![]() “The main issue is that the public understand this, and don’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,” said Loo, who was part of a steering committee of The Royal Australian and New Zealand College of Psychiatrists, RANZCP, that drafted guidance on how the treatment should be approached and monitored. Colleen Loo, a professor of psychiatry at the University of New South Wales and the Black Dog Institute in Sydney. “It is early compared to the usual process of developing and rolling out new treatments,” said clinical psychiatrist Dr. ![]() Psilocybin ‘trips’ combined with therapy reduce alcohol use, study finds Psilocybin mushrooms with golden caps on a pink background Rafael/Adobe Stock However, some psychiatrists and researchers are concerned that the move may be premature, given that the drugs in question are still being tested in clinical trials and haven’t been formally approved for the treatment of any mental health disorders by the US Food and Drug Administration for clinical use. “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 that have been studied in clinical trials,” said Australia’s Therapeutic Goods Administration, or TGA, when announcing the move. Both drugs are otherwise illegal in Australia. Starting July 1, authorized psychiatrists will be able to prescribe MDMA for the treatment of post-traumatic stress disorder and psilocybin for treatment-resistant depression, according to a February news release. ![]() Australia is set to become the first country in the world to legalize clinical prescribing of MDMA, better known as ecstasy, and psilocybin - the main psychoactive ingredient in magic mushrooms - for certain mental health disorders. ![]()
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