Psilocybin for Stroke

(PHATHOM Trial)

This trial explores whether psilocybin, a compound found in certain mushrooms, is safe and tolerable for individuals who experienced a stroke over a year ago. Researchers are testing two different doses to observe participant responses. Suitable candidates have had a confirmed stroke diagnosed by a doctor using a scan such as a CT or MRI and are willing to adhere to specific guidelines during the study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

You may need to stop taking certain medications before joining the trial, especially if you are on specific drugs like antidepressants or antipsychotics. It's best to discuss your current medications with the study team to see if any changes are needed.

Research has shown that psilocybin, the treatment under study for people with chronic stroke, has been safe in other settings. Studies have found that when taken in controlled environments with medical supervision, psilocybin is generally well-tolerated. While some individuals might experience mild side effects, serious problems are rare.

In these studies, participants have performed tasks under the effects of psilocybin, suggesting it doesn't cause major issues. Although known for its psychedelic effects, psilocybin has a strong safety record in controlled settings. This trial tests different doses: one group will receive a single 25 mg dose, and another will receive two 12.5 mg doses two hours apart. This approach helps researchers understand how different amounts might affect safety.

Researchers are excited about using psilocybin for stroke recovery because it offers a novel approach compared to traditional treatments like physical therapy and medications that prevent blood clots. Unlike these standard therapies, psilocybin is a psychedelic compound that may promote neural plasticity, potentially aiding the brain in forming new connections after a stroke. This mechanism could accelerate recovery and improve outcomes in ways that current treatments cannot. Additionally, the study explores two dosing strategies, which could provide insights into optimizing its therapeutic effects.

Research shows that psilocybin might aid stroke recovery by promoting brain healing. In animal studies, psilocybin reduced brain damage and improved movement in rats that experienced strokes. This effect may occur because psilocybin increases brain connections and boosts levels of substances that help brain cells survive and heal. Reviews suggest that psilocybin could enhance the brain's ability to change and adapt in stroke survivors. Although human studies provide limited information, these findings indicate that psilocybin might support recovery after a stroke. In this trial, participants will receive either a single 25 mg dose of psilocybin or two 12.5 mg doses spaced two hours apart to evaluate its potential benefits in stroke recovery.¹²⁵⁶⁷