This
appeared last week:
Inside the secretive but growing world of MDMA-led therapy
Shrouded in controversy, tightly regulated but the science
far from settled: inside the veiled world of Australia’s legal, cutting-edge,
MDMA-led therapy.
Penny
Timms
5:00 AM April 25, 2025.
Regan Ballantine can feel the drug working less than an hour
after swallowing the pill.
Her mind is already shifting. She isn’t hallucinating.
Rather, she is visualising scenes of metaphorical importance. All seem to
provide her with an enhanced perspective about her untapped trauma and how to
deal with it.
The first scene shows two old-fashioned movie projectors
sitting side-by-side. They play films in unison, with the one on the left
representing her son, Wesley, and the one on the right representing her. Then,
Wesley’s film begins to flicker as if there is a technical error.
Abruptly, Wesley’s film stops.
“It represented these two lives living side-by-side, these
two stories of a life, and how his just flickered off and mine just kept
going,” Ballantine says.
“It’s such a beautiful metaphor, but there was so much pain
around that.”
Ballantine’s son, Wesley, fell to his death at a
construction site in Perth in 2017. His death was found later to have been
avoidable. It sent Ballantine into an instant state of shock.
“I went to the building site the day after he died and I
didn’t shed a tear,” she recalls.
“I felt nothing. I didn’t even cry at his funeral, I gave a
eulogy at my own son’s funeral and did not cry. That’s disassociation, it’s
compartmentalising. You do it to survive, because if you feel that part you
can’t survive.”
She estimates it took 18 months just for the shock of
Wesley’s death to wear off. By then, Ballantine was campaigning to get Western
Australia’s industrial manslaughter laws changed to hold employers to a higher
account for avoidable workplace deaths.
As an advocate, she was smart, calm and composed without
being cold; a formula that made her compelling in the eyes of politicians,
media and the public. She was someone who commanded attention and respect.
“I was tormented by memories of Wesley. Every time something
would remind me of him, my breath would leave my body, I’d almost gasp, that’s
how much of a state it put me in.”
It was a big responsibility but her resolve was strong and
the cut-through she was able to achieve was remarkable.
Her fight for greater justice took years, bringing her
before inquiries and into courtrooms.
When all of that finally ended and the courts made their
rulings, and the legislation was changed, and the cameras stopped rolling and
people stopped looking, Ballantine did something she hadn’t done in years: she
paused. It was then that the weight of all that responsibility and pent-up
emotion came crashing down.
“I just fell into an abyss,” Ballantine says. “It was like a
lid blew off a pressure cooker.
“Essentially my nervous system was fried, which meant I
could not be in the world in the same way. Loud noises, too many people, being
too far away from home would all induce anxiety or panic.”
It became clear Ballantine had a profound psychological
injury from the shock of Wesley’s death, the years of reliving it and the
fight-or-flight response she had experienced for years. She was diagnosed with
complex post-traumatic stress disorder.
“I was tormented by memories of Wesley,” she says. “Every
time something would remind me of him, my breath would leave my body, I’d
almost gasp, that’s how much of a state it put me in. I couldn’t even have
photos of him in the house. This emotional derailing would happen multiple
times a week.”
As Ballantine’s PTSD intensified, her world shrank. She
avoided any potential triggers but the triggers kept growing so her world kept
shrinking. At its worst, she was unable to get out of bed for long stretches of
time. Holding down a job seemed like a fantasy.
“It was honestly the most terrifying experience,” she says.
“I could no longer control my emotions, and I was in an
emotional shutdown response and went into a major depression and could not
function. I couldn’t get out of bed, couldn’t shower, couldn’t cook, couldn’t
leave the house, was having panic attacks. For the first time, I started taking
medication.”
She tried various therapies but nothing took. She even
considered checking into a psychiatric facility. Then she came across an
article about MDMA-led therapy and how Australia had become the first country
in the world effectively to legalise it as a last-line treatment for PTSD.
Regan Ballantine was suffering severe PTSD when the new
treatment became available. Here, she speaks to the experience.
