Inside Australia's First MDMA-Assisted Therapy Trial

In early 2022, the Morrison government funnelled $15 million from the Government’s Medical Research Fund (MRFF) into 7 clinical trials around Australia that would test potential breakthrough therapies for debilitating mental illnesses. These trials included the use of MDMA and various other psychoactive substances – drugs that for decades have been highly stigmatised and classed by the Therapeutic Goods Administration (TGA) as a schedule 9 prohibited substance in Australia.

This month the TGA announced that, as of July 1st, MDMA and psilocybin would gain entry under Schedule 8 (controlled substances) for specific circumstances, but remain in Schedule 9. 

This meant the drugs could now be prescribed by authorised psychiatrists within a restrictive framework. Despite the reclassification, and though international research has been extensive, national studies have not yet concluded the benefits of drugs like MDMA. But they’re well on their way.

It’s a move that Associate Professor Petra Skeffington, who is currently researching MDMA in therapy based settings, calls “surprising”. 

“Rescheduling before we've seen more evidence come out is surprising,” she told VICE.

“But the way it's been rescheduled is still incredibly restrictive. It's not changing the landscape dramatically at this point, but I think it pushes us in that direction.”

Skeffington, who is an Associate Professor of psychology at Murdoch University and Stephen Bright (the lead researcher from Perth’s Edith Cowen University) are currently conducting the first active MDMA-therapy study in Australia. Their research delves into the effect of MDMA-therapy on participants with debilitating PTSD symptoms and kicked off in mid-2022.

When the results are set to be published is still unknown, but Skeffington believes it will likely be a while after the 1st of July when the drug is set to be rescheduled.

Skeffington and Bright’s study is an open-label feasibility study, which means all parties (including the participants) are aware of the drug or treatment being given. Though it doesn’t necessarily have a research question, the goal, according to Skeffington, is “to demonstrate to international partners that it would be possible to get all approvals to be able to successfully and safely run trials in Australia.”

The study aims to treat four participants suffering from severe PTSD symptoms that in the past have been resistant to both psychotherapy and pharmaceutical therapy.

“I don’t think MDMA treatment should ever be the first line of treatment because it has risks associated with it, and we have quite good treatments already that don’t require MDMA,” said Skeffington.

“So, people get referred to this trial. They go through a rigorous assessment with psychologists and psychiatrists and then through a medical assessment to make sure that they are physically and psychologically safe to take MDMA.”

After participants are cleared to continue, they meet both Skeffington and Bright. 

“We do a number of preparation sessions to explain to them how it may be on dosing day,” said Skeffington.

Through those sessions, the pair work on building a relationship to avoid the awkwardness of being strangers on the day, and to “feel confident in each other”.

“We work through what coping mechanisms these people already have. What strategies we might need to give them so that if they have a challenging experience on their dosing day we know that they have strategies to manage them and be okay,” Skeffington said.

Once these preparations have been made, the participant is given a date for “dosing,” which occurs in hospital. Arriving in the morning, participants will forego physical checks before undertaking an eight-hour session.

Two therapists are on standby throughout this time, intermittently taking turns to leave the room if they need a bathroom break or to take lunch. After the session they stay overnight in the hospital. Therapists will return the next day to do a first integration session where participants start processing what came up the day before. 

“The MDMA really down, regulates our fear systems And so, what we see most often is that these participants start to engage in spontaneous cognitive restructuring of their trauma,” says Skeffington.

“They start thinking about it in different ways.”

That process will happen two more times for a total of three cycles.

While dosage differs in pharmaceutical therapies, the dosage in MDMA-trials is the same for each participant.

“In international trials they found that, with MDMA, everyone gets the same dose. There’s an initial dose and then an hour into the session there’s an option for a supplementary dose,” says Skeffington.

“The supplementary dose doesn’t make their experience more intense. It doesn’t push them further in an MDMA experience, but it will prolong how long they stay in their MDMA experience. I think one of the misconceptions is that we’re holding people up in a room, giving them a bunch of MDMA and they’re having a great time.”

