Vancouver-based Numinus Wellness is developing psychedelic drug clinical trials for mental health treatment purposes as Ottawa eases restrictions surrounding the testing of illicit mind-altering substances.

Numinus has received Health Canada approval to conduct a clinical trial to test the effects of MDMA, the amphetamine more commonly known as ecstasy, in the treatment of patients suffering from severe post-traumatic stress disorder (PTSD).

Psychedelics research has grown in recent years as universities receive more private funding and wellness companies promote the potential of psychedelics for psychotherapy. Other new firms include the Toronto-based Field Trip Health and Calgary-based Bloom Psychedelic Therapy and Research Centre.

The Numinus study is part of broader North America-wide research sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), a U.S.-based non-profit.

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Under a project named Hope, Numinus is also seeking federal approval for first-phase testing of its psilocybin extract. Psilocybin is a key naturally occurring ingredient found within magic mushrooms and produces their hallucinogenic effects.

Numinus received Health Canada permission to use MDMA in the PTSD study under what is known as a Section 56 exemption of the Controlled Drugs and Substances Act. Section 56 exemptions led to the development of safe-injection sites in Vancouver and other parts of Canada that have been credited with curbing illicit drug use and overdoses.

The health minister will permit a person or class of persons to purchase, possess or use illicit drugs legally if the exemption is necessary for a medical or scientific purpose, or if it is a matter of public interest. Researchers studying controlled substances in clinical trials involving people and animals also require Section 56 exemptions — and must prove that substances will not be diverted from studies or abused.

Company included in special Health Canada program

Numinus is included in Health Canada’s Special Access Programme (SAP), which was amended in January to allow physicians to seek patient access to psychedelic treatments. Under the SAP, a doctor may request a drug that is not available for sale in Canada to treat patients suffering from serious or life-threatening conditions that can not be treated through conventional treatments.

“Amending the SAP highlights the wave of evidence supporting the use of certain psychedelic medicines for mental disorders and Canada's commitment to making access to evidence-based medicines a possibility for the many Canadians who struggle with mental wellness regardless of the historical stigma towards psychedelics,” said Numinus co-founder, president, CEO and chairman Payton Nyquvest.

Psychedelic drugs research regarding mental health problems and substance abuse was prominent in the 1950s, particularly in Saskatchewan, but fell out of favour in the 1960s as the substances were reclassified as dangerous.

“We believe this [SAP revision] is only the beginning of greater change to come,” said Nyquvest. “It signifies an important step towards creating expanded safe access to treatment and care in the mental health sector through psychedelic-assisted psychotherapy.”

The MDMA clinical trial, to be conducted at Numinus facilities in Vancouver and Montreal, will assess safety and bioavailability and be a “stepping stone” to the next stage of the company’s intellectual property development, he added.

Bioavailability refers to the extent a drug or substance becomes completely effective at its intended destination in a person’s body. A higher bioavailability spells a smaller dose and a lower bioavailability requires a larger dose.

Pending Health Canada approval, the Hope project’s first phase will evaluate healthy volunteers’ bioavailability and tolerability of the psilocybin extract. Numinus expects to enroll study volunteers within the next few weeks.

If Hope’s first phase goes as planned, the second and final phase will involve a clinical trial in partnership with a contract research organization, said Nyquvest.

A former investment advisor, Nyquvest says he turned to psychedelics as “a last attempt" after struggling with chronic pain since birth. He originally founded the company to provide infrastructure and resources to make psychedelic therapies accessible, he said.

Legal barriers are being rolled back

Scott Bernstein, executive director of MAPS Canada, which is distinct from the U.S. organization, said Numinus is a Canadian industry leader when it comes to providing psychedelic services to address mental health issues.

"They are approaching the psychedelic field from a variety of approaches, including providing therapeutic treatment with psychedelics, production of psychedelic compounds, and research into the safety and efficacy of psychedelics and psychedelic therapy," he said.

In a growing field such as psychedelics, each study contributes to the general body of knowledge and confidence of regulators to allow access to psychedelics medicine, he added.

Mark Haden, a psychedelics developer and the founder and former executive director of MAPS Canada, said legal barriers to psychedelics research and development have changed dramatically.

"[The federal government] wouldn't say that they were preventing it, but they would make it so difficult that you couldn't do it," he said. "So they would prevent. Psychedelic research was never criminalized. But any time you applied to do it, the endless barriers would prevent it from moving forward. So that's changed."

Haden said former prime minster Stephen Harper's government approved MDMA research into PTSD that he was involved with, and approvals have become easier under current Prime Minister Justin Trudeau.

"So I would describe it as the normal clinical trial research process now," said Haden, who is the director of clinical research for psychedelic wellness companies Psygen and Clear Mind Medicine.

Haden listed Numinus, his two companies, and Field Trip among psychedelics research leaders. He predicts that psychedelics and related treatments will be legalized within the next decade with more coming on track afterward. MDMA-related treatments for PTSD will be out first, he says.

"Psilocybin for end-of-life anxieties is second and psilocybin for depressions is third, and then the list goes on," he said.

Cultural change is underway

Simon Fraser University criminologist Neil Boyd said Numinus and other Canadian psychedelic drug therapy developers are caught up in “a realization that drug use is ultimately a matter of public health and not properly situated within the criminal law.”

“While we certainly don't see a move by government to decriminalize all forms of illicit drug possession or to regulate the sale of distribution and sale of currently illicit drugs, we do see a change in our culture around the extent to which drug use is perceived as a public health issue as opposed to a moral failing,” he said.

“Health Canada cannot help but be influenced and impacted by these changes within our culture and, therefore, more likely to issue approvals for Section 56 exemption for possession of some currently illicit drugs.”

Boyd said the culture change was likely sparked by thousands of deaths caused by opioid overdoses. More rigorous analysis of psychedelics is needed to understand the potential costs and mental health benefits of psychedelics, but “meaningful research is only going to happen if people get access to these drugs,” he said.

“Only when we take the shackles of criminalization away from this area, mind-active drugs, will we be able to develop good data about effects, and about [financial and social] benefits and costs, and about [use-related] harms and benefits,” said Boyd.

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