The more she read, the more compelled she became. She
discussed it with her medical team and was assessed and approved to receive it
at one of the nation’s accredited facilities.
In Australia it is legal to use MDMA as a treatment tool for
PTSD. Psilocybin, the psychedelic compound found in magic mushrooms, can be
used for treatment-resistant depression. However, both drugs must be used only
in combination with psychotherapy under tight restrictions and only a selection
of trained and approved psychiatrists can prescribe them.
One clinician who oversees MDMA-led therapy in Australia
describes the therapies as “the biggest step forward” he has witnessed in his
30-year psychiatry career. That’s based on the results he is seeing with
patients.
But doubts and concerns remain. Medical
groups urge caution, saying there’s too much enthusiasm from too little firm
evidence. In the void of information, they fear patients could be harmed.
One psychiatrist tells The Australian there are anecdotal
accounts suggesting the therapies are only, potentially, slightly more
effective than other treatments, though their costs are considerable.
Data to back claims for or against the long-term results of
psychedelic therapy, and who may respond well to them and who will not, is
scant and still being gathered.
All of this comes while psychedelic-led therapy is growing.
Health insurer Medibank Private recently announced it was funding a clinical
study into psychedelic therapy.
The Department of Veterans’ Affairs has confirmed to The
Australian it also will fund MDMA and psilocybin-led therapies under strict
clinical conditions for ill veterans.
“Where eligibility requirements are met, veterans will not
be required to pay upfront for MDMA and psilocybin-assisted treatment which
they have been prescribed,” a department spokeswoman says.
“DVA is continuing work to finalise the administrative
processes as soon as practicable this year, including necessary governance and
safety standards.”
Once that happens, the department says it will begin
assessing requests for treatment.
Australia’s drug regulator also is considering amending the
Poisons Standard to allow psilocybin to be used also for people in “existential
distress” during end-of-life care. Public submissions on the proposal close in
late May.
For Ballantine, her experience with psychedelic therapy has
been positive and, so far, transformative. But she says it has taken a lot of
hard work, reflection and therapy.
“It’s not like you take these medicines and it’s a passive
process where you go on this journey and come out healed,” she says. “You get
out what you put in.”
Welcome to the complicated, messy, secretive and intriguing
world of MDMA-led therapy.
A brief history of MDMA
MDMA originally was intended as an appetite suppressant but
it attracted little attention and was shelved for decades until it was
rebranded as a tool for psychotherapy in the 1970s.
It also became popular for its off-label recreational
misuse, which happened to coincide with a cultural uprising and the US war on
drugs, leading to the effective global banning of MDMA in 1985 when governments
decided it served no medical purpose and easily could be abused. It was then
added to the UN’s International Convention on Psychotropic Substances,
cementing its status as little more than a party drug.
However, as a Schedule 9 prohibited substance, the drug
could be used in limited clinical research, mostly for PTSD though it was
tested for other conditions including anxiety, with limited effect.
Its use also has been growing in the fraught underground
“wellness” scene. There, unauthorised and self-titled “therapists” have been
offering services to paying customers who are desperate for help.
It was a topic canvassed in the 2024 memoir Sassafras by
Australian author and researcher Rebecca Huntley, who spoke highly of her
experience towards healing from childhood rejection and judgment.
Then there is the much-hyped memoir The Tell by venture
capitalist Amy Griffin. The book details the author’s experience of underground
MDMA “therapy” in the US. It has been a New York Times bestseller, an Oprah
Book Club pick and promoted by the likes of the author’s high-profile
associates including actor and celebrity influencer Gwyneth Paltrow.
However, the story leaves you with a resounding sense that
the therapy should be delivered only by somebody with the appropriate training.
But what truly threw MDMA-led therapy into the spotlight was
a shock decision in 2023 by Australia’s typically conservative drug regulator.
Australia became a global outlier when the Therapeutic Goods
Administration went against the advice of medical groups and down-scheduled
MDMA to allow it to be used for the treatment of PTSD.
It did the same with psilocybin, allowing it to be used in
combination with psychotherapy for treatment-resistant depression. It remains
illegal to use either of the drugs recreationally or in an unapproved or
non-clinical setting.
