Over the past two years, Australia, a country long known for its strict drug laws, has been allowing psychiatrists to treat post-traumatic stress disorder (PTSD) with MDMA, the chemical compound better known as ecstasy or molly. The early results have been striking, researchers say, with more than half the patients who received MDMA along with psychotherapy reporting significant relief from PTSD.
Just as notably, Australian drug regulators have not recorded any serious adverse events among the nearly 200 patients who have been through the program, which includes up to three dosing sessions with MDMA, a synthetic stimulant that promotes empathy, emotional connection and feelings of euphoria.
That data point is especially relevant given the contentious debate in the US over the safety of MDMA one that, in 2024, helped sink the prospects for MDMA therapy at the Food and Drug Administration. “Compared to conventional treatments, the outcomes we’re seeing to date with MDMA-assisted therapy have been extraordinary,” said Dr Ranil Gunewardene, a psychiatrist in Sydney, who has treated more than 40 patients since the Australian regulators created a legal pathway for the drug.
But Australia’s experiment with psychedelic medicine also highlights the limitations and constraints that the nascent field is likely to face as it gains wider attention from regulators and practitioners.
With an average cost of $20,000 for up to three dosing sessions and 40 hours of counselling, MDMA therapy is largely out of reach for the estimated 1 million Australians who suffer from PTSD, a mental health condition that is often hard to treat and is associated with high rates of suicide.
Much of the cost is related to the extensive counselling component. Another issue is access. Fewer than 50 psychiatrists are authorised to prescribe the drugs in a country of 28 million people, and most practice in a handful of coastal cities.
Advocates say complex licensing requirements dissuade participation in the program, which is administered by the Therapeutic Goods Administration, Australia’s counterpart to the FDA. The licensing process, which includes approval by an ethics panel, can take six months. And because the government prohibits drug advertising, many patients are unaware the therapies exist.
Mind Medicine Australia, an advocacy group that provides financial assistance to patients seeking psychedelic therapy, has been pressing regulators to reduce costs and widen access by loosening restrictions on who can dispense the drug and who qualifies for treatment.
Under the current rules, only patients who failed to experience significant improvement with conventional psychiatric interventions are eligible for psychedelic therapy. Other rules also contribute to the programme’s high costs, like requiring the prescribing psychiatrist to remain on site during the six-to-eight hour dosing sessions along with two psychologists who sit with the patient.
Tania de Jong, the executive director of Mind Medicine Australia, said, “A growing backlog swelled the organisation’s waiting list to more than 1,000 people. Given the immense suffering of patients who potentially could end up taking their own lives, the lack of access is unacceptable,” said de Jong, who played a key role in the years-long effort to persuade drug regulators to loosen the restrictions on MDMA.
In a statement, the Therapeutic Goods Administration said stringent oversight was necessary given that MDMA is considered an experimental and unapproved medication.
Those who have experienced MDMA therapy say the benefits have been life-changing. Maddison Bright had tried just about every therapeutic intervention for the anxiety and depression that was making her life unbearable, from beta-blockers, hypnotherapy and electromagnetic brain stimulation to conventional antidepressants.
“Sometimes I was so heavily sedated, I wasn’t able to actually see properly,” said Bright, a survivor of sexual abuse who was diagnosed with complex PTSD, a more serious form of the mental health condition.
When her therapist suggested MDMA therapy, she jumped at the opportunity, becoming the first patient in Australia to undergo a psychedelic treatment. “I was so desperate for peace in my life,” said Bright, the mother of two children who lives in a rural community outside Canberra, the Australian capital.
In the two years since her final dosing session, Bright said she had found peace. She no longer takes psychiatric medication and describes herself as “grounded, connected and transformed.” Her anxiety has not been fully vanquished, but she said that MDMA therapy had given her the tools to deal with the occasional panic attack. “MDMA isn’t a miracle cure,” she said. “It’s hard work.”
The treatments typically involve three dosing sessions, each separated by at least a month, with psychotherapy before and after each session.
Bright’s therapist, Monica Schweickle, said psychedelic therapies were not a good fit for everyone who is eligible. For starters, patients must halt their existing psychiatric medication before the first session, a potentially difficult tapering process that can take as long as a year.
