Psychedelics at Monash: World-first trials, therapist training, a feature documentary, and a proposed centre of excellence

Monash University’s pioneering Clinical Psychedelic Lab was established by Dr Paul Liknaitzky in 2020, but has grown rapidly. It now has its own psychedelic research facility, with 25 clinicians, and about 25 multidisciplinary researchers, trainers, and volunteers.

It was the first of its kind in Australia, and now has the largest and most experienced team of psychedelic clinicians and researchers in the country.

Dr Liknaitzky says it has “consistently punched above its weight” and played “a central role in establishing the field in Australia, running world-first trials, numerous therapist trainings, and collaborating with an extensive network of international groups”.

Late last year, the group moved into a new purpose-built facility.

“We’ve just finished a large psilocybin trial, and a number of new projects have kicked off, with various exciting developments slated for this year,” he says.

“We’ve got a big vision to make a meaningful difference in mental healthcare, and we’re building one diligent brick at a time.”

Dr Liknaitzky says the psychedelic field is dynamic and rapidly changing, with hundreds of universities and companies researching psychedelic treatments globally.

TGA go-ahead

Last year, Australia’s Therapeutic Goods Administration (TGA) green-lit a world-first change to the way two psychedelics are classified.

This change permits authorised psychiatrists to prescribe psilocybin (which is found in “magic” mushrooms) and MDMA (which is found in ecstasy) to patients diagnosed with either depression or post-traumatic stress disorder where those conditions have been resistant to other treatments.

The ABC reported that it was a “surprise decision” that caught even those working in the field unaware. Dr Liknaitzky says the regulator’s decision was seen as globally significant.

Reports suggest the US Food and Drug Administration (FDA) may soon approve the first psychedelic for treatment in the US – MDMA (with therapy) for PTSD.

Dr Liknaitzky says the term “psychedelic renaissance” is now outdated.

“We’re now more than two decades into it, with at first gradual and then rapid progress in the science, public attitudes, and now policy,” he says.

“This is a notable cultural reversal since Nixon’s ‘war on drugs’ in the late 1960s, when psychedelics and related substances were prohibited from clinical use, restricted in science, and demonised in much of the community.”

New perspectives for patients

The kind of work Dr Liknaitzky’s Clinical Psychedelic Lab does now is not so much about targeting and reducing specific symptoms of mental health conditions. It turns that idea of typical psychiatric medicine on its head. Instead, it’s about bringing a patient closer to the source of their distress, alongside high levels of support.

“We’re providing a context in which people can potentially have very new and helpful perspectives on themselves and their struggles, which can lead to a virtuous cycle of change over time,” he says.

The stigmas left over from the “war on drugs” are lifting. Last year, US researchers replicated their earlier trial showing that MDMA in conjunction with therapy substantially helped patients with moderate to severe PTSD, and there are hundreds of trials now, evaluating psilocybin, LSD, ibogaine, as well as other substances such as ketamine and DMT.

A new study from Canada shows psilocybin-assisted therapy for people with “high levels of treatment resistance, significant comorbidities, and both major depressive disorder and bipolar II disorder” showed “significant”, safe antidepressant effects.

‘Remarkable’ results

The world-first clinical trial by Monash’s lab, soon to be published, will show what Dr Liknaitzky calls “remarkable” results with psilocybin and severe generalised anxiety disorder, a chronic, relapsing disorder characterised by excessive anxiety and worry, which generally has poor treatment outcomes.

The trial ran for 16 months with 72 people.

“We found a large clinical difference in anxiety symptoms between our psilocybin group and our placebo group six weeks following their last treatment,” he says.

“I believe it may have been the fastest psychedelic therapy trial run out of a single site in the modern era, and just a tremendous learning process. It was very complex, challenging, and satisfying work for the whole team.

“We witnessed many different journeys, from agony to catharsis to joy and relief and inspiration, and many deeply transformational outcomes.

“Across the whole trial, we saw four times as many participants showing clinically substantial response in our psilocybin group, and five times as many showing full remission, as compared to the placebo group.”

Read more: Psychedelic research renaissance: The urgent quest for new mental health medicines

It’s complex science, in part due to the very close interactions between patients and therapists.

“These therapists are hand-picked, tremendous people with lots of skill and experience. We also provided them with an extensive three-month training in psilocybin therapy, ongoing supervision, and also the option to participate in a world-first study of psilocybin-assisted therapist training.

“There was a lot of rigour and consideration and care put into all aspects of this trial, and my sense is that the very positive outcomes from this trial may in part be attributed to such a well-equipped, experienced, and cohesive team, working together brilliantly, with a very participant-centric focus.

“In many trials,” he says, “the participant can fall through the cracks. There's just so much bureaucracy, and complicated procedures and protocols, and some research groups can forget that there’s a participant there. But that didn’t happen.”

Not a typical trial

One of the lessons the researchers learned, he says, is that for the participants it can take time, often more than the “one-size-fits-all and quite brief intervention” typical of some other trials.

“People can make tremendous progress with psychedelic treatments,” he says.

“The whole package of care can be very intense, and the psychedelic dosing sessions are often rated as one of the most personally profound and psychologically challenging experiences of a person’s life.”

But he says supporting that properly “takes skill and care” and, for some people, time.

“People are sometimes dealing with a dramatically altered perspective on themselves or the world, and might need considerable support around that.”

The Monash psychedelic lab researchers, and a number of their trial participants from a recently completed trial, appear in a new SBS documentary, Psychedelics: Stepping into the Unknown.

He says psilocybin therapy will not work for everybody with anxiety.

“While our results and others from around the world have been impressive, I think we can still do better. And my hunch is that one aspect to focus on is a longer course of psychotherapeutic support. We are starting to map out key factors in a future best-practice of psychedelic therapy.”

The new trial results are a “mandate” for further research – “a very promising signal”, he says.

Two more new trials within the Clinical Psychedelic Lab at Monash are now recruiting patients: MDMA-assisted therapy for post-traumatic stress disorder in first responders and military veterans; and 5MeO-DMT for treatment-resistant depression.

Centre of excellence planned

Dr Liknaitzky and his group are also launching a call for philanthropic funding and partnership to establish a centre of excellence in psychedelic therapies at Monash University, with three areas of focus – science, training, and implementation.

With the down-scheduling by the TGA, and various imminent regulatory and policy changes globally, Dr Liknaitzky believes there are both opportunities and challenges “to enable the delivery of safe, effective, accessible and affordable psychedelic therapies in the community”.

The proposed centre would work on trials, training, and practice standards, he says, including a project investigating optimal psychedelic dosing using a data-driven treatment algorithm for both psilocybin and MDMA.

It would also look at tailored and timed dosing sessions alongside therapy for people on or off other psychiatric medications.

Another proposed project is a world-first trial to assess MDMA-assisted couples’ therapy for co-parents with high levels of conflict – “a devastating issue hidden in plain sight, potentially with intergenerational implications for mental health, behavioural, and addiction problems,” Dr Liknaitzky says.

The proposed centre also plans to launch the country’s first university-accredited course in psychedelic therapies for therapists and prescribers. This is because the future of this kind of therapy “very likely depends on the competence and care of the professional community that supports the process”.

“There’s reason for hope," he says, “yet the future of psychedelic therapies still hangs in the balance.”

Psychedelics: Stepping into the Unknown streams on SBS On Demand from 29 February.