In the lead-up to its decision, the TGA considered thousands
of submissions as well as the advice of an independent expert panel. The panel
noted limitations with clinical data but supported the down-scheduling.
The regulator also was heavily lobbied by Mind Medicine
Australia, a non-medical advocate of psychedelic medicine. It is also a
registered charity. The group tells The Australian it is now the nation’s
largest importer of the psychedelic medications.
It is also behind the push to expand the use of psilocybin
to the terminally ill.
What is MDMA-led therapy?
MDMA is a drug officially named
3,4-methylenedioxymethamphetamine but is better known by the street names of
ecstasy, E, pingers or Molly.
The National Drug and Alcohol Research Centre describes it
as a stimulant drug known to increase a person’s feelings of empathy,
friendliness and social connectedness with others. Street versions sometimes
can include other stimulants and hallucinogens.
When used medically in Australia, the pure drug is sourced
from a specialist facility in Canada. It arrives under strict security controls
and is delivered only to clinics, under guard, shortly before it is provided to
the patient. In that briefest of windows between its delivery at a clinic and
its use, two clinicians must remain with the medication any time it is not
being stored in a bulletproof safe.
The idea of MDMA therapy is that the drug triggers chemical
changes in the brain, helping to lower a patient’s defences that may otherwise
prevent them from delving too deep into their trauma. Once those barriers come
down, therapists will try to achieve a new level of counselling.
For patients who do qualify for it, they typically will have
three regular therapy sessions in the lead-up to the first dosing session. They
will be told what to expect, discuss their treatment goals and develop a
working relationship with two therapists – usually a psychologist and a
counsellor – who will remain with them for each individual dosing session.
There are typically two or three dosing sessions and each will be overseen by a
prescribing psychologist also.
A single dosing session lasts between six and eight hours
and must be delivered only in a clinical setting under tight security controls
and the drug can be administered only by an approved prescriber who has been
cleared by regulators. The patient will be offered two doses of the drug across
the course of each session, where they will be guided through intensive therapy
while under the influence of MDMA.
Then there’s the music.
“Music is actually a key part of the therapy,” says Michael
Winlo, a trained but non-practising doctor and managing director of biotech company Emyria. The company operates several
regular clinics and also has been running psychedelic trials and services.
“We have a special service that actually generates a
non-repetitive soundscape that is matched to the drug effect. So, we start off
with pleasant uplifting music, and then as the drug’s peak happens about an
hour and a half into the dosing session we will increase the rhythm and
intensity of the music. That helps people go into the experience a bit more
deeply. And then we bring people out towards the end of the day as well.”
He says the sessions often are gruelling.
“We’re deliberately trying to confront difficult content
that might require revisiting traumatic events or situations or reflecting
deeply on broken relationships,” he says.
“But what the medication allows is that the sense of fear
diminishes. The trust is there, people feel relaxed and open, and finally can
talk about that difficult event, situation, circumstance.
“The medicine’s there to unlock the power of the therapy.”
Dosing sessions are held at least a month apart, with
intensive therapy after each. Patients also will experience a comedown effect.
They are banned from driving for 48 hours after treatment, must be released
into the care of a competent adult and are advised to spend the next few days
in a calm environment.
For Ballantine, her second dosing session involved the
hardest work.
“I described my second dose as doing 10 rounds with Mike
Tyson in a cosmic washing machine,” she says.
“I was literally traversing the terrain of my subconscious
and facing some truths about myself, often hidden truths. That’s super
challenging.”
She says the drug helped her to revisit past events but to
consider them from other perspectives, which made it easier to be able to find
new ways to confront and deal with them rather than bury them.
One of the other scenes her mind took her to while on MDMA
was of a street lined with full garbage bags. The trash represented her grief,
fear, anger and rage.
“Because I hadn’t dealt with it, it was piled up,” she says.
“So, I started taking it out, putting it in the bins. It was
about renewal, reprogramming … processing. I started processing the grief and
anger. Now I can actually connect to my feelings. This means I can actually
take the rubbish out and process my feelings rather than just bury them.”
