Psilocybin clinical trials in Toronto: how to find and assess one

Is there a psilocybin trial in Toronto that you could join? The honest answer is that there may be, but a registry listing alone cannot tell you. Health Canada says that there are no approved therapeutic products containing psilocybin in Canada or elsewhere, and calls clinical trials the most appropriate and effective way to advance research with psilocybin while protecting patients. So in Toronto, as in the rest of the country, psilocybin given for a health reason is research, not a service.

This article explains how clinical trials work in Canada, how to search the two public registries, how to read a listing critically, and what to ask a study team. It ends with a dated summary of what the registries showed for Toronto. It does not recommend any study, hospital, clinic or provider, and listing an institution here is not an endorsement. The full and current Canadian list is on our psilocybin trials tracker, which is refreshed daily from ClinicalTrials.gov.

How does a clinical trial get approved in Canada?

Through two separate reviews. Health Canada says that before conducting a trial, the sponsor submits a [clinical trial application](https://www.canada.ca/en/health-canada/services/clinical-trials.html) to it, and that its scientists review the application to make sure, among other things, that the risks of the drug are lowered as much as possible and that the best interests of participants have been considered. The same page says trials must follow Division 5 of the Food and Drug Regulations and good clinical practices, and must be reviewed by a research ethics board. The sponsor is usually a drug company, or researchers from a hospital, university or research organization; Health Canada says it does not sponsor or conduct drug research.

The regulation itself is specific. Section C.05.010 of the [Food and Drug Regulations](https://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._870/section-C.05.010.html) requires the sponsor to ensure that, for each trial site, the approval of a research ethics board is obtained before the trial begins there, and that written informed consent is obtained from every person before they take part, after they have been told the risks and anticipated benefits. Health Canada’s psilocybin page adds that, once a trial is authorized, a separate authorization under the Controlled Substances Regulations is required to permit the sale of psilocybin, a restricted drug, for clinical testing, and that organizations working with it need a licence, authorization or exemption (Health Canada). Health Canada updated that sentence on 20 October 2026; before then it named Part J of the Food and Drug Regulations, so check the page for the current wording.

What do the trial phases and a placebo mean?

Health Canada describes four phases. Phase 1 tests an experimental drug on a small group of people for the first time, to look at safety, the safe dosage range and side effects. Phase 2 gives it to a larger group, usually 100 or more, to gather data on how well it works and its safety. Phase 3 uses even larger groups, usually 1,000 or more, and compares it with commonly used treatments. Phase 4 takes place after a drug is approved. Some trials combine phases. ClinicalTrials.gov also uses “Phase Not Applicable” for trials without FDA-defined phases, such as behavioural interventions.

Many trials compare the new drug with a placebo. ClinicalTrials.gov defines a placebo as something that looks the same, and is given in the same way, as the treatment being studied, but contains no medicine. In a randomized trial, participants are assigned to groups by chance, and often neither they nor the staff know who received what, which the registry calls masking or blinding (ClinicalTrials.gov). Health Canada warns that if your reason for joining is to get a new treatment, this may not happen, and that even the new drug may not help you (Health Canada).

What are your rights as a participant?

Taking part is voluntary, and you can leave. Canada’s Tri-Council Policy Statement on research ethics (TCPS 2) states that consent shall be given voluntarily and can be withdrawn at any time. It says participants shall be free to withdraw without giving a reason, should not suffer any disadvantage for doing so, and should not lose payments already due. Health Canada puts it plainly: you have the right to quit a clinical trial at any time, and the trial’s medical staff will make sure you are taken off the medication safely (Health Canada).

TCPS 2 also lists what the consent process should generally cover, including the purpose and procedures in plain language, the identity of the funder or sponsor, foreseeable risks and potential benefits, conflicts of interest, confidentiality, and information about any payments, reimbursement for participation-related expenses and compensation for injury (TCPS 2). It notes that withdrawal may not always be practical partway through, for example in a study with a single intervention.

Do psilocybin trials charge for the study drug?

We could not find a Canadian rule that says so in general terms, and we do not claim one. ClinicalTrials.gov says that many clinical studies pay for the cost of the intervention and research-related tests and visits, that some pay participants, and that the informed consent form describes the study’s payments and costs. Treat cost as a question to ask, not an assumption, and be wary of anyone who asks you to pay to receive psilocybin.

How do you search for a psilocybin trial in Toronto?

There are two public places to look, and they work differently.

1. ClinicalTrials.gov, run by the US National Library of Medicine, lists studies from around the world. Search for psilocybin as the intervention and Toronto as the location. Each study has an NCT number, the registry’s unique identifier.
2. Health Canada’s Canadian Clinical Trial Search Portal replaced the 2013 Clinical Trials Database, with the portal launched on 29 July 2026. It covers drug trials that Health Canada has approved since 1 April 2013, mainly phases 1 to 3 in patients, and links to international registry records for more detail (Health Canada).
3. Compare the two. The portal tells you a trial was approved by Health Canada and when; the registry record usually has the fuller description and the eligibility criteria.
4. Take what you find to your own doctor before contacting anyone.