“I declined to recommend MDMA to about half my patients. Sometimes they lack a stable living situation, or they struggle to come off antidepressants,” sh pointed out.
Some patients also grapple with concerns from family members. Zoe Marshall (40) said her husband was uncomfortable with his wife taking an illegal drug. “He was worried I’d become addicted or that it would have a lasting negative impact on my life,” said Marshall, a podcaster who struggles with PTSD and obsessive compulsive disorder.
Marshall is roughly halfway through the MDMA therapy process, which she described as emotionally draining. She said she found it hard to socialise or work, but recognised that those challenges were part of the healing process. “It’s not for the faint-hearted,” she said.
Australia’s experimental programme also allows psychiatrists to treat severe depression with psilocybin, the key active ingredient in ‘magic mushrooms’. Although illegal at the federal level in the US, psilocybin is available at state-regulated clinics in Oregon and Colorado, with New Mexico to follow later this year.
“It’s an exciting moment, but at the same time we know the world is watching, so we have to get it right,” said Dr Kevin Ong, a psychiatrist in Melbourne who has treated a half-dozen patients with MDMA.
The preliminary positive results have caught the attention of Australian insurers, including Medibank, the country’s largest private health insurance company, and the Department of Veterans Affairs, each of which recently agreed to cover the cost of MDMA and psilocybin therapy.
In a statement announcing expanded coverage for the treatments, Dr Andrew Wilson, Medibank’s chief medical officer, said the company hoped the therapy would lead to a reduction in mental-health-related hospitalisations, which cost the company $1.4 billion each year.
“For many people, the current system is not working,” said Wilson, noting that half of all psychiatric patients covered by the company are readmitted to the hospital within 12 months. “In many cases, it’s multiple readmissions over the course of their life.”
Paul Fitzgerald, a psychiatrist who runs a patient registry at Australian National University that is assessing the efficacy and safety of the drugs, said it was too early to release data on outcomes.
But after more than 20 years of conducting clinical trials on intractable mental health conditions, he said he had been struck by the number of patients who had reported significant improvements. Whether those benefits persist remains to be seen. “The key question is durability,” he added.
One early data trend has become apparent: So far, the patients who take MDMA seem to experience more lasting improvement than those who undergo psilocybin therapy. “If that proves to be true, it will be a very important finding,” Fitzgerald said.
Australia’s MDMA-assisted therapy programme is modelled on protocols developed by the Multidisciplinary Association for Psychedelic Studies, or MAPS, a US non-profit that has spent 40 years developing a therapeutic model for MDMA that could pass muster with the FDA.
In 2023, experts from MAPS travelled to Australia to provide the first training for mental health providers there. A year or so later, around the time MDMA therapy was being introduced in Australia, the FDA declined to approve the application, claiming insufficient data on efficacy and safety.
Since then, Lykos Therapeutics, the drug development company spun off by MAPS, has been conducting additional clinical trials requested by the FDA.
MDMA is not a classic psychedelic like psilocybin and LSD, which induce hallucinations and other changes in sensory perception. MDMA is an empathogen, a class of drugs that produce feelings of social connection and emotional openness. The drug floods the brain with serotonin, dopamine, oxytocin and other neurotransmitters that play key roles in regulating euphoria, movement and memory. It also reduces activity in the amygdala, often referred to as the brain’s ‘fear centre’.
Common side effects include an elevated heart rate, nausea, jaw-clenching and blurred vision. But many experts say there is a need for more research into whether there are long-term effects.
Invented in the early 20th Century, MDMA’s therapeutic promise was born in the 1970s, when therapists in the Bay Area found the drug enabled patients to confront the deeply buried trauma that was often the unacknowledged root of their depression or distress.
Gunewardene, the psychiatrist in Sydney, said MDMA had soothing, anti-anxiety effects on patients whose trauma, often related to childhood abuse, had left them dissociated from their emotions. “You end up disconnected from people, nature, music, emotions and your own body,” he said. “It’s like living in a dense glass prison.”
The New York Times