The controversy
When drugs are even partially legalised, it can lead to a
spike in their recreational use and subsequent harm. MDMA has a well-documented
history of harm, including overdose and death.
One of the groups most critical of the TGA’s rescheduling
decision has been the Royal Australian and New Zealand College of
Psychiatrists. It had advised the TGA against the move, saying that while
promising evidence was emerging about the role of psychedelics in treatment,
the trials were significantly limited and the results still in development.
It urged the TGA to keep the drugs restricted to authorised
trials to allow evidence to keep building, but the regulator chose otherwise.
To add salt to the wound, the college then was tasked with
developing the industry’s clinical guidelines.
“It is a very cautious set of guidelines and that’s for good
reason,” says Richard Harvey, a practising psychiatrist who chaired the
college’s psychedelic-assisted therapy steering group.
“This is a treatment where we don’t have convincing evidence
that it’s effective. It is an incredibly expensive therapy and we remain very
cautious.”
Harvey says he has spoken to several clinicians who are
delivering psychedelic therapy in Australia and he worries the positives are
being over-hyped, instilling unrealistic expectations in patients.
“What I hear, and this is absolutely anecdotal, is that
these treatments are almost no different to any other treatment we have in
psychiatry,” he says. “Typically, 30 to 40 per cent of patients might see some
benefit, 30 to 40 per cent of patients experience not much at all and get no
benefit, and 30 to 40 per cent of patients experience some sort of adverse
experience.”
Those anecdotal accounts make him worried, given the
treatment’s hefty price tag. The cost of MDMA-led therapy sits at about
$30,000, putting it out of reach of many people unless they can secure
financial support elsewhere or be part of a clinical trial.
Harvey points to the US, where in 2024 the drug regulator
rejected legalising MDMA for therapy because, unlike the TGA, it said human
trials did not prove MDMA’s efficacy and it ruled there was not enough clinical
data to outweigh the potential harms of the drug.
“They have raised concerns that we also identified, which is
partly around what we call allegiance bias,” Harvey says.
“So, the people wanting to do these therapies – the
psychiatrists and psychologists – are often very positive about those
treatments.
“Patients are often very desperate and have enormous
expectations that this is going to be the miracle treatment, partly because of
what they read from the people that provide the treatment. It sort of sets up
an environment where people can be harmed. And that’s not only harm from the
medication but harmed financially.”
One of the problems with clinical trials for psychedelics is
that, even in blind studies, it is apparent to everyone who has taken a
mind-altering substance and who has not. That runs the risk of skewing results.
The most comprehensive trials also have included intense psychotherapy rather
than relying on the drugs alone. Sample sizes and study durations generally
have been quite limited also.
Harvey is not vehemently against the therapies but he would
like to see more evidence they work, are safe and are worth the significant
financial outlay and staffing required to deliver them, especially amid a
shortage of mental health workers.
Paul Fitzgerald is head of the Australian National
University school of medicine and psychology and is a qualified psychiatrist.
His research interests include PTSD and depression as well as
psychedelic-assisted psychotherapy.
“I think in some of the trials it looked a little bit better
than (the success rate suggested by Harvey). But, given the limitations we have
in terms of the trials, I just don’t think we really know the results yet,”
Fitzgerald says.
He is collecting real-world clinical data through a project
he is running through ANU, though he says it will take time to develop a clear
picture of things.
“One of the very big unanswered questions here is, how much
of these treatments is a one-off; do you do the therapy and then it has
benefits for years? Or is this something, like most other treatments in
psychiatry, where the condition is going to come back again and patients will
require further rounds of treatment? That’s a really critical but at this stage
unanswered question.”
It is a question he is working hard to answer.
In March 2025, private health insurer Medibank Private
announced it would invest $50m across the next five years into mental health
support. A portion of that will fund a psychotherapy program for eligible
patients to analyse their clinical outcomes. Information from that trial will
be fed back to the database being run by Fitzgerald.
