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Initial Results: Clinical Trial of Psilocybin for Cluster Headache

by | Nov 23, 2022 | News

The first results of a small randomized controlled study of psilocybin for cluster headache have been published in the medical journal Headache. The study showed a good effect size for psilocybin treatment and the safety of the substance was demonstrated.

Participants were randomized to get either psilocybin (about 10mg) or placebo (fiber pill) in a 3-dose busting regimen (each dose separated by about 5 days). Then headache burden was measured over time and compared to baseline. Placebo didn’t have much effect, but psilocybin reduced attack frequency by about 30%.

The trend line of the results is positive, but because this is a small, preliminary study (just 14 participants), the statistical analysis couldn’t definitively show that psilocybin was better than placebo.

When looking just at the patients who got psilocybin (n = 8), half of them responded to the first busting regimen and these responders had a large 75% reduction in cluster headache burden.

Participants in the study were able to take a second 3-dose busting regimen and those who initially received placebo were able to try psilocybin. The results of this open label, treatment-extended study can be found here.

This study was led by Dr. Emmanuelle Schindler and took place at the Veterans Affairs Hospital in West Haven, Connecticut, an affiliate of Yale University School of Medicine.

Additional studies of psilocybin for cluster headache are being planned and they will explore factors such as different doses, timing of dosing, and possibly adjusting treatment based on initial response. We will share announcements about upcoming studies when details are finalized.

Statement from Bob Wold, Founder and Executive Director of Clusterbusters.

“It’s been a long road of discovery, but we are still in the early stages of clinical research on psychedelics for cluster headache. This data shows a good signal of positive efficacy for psilocybin and I’m confident that further research with more patients and increased number of treatments will show even stronger results. The pain of cluster headache is excruciating, and we are thankful for all researchers and funding sources exploring more treatments for this devastating disease.”

Any reporters interested in interviewing Bob Wold can reach him at Bob@Clusterbusters.org.


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