Australia will be the first country to reclassify medicines containing methylenedioxymethamphetamine, more commonly known as MDMA (ecstasy) and psilocybin, to treat certain mental health conditions.
Therapeutic Goods Administration (TGA) announced On February 3, it announced that it would allow licensed psychiatrists to prescribe MDMA for post-traumatic stress disorder (PTSD) and psilocybin for treatment-resistant depression.
MDMA is the active ingredient in the party drug Ecstasy, and psilocybin is the active ingredient in the psychedelic “magic” mushroom.
Starting July 1, board-certified psychiatrists with professional qualifications and expertise in diagnosing and treating patients with severe mental health conditions will be able to prescribe medications containing these psychedelic substances.
This occurs even though these treatments are not well established.
MDMA and psilocybin continue to be listed as banned substances, but all other legal uses remain limited to clinical trials.
A psychiatrist must be approved to prescribe MDMA and psilocybin. Accredited Prescriber Scheme Following approval of the TGA by the Human Research Ethics Committee.
TGA’s accredited prescribers are authorized to prescribe drugs and provide therapeutic supplies to selected patients under strict controls to ensure patient safety. A licensed prescriber must report to her TGA the number of patients treated every six months.
The Greatest Attempts at Psychedelic Effects
Swinburne University in Australia signed a $5 million (US$3.46 million) clinical research trial with Woke Pharmaceuticals to examine the effects of psilocybin, the active ingredient in psychedelic mushrooms, in treating treatment-resistant depression.
The trial, which will begin in mid-2023, will be the largest study agreement In this part of Australia, approximately 160 patients will participate in a randomized controlled trial of two or three doses of psychotherapy and placebo psilocybin.
During the trial, the psilocybin drug candidate, WP002, will be administered via rapid-release tablets formulated by the pharmaceutical company.
“Psychedelics have the potential to change the landscape of treatment for many mental illnesses, including major depression,” said lead investigator of the study, Professor Susan Rossell.
“The first positive findings from the literature should be pursued in large-scale real-world trials, such as the one we are conducting. By investigating the efficacy of two or three dosing sessions, , provides important data on the durability of effects and effective real-world treatment regimens of psilocybin-assisted psychotherapy for patients with treatment-resistant depression.”
Additionally, funding and clinical materials will be provided by Woke Pharmaceuticals, allowing Swinburne University to collaborate on research with Monash University and the University of Tasmania.
Insufficient long-term data
However, the TGA’s decision to list hallucinogens has been met with mixed reactions from researchers and academics in the medical field, including the study’s principal investigator.
Rossell said he was concerned about scaling up treatment on a large scale without long-term data to analyze.
“These treatments are not well established for large-scale implementation at sufficient levels, so we are taking this decision with considerable caution. Considerable further research needs to be done,” he said. Rossell said in a comment. It was published with Simex.
“First, we review efficacy against international standards for all psychotropic drugs to understand which conditions are most suitable for treatment and which formulations will best benefit patients and minimize risks. I am very worried because I have no data on the outcome at all, which is one of the reasons why I am doing such a large study.”
More research is needed on efficacy
Mike Musker, an Enterprise Fellow in Clinical and Health Sciences at the University of South Australia, said the long-awaited access to MDMA and psilocybin could help many people experiencing PTSD and depression, especially veterans and those working in emergency services. but not treated with standard psychiatric medications.
“The prescriptions for these drugs have been banned from use by government drug agencies (TGA, FDA) despite promising results in early studies over the last two decades, but there are still significant concerns about their use. Resistance remains.
” journal “Nature” suggested that these drugs were “shaking up psychiatry” by offering treatments for conditions previously considered intractable. But with any new drug there are risks, and use of mood-altering drugs can lead to psychosis, and this is seen with drugs like cannabis.”
Professor Kim Felmingham, Professor of Clinical Psychology at the University of Melbourne, said the approval of MDMA-supported therapy for PTSD is promising and exciting based on positive clinical results, but the Additional research was needed to understand the underlying mechanisms and address what treatments. Works for each individual with PTSD.
“There is no one PTSD treatment that is a panacea that effectively treats all PTSD patients, and MDMA is no exception,” he said.
“Additional research on this topic will help streamline healthcare resources, direct people to the most effective treatments, and improve access to treatment for people living with PTSD.”
Meanwhile, Richard Bryant, a professor of psychology at the University of New South Wales, said the science was at a stage where it would be premature to prescribe MDMA for people with PTSD.
“Instead, we should invest in research to understand how MDMA can be used in relation to proven therapies.