It’s been more than 10 years since researchers noticed that the active ingredient in magic mushrooms could help terminally ill people come to terms with their deaths. During a study at California’s Harbor-U.C.L.A. Medical Center, psychiatrist Charles Grob found that administering a dose of psilocybin to end-stage cancer patients noticeably reduced their end-of-life anxiety.
Five years later, two more studies – one out of New York University and the other out of Johns Hopkins University – similarly investigated the potential of the powerful psychedelic in palliative care, and yielded similar results. After receiving a dose of the drug in the company of psychotherapists, subjects showed a significant and enduring reduction in anxiety, depression and existential distress.
These trials represented major stepping stones in what has come to be known as the “psychedelic renaissance” – a recent, booming interest in the therapeutic potential of otherwise illicit drugs – and their findings have been instrumental in highlighting psilocybin as one of the movement’s more promising candidates. But experts believe that the potential of psilocybin in treating mental health issues, and anxiety in particular, is yet to be properly investigated. To date, there has never been a clinical trial studying the efficacy of psilocybin in treating a primary anxiety disorder.
A team of researchers at Melbourne, Australia’s Monash University is hoping to change that.
Last month, they became the first in the world to gain ethics approval for the clinical study of psilocybin as a treatment for Generalised Anxiety Disorder (GAD): a severe, chronic type of anxiety that can manifest as worry or panic on an ongoing, day-to-day basis.
“Previously we’ve seen psilocybin used with good outcomes in the treatment of anxiety symptoms associated with a terminal diagnosis... but this is the first trial where we're looking at this treatment for quite a different kind of anxiety – one that is chronic, entrenched and generalised,” Paul Liknaitzky, head of clinical psychedelic research at Monash, tells VICE.
The trial is set to take place at Monash’s “Brain Park” facility, a world-first neuroscience research clinic that comes fitted with a meditation room and consultation suites. Patients will be administered a high dose of psilocybin over the course of two sessions – starting with 25 milligrams in the first, and an even higher quantity in the second – and each dosing session will be preceded and followed by at least three psychotherapy sessions with two qualified therapists.
“The treatment duration is only seven weeks,” Liknaitzky explains, “but participants’ involvement in the trial is about six months, with assessments before, during and after the treatment phase.”
The intended function of the specialised form of psychotherapy is to help participants prepare for the often intense psychedelic experiences, support them during the all-day dosing sessions, and then process these experiences afterwards – a crucial part of the process that Liknaitzky compares to “preparing the launchpad for a profound cosmological journey, and then providing the support needed for a safe and fruitful mission.”
Mentally preparing anxiety sufferers for an experience as potentially anxiety-inducing as a psychedelic trip is a delicate process. According to Liknaitzky, trust between the patient and their therapists is key. For this reason, the trial has sought and secured world-first approval of another kind.
“We’re also providing psilocybin as an option to our therapists as part of their training,” says Liknaitzky. “While this was commonplace for psychedelic therapists using LSD during the first wave of psychedelic research in the 50s and 60s, this is the first trial ever to offer psilocybin as a training tool for therapists, and the first to offer a classical psychedelic for this purpose since 1974.”
A therapist’s own, personal experience with psychedelic substances appears to play an important role in facilitating therapeutic benefits for patients. Liknaitzky points out that during an overseas trial into MDMA-assisted psychotherapy as a treatment for PTSD, almost all patients asked their therapist whether they’d experienced the drug before.
“When you’re dealing with the crucial element of trust in this treatment approach, an affirmative response from your clinical support team – ‘yes, I’ve been there before, it was challenging but I survived and benefitted, and I can help you’ – that helps an enormous amount with the participants’ trust,” says Liknaitzky.
“Crucially, the psychedelic experience is impossible to describe, and the ability to support people in these very profound states of altered consciousness may depend in part on the therapist’s own experience in that environment.”
By way of explanation, he offers a metaphor: if you’re about to be rocketed to a new planet with an alien landscape that is completely different to anything you’ve ever encountered before, and it’s likely to be challenging, you’ll probably want “the safety and confidence of someone who’s been there before,” he says. “Or at least someone who’s been somewhere similar.”
Getting approval for this particular arm of the study, he adds, is a major breakthrough.
“This is a real step forward for the field. Our trial, which is the biggest trial in Australia with 72 participants, is the first primary anxiety trial with psilocybin ever. In addition, a notable achievement for this trial is that we're able to offer psilocybin to our therapists as an optional part of their training.”
It was the ethics approval for the trial overall, though, that was the major hurdle. Now that it’s been given, the researchers are securing all the required state and federal permits and licences to import psilocybin into Australia, and hope to start recruiting patients to participate in the study in the first quarter of 2022.
So how long until psilocybin-assisted therapy for GAD will be available to the general population? It’s still early days.
Liknaitzky suggests that the first psychedelic-assisted treatment to become a regulated legal option – ”psychedelic” having become an umbrella term in the clinical context – will likely be MDMA-assisted therapy for PTSD. The Multidisciplinary Association for Psychedelic Studies (MAPS), an American non-profit organisation, is currently running those trials overseas – and they’re showing such strong promise that it’s believed the Food and Drugs Administration (FDA) may green-light MDMA for the therapeutic treatment of PTSD within the next few years. Liknaitzky suggests that psilocybin-assisted therapy for the treatment of GAD could follow shortly thereafter.
“They [MAPS] look very likely to get approval in the U.S., and probably at a similar time in Australia, in late 2023 or early 2024,” he says. “Which is pretty soon; it’s a lot sooner than a lot of people might imagine, given the field spent the better part of four decades in a deep freeze. And psilocybin-assisted therapy is likely to be two or three years behind that.”
It is also just one part of an emergent local industry, though.
Liknaitzky has established Australia’s first clinical psychedelic lab at Monash, has obtained the first industry funding for psychedelic research in Australia and is coordinating the country’s first applied psychedelic therapist training programs, as well as a number of research programs within the space of psychedelic medicines. He is, currently, the only full-time psychedelic researcher in the country. But in the next few months, that’s likely to change.
Earlier this year, the Australian government pledged $15 million of competitive grants to “kick start Australian clinical trials exploring the use of potential breakthrough combination therapies for the treatment of debilitating mental illnesses” – pointing to the growing body of evidence showing that drugs like psilocybin, ketamine and MDMA can be used to effectively treat conditions like PTSD, depression and addiction.
“That'll fund a number of large trials,” Liknaitzky predicts, “and there’ll be a number of new groups kicking off.”
He has concerns, however, about the level of hype that’s building within the field of psychedelic medicine – a space that has spent decades getting to where it is today. Liknaitzky is worried that the sudden surge of interest may be exploited by some commercial and advocacy groups who are attempting to rush through the research and development process prematurely, potentially risking patient safety and setting the field back again.
“While the results from these trials have been incredibly promising,” he says, “the field is young, the body of data is still small, and no psychedelic treatment has satisfied all the standard tests applied to any new medicine yet.”
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