MDMA and the active ingredient in magic mushrooms will be used to assist therapy sessions in Australia.
The move makes Australia the first country to classify psychedelics as medicine nationally.
The changes come into effect on Saturday and will see psilocybin (the active ingredient in magic mushrooms) used for treatment-resistant depression.
MDMA, also known as ecstasy, will be trialled as a therapy for post-traumatic pressure disorder (PTSD).
Several studies have shown that MDMA can positively affect patients who have post-traumatic stress disorder (PTSD).
The US Food and Drug Management (FDA) will be asked to approve MDMA for medical use this year; it has been reported to treat PTSD.
Australia’s Therapeutic Goods Administration, or TGA, said, “Psilocybin and MDMA are relatively safe when used in a medically controlled setting under the supervision of appropriately trained healthcare professionals and in the dosages studied in clinical trials.”
How MDMA and Magic Mushrooms Work in the Brain
Clinical psychiatrist Dr Colleen Loo, a professor of psychiatry at the University of New South Wales and the Black Dog Institute in Sydney, said, “It is early compared to the usual process of developing and rolling out new treatments.”
“The main issue is that the public understands this and doesn’t think that the TGA making these drugs available means that the level of evidence of efficacy and safety is comparable to that usually required for new treatments before they are approved for clinical use,”
Other countries have licensed psychedelic drugs but on a more limited scale.
Israel’s Ministry of Health approved using MDMA to treat PTSD in 50 patients in Haifa’s Rambam Medical Center, plus psychiatric hospitals in Be’er Yaakov, Lev Hasharon, and Be’er Sheva.
Speaking to Israeli news outlet Haaretz in 2019, Ministry of Health official Bella Ben-Gershon said, “There is a considerable population in Israel of people who have PTSD that is resistant to other treatment.”
MDMA and Magic Mushrooms as Controlled Substances
In a controversial move, Australia will become the world’s first country to allow the drugs psilocybin and MDMA to be prescribed by doctors to treat psychiatric conditions, including depression and post-traumatic stress disorder. But many scientists are concerned that research has not yet conclusively shown that these drugs are safe or effective. And some clinicians fear that the regulation governing drug access is insufficient.
Australia’s drug regulator, the Therapeutic Goods Administration (TGA), which approved the move, says the decision followed a nearly three-year process and included extensive consultation with experts.
Research over the past few decades1 has shown that some drugs that are illicit but are often used recreationally are effective in treating certain mental health disorders when combined with psychotherapy. MDMA is widely known as the party drug ecstasy, and psilocybin is the active ingredient in hallucinogenic mushrooms. A phase II trial, published late last year 2, showed that a 25 mg dose of psilocybin was twice as effective as a 1 mg dose in combating treatment-resistant depression, although significant side effects were noted. And a report on a phase III trial of MDMA described it as a “potential breakthrough treatment” for PTSD. The drugs have also shown potential in treating anxiety, anorexia and substance addiction.
Nations, including the United States, Canada and Israel, allow individual use of these drugs on compassionate grounds or in clinical trials. Still, on 1 July, Australia will be the first to regulate the drugs as medications to be prescribed by approved psychiatrists.
Among researchers’ concerns is that research has yet to show which patients are best suited to the treatments. “It’s not for everybody.
Risks and Precautions of MDMA and Magic Mushroom Therapy
We need to work out who these people are that are going to have bad experiences and not recommend it,” says Susan Rossell, a psychiatrist at Swinburne University of Technology, Melbourne, who is working on Australia’s only active clinical trial testing psilocybin-assisted psychotherapy for treatment-resistant depression. Rossell fears that, administered improperly, the drugs could give people bad trips and leave them with increased psychological issues. “That’s the worst-case scenario,” she says. Her unpublished research suggests that 10–20% of trial participants have a “really terrible time” with these drugs.
The TGA approval follows an application in March 2022 by Mind Medicine Australia, a non-profit group in Melbourne that advocates psychedelic therapy for MDMA and psilocybin to be made available in therapeutic settings. In December 2021, the TGA denied a 2020 application by the organization after a lengthy consultation process involving an independent expert panel.
Steve Kisely, a psychiatrist at the University of Queensland in Brisbane, was one of three researchers who worked on the 2021 report to the TGA. He says that the drugs show promise in some people when administered in clinical settings with professional support. However, researchers are still working out which patients are most suited to psychedelic medicines and what kind of psychotherapy leads to the best results.