Vancouver-based Numinus Wellness Inc. has announced a 30-person clinical trial to establish the best practices for treating substance use disorders with psilocybin-assisted psychotherapy.
According to a press release, the trial will be focused on treating tobacco, stimulant, alcohol and opioid disorders.
A 2017 study published in The American Journal of Drug and Alcohol Abuse found that psilocybin-assisted psychotherapy “holds considerable promise” for treating tobacco addiction. After 12 months of psilocybin therapy sessions, roughly 70 per cent of participants had abstained from smoking.
A Vancouver-based pharmaceutical company will run the first take home psilocybin clinical trial in North America.
Health Canada has approved phase two of the trial by Apex Labs, which will evaluate the safety and efficacy of its low dose, multi-dose product APEX-52 in treating depression in veterans with post-traumatic stress disorder.
Veterans Affairs Canada estimates up to 10 per cent of war-zone veterans have been diagnosed with PTSD. That’s twice the amount of diagnoses the general adult population has received, according to Statistics Canada.
Apex Labs CEO Tyler Powell says many veterans are already self-medicating with micro-doses of unregulated psilocybin products
“Our goal is to expand access to pharmaceutical grade drug products through regulated systems, providing transparency and support for patients in need,” Tyler said in a statement released Tuesday.
The Oct. 24 approval comes nearly 11 months after Health Canada broadened the Special Access Program to include MDMA and psilocybin, a psychedelic compound found in “magic mushrooms” that research shows can have antidepressant effects.
This exemption means that health care professionals can use psilocybin on a case-to-case basis if they think a patient would benefit.
A boy who used to endure 500 life-threatening fits a month is set to celebrate his 1,000th seizure-free day, thanks to medical cannabis.
Alfie Dingley, who suffers from severe epilepsy, is one of just three people in the UK to have been handed an NHS prescription for the drug.
Mum Hannah Deacon says the cannabis – which was legalised for medicinal use on November 1, 2018 – has made a huge difference to the 11-year-old’s life.
Yet thousands of people are still unable to access funded prescriptions, with families forced to spend thousands of pounds a month to go private, or buy the drug illegally.
National Institute for Health and Care Excellence guidance allows clinicians to prescribe medical cannabis if the evidence suggests it could be beneficial.
But the British Paediatric and Neurology Association does not support the use of whole plant medicinal cannabis, which contains the psychoactive ingredient THC, claiming that the firms producing the products have not undertaken the required clinical trials to prove their safety.
Hannah, 43, who co-founded MedCan Support for families looking to access the drug, said this stance has created what she described as “a block” on NHS prescriptions.
She told how medical cannabis had given Alfie back his “quality of life”, allowing him to attend school full-time and start making friends.
But she said: “Some people have no choice but to spend £24,000 a year during a cost-of-living crisis just to keep their child safe.
Alfie suffers from a rare form of epilepsy ( Image: Rowan Griffiths)
“We see families fundraising, which is demoralising, but others are going to the illegal market, where they don’t know what’s in the product and they are risking prosecution.
“As many as 1.8 million people use illegal cannabis for medical reasons. The Government has a responsibility to keep them safe.”
Alfie, who started having seizures when he was a baby and is also autistic, has a funded prescription for Bedrolite – a CBD oil that contains less than 1% THC and 7.5% CBD.
Alfie suffers from a rare form of epilepsy ( Image: Rowan Griffiths)
He made history in June 2018 when the Home Office gave his doctor the first licence to prescribe medical cannabis. Today, Alfie marks his 985th day without a seizure – and next month he will hit the milestone of 1,000. Hannah said: “Alfie is evidence it works… it is safe for him.
“It is not a miracle cure as he still has an epilepsy condition, but because the seizures are not happening, it has helped him sleep and engage.
“It has given him a quality of life. He’s reading – before, he couldn’t say more than two or three sentences – and he is learning and understanding normal relationships and asking questions. He has made friends and as a result, I have made friends.”
