Researchers at the University of Colorado Anschutz Medical Campus and New York University are conducting a large national clinical trial to determine whether psilocybin, the active compound in psychedelic mushrooms, can help patients with advanced cancer who are experiencing anxiety, depression, fear of death, and loss of hope. The study is funded by the National Cancer Institute and continues to enroll participants.
Dr. Stacy Fischer, a geriatric and palliative care specialist at UCHealth University of Colorado Hospital, leads the trial alongside Jim Grigsby, professor at University of Colorado Denver, and Dr. Steven Ross from New York University Grossman School of Medicine. Fischer explained that traditional treatments for depression often fall short for these patients: “Antidepressant medications, like SSRIs, often have no benefit or very little benefit for these patients,” she said. “There are real limits to our current pharmacological treatments.”
The clinical trial involves several preparatory therapy sessions before participants receive either a 25-milligram dose of synthetic psilocybin or a placebo during an eight-hour session in a controlled environment. Two therapists accompany each patient throughout the session and remain involved through follow-up integration meetings intended to help patients process their experiences.
Fischer described this integration as essential: “We call it ‘integration’ because it is an opportunity for patients to integrate the experience of the dosing session into the larger context of their lives.” The Center for Psychedelic Research at CU Denver has developed a 16-week facilitator training program—the first in Colorado approved under state law—which aims to ensure ethical administration and patient safety during psychedelic-assisted therapy.
Jim Grigsby highlighted the importance of trust between facilitators and participants: “These kinds of interactions contribute to a feeling of security, safety and confidence in the people who are conducting the study,” he said.
While Fischer cannot comment on individual outcomes due to study protocols, previous research led by Ross found that psilocybin treatment resulted in rapid reductions in depression as well as improved quality of life among cancer patients. Some also reported so-called mystical-type experiences contributing to reduced symptoms. As Fischer noted: “People often describe this experience as ‘ineffable,’ or beyond words…that we are all connected – and that this isn’t a subjective belief, but an objective reality.”
Grigsby added that such experiences have been documented worldwide across different cultures: “They are subjectively very similar to the kinds of experiences that have been reported around the world by people of different religious and philosophical orientations.”
Research into psychedelics began decades ago but was largely halted in the early 1970s due to political opposition. Interest revived slowly from the 1990s onward with studies investigating substances like MDMA and psilocybin for various mental health conditions including end-of-life distress.
Currently at UCHealth Memorial Hospital and other sites affiliated with UCHealth, about thirty out of fifty planned local participants had received treatment by mid-August; overall enrollment aims for one hundred across both universities.
UCHealth researchers are also pursuing additional trials exploring psilocybin’s potential benefits beyond advanced cancer—including its use for major depressive disorder resistant to standard therapies as well as fears related to cancer recurrence among survivors.
Despite regulatory hurdles and persistent stigma surrounding psychedelics, Fischer expressed optimism about future prospects: “We have compelling preliminary evidence to suggest it works…I think over time these stigmas will fall away especially if we conduct high-quality rigorous science.” Grigsby echoed cautious hope based on ongoing research efforts.
