Australian Doctor 16th June 2023 16JUNE2023 issue | Page 7

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The drug approved by the TGA is generally taken once , with the patient supported through their ‘ trip ’ over a period of 6-8 hours .
They then undertake counselling over the following few months to integrate the insights they gained over the day session .
“ If there is a benefit from the first session and follow-up counselling , additional treatment sessions followed by counselling may be appropriate ,” the RACGP has said . “ This is very different to starting a medication and taking it daily for months , or years .”
For instance , in an often-cited randomised controlled trial of psilocybin for major depressive disorder , patients in the intervention group were administered 20-30mg / 70kg of psilocybin in opaque gelatine capsules .
Staff then supported the patients ’ physical and emotional needs during the day-long session .
Patients were instructed to lie on a couch in a living room – like environment and encouraged to focus their attention inward and stay with any experience that arose .
And to enhance that inward reflection , music was played while the patients wore eyeshades and headphones .
Kaleidoscope eyes
To give a sense of the psychotherapy element that can be involved , in 2021 Australian Doctor interviewed Jon Kostakopoulos , who spoke about his treatment with psilocybin , not for depression but for alcohol dependence .
It took place at Bellevue Hospital in New York .
“ The treatment room had been set up to look like a living room . It had a couch , chairs and a vase of flowers on the table .” His pill was presented in a wooden chalice , a nod to psilocybin ’ s historical use in religious and healing rituals .
Mr Kostakopoulos said 20 minutes later he began to hallucinate .
“ It was like looking through a kaleidoscope and seeing the geometric shapes . At the time it felt normal . It took a while to realise this was it .
“ I had expected the experience to hit me like a bag of bricks ,” he said . “ But it crept in , slowly .”
“ There was stuff I hadn ’ t really thought about before that came up ,” he said .
Two particular experiences during these sessions were heavily symbolic .
The first was when he saw an empty bottle appear in the middle of a desert , only for it to suddenly disintegrate into sand .
At another point , he was looking down on his dead body in what he describes as an Aztec-type ceremony when a sword came down through his neck .
“ This death experience was the most peaceful part of the session ,” he said .
“ I saw that as my addiction leaving me , and that I was killing a small and bad part of myself off — the part of me that loved going out and not caring about anything other than the next drink .” He said the treatment worked for him . But Professor Colleen Loo , a Sydney
psychiatrist involved in two clinical trials for psilocybin , remains concerned about the speed of TGA approval for the use of MDMA and psilocybin in the context of PTSD and treatment-resistant depression .
Her concerns include patients jumping straight to psychedelic therapy without trying other options , high treatment costs , and the risk of rapid mood shifts for patients , which could lead to self-harm .
“ Treatment is not a simple protocol where everybody does step A , then step B , then step C ,” says Professor Loo of UNSW Sydney and the Black Dog Institute .
“ The best clinical approach for that person at that time might not always be psychedelics .
“ I ’ m concerned about the public being told clearly all the things that they should consider and know before they front up the money . It will be quite expensive — $ 10,000 or more for a treatment course .
“ People who are desperate will pay that .”
Professor Patrick McGorry , professor of youth mental health at the University of Melbourne , has also said he is worried about the activist role of Mind Medicine
Australia , the charity that vigorously lobbied the TGA for the rescheduling change after the watchdog had initially declared the drugs should not be rescheduled because of questions about their safety and therapeutic value .
“ Mind Medicine Australia has been planning for this decision to be made and is funding the training of significant numbers of psychiatrists and also the distribution of the two drugs throughout Australia ,” Professor McGorry told Dr Norman Swan on ABC Radio back in February .
“ So it ’ s going to spread , I think — I hope I ’ m wrong — to large , large numbers of people , and treatment-resistant depression is a very common condition in Australia , so I think the risk is going to
He was looking down on his dead body in an Aztec-type ceremony when a sword came down through his neck .
potentially outweigh the benefits if there are any .”
International interests
Professor McGorry ’ s prediction about Mind Medicine Australia ’ s involvement has proved accurate .
The charity has announced that it has joined with Optimi Health Corp , a Canadian end-to-end drug manufacturer of medical-grade psilocybin and medical-grade MDMA for clinical use and use in clinical trials .
It is to ensure that medicines are available in Australia on 1 July when clinical prescriptions become legal .
Dr Paul Liknaitzky , head of the Clinical Psychedelic Lab at Monash University and Incannex ’ s chief scientific officer , acknowledged the treatment could be out of reach for many Australians , especially at first .
But he added : “ Sensible and safe treatment approaches , based on decades of best-practice development , will include considerable screening , psychotherapy and other support …
“[ And ] if it turns out to be cost-effective , it will be in the government ’ s interest to fund it .”
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References : 1 . Pharmaceutical Benefits Scheme ( PBS ). Available at : www . pbs . gov . au . 2 . Approved Trimbow Product Information . Chiesi Australia Pty Ltd , Hawthorn East , VIC . 3123 . Tel : + 61 3 9077 4486 ; Email : medicalaffairs . au @ chiesi . com ; Website : www . chiesi . com . au . Copyright © Chiesi 2022 . All rights reserved . Date of preparation : January 2023 . AU-TRI-2200169 . CHIE00042o .