Psilocybin for end-of-life distress: what the research and Canadian access look like

Few questions are heavier than how to face the end of life. Depression, anxiety and a lost sense of purpose are common in advanced illness (one registered Canadian trial puts it at 30 to 50% of patients), and researchers have asked whether psilocybin, given with psychotherapy in a clinic, might play a role. This page describes what the research found, where its own authors see weak points, and what the Canadian rules say as of 4 October 2026.

It is not medical advice. It does not say that psilocybin works, and it does not tell anyone what to do. Studies in supervised clinics say nothing about use outside them. If you or someone close to you is struggling now, the box below lists support in Canada.

What did the main studies of psilocybin and end-of-life anxiety find?

Three small studies carry most of the weight. All three recruited adults with life-threatening cancer who also had anxiety or depression. All paired psilocybin with psychotherapy, and all were done in clinical research settings. We leave out dose amounts on purpose: this page is about what was found, not how to use anything.

Scores come from different scales, so the numbers are not directly comparable across rows. The studies were run as research, with screening, preparation and follow-up that a person outside a trial would not automatically receive.

Griffiths et al., 2016: the Johns Hopkins trial

This was the largest of the three. 566 people were screened by telephone and 56 were randomized, with 51 completing at least one session. Participants had a potentially life-threatening cancer diagnosis, and 65% had recurrent or metastatic disease. They received a very low psilocybin dose in one session and a high dose in the other, in random order, with 5 weeks between sessions and a follow-up at about 6 months (Griffiths et al., 2016).

The primary outcomes were clinician-rated depression and anxiety scales. Five weeks after the first session, 92% of people who had the high dose first showed a clinically significant response on the depression scale, compared with 32% of those who had the very low dose first. After the crossover, scores in the second group moved too. The authors report that effects were sustained at 6 months, when the overall clinician-rated response rate was 78% for depression and 83% for anxiety (Griffiths et al., 2016).

The authors flag several limits. Because everyone crossed over after 5 weeks, the design ruled out a double-blind group comparison of the high dose after that point. The sample was small and predominantly White (94%) and highly educated. Two questionnaires on lasting changes (one participant-rated, one completed by community observers) have not been independently validated, and blinded clinician ratings would have strengthened the study. They also note that some activity from the very low dose cannot be ruled out, and that six people started an antidepressant or anxiolytic during the follow-up (Griffiths et al., 2016).

Ross et al., 2016: the New York trial

Ross and colleagues randomized 29 people with cancer-related anxiety and depression to a single psilocybin session or to niacin, both given with psychotherapy. Groups were compared before the crossover at 7 weeks. Prior to the crossover, psilocybin was associated with lower anxiety and depression scores, and with lower demoralization and hopelessness and higher spiritual wellbeing and quality of life. At 6.5 months, about 60 to 80% of participants still showed clinically significant reductions in depression or anxiety (Ross et al., 2016).

Its own limitations section is short and direct: a relatively small sample, a population that was not nationally representative (62% women, 90% White), a crossover design that limited the interpretation of clinical benefits after the crossover, and a control with limited blinding (Ross et al., 2016).

Grob et al., 2011: the earlier pilot

Twelve adults with advanced-stage cancer and anxiety took part, each acting as their own control in a double-blind, placebo-controlled design. Follow-up measures over 6 months were collected unblinded. The authors reported lower trait anxiety at 1 and 3 months and lower depression scores at 6 months, while a mood scale approached but did not reach significance. They described the study as establishing feasibility and safety, saw a positive trend in some data, and said the results support the need for more research (Grob et al., 2011).

What do the follow-up studies show?

A long-term follow-up of the New York trial contacted all 16 participants still alive and heard back from 15, at an average of 3.2 and 4.5 years after treatment. Reductions in anxiety, depression, hopelessness, demoralization and death anxiety were reported as sustained. At 4.5 years, about 60 to 80% met criteria for a clinically significant response, and most participants attributed positive life changes to the experience. The authors themselves add that limited conclusions about efficacy can be drawn because of the crossover design of the parent study (Agin-Liebes et al., 2020). It is a follow-up of survivors, with no comparison group, using self-reports.

Do reviews and meta-analyses change the picture?

