First Health Canada-approved at-home psilocybin trials launched in Kingston

Kingston Health Sciences Centre (KHSC) has announced the launch of the first ever Health Canada-approved at-home psilocybin clinic trials.

In a press release on Thursday, Oct. 9, 2025, KHSC said that “for the first time ever” researchers are studying the at-home use of non-hallucinogenic/micro-dose levels of psilocybin, which it defined as “the active compound found in psychedelic mushrooms,” also known as ‘magic mushrooms.’ The trial will look at this use of psilocybin in the treatment of generalized anxiety disorder, the Kingston-based medical organization said.

According to KHSC, the study is being led by researchers at the Kingston Health Sciences Centre Research Institute (KHSC-RI), and the study – a Phase 2a clinical trial – has been recently approved by Health Canada. The organization said that the goal of the trial is to “test” if at-home use of micro-dose psilocybin “can safely and effectively reduce symptoms of anxiety, without triggering the psychedelic effects typically associated with psilocybin.”

KHSC explained that Dr. Claudio Soares, an attending physician in KHSC’s Mental Health and Addiction program, is acting as the study’s principal investigator at KHSC-IR.

“There are significant unmet needs among people living with Generalized Anxiety Disorder, and they are seeking effective, well-tolerated treatments,” Soares said in the release.

Dr. Soares, who is also a professor of psychiatry at Queen’s University and the Director of the Centre for Psychedelic Health and Research at Providence Care, spoke to the significance of this clinical trial.

“This study represents a major shift — a new way of targeting anxiety by engaging the brain in novel ways, but without the sedation or emotional numbing caused by many of the current medications used to treat anxiety,” he said.

KHSC said that generalized anxiety disorder affects around five per cent of Canadian adults, or more than 1.6 million people, disproportionately affecting women. The organization explained that despite those facts, treatment options currently available “can be slow to work and come with side effects that make long-term use difficult to tolerate for some individuals.”

The local medical organization — which oversees the operations of a number of local hospitals and clinics, including Kingston General Hospital (KGH), Hotel Dieu Hospital (HDH), and the Cancer Centre of Southeastern Ontario — said  the study is being supported by a grant from the Southeastern Ontario Academic Medical Organization and funding from Diamond Therapeutics.

“Generalized Anxiety Disorder is one of the most common and disabling mental health conditions,” Dr. Michael McDonnell, Chief Medical Officer at Diamond Therapeutics, said in the release.

“If successful, this trial could open the door to new, more accessible treatment options for people who urgently need them.”

According to KHSC, early research — of which Kingston is on the cutting edge — has shown that very low doses of psilocybin “may improve motivation and attention without triggering a psychedelic response.” This suggests that hallucinogenic effects may not be necessary to achieve mental health benefits from psilocybin for patients with generalized anxiety disorder, the organization stated.

As previously reported, Kingston has continually blazed trails in psilocybin research. In 2021, Queen’s University began research into the medical applications of psilocybin, with the Faculty of Health Sciences at Queen’s University positioning itself “at the forefront” of the field, Dr. Jane Philpott said at the time. Queen’s and KHSC launched a study into the effects of psilocybin in treating alcohol use disorder in April 2023, the same year the Neuma Centre and ATMA Journey brought psilocybin research trials to Kingston. And last year, the Centre for Psychedelics Health and Research officially opened at Providence Care Hospital.

KHSC is continuing Kingston’s leadership role in the ever expanding field of study.

“As one of the largest mental health research trials currently underway at KHSC, the study represents an important step in advancing evidence-based innovation in psychiatric care and speaks to the role KHSC-RI plays in driving mental health research in Canada,” KHSC said.

The trial will enrol up to 60 people and will involve a four-week treatment period. That treatment period will be followed by either an extension of the treatment for four additional weeks, or a placebo — all depending on random assignment, according to the release.

“Participants will take the medication at home and are not aware of which group they were assigned,” KHSC explained.

Researchers are currently looking for adults living with generalized anxiety disorder (GAD) to join the study. Those who would like to learn more or participate can email the research team at [email protected], KHSC said.

“Promising new therapies such as this need to be evaluated in trusted institutions that place patient safety, rigorous science, and ethical oversight at the centre of everything we do,” said Dr. David Pichora, President and CEO of KHSC.

“By leading this study, KHSC and the KHSC-RI are ensuring that the search for innovative treatments happens in a safe, transparent, and responsible way.”