A Second Psilocybin Group Therapy for the Treatment of Cancer-Related Anxiety in Partial Responders With Metastatic Cancer

This Phase I interventional trial (n=16) will evaluate the safety, tolerability, and efficacy of a second psilocybin-assisted group therapy session in treating anxiety and distress in patients with metastatic cancer who had a partial response to their first retreat.

Conducted by the University of Washington, the study aims to assess whether a second psilocybin session can further alleviate anxiety in this patient population.

Participants will receive psilocybin orally on day 0, with an optional booster dose. They will attend individual and group preparation sessions before dosing and integration visits afterward. The primary outcome will measure the incidence of adverse events, while secondary outcomes will track changes in anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). Follow-up assessments will occur at 2, 3, and 6 months post-treatment.

Trial Details

This phase I trial tests the safety and side effects of a second episode of psilocybin-assisted group therapy and how well it works in treating anxiety and distress in patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and had a partial response to their first retreat. Up to 50% of patients with metastatic cancer have clinically significant anxiety and unaddressed anxiety and distress may add to the suffering caused by cancer itself. Psilocybin, a psychedelic drug, is made using an extract from the psilocybe mushroom, also known as "magic mushrooms". Psilocybin binds to serotonin receptors (natural body chemicals that control moods) on brain cells producing intense changes in mood, including anxiety. This may change perceptions and patterns of thinking in ways that may decrease anxiety. Group therapy may reduce stress and improve the well-being and quality of life of patients with metastatic cancer. A second episode of psilocybin-assisted group therapy may be safe, tolerable and or effective in treating anxiety and distress in partial responders with metastatic cancer.

Trial Number NCT06644170

Data attribution

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