Psilocybin and MDMA will be available for therapeutic use in Australia beginning on Saturday after regulators approved the psychedelic drugs to treat certain mental health conditions earlier this year.
In February, Australia’s medical regulator, the Therapeutic Goods Administration, authorized psychiatrists to use MDMA, also known as the popular party drug ecstasy, as a treatment for post-traumatic stress disorder (PTSD). At the same time, the agency approved psilocybin, the primary psychoactive compound found in magic mushrooms, as a therapy for treatment-resistant depression. Both drugs were authorized for use beginning on July 1.
After decades of prohibition, psychedelic drugs are receiving renewed interest for their potential to treat a host of serious mental health conditions. As one of the first nations to legalize psilocybin and MDMA for therapeutic use, some believe that Australia’s actions could have repercussions in evolving psychedelics policy for countries around the globe.
“Australia is creating an interesting model that could pave the way forward for the rest of the world,” Dr. Michael Alpert, a psychiatrist at Harvard Medical School, told ABC News.
New Guidelines For Psychedelic Therapy
The Royal Australian and New Zealand College of Psychiatrists has established guidelines for the therapeutic use of psychedelic drugs. Under the new standards, the drugs may only be administered in a hospital or clinic, where two psychotherapists must attend to the patient for six to eight hours to ensure safety. The organization acknowledges, however, that a shortage of mental health professionals will likely mean that only a limited number of therapists will be able to meet the prescribed conditions.
Susan Rossell, a cognitive neuropsychologist at Swinburne University in Melbourne, is conducting one of the biggest clinical trials of psilocybin in Australia to date. Early results show significant mental health improvements in some patients, while others have not seen success with the drug.
“We have been stuck for very many years in terms of mental health treatments for people with treatment-resistant conditions,” Rossell told the Australian Broadcasting Corporation in a statement quoted by VOA. “So, the fact that psychedelic medicines do seem to be working for a number of people is fantastic. However, they are not working for some people as well, and that is where I would note a great deal of caution in this field at the moment.”
Psilocybin And MDMA For Mental Health
Clinical research and other studies into psychedelics such as psilocybin and MDMA have shown that the drugs have potential therapeutic benefits, particularly for serious mental health conditions such as depression, PTSD, substance misuse disorders and anxiety. In January, a California biopharmaceutical company announced positive results from a clinical trial testing MDMA as a treatment for PTSD. Research published in the peer-reviewed journal JAMA Psychiatry in 2020 found that psilocybin-assisted psychotherapy was an effective and quick-acting treatment for a group of 24 participants with major depressive disorder. A separate study published in 2016 determined that psilocybin treatment produced substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer.
The U.S. Department of Health and Human Services projects that the Food and Drug Administration will eventually approve MDMA and psilocybin mental health treatments, according to a letter from the department in May 2022. In 2017, the FDA granted MDMA-assisted therapy Breakthrough Therapy designation, indicating that the therapy is a significant improvement over existing treatments. But so far, MDMA-assisted therapy has not been approved by any regulatory agency and the safety and efficacy of MDMA-assisted therapy for the treatment of PTSD have not been firmly established.
Payton Nyquvest, the co-founder and CEO of Numinus, a mental health care company specializing in evidence-based psychedelic-assisted therapies, applaued Australian regulators for setting a new milestone in psychedelics policy reform.
“The TGA’s approval surrounding MDMA and psilocybin for specific and controlled usage is a welcome step forward for Australia as well as the entire mental health field,” Nyquvest writes in an email. “This decision impacts the millions of people who are enduring treatment-resistant mental health conditions and opens a pathway to profoundly change their lives. I look forward to watching progress being made on a global scale as a result of our industry’s collective mission to help the world heal.”