Leading by example in the cultivation of quality psilocybin research
Dr. Joshua Rosenblat has had a front-row seat to the surge in interest over the last several years on the therapeutic effects of psilocybin. With five clinical trials at various stages of completion and major contributions in policy development and knowledge synthesis, the University Health Network (UHN) clinician-researcher has become a national leader on exploring the subject.
“There’s been so much interest, even people that usually aren’t listening to science are listening to the story,” he noted.
“Lay people want to know about the science around psilocybin, even those who generally wouldn’t be interested in hearing about clinical trials.”
Before turning his attention to psilocybin in 2020, Dr. Rosenblat was exploring the therapeutic effects of ketamine in patients with severe treatment-resistant depression. Many experienced positive outcomes, but for too many, the status quo remained.
“My entry into psilocybin was as a psychiatrist wanting to help my patients that had tried everything else,” explained the University of Toronto professor.
“Once I started doing these trials, I saw participants having major positive shifts in the way that they think and feel about themselves and the world around them. That motivated me to do more of this work.”
A national catalyst for research interest
His first psilocybin clinical trial, completed in early 2024, explored flexible, repeated psilocybin doses incorporated into psychotherapy for complex mental health issues. It was Canada’s first investigator-initiated (as opposed to industry-sponsored) trial in this area.
Now equipped with Canadian Institutes of Health Research (CIHR) funding, Dr. Rosenblat is building on this research through a study on the optimal number of psilocybin doses in treating depression. It’s one of three clinical trials supported by the CIHR’s Psilocybin-assisted Psychotherapy for Mental Health and Substance Use Disorders funding opportunity.
“If you were to submit a psilocybin grant five years ago, you'd probably get a lot of raised eyebrows, but things have drastically changed. It’s been amazing to see so many more clinical trials up and running, and I have a huge amount of appreciation for CIHR for lighting that spark in our country.”
Mentorship toward a higher standard
Given his unique expertise, Dr. Rosenblat has been a key resource for others looking to get psilocybin studies off the ground.
“I've had dozens of investigators reach out to me saying, 'We want to do a psilocybin trial. How do you do it?' And I’m happy to help,” he said.
This involves supporting colleagues toward a ‘gold standard’ in trial design. The psychotherapy research field took notice in August 2024 when the US Food and Drug Administration rejected MDMA as a psychiatric treatment, citing shortcomings in trial methodology. For researchers exploring other potential psychedelic therapies, the decision highlighted the importance of rigorous, high-quality approaches.
“When something gets breakthrough designation and everyone’s excited, there’s temptation to do faster trials that might be of poorer quality. But we need to hold psilocybin to the same standard we would hold any new intervention to,” said Dr. Rosenblat.
This involves a few key principles: consistent standards, robust blinding, focused primary outcomes, and well-trained staff. That last one is key: psilocybin is not an easy topic for someone’s first clinical trial.
“People in this space should have significant expertise in other clinical trials. And if they don’t, it’s important to hire someone that does.”
Balancing exuberance with restraint
Of course, the potential for over-enthusiasm extends beyond the research community.
“Sometimes, there’s a tension there of people wanting me to be like a spokesperson for psilocybin. Interviewers can be very enthusiastic and want me to say things like ‘this is amazing,’ or ‘this is going to change the world’. But I take a very guarded approach: it's early days, we need to do a lot more testing, we still don't know everything about the safety about this.”
Dr. Rosenblat takes care to temper expectations among patients as well.
“People have seen the Netflix series, they've read Michael Pollan's book, and feel ‘this is what's going to help me,’ which is sometimes a challenge. Psilocybin is often viewed as a panacea, and it’s important to pump the brakes.”
Still, while he generally advises patients begin with conventional psychotherapy, the positive outcomes emerging from psilocybin-focused research aren’t lost on Dr. Rosenblat. They aren’t lost on potential participants in his clinical trial either.
“Usually with clinical trials it’s hard to find people that are interested, but with psilocybin, they’re coming to us. It’s wonderful when there’s that buy-in and you can actually give someone an intervention they’re requesting.”
Dr. Rosenblat and his team are actively enrolling up to 90 participants (some at UHN, some at the Centre for Addiction and Mental Health) with therapists trained on the Yale Manual. Expecting a 2025 study completion date, the research team hopes their comprehensive and stringent approach will offer Canadians a deeper understanding of this novel intervention.
Said Dr. Rosenblat, “I believe in science. And through science, we’ll get to find out whether psilocybin is helpful.”
For future updates, more information on the psilocybin clinical trials and other substance use research supported by the CIHR Institute of Neurosciences, Mental Health and Addiction, visit the Research in Substance Use initiative webpage.
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