Psilocybin for the Treatment of Cluster Headache

The purpose of this study is to investigate the effects of an oral psilocybin pulse regimen in cluster headache. Subjects will be randomized to receive oral placebo, low dose psilocybin, or high dose psilocybin in three experimental sessions, each separated by 5 days.

Topic Pain Headache Disorders
Compound Placebo Psilocybin
Country United States of America
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Trial Details



Trial Number

Sponsors & Collaborators

Yