A groundbreaking observational study is set to investigate the real-world efficacy of MDMA-assisted therapy through Health Canada’s Special Access Programme (SAP).
MDMA-assisted therapy has been added to Canada’s SAP to allow authorised patients access for conditions such as PTSD.
While there have been a number of clinical trials investigating MDMA-assisted therapy, this is the first observational trial that will assess data pertaining to the efficacy of MDMA in the treatment of PTSD under real-world circumstances.
PharmAla Biotech the University of Calgary and Heroic Hearts Canada – a non-profit organisation that supports Veteran access to psychedelic therapies – are partnering to carry out the trial.
The organisations have completed a Letter of Intent (LOI) and have now received initial Ethics Board Approval to begin the trial. As part of the trial, Heroic Hearts Project Canada will offer its future programme participants who receive MDMA-assisted therapy via the SAP with the option to participate.
PharmaAla, which is currently the only GMP-certified MDMA manufacturer in Canada, will supply the trial with the compound, and The University of Calgary, under the direction of Dr Leah Mayo, Parker Research Chair in Psychedelics, will assess the data.
PharmAla Biotech CEO, Nick Kadysh, stated: “Our ability to treat patients through SAP, while imperfect, remains a credit to Canadian regulators and an incredibly valuable tool for the collection of evidence of MDMA’s efficacy in real-world clinical outcomes. We’re incredibly pleased to work with Dr Mayo and Heroic Hearts to bring together patients, clinicians, and scientists.
“We are already seeing amazing results in patients, and we believe we are currently the only company in the world that can generate evidence from SAP which can be shared directly with regulators, as well as the scientific community.”
The announcement of the trial comes on the heels of a new report from the Senate of Canada’s Subcommittee. The report, ‘The Time is Now: Granting equitable access to psychedelic-assisted therapies’, has urged Veterans Affairs Canada to launch a large-scale research programme investigating psychedelic-assisted therapies for veterans – including MDMA-assisted therapy.
The organisations have stated that they hope the data collected will add to the knowledge base of both regulators and the scientific community on the real-world evidence of the efficacy and safety of these treatments.
Parker Psychedelics Research Chair, University of Calgary, Dr Leah Mayo, stated: “While clinical evidence in the form of trial data on the efficacy of MDMA as a treatment for PTSD has been published – and is encouraging – this is a global first: an assessment of the efficacy of MDMA in treating PTSD outside the bounds of a clinical trial.
“This observational trial is only possible due to the unique partnership of the 3 groups represented here, and the data gathered should significantly add to the body of knowledge around MDMA-assisted therapies.”
“Heroic Hearts Canada is committed to making MDMA-assisted therapy and other innovative psychedelic-assisted therapies accessible to veterans, who experience disproportionately high rates of trauma and mental illness after service,” added David Fascinato, Executive Director of Heroic Hearts Canada.
“This partnership is an important opportunity to add to the body of knowledge and support Health Canada and stakeholders such as Veterans Affairs Canada, in understanding the potential of MDMA-assisted therapy, with the goal of eventual approval so that it is accessible to all in need through approved healthcare channels.”
