The Therapeutic Goods Department (TGA) is considering reschedule psilocybin and MDMA from the current classification of Schedule 9 banned substances to Schedule 8 regulated substances.
This allows psychiatrists to use these drugs in combination with psychotherapy for the treatment of conditions such as depression and post-traumatic stress disorder (PTSD).
This is why we believe it is a good idea.
A little background
On February 3, TGA announced a tentative decision to retain psilocybin and MDMA as Schedule 9 drugs.
The TGA cited limited evidence of therapeutic efficacy, safety concerns, potential abuse, and a shortage of properly trained psychiatrists.
However, the final decision scheduled for April 22 is currently postponed while the TGA seeks independent expert advice on the “therapeutic value, risks, and benefits to public health” of the change.
For MDMA and psilocybin
Research on psychedelic substances such as LSD and psychedelic began in the 1960s.
The number of clinical trials involving psilocybin or MDMA has steadily increased over the last decade, with more than 70 studies completed since 2010.
Approximately 60 trials, including MDMA or psilocybin, are underway in Europe and the United States.
The results of the completed study are very promising.
For example, last month, a study of 59 patients with major depression showed that two sessions of psilocybin-assisted therapy were as effective as a six-week course of the antidepressant escitalopram. I did. Twice as many patients in the psilocybin group were disqualified from being diagnosed with major depression after treatment.
This month, the results of one of the largest trials of MDMA-assisted psychotherapy for PTSD were announced. In a phase 3 trial, MDMA-assisted psychotherapy was used to treat 90 patients with severe chronic PTSD. After three sessions, 67% of participants were disqualified from PTSD diagnosis, but only 32% received treatment alone.
These latest studies show the therapeutic benefits of thyrosibin or MDMA in social anxiety in adults with depression, PTSD, end-stage disease-related anxiety, obsessive-compulsive disorder, alcohol and tobacco addiction, and autism. It is being added to more and more exams from the inside.
Scientists are now investigating the use of psilocybin in other conditions, including anorexia nervosa, generalized anxiety disorder, opioid and cocaine addiction, for the first time.
Are MDMA and Psilocybin Safe?
Unlike many Schedule 8 medications, psychotherapy treatment with psilocybin or MDMA is not given on a regular basis. This substance is usually used only a few times with a trained professional as part of a psychotherapy program.
Despite the safety concerns cited by the TGA, there were no seriously harmful reported events with psilocybin or MDMA from dozens of clinical trials. Less serious effects include temporary anxiety, delusions, fear, nausea, post-treatment headaches, or mild increases in blood pressure and heart rate.
Of course, these trials use drug-grade drugs that are given by doctors.
However, one of the most comprehensive studies on the harm of commonly used illicit drugs has found that even illicit forms of psilocybin and MDMA are the least harmful. In fact, “mushrooms” containing psilocybin had the lowest overall harm score, and illegal forms of clinically used Schedule 8 substances such as cocaine, cannabis, and ketamine were all more harmful than psilocybin and MDMA.
It is not known which dose of psilocybin is fatal to humans, but it is estimated to be about 1,000 times the therapeutic dose. No deaths from overdose due to psilocybin toxicity alone have been reported so far.
The use of illegally manufactured MDMA (which often contains other drugs and impurities) can result in death. An estimated 600,000 Australians use illegal MDMA each year, and an average of about 3 deaths per year since 2000 is associated solely with MDMA toxicity.
However, the illegal use of MDMA of unknown dose and purity is far more dangerous than the administration of the drug MDMA under medical supervision in a clinical environment.
In recent years, revered academic and medical institutions around the world have set up dedicated centers for psychedelic and MDMA research, such as Johns Hopkins University and Imperial College London.
And recently, research on the therapeutic effects of psilocybin and MDMA has begun in Australia. St. Vincent Hospital in Melbourne is conducting clinical trials using psilocybin-supported psychotherapy to treat terminally ill patients with anxiety and depression. Clinical trials at Monash University are investigating psychocibin-supported psychotherapy for generalized anxiety disorder and MDMA-supported psychotherapy for PTSD.
The Australian Government recently announced that it will fund A $ 15 million in research into the medical potential of psychedelics and MDMA.
It is difficult to coordinate TGA’s tentative decision to retain Schedule 9 for substances that have been shown to be effective in some mental health conditions and have less safety concerns than many existing Schedule 8 medications.
US drug regulators have recently approved the designation of “breakthrough therapy” for MDMA and psilocybin. Special status for highly promising medicines that speed up the road to the clinic.
The down schedule for silocibin and MDMA could bring significant medical benefits to Australian patients, especially if Australia spends A $ 10.6 billion on mental health between 2018 and 2019.
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Why Australia Needs to Reschedule MDMA and Psilocybin for Treatment of Mental Illness
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