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In an ongoing randomized clinical trial, researchers at the University of Colorado and New York University are studying whether a single 25-milligram dose of synthetic psilocybin, paired with preparatory and integration therapy sessions, can ease anxiety and depression in patients with advanced cancer. Results are not yet published.
- This is an active, enrolling trial. The study is the largest national clinical trial of psilocybin in cancer patients, funded by the National Cancer Institute. No outcome data have been published from this specific trial yet.
- The protocol is structured. Participants receive three preparatory therapy sessions, a single supervised eight-hour dosing session, and multiple follow-up integration sessions, all with the same therapeutic team.
- Earlier related work suggested sustained effects. A 2016 study by one of the trial co-leads found decreased depression and existential distress, improved spiritual wellbeing, and effects that potentially lasted up to eight months, though that was a separate, smaller study.
- Integration is treated as essential, not optional. The trial team frames the post-dose integration sessions as a core part of the treatment, not an afterthought.
- Model
- Human
- Sample
- Advanced cancer patients with anxiety and depression; enrollment ongoing
- Dose
- 25 mg synthetic psilocybin (single dose) or placebo
- Design
- Randomized, placebo-controlled clinical trial at two sites (University of Colorado Anschutz and NYU)
- Key outcome
- Anxiety, depression, existential distress, spiritual wellbeing, and quality of life (endpoints not yet publicly reported)
- Main limitation
- No outcome data from this trial have been published; the article draws on an earlier 2016 study by a co-investigator for illustrative context
What the Research Examined
The Psilocybin Therapy in Advanced Cancer trial (NCT05398484) is a randomized, placebo-controlled study taking place at the University of Colorado Anschutz Medical Campus and New York University. It is funded by the National Cancer Institute and described as the largest clinical trial of psilocybin use in cancer patients in the United States. The trial is led by Dr. Stacy Fischer, a geriatric and palliative care specialist at UCHealth; Jim Grigsby, a psychology professor at the University of Colorado Denver; and Dr. Steven Ross, a clinical professor of psychiatry at the NYU Grossman School of Medicine. As of this writing, the trial is still enrolling participants.
Eligible participants are adults with advanced cancer who are experiencing anxiety that is also driving depression. Before any dosing occurs, each patient completes three preparatory therapy sessions with a dedicated therapeutic team. The dosing session itself runs approximately eight hours: patients rest in a quiet room, wearing eye shades and listening to a curated music playlist through headphones, while two trained therapists remain present throughout. The active arm receives a single 25-milligram dose of synthetic psilocybin; the control arm receives a placebo. Anti-anxiety medications are available if needed, though the lead investigator described that scenario as highly unlikely. After the dosing session, patients attend multiple integration sessions with the same therapists, a process the team describes as central to the therapeutic model. For those interested in the broader landscape of psilocybin research in therapeutic contexts, this trial represents one of the most rigorously designed efforts to date in an oncology population.
The UCHealth article also references a 2016 study published in the Journal of Psychopharmacology by co-investigator Dr. Steven Ross, which found that cancer patients who received psilocybin quickly reported less depression and decreased cancer-related existential distress, along with improved spiritual wellbeing and attitudes toward death, with effects potentially lasting up to eight months. That earlier study is cited for context; it is a separate, smaller study and its findings do not represent the results of the current national trial, which has not yet reported outcome data.
What the Findings Show
- Current trial status.Enrollment is ongoing. No efficacy or safety outcome data from the current national trial have been published as of the source date.
- Dose used.A single 25-milligram dose of synthetic psilocybin is administered in the active arm, preceded by three preparatory therapy sessions and followed by multiple integration sessions.
- 2016 reference study: depression and distress.In a separate 2016 study by co-investigator Dr. Ross, published in the Journal of Psychopharmacology, cancer patients who received psilocybin reported decreased depression, reduced cancer-related existential distress, increased spiritual wellbeing and quality of life, and improved attitudes toward death.
- 2016 reference study: duration.The authors of the 2016 study noted that the observed effects potentially lasted as long as eight months after treatment, though the word ‘potentially’ reflects the uncertainty acknowledged by the researchers themselves.
It is important to read these figures carefully. The depression and distress outcomes come from Dr. Ross’s 2016 study, which was a distinct, earlier investigation. They are offered here as context for why the current larger trial was designed, not as results of the ongoing national study. The current trial’s outcomes will depend on its own data, which have not yet been reported.
What does the psilocybin cancer clinical trial involve and what has research found so far?
The trial gives advanced cancer patients with anxiety and depression a single supervised 25-milligram dose of synthetic psilocybin, wrapped in preparatory and integration therapy. An earlier related study found reduced depression and existential distress lasting potentially up to eight months, but this trial’s own results have not yet been published.
What This Is, and What It Is Not
This is This source is a press article from a hospital system describing an active, enrolling clinical trial; no peer-reviewed outcome data from the current trial are available yet.
This is not This is not a completed study with confirmed results, and the 2016 findings cited for context came from a separate, smaller investigation. Nothing here constitutes medical advice, and psilocybin remains a Schedule I substance under federal law. Anyone considering participation in a clinical trial should speak with their own medical team.
Our Take
What strikes our community about this trial is not only the scientific rigor but the deliberate architecture of relationship built around the session itself. The same therapists prepare, accompany, and integrate with each patient. The UCHealth team uses the word ‘integration’ in exactly the way we do: as a sacred continuity between the experience and the life that holds it. Advanced cancer brings a person face to face with the most elemental questions any of us carry. That medicine, offered in a field of trust and care, might ease that passage even a little is something worth studying with the utmost seriousness. We will watch this trial closely.
If you or someone you love is living with advanced cancer and is curious about this trial, the contact information in the source is public: Mary Mancuso at the University of Colorado Anschutz Medical Campus. For the rest of us, this unfolding research is a reminder that the relationship between consciousness, suffering, and healing is vast and not yet fully mapped. Whether you are in the Grounding station of your own path or somewhere further along, there is always more to learn, and always someone worth accompanying. We are glad you are here with us for these conversations.
Frequently Asked Questions
What is the psilocybin cancer clinical trial and who is running it?
It is a randomized, placebo-controlled study funded by the National Cancer Institute, led by researchers at the University of Colorado Anschutz Medical Campus and New York University. It is the largest U.S. clinical trial of psilocybin in advanced cancer patients and is still enrolling participants.
What dose of psilocybin is used in the cancer trial?
Participants in the active arm receive a single 25-milligram dose of synthetic psilocybin during a supervised eight-hour session. They also complete three preparatory therapy sessions before the dose and multiple integration sessions afterward.
Has psilocybin been shown to help cancer patients with depression?
A separate 2016 study by one of the trial co-leads found reduced depression and existential distress in cancer patients after psilocybin, with effects potentially lasting up to eight months. The current larger national trial has not yet published its own outcome data.
What is integration therapy in the context of psilocybin treatment?
In this trial, integration refers to a series of follow-up sessions with the same therapists after the dosing day. The team describes these as an opportunity for patients to connect the experience of the session to the broader context of their lives, and considers them central to the treatment.
Can I enroll in the psilocybin cancer trial?
The trial was still enrolling as of this report. Adults with advanced cancer who have anxiety and depression may be eligible. Contact the project manager, Mary Mancuso, at mary.mancuso@cuanschutz.edu or 303.724.5729 for information. Always consult your own medical team first.
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