Health Canada is clear about the portal’s limits. It says the portal is different from a registry because it holds only select information, that some information may be out of date, and that Health Canada does not sponsor clinical trials and the portal is not used to recruit patients. It also says about 17% of trials were matched to registry records with the help of AI at launch, which can lead to incorrect registry information, and that the official protocol title always represents the trial Health Canada approved.

How do you read a trial listing critically?

Start with what a listing is. ClinicalTrials.gov says the US government does not review or approve the safety and science of all studies it lists, and that the sponsor or investigator is responsible for the accuracy of the record. Then check these fields, using the registry’s own definitions:

• Status. “Recruiting” means the study is currently recruiting. “Not yet recruiting” means it has not started. “Enrolling by invitation” means it is not open to everyone who meets the criteria, only to people specifically invited. “Active, not recruiting” means it is under way but not enrolling. “Unknown” means a record that should be current has not been confirmed for two years.
• Site status. A study can be recruiting overall while one of its sites is not. Look at the Toronto site line, not just the headline status.
• Sponsor. The organization or person who starts the study and has authority over it. It may be a hospital, a university, a company or an individual investigator.
• Phase. Phase 1 studies focus mainly on safety and usually involve few participants; some studies, such as brain-imaging studies, are registered as basic science rather than treatment.
• Eligibility criteria. Inclusion criteria are requirements you must meet; exclusion criteria are reasons you cannot take part.
• Last update posted. The most recent date changes to the record appeared. An old date on a “recruiting” study is a reason to ask whether it still is.

Eligibility criteria are often long and strict. As one example of their shape, not a suggestion to apply, a recruiting Toronto depression study (NCT07211438) requires, among other things, that participants be 18 to 70, taper off several kinds of psychiatric medicines with their prescribing physician confirming it is safe, and have a designated caregiver for 24 hours after dosing. It excludes people with a lifetime diagnosis of bipolar disorder or a psychotic disorder, or a first-degree relative with schizophrenia-spectrum or psychotic disorders, along with several heart and blood-pressure conditions. Criteria like these exist, the registry says, to keep participants safe and answer the research question (ClinicalTrials.gov).

What questions should you ask a study team?

ClinicalTrials.gov advises people to get answers to their questions and to talk with their doctor before deciding. Drawing on what the sources above say a consent process should cover, these are reasonable questions:

• Has this trial been authorized by Health Canada, and approved by which research ethics board?
• What phase is it, and is it testing whether psilocybin works, or something else, such as brain imaging?
• What is the chance I receive a placebo or a comparison treatment?
• Will I need to stop or change any of my current medicines, and who decides whether that is safe?
• How many visits, how long, and what happens on the day of dosing and afterwards?
• What does it cost me, and are travel or other expenses reimbursed?
• What happens if I am harmed, or if I want to leave partway through?
• Who outside the research team can I contact about ethical concerns?
• Will my own doctor be told, and what care is there after the study ends?

Which Toronto institutions have registered psilocybin studies?

On 17 October 2026 we queried the ClinicalTrials.gov API for studies with psilocybin as an intervention and a Toronto location (API version 2.0.5, data timestamp 16 October 2026). It returned 23 studies, each with at least one Toronto site. By overall status, 7 were recruiting, 1 was enrolling by invitation, 2 were not yet recruiting, 6 were active but not recruiting, 6 were completed and 1 had an unknown status. By phase, 17 were listed as phase 2, 4 as phase 1, 1 as phase 3 and 1 as not applicable.

Health Canada’s search portal, searched the same day for “psilocybin” with Toronto as the city, returned 18 approved trials. The two sources do not line up exactly, which is a good illustration of why to read both. For one University Health Network study (NCT06341426), the portal names an individual investigator as sponsor; a study that ClinicalTrials.gov calls “completed” appears in the portal as “closed”; and one study recruiting overall lists its Toronto site as not yet recruiting. The oldest record still marked recruiting had last been updated on 30 March 2025.

What this summary shows is that psilocybin research in Toronto is concentrated in a few large hospital and university networks, and that most of it is phase 2. It does not show that any study is open to you, that it suits you, or that psilocybin works for any condition. For the full list, with titles, conditions and current status, use our Canadian trials tracker. For what exists outside trials, see psilocybin therapy in Ontario and the Special Access Program.

What is the sensible next step?

Talk to your own doctor. Health Canada says that individuals wanting to participate in a clinical trial should talk to their health care provider, and its search portal page tells people who want more information to speak with their health care provider and contact the trial sponsor (Health Canada). Your doctor knows your history, and many of the exclusion criteria above are things only a clinician can assess. Bring the NCT number, read the consent form before you decide, and remember that you can say no, or leave later, without giving a reason.

Shroomverse sells mushroom products. This article is general information about the law and clinical research. It is not medical or legal advice, and it does not recommend any product, provider or clinic.