As I sit down to write about the significant impact of psychedelics on the realm of psychiatry, I find myself reflecting on how far we've come. Treatment for mental illness has been making a gradual but definite shift to a more holistic and open-minded approach. Psychedelics, formerly deemed as 'alternative’, are making a triumphant comeback as potential agents for healing and transformation.
Humphry Osmond, MD, a psychiatrist, coined the term “psychedelic” in the 1950s, which literally translates to "mind-manifesting." As some may know from previous experience, this class of drugs has the ability to alter your perception, thinking, and mood with little disorientation or confusion (f taken responsibly, obviously). Unlike alcohol, benzodiazepines, and barbiturates, psychedelics do not cause cognitive slowdown or acceleration, as found with stimulants.
Though this may be, many people were greatly surprised last month when Australia's generally conservative medicines body (the Therapeutic Goods Administration) approved the use of psychedelics to aid therapy sessions. This decision now allows Australian doctors to prescribe MDMA and psilocybin for clinical use, albeit under very limited circumstances. Although other countries - including Switzerland, Canada, and Israel - have explored psychedelics for compassionate use, it has not been on a national level, as in Australia. The amendments, which came into effect on July 1, 2023, make Australia the first country in the world to officially classify psychedelics as medicines, nationally.
How will the drugs be prescribed?
Previously, psilocybin and MDMA held the classification of schedule 9 - a prohibited substance. Now, however, they have been re-classified as schedule 8 (restricted drugs), but only for certain medical purposes in psychedelic-assisted psychotherapy, according to the decision made by the Therapeutic Goods Administration (TGA). The limitations put in place by the TGA mean that doctors can now prescribe MDMA, often known as ecstasy, to patients with post-traumatic stress disorder, whereas psilocybin may only be administered to those with a history of depression typically unresponsive to treatment. Why, you may ask? The answer is surprisingly simple. Ostensibly these are the only two conditions, according to studies, that have sufficient evidence demonstrating that certain people may benefit.
To be able to prescribe MDMA or psilocybin, a doctor must first have to be registered as an Authorised Prescriber (AP) under the TGA’s Authorised Prescriber scheme, which allows registered psychiatrists to prescribe medicines yet to be formally included in Australia’s register of therapeutic goods. Before seeking approval to be an AP, however, the psychiatrist must be granted approval from the Human Research Ethics Committee (HREC), a panel that evaluates applications for human clinical-trial work.
In addition, explains Prof. Daniel Perkins, executive director of the Psychae Institute in Melbourne, psychiatrists will need to present a clinical justification for why they believe psilocybin or MDMA would be appropriate for the patient population they intend to treat. Home use will not be permitted, and patients will only have access to the drugs in strict clinical settings. Prescribers will also need to submit a specific treatment plan; one which includes the dose and number of therapy sessions.
Finally, once the above is approved by an HREC and the TGA, the doctor or psychiatrist will need to provide the TGA with reports every six months, detailing patient numbers as well as any serious adverse effects that may occur.
How will the drugs be administered?
According to prescribed studies, MDMA/psilocybin administrations will be limited to 1 – 3 full-day, high-dose sessions supported by pre- and post-psychotherapeutic assistance. There will be no access to any other patient groups under alternative circumstances and no off-label prescribing. So far, clinical trials have made use of a therapist dyad concept, which essentially means that two therapists are assigned to each patient. According to regulations, at least one of the therapists must be medically trained (most commonly a psychiatrist).
When Psilocybin Therapy is utilized, three stages are typically established: preparation, medication administration, and integration. Therapists assist patients in understanding their symptoms and preparing for the psychological or emotional effects of the drug during the preparatory period. During the administration session, therapists observe the patient and make sure to maintain patient safety for six to eight hours. Then, in the integration stage, therapists discuss the psychedelic effects of the medicine and help the patient in interpreting these effects.
Barriers to Access?
Before advocates rush to celebrate, however, experts warn that there remain quite a few questions surrounding just how many people will have viable access to these psychedelic treatments.
Unfortunately, the treatments are anticipated to come with quite a price tag. One psychedelics specialist estimates that total costs, which include the drugs themselves, supervision from multidisciplinary teams, psychiatrist consultations, and leasing a private facility, might reach up to $25,000 per treatment. So far, health insurance won't be providing coverage for the procedures. And with no anticipated government subsidies, it's highly likely that it will initially be a therapy choice only available for the reasonably well-off.
Interestingly, the loudest voices against psychedelic therapy treatments include the Australian Medical Association (AMA) and the Royal Australian and New Zealand College of Psychiatrists (RANZCP) – two of Australia’s leading medical and mental health organizations. Both organizations have urged for more extensive study and research into psychedelic therapies, while cautioning about the unknowable risks, long-term adverse effects, and "potentially very limited benefits" of its usage in therapy.
Lastly, not just any psychiatrist or psychologist can safely administer this kind of therapy. Simon Ruffell, a psychiatrist and senior research fellow at the Psychae Institute at the University of Melbourne, points out that in well-established Indigenous psychedelic practices around the world, people spend from five to 10 years, at least, training to be able to work with these kinds of substances. According to Ruffell, it would be a “grave error” to think that psychiatric and psychological qualifications are transferable to psychedelic substances without enforcing any additional training.
The Bottom Line
There remains something fascinating about psychedelic drugs. The news from Australia and beyond show that we’ve entered a new era, one in which our understanding of the mind and its complexities is expanding beyond conventional limits. However, although psychedelic-assisted therapy may offer hope to those who have tried and failed other treatments, it’s important that we proceed with a cautious, considered and informed approach. The resurgence of psychedelics in psychiatry is not without its challenges. It’s not a “fix-all miracle cure”. Regulatory obstacles, societal stigma, and the possibility of misuse are all legitimate concerns. But as the volume of research grows and stories of transformation build, it does become more difficult to deny the potential benefits these medicines may give to those in need.