A 2021 systematic review and meta-analysis, titled "Psilocybin for End-of-Life Anxiety Symptoms", pooled five studies. It reported lower state anxiety scores with psilocybin than with placebo at 1 day (Hedges' g -0.70) and 2 weeks (-1.03), and lower trait anxiety scores at 6 months (-0.84). Blood pressure rose transiently, and differences in serious adverse events and discontinuation were not significant. The authors stress the small sample sizes and high heterogeneity on long-term outcomes, and call for larger randomized trials (Yu et al., 2021).

A 2026 meta-analysis in BMC Psychology searched six databases up to November 2024. It reported lower depression scores in randomized trials and mixed results on anxiety: one anxiety scale was not significant, and another gave inconsistent results. The authors call their findings preliminary, citing the small number of studies, high heterogeneity, challenges with blinding and expectancy, and frequent combination with psychotherapy (Moshfeghinia et al., 2026). The newer review is more cautious than the older one.

Why do researchers say these results need caution?

Not because the numbers are small and nothing happened, but because the designs make it hard to know how much of the change came from the drug. The studies themselves and the reviews point to the same set of limits.

• Small samples. The three trials enrolled 12, 29 and 51 people (Grob et al., 2011; Ross et al., 2016; Griffiths et al., 2016). Small samples can overstate or understate effects.
• Crossover designs. Everyone eventually receives psilocybin, so after the switch there is no controlled comparison. The authors of both the Griffiths and Ross trials say this limits what can be concluded after the switch.
• Unblinding and expectancy. Psilocybin’s effects are often noticeable, so people can guess what they received. Griffiths’ team tried to protect blinding with a very low dose comparison and instructions that obscured the design. Even so, five of eight staff members made incorrect inferences about the design, and monitors’ guesses about dose overlapped for some sessions (Griffiths et al., 2016). Ross’ authors say their control had limited blinding.
• Psychotherapy is part of the package. Every study combined psilocybin with preparation and psychotherapy, so the studies cannot separate the two. The 2021 review notes that psychotherapy might have contributed to long-lasting effects (Yu et al., 2021).
• Who took part. Participants were screened and had to meet exclusion criteria. Griffiths’ authors note that the approach is limited by its exclusion criteria and by the time and cost of the professional support around each session. The samples were mostly White and, in Griffiths’ case, highly educated (Griffiths et al., 2016).
• Mechanism. How psilocybin might act here remains speculative, according to the Griffiths paper.

For how this plays out in depression trials, which have faced the same blinding problem, see our summary of psilocybin for depression: what the clinical trials found.

What side effects and adverse events were reported?

In Griffiths’ trial, no serious adverse events were attributed to psilocybin. Raised blood pressure above the study’s thresholds occurred in 34% of participants in the high-dose session (systolic) and 13% (diastolic), nausea or vomiting in 15%, and some psychological discomfort in 32%, including an episode of anxiety in 26%. One participant had a transient episode of paranoid ideation. There were no cases of hallucinogen persisting perception disorder or prolonged psychosis (Griffiths et al., 2016). In Ross’ trial, no serious adverse events were attributed to psilocybin. Commonly reported events were non-clinically-significant rises in blood pressure and heart rate (76%), headache or migraine (28%), nausea (14%), transient anxiety (17%) and transient psychotic-like symptoms (7%) (Ross et al., 2016).

These were supervised sessions with trained staff, screening and monitoring. The 2021 review, drawing on a small number of studies, also found transient blood pressure rises and no significant difference in serious adverse events. Our own summary of risks is on the safety page.

Is psilocybin available for end-of-life distress in Canada?

As of 24 October 2026, Health Canada’s page (date modified 20 October 2026) says that the production, sale and possession of magic mushrooms are illegal in Canada, and that there are no approved therapeutic products containing psilocybin in Canada or elsewhere (Health Canada). Approval positions can change, so check that page for the current position. For the history behind the law, see how magic mushrooms became illegal in Canada, and for one company’s regulatory path, our explainer on COMP360 and the FDA.

Health Canada’s page sets out three formal routes outside ordinary sale: the Special Access Program, individual exemptions under subsection 56(1) of the Controlled Drugs and Substances Act, and clinical trials. We describe each below. This is a description of the rules, not a how-to, and none of these routes is a service a person can simply sign up for.

What is the Special Access Program?

Health Canada says the ability for health care practitioners to request restricted drugs such as psilocybin through the Special Access Program was restored in January 2022. Only regulated health care practitioners who are authorized to treat patients with prescription drugs may file requests on behalf of their patients, and Health Canada says there is no guarantee that a request will be granted (Health Canada). The program covers non-marketed drugs for serious or life-threatening conditions where conventional treatments have failed, are unsuitable or are unavailable in Canada, and each request is assessed case by case (Health Canada, Special Access Program).

