Clinical trial investigating psilocybin for opioid addiction approved

Health Canada has given Filament Health authorisation to carry out a Phase 2 clinical trial investigating PEX010 – the company’s botanical psilocybin drug candidate – for the treatment of opioid use disorder (OUD).

The trial will be carried out at the University of British Columbia (UBC) and will study the effects of PEX010.

Currently, the standard treatment for OUD is opioid agonist therapy (OAT), however, Filament Health highlights that less than half of those who start the therapy remain for six months, and approximately one in 10 patients receiving professional help due to an overdose were receiving OAT. 

This underlines the critical need for research into new interventions to support those with OUD.

Research indicates that psychedelic-assisted therapy may be a promising approach. A recent review of studies investigating classic and non-classic psychedelics for the treatment of substance use disorders (SUDs) found that “psychedelics’ abilities to normalize abnormal levels of synaptic markers in some brain regions could contribute to their treatment potential for SUDs.”

In the review, published in Frontiers, the authors write: “…these articles provide a valuable view into the emerging field of psychedelics as potential treatment for SUDs. With growing interest among researchers in exploring this line of inquiry, we expect this collection will prepare readers for deeper future engagement with an area of research that could yield important assistance in humanity’s quest to ameliorate the widespread suffering wrought by SUDs.”

Professor of Psychiatry at UBC and Principal Investigator for the Filament Health trial, Dr Christian Schütz, stated: “Opioid use disorder is one of the most challenging public health issues and a major contributor to the escalating overdose crisis in Canada.

“This trial will assess the safety and feasibility of delivering psilocybin in the treatment of OUD, and evaluate potential changes in participants’ opioid use. We are grateful to Filament Health for funding and facilitating this trial.”

“This is a landmark moment in Filament’s mission to support the treatment of substance use disorders with naturally-derived psychedelics,” added Benjamin Lightburn, Chief Executive Officer and Co-Founder of Filament Health. 

“As a Vancouver-based company, we are quite aware of the ongoing toxic drug crisis fuelled by OUD. We are proud to sponsor this much-needed research by Dr Schütz and his team.”

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