In actual fact, the dosage is subtle compared to what people might take recreationally. Categorically, people aren’t having a good time when they take it.

“International trials have tested slightly higher and slightly lower doses. They found that if you go too high, people do start enjoying themselves and don’t engage in their therapy. So we don’t get that therapeutic outcome.”

Throughout the session, the therapists may or may not ask the participant questions.

“It’s a mixed bag,” says Skeffington.

“It looks really unusual to people who are familiar with a standard talk therapy model. One, because the session goes for so long, and we’re certainly not talking to each other for that entire time.”

The therapists are usually set on either side of the hospital bed while the participant is given headphones with a playlist specifically designed for the study. They receive eye shades as well. 

As the MDMA kicks in the therapists will engage in small talk usually surrounding their expectations of the therapy.

“Then there will be a time when we’ll encourage them to go inside,” said Skeffington.

“So that means to have their headphones in and their eye shades on. Typically, what happens in that time is that their trauma content that they’ve had difficulty engaging with will start coming up and they’ll engage with themselves internally.”

Usually, Skeffington says, researchers can see that happening. Whether that be because of a posture change or a physical and verbal reaction.

“When they feel like they have to tell us something, they may come back out of that. Take off their eye shades and their headphones and talk to us. If someone has their eyeshades on for a very long time, we may check on them.”

According to Skeffington and previous literature, three sessions seems to be the sweet spot for an effective treatment. They also can’t extend past three sessions in their research as they currently do not have permission. 

“What I’ve seen from international case studies, is that further down the line, people think they may benefit from additional cycles. But that doesn’t seem to be very common with MDMA. It’s not enjoyable enough that people think that they want to do it again,” said Skeffington.

“People think that you go in, take the MDMA, have a little dance party with your therapists and then you’re cured. It’s really not like that. It's hard work processing the trauma in this really compressed timeframe. So it’s really confronting for everyone involved.”

As Skeffington and Bright’s study is still underway there aren’t any results to report so far. 

“The results that I hope we can report is, ‘Yes, it’s possible to deliver the MDMA therapy legally, safely and effectively in Australia,’” said Skeffington.

If you’re well-read on your medicinal history you’ll know that, in the 1970s and 80s, MDMA had a cult following of psychiatrists that believed in its healing abilities, despite not having approval from national bodies. In 1985, in the U.S., an emergency ban suddenly stilted research after it became more readily available in recreational settings and on the streets.

Despite that, alternate sides of literature have long been advocating for the medicinal and psychological benefits of MDMA in controlled therapeutic settings. 

“We have a lot of really effective mental health treatments that may be effective in up to two-thirds of people,” says Skeffington.

“But we are also seeing an increasing rate of reported distress and reported mental health issues. If we think that that there’s at least one-third of people – possibly more – who are not responding to the treatments that we currently have and who are staying incapacitated and unwell, then we really have a responsibility to look for other treatments that can help those people rather than leaving them in the treatment-resistant basket.”

While Skeffington said that when she first heard of MDMA treatment she was sceptical, looking at data confirmed that it was relatively safe to do under clinical trials and that it really did seem to help.

At this point in time it’s hard to imagine what MDMA therapy would look like in the future if it were to be accepted into mainstream treatment. Yet Skeffington says it would look quite similar to the trials that they are currently conducting. 

“But it might be more flexible,” says Skeffington.

“If someone has a really good treatment after one session they could conclude their treatment at that point, but equally if someone needed something additional, that would be possible.”

However, it’s not likely that MDMA will ever be available outside of a clinical setting.

“I don’t see a pathway to break free from that therapeutic container, where you go to your local pharmacist and pick it up and just take it by yourself at home,” says Skeffington.

“It will probably always need a therapist or multiple therapists to make sure that the person is engaging in therapy safely. Beyond that it’s very hard to imagine in practical terms.”

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