What actually happened is described in a 2025 comment in Nature Mental Health. Its authors, who say they have direct experience providing psilocybin-assisted therapy through the program, report figures they obtained from Health Canada by access to information request. Between January 2022 and December 2024, the program processed 436 requests for clinical access to psilocybin, mostly for major depressive disorder and end-of-life distress. 304 (69.7%) were authorized. For end-of-life distress, the table in the comment shows 108 requests: 95 authorized (88.0%) and 13 not authorized. Of those 13, six were recorded as incomplete, six as withdrawn by the requesting practitioner and one as denied (Garel et al., 2025).

The same comment reports that overall approval rates fell from 82% in 2022 to 74.5% in 2023 and 59.1% in 2024. Approval rates for end-of-life distress stayed higher than for depression (80.6% against 56.7% in 2024). The authors say they know of no major regulatory changes over the period, and they list possible barriers: complex paperwork, the lack of training standards, the cost and length of treatment sessions, limited supply of pharmaceutical-grade product, stigma and the lack of standards of care (Garel et al., 2025). It is a commentary, not a full study, and "end-of-life distress" is the program’s category, which we cannot break down by illness.

A September 2025 release from PsyCan, a trade association of legally operating psychedelic medicine and therapy companies, said that, according to Health Canada records it obtained under access to information, approvals were falling further and decisions taking longer. The release gave no figures, and we could not see the underlying records (PsyCan, 2025). We found no official, published figures for 2025 or 2026, so the 2024 data above are the most recent we can verify.

What are section 56 exemptions, and who has received them?

Subsection 56(1) of the Controlled Drugs and Substances Act is a discretionary power that lets the Minister of Health exempt persons or controlled substances from provisions of the Act for a scientific or medical purpose, or for a purpose that is otherwise in the public interest. Health Canada says a request for an individual exemption should include a letter of support from a medical practitioner showing that other legal routes were pursued, with the diagnosis, prognosis, clinical evidence and treatment details (Health Canada).

In 2020, four people with incurable cancer were granted such exemptions by the then Health Minister, Patty Hajdu, to use psilocybin therapy for end-of-life distress. Canadian Lawyer reported it as the first legal use of psilocybin in Canada since it was banned in 1974, and said the people had applied with support from the non-profit TheraPsil (Canadian Lawyer, 2020). TheraPsil, an advocacy group that supported the applications, announced the approvals on 4 August 2020 (TheraPsil, 2020). We have not verified how many exemptions have been granted since, and we cite only these two sources for the 2020 decision.

Which clinical trials in Canada are studying this?

Health Canada says clinical trials are the most appropriate and effective way to advance research with psilocybin while protecting patients, and that authorized trials are listed in its Clinical Trials Database (Health Canada). On 4 October 2026 we searched the US registry ClinicalTrials.gov for psilocybin trials in cancer, palliative care or advanced illness with a Canadian location. The table shows what that search returned, using the status each record displayed. The search may not be complete.

Registered target sizes range from 15 to 120 participants (NCT06416085; NCT07063862), so these are small studies too. A registry entry is a research record, not an invitation or a treatment service. Each trial sets its own eligibility rules, sites and timing, and registry data can be out of date. We give no instructions on joining a trial; a person’s own care team is the right place to ask.

What is still unknown?

• How much of the reported change comes from psilocybin, and how much from psychotherapy, preparation, expectancy and the unblinding of a noticeable drug. The authors of the trials and of the reviews all raise this.
• How long any effect lasts when a controlled comparison is kept. The longest follow-up we found, 4.5 years, had no comparison group.
• How results hold up in larger, more diverse and less highly screened groups, and in people who were excluded from the trials.
• How the Canadian rules work for patients in practice. The published Special Access Program figures end in December 2024, and we could not verify later ones.
• Whether the registered Canadian trials will report results that confirm, narrow or contradict the early studies.

The honest summary is that early studies reported lower anxiety and depression scores in a small number of people with life-threatening cancer, that their designs leave open how much of that was the drug, and that Canadian access is exceptional, case by case and under review. Larger, better-blinded trials are what the authors call for. For background on the compound, see what psilocybin is and what magic mushrooms are.

Shroomverse sells mushroom products. This article is general information about clinical research and Canadian access rules. It is not medical, legal or purchasing advice, and it does not recommend any product.