Green light for psychedelic drugs trial to treat binge-eating
Australian researchers will soon deploy a psychedelic compound found in 'magic mushrooms' to treat binge-eating in a world-first clinical trial.
Experimental healthcare company Tryptamine Therapeutics announced the radical trial in a statement to the Australian Securities Exchange this week, telling investors Swinburne University would conduct the open-label research on 12 patients suffering from binge-eating disorder.
Open-label means there are no placebos involved and all patients and researchers know what is being administered.
The patients will receives two doses of TRP-8803, a psilocin-based IV infusion.
Psilocin, which is produced when psilocybin is broken down in the body, is a psychedelic compound that triggers changes in mood, perception and thinking patterns.
Cognitive neuropsychologist Professor Susan Rossell, from Swinburne, designed the trial with Tryptamine and told NewsWire she hoped the psychedelics would open up the trial's participants to new ways of thinking.
'What we have found in other psychedelics work is that the psychedelic itself opens up people to think differently,' she said.
'And one of the things that we know with a lot of mental health conditions, is they start to have repetitive thinking and it becomes very rigid.
'So people with binge eating disorder, 'I need to consume lots of food to help with my emotional issues'.
'They are in that very stuck, rigid thought pattern and they can't find other ways to deal with their life stressors.'
Binge-eating is the uncontrollable consumption of food and can lead to a range of serious health problems, including social isolation and weight gain.
It is the second most common eating disorder in Australia.
In the US, an estimated 1.25 per cent of adults experience the disorder each year and 1.6 per cent of teenagers aged 13 to 18 are affected.
'It's extraordinarily costly,' Professor Rossell said.
The trial is expected to run for three to four months, with initial results due at the end of the year.
Tryptamine CEO Jason Carroll said the primary objective of the trial was to assess TRP-8803's utility in treating the disorder, but it could also generate insights into how the product might help with other neuropsychiatric disorders.
'With patient recruitment initiatives now underway, we look forward to first enrolment and the commencement of baseline data generation from participations, prior to first patient dosing,' he said.
Clinical trials involving psychedelics to treat medical conditions are growing around the world, but the impacts are not yet clear.
Psychedelic drugs are illegal in Australia and there is evidence that consuming mind-altering substances can lead to adverse outcomes.
A study on single-dose Psilocybin for treatment-resistant depression, funded by psychedelics company Compass Pathways and published in the New England Journal of Medicine in 2022, revealed mixed results, with most participants experiencing 'adverse events'.
'Adverse events occurred in 179 of 233 participants (77 per cent) and included headache, nausea, and dizziness,' the researchers found.
A small number of participants suffered serious negative impacts, the study revealed, including suicidal ideation and intentional self-injury.
Professor Rossell said the Swinburne trial would be safe.
'I don't know whether these medications are going to work or not but I've worked with them now for two years and I haven't had anything negative happen with anybody in my trials, in the right and safe environment,' she said.
She also said the use of an IV solution added an additional layer of control.
'The IV is even more safe,' she said.
'If we start to be aware that the person is having an unpleasant reaction, we can stop it straight away with the IV.
'With the oral preparations, they have to work through it. And it can leave people with some unpleasant feelings.'
Tryptamine, a listed company with a market capitalisation of $43m, stresses the 'confirmed reversibility' of TRP-8803 as a key selling point for the product.
'This formulation aims to overcome several limitations of oral psilocybin, including significantly reducing the time to onset of the psychedelic state, controlling the depth and duration of the experience and reducing the overall duration of the intervention to a commercially feasible time-frame,' the company states.
'TRP-8803 also provides dosing flexibility and the ability to terminate treatment if the patient is experiencing an adverse event.'
The company held $4.6m in cash as of March 31.
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Green light for psychedelic drugs trial to treat binge-eating
Australian researchers will soon deploy a psychedelic compound found in 'magic mushrooms' to treat binge-eating in a world-first clinical trial. Experimental healthcare company Tryptamine Therapeutics announced the radical trial in a statement to the Australian Securities Exchange this week, telling investors Swinburne University would conduct the open-label research on 12 patients suffering from binge-eating disorder. Open-label means there are no placebos involved and all patients and researchers know what is being administered. The patients will receives two doses of TRP-8803, a psilocin-based IV infusion. Psilocin, which is produced when psilocybin is broken down in the body, is a psychedelic compound that triggers changes in mood, perception and thinking patterns. Cognitive neuropsychologist Professor Susan Rossell, from Swinburne, designed the trial with Tryptamine and told NewsWire she hoped the psychedelics would open up the trial's participants to new ways of thinking. 'What we have found in other psychedelics work is that the psychedelic itself opens up people to think differently,' she said. 'And one of the things that we know with a lot of mental health conditions, is they start to have repetitive thinking and it becomes very rigid. 'So people with binge eating disorder, 'I need to consume lots of food to help with my emotional issues'. 'They are in that very stuck, rigid thought pattern and they can't find other ways to deal with their life stressors.' Binge-eating is the uncontrollable consumption of food and can lead to a range of serious health problems, including social isolation and weight gain. It is the second most common eating disorder in Australia. In the US, an estimated 1.25 per cent of adults experience the disorder each year and 1.6 per cent of teenagers aged 13 to 18 are affected. 'It's extraordinarily costly,' Professor Rossell said. The trial is expected to run for three to four months, with initial results due at the end of the year. Tryptamine CEO Jason Carroll said the primary objective of the trial was to assess TRP-8803's utility in treating the disorder, but it could also generate insights into how the product might help with other neuropsychiatric disorders. 'With patient recruitment initiatives now underway, we look forward to first enrolment and the commencement of baseline data generation from participations, prior to first patient dosing,' he said. Clinical trials involving psychedelics to treat medical conditions are growing around the world, but the impacts are not yet clear. Psychedelic drugs are illegal in Australia and there is evidence that consuming mind-altering substances can lead to adverse outcomes. A study on single-dose Psilocybin for treatment-resistant depression, funded by psychedelics company Compass Pathways and published in the New England Journal of Medicine in 2022, revealed mixed results, with most participants experiencing 'adverse events'. 'Adverse events occurred in 179 of 233 participants (77 per cent) and included headache, nausea, and dizziness,' the researchers found. A small number of participants suffered serious negative impacts, the study revealed, including suicidal ideation and intentional self-injury. Professor Rossell said the Swinburne trial would be safe. 'I don't know whether these medications are going to work or not but I've worked with them now for two years and I haven't had anything negative happen with anybody in my trials, in the right and safe environment,' she said. She also said the use of an IV solution added an additional layer of control. 'The IV is even more safe,' she said. 'If we start to be aware that the person is having an unpleasant reaction, we can stop it straight away with the IV. 'With the oral preparations, they have to work through it. And it can leave people with some unpleasant feelings.' Tryptamine, a listed company with a market capitalisation of $43m, stresses the 'confirmed reversibility' of TRP-8803 as a key selling point for the product. 'This formulation aims to overcome several limitations of oral psilocybin, including significantly reducing the time to onset of the psychedelic state, controlling the depth and duration of the experience and reducing the overall duration of the intervention to a commercially feasible time-frame,' the company states. 'TRP-8803 also provides dosing flexibility and the ability to terminate treatment if the patient is experiencing an adverse event.' The company held $4.6m in cash as of March 31.
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