By Alexandra Keeler 

There is mounting evidence of psychedelics’ effectiveness at treating mental disorders. But researchers face obstacles conducting rigorous studies

In a move that made international headlines, America’s top drug regulator denied approval last year for psychedelic-assisted therapy to treat post-traumatic stress disorder.

In its decision, the U.S. Food and Drug Administration cited concerns about study design and inadequate evidence to assess the benefits and harms of using the drug MDMA.

The decision was a significant setback for psychedelics researchers and veterans’ groups who had been advocating for the therapy to be approved. It is also reflective of a broader challenge faced by researchers keen to validate the therapeutic potential of psychedelics.

“Sometimes I feel like it’s death by 1,000 paper cuts,” said Leah Mayo, a researcher at the University of Calgary.

“If the regulatory burden were a little bit less, that would be helpful,” added Mayo, who holds the Parker Psychedelics Research Chair at the Psychedelic and Cannabinoid Therapeutics Lab. The lab develops new treatments for mental health disorders using psychedelics and cannabinoids.

Sources say the weak research body behind psychedelics is due to a complex interplay of factors. But they would like to see more research conducted to make psychedelics more accessible to people who could benefit from them.

“If you want [psychedelics] to work within existing health-care infrastructure, you have to play by [Canadian research] rules,” said Mayo.

“Therapy has to be reproducible, it has to be evidence-based, it has to be grounded in reality.”

Psychedelics in Canada

Psychedelics are hallucinogenic substances such as psilocybin, MDMA and ketamine that alter people’s perceptions, mood and thought processes. Psychedelic therapy involves the use of psychedelics in guided sessions with therapists to treat mental health conditions.

Psychedelics are generally banned for possession, production and distribution in Canada. However, two per cent of Canadians consumed hallucinogens in 2019, according to the latest Canadian Alcohol and Drugs Survey. Psychedelics are also used in Canada and abroad in unregulated clinics and settings to treat conditions such as substance use disorder, post-traumatic stress disorder (PTSD) and various mental disorders.

“The cat’s out of the bag, and people are using this,” said Zachary Walsh, a professor in the Department of Psychology at the University of British Columbia.

Within Canada, there are three ways for psychedelics to be accessed legally.

The federal health minister can approve their use for medical, scientific or public interest purposes. Health Canada runs a Special Access Program that allows doctors to request the use of unapproved drugs for patients with serious conditions that have not responded to other treatments. And Health Canada can approve psychedelics for use in clinical trials.

Researchers interested in conducting clinical trials involving psychedelics face significant hurdles.

“There’s been a concerted effort — and it’s just fading now — to mischaracterize the risks of these substances,” said Walsh, who has conducted several studies on the therapeutic uses of psychedelics. These include studies on MDMA-assisted therapy for PTSD, and the effects of microdosing psilocybin on stress, anxiety and depression.

The U.S. government demonized psychedelic substances during its War on Drugs in the 1970s, exaggerating their risks and blocking research into their medical potential. Influenced by this war, Canada adopted similar tough-on-drugs policies and restricted research.

Today, younger researchers are pushing forward.

“New ideas really come into the forefront when the people in charge of the old ideas retire and die,” said Norman Farb, an associate professor in the Department of Psychology at the University of Toronto.

But it remains a challenge to secure funding for psychedelic research. Government funding is limited, and pharmaceutical companies are often hesitant to invest because psychedelic-assisted therapy does not generally fit the traditional pharmaceutical model.

“It’s not something that a pharmaceutical company wants to pay for, because it’s not going to be a classic pharmaceutical,” said Walsh.

As a result, many researchers rely on private donations or venture capital. This makes it difficult to fund large-scale studies, says Farb, who has faced institutional obstacles researching microdosing for treatment-resistant depression.

“No one wants to be that first cautionary tale,” he said. “No one wants to invest a lot of money to do the kind of study that would be transparent if it didn’t work.”

Difficulties in clinical trials

But funding is not the only challenge. Sources also pointed to the difficulty of designing clinical trials for psychedelics.

In particular, it can be difficult to implement a blind trial process, given the potent effects of psychedelics. Double blind trials are the gold standard of clinical trials, where neither the person administering the drug or patient knows if the patient is receiving the active drug or placebo.

Health Canada also requires researchers to meet strict trial criteria, such as demonstrating that the benefits outweigh the risks, that the drug treats an ongoing condition with no other approved treatments, and that the drug’s effects exceed any placebo effect.

It is especially difficult to isolate the effects of psychedelics. Psychotherapy, for example, can play a crucial role in treatment, making it difficult to disentangle the role of therapy from the drugs.

Mayo, of the University of Calgary, worries the demands of clinical trial models are not practical given the limitations of Canada’s health-care system.

“The way we’re writing these clinical trials, it’s not possible within our existing health-care infrastructure,” she said. She cited as one example the expectation that psychiatrists in clinical trials spend eight or more hours with each patient.

Ethical issues

Psychedelics research can also raise ethical concerns, particularly where it involves individuals with pre-existing mental health conditions.

A 2024 study found that people who visited an emergency room after using hallucinogens were at a significantly increased risk of developing schizophrenia — raising concerns that trials could harm vulnerable participants.

Another problem is a lack of standardization in psychedelic therapy. “We haven’t standardized it,” said Mayo. “We don’t even know what people are being taught psychedelic therapy is.”

This concern was underscored in a 2015 clinical trial on MDMA in Canada, where one of the trial participants was subjected to inappropriate physical contact and questioning by two unlicensed therapists.

Mayo advocates for the creation of a regulatory body to standardize therapist training and prevent misconduct.

Others have raised concerns about whether the research exploits Indigenous knowledge or cultural practices.

“There’s no psychedelic science without Indigenous communities,” said Joseph Mays, a doctorate candidate at the University of Saskatchewan.

“Whether it’s medicalized or ceremonial, there’s a direct continuity with Indigenous practices.”

Mays is an advisor to the Indigenous Reciprocity Initiative, which funnels psychedelic investments back to Indigenous communities. He believes those working with psychedelics must incorporate reciprocity into their work.

“If you’re using psychedelics in any way, it only makes sense that you would also have a commitment to fighting for the rights of [Indigenous] communities, which are still lacking basic necessities,” said Mays, suggesting that companies profiting from psychedelic medicine should contribute to Indigenous causes.

Despite these various challenges, sources remained optimistic that psychedelics would eventually be legalized — although not due to their work.

“It’s inevitable,” said Mays. “They’re already widespread, being used underground.”

Farb agrees. “A couple more research studies is not going to change the law,” he said. “Power is going to change the law.”

This article was produced through the Breaking Needles Fellowship Program, which provided a grant to Canadian Affairs, a digital media outlet, to fund journalism exploring addiction and crime in Canada. Articles produced through the Fellowship are co-published by Break The Needle and Canadian Affairs.