“We’re certainly seeing in the very preliminary analysis
that patients are responding to these treatments, having substantial reductions
in their PTSD,” he says.
“What we don’t have yet is the sort of longer-term follow-up
to see how long those benefits last. And what we also don’t have yet is some of
the data we’re hoping to get, in terms of the collaboration with Medibank
Private, which is how these treatments look in terms of cost effectiveness.
“We need to understand whether that upfront cost pays off
over time, including through a reduction in the necessity of other treatments
and increasing people’s ability to get back into a productive lifestyle.”
The support
Supporters point to limited but seemingly encouraging
clinical data.
However, these therapies certainly are not for everyone.
They are not appropriate for people with certain medical and psychiatric
disorders or those taking particular medications. Even patients taking
antidepressants will need to wean off their medication before being allowed to
take these drugs.
The therapy also is not advised for people who have taken
the drugs recreationally.
Many of those working with psychedelics describe the drugs
as last-line treatments for people who often are unable to live their lives
well and who don’t have other options.
Winlo says when the therapies do work, small changes can
happen quickly.
“Often, the steps start small because we’re dealing with
people who’ve been really severely disabled by their mental health condition,
in some cases for many years,” he says.
“Patients will turn up the next morning wearing colours for
the first time in years. Or say: ‘I’m going to cook for myself today’, or ‘I
took out the garbage’.
“These small steps are the building blocks where we help
people back into their lives.”
While the pool of patients treated with the therapies is
still somewhat small, Winlo says his team has tracked the progress of all of
them and he is not aware of any who have returned to taking medications to
treat their mood disorders.
Jon Laugharne is a psychiatrist based in Perth who oversees
MDMA-led therapies alongside Winlo. He is also the group’s psychedelics
prescriber and says so far the clinic has prescribed MDMA to more than 20
patients.
“Having worked in psychiatry for 30 plus years, this is the
biggest step forward that I’ve seen in my working career,” Laugharne says.
“The idea is that it makes the brain very neuroplastic for
days, if not weeks, and it creates this opportunity. What we’re seeing with
patients is new ideas and perspectives, they have new ways of seeing the world
and their experiences start to land very quickly in the integration session,
sometimes even on the dosing day.
“Some people say: ‘I’m finding new rooms in my mind and new
doors to walk through that I didn’t realise were there.’ ”
Results from the clinic also are fed back to the national
database at ANU. Laugharne says the clinic has data from the first patients
treated with the therapies a little more than a year ago and most are
continuing to show improvements.
He understands, to an extent, the reservations about
psychedelic therapy. But Laugharne argues the regulations in place mean there
are plenty of safeguards to protect patients from harm.
“There are always going to be questions,” Laugharne says.
“There’s always going to be potential risks and you always want to minimise
those. But what do these patients who are really struggling do in the meantime,
while we’re waiting for the next study and the next study?”
According to the TGA, there have not been any recorded adverse effects from approved MDMA or psilocybin use since
the drugs were down-scheduled.
It has been about eight months since Ballantine received her
treatment and she describes herself as being in remission. She also is back at
work.
Now, the photographs of Wesley that once were banished
painfully from the walls and countertops of her home are back on proud display.
Sure, she still gets triggered. But she says her nervous
system is better equipped to cope with those triggers and the challenges life
throws at her. She says she also has some new perspectives.
“The anniversary of my son’s death is on January 5 and my
birthday is on January 6,” she says. “So, I’m faced with this situation where I
can either have that reaction for the rest of my life and just be impacted by
this rollercoaster of loss and celebration.
“You get to a fork in the road and it becomes a choice of
how you see things.
“I’m just so lucky that I get a birthday. That’s been a
lesson for me; I have the gift of life. When you lose a life like that, in a
heartbeat, you understand the sanctity of it. I honour my son by honouring my
own life and living my life well.”
Here is the
link:
https://www.theaustralian.com.au/health/mental-health/inside-the-secretive-but-growing-world-of-mdmaled-therapy/news-story/3cf3f52f12d3c9c2d52b048785b1453c
It is
interesting to see how the use of MDMA is evolving and loosing its stigma!
David.
