedelics work in the opposite direction: they bring up emotions.

Strauss is concerned that the Therapeutic Goods Administration (TGA)’s reclassification — officially called rescheduling — of MDMA and psilocybin from prohibited to controlled substances has been conducted through this biomedical lens.

“There’s an attitude that this is like a new antidepressant drug, but it’s not,” he said. 

“These drugs are adjuncts to psychotherapy. It’s not a matter of giving someone some psilocybin, putting them on a couch for six hours and coming back and saying, ‘How are you?’”

Psychiatrists have been identified as the sole practitioners authorised to dish out the drugs. To qualify they must be trained. Australia currently has no accredited training and no guidelines for what constitutes accredited training.

An intro to psycho-assisted therapy

The lobby group responsible for the TGA’s change of heart, Mind Medicine Australia (MMA) — featured in a Four Corners report last year — has positioned itself as the premiere training program for psycho-assisted therapy in Australia. It offers a 90-hour course of in-person and online classes that runs at $9250 ($8250 if you pay upfront).

It’s sold as the “first course of its kind” in the southern hemisphere, based on “best practice” and protocols developed by MAPS — the US-based Multidisciplinary Association for Psychedelic Studies that has led the charge on clinical research of MDMA and psychedelic-assisted therapies.

The association’s executive director, Tania de Jong, claims that the MMA has been approached by “well over 1000 psychiatrists in Australia” wanting to do the course, with the recent TGA announcement prompting a surge of interest. She said that she “absolutely expects” their training to qualify for a TGA tick of approval.  

MAPS founder and executive director Rick Doblin, who has taught in MMA’s training, said “it’s good” but nowhere near what’s required for the prescription, administration, monitoring and follow-through of psychedelic-assisted therapy: “It’s a background course on psychedelic therapy. So no, it’s not acceptable training.”

What does a proper training model look like?

Doblin says the gold-standard MAPS model is broken down into three parts — two required, one recommended. Part one is 100 hours of online and in-person learning. Part two (“never required, always optional, but strongly recommended”) is where therapists themselves receive MDMA-assisted therapy.

“Psychiatrists don’t need to do electro-convulsive therapy to administer it. But the difference is that’s medicine. This is therapy,” Doblin said.

“Every therapist working with MDMA would be more effective themselves if they’ve had the therapy.”

Part three is supervised training videotaped from start to finish and then reviewed in an educational setting. Psychiatrists and psychologists are given feedback on their methods; for example, “don’t be scared of strong emotions”, or steps of what to do if the patient starts talking about bodily pains. The point is to watch practitioners work with post-traumatic stress disorder (PTSD) patients in the real world.

In Australia, only 12 people have received MAPS-standard training. Doblin is concerned that the TGA has greenlit the use of MDMA and psilocybin-assisted therapies without appropriately trained psychiatrists, with no detail on training requirements for psychiatrists, and no mention of training other psycho-therapeutic practitioners including psychologists, social workers and nurses.

In a statement to Crikey, the TGA said it requires authorised prescribers to be “registered as psychiatrists in Australia”, to “adhere to principles of Good Medical Practice”, and to seek ethics approval, adding that “these measures are necessary because there is only limited evidence that the substances are of benefit in treating mental illnesses, and only in controlled medical settings”.

When will we learn?

In Australia, most “get your hands dirty” psycho-therapeutic training comes from clinical trials.

In March 2021, the federal government put out a $15 million competitive grant designed to “kickstart Australian clinical trials” in this space. Researchers say it certainly did, but less than a year later these trials are still in their infancy. To date, only one dose of MDMA has been administered in an Australian clinical setting.

MMA chair Peter Hunt says that trials in Australia aren’t required to register medicine in Australia, pointing to extensive research in the US as efficacy enough.

“Are we really in a world where researchers can block access to those people just so they can finish their own research? There’s perfectly good data overseas,” he said, adding that the American brain is no different from the Australian brain.

“To suggest it is not is the most bizarre comment I have ever heard.”

Dr Simon Amar, a trained Canadian psychiatrist and principal investigator in the Montreal-based MAPS phase three clinical trial of MDMA-assisted therapy, said the case for homegrown data is about uptake, not efficacy. Yes, the research evidence carries over from the US, but the purpose of clinical trials in Australia is to demonstrate we have the infrastructure and skills to implement psycho-assisted therapy. He says that science has been cut short.

“The regulations talk about how there has to be reporting of serious adverse effects, but most psychiatrists don’t even know what those serious adverse effects are,” he said.

Little is known by Australian practitioners about how to use the drugs, what the drugs can do, what a positive versus negative experience looks like, who the drugs do and don’t work for (and why), how many sessions are required, what’s the follow-up, what’s the cost — the list of questions from experts goes on. 

It’s all information Amar says they’re “still filling in”.

MMA’s Hunt and de Jong told Crikey that “it’s not an either-or” in terms of rollout to research, with the TGA’s rescheduling to constitute a form of real-world research.

But industry experts say this not only risks medical malpractice but also narrows the research field courtesy of high costs and diminished access.

Edith Cowan University’s Dr Stephen Bright, lead on the sole Australian MDMA study that’s commenced recruitment, says the cost per person for a single treatment of psychedelic-assisted therapy (currently subsidised by the research grant) is $20,000. That includes psychiatry time, two psychologists’ time, eight-hour sessions for the drug dosing, and an overnight stay in a hospital — all pre-profit margin. 

“I’m really concerned about accessibility and how the people that need this are ever going to be able to access it within this new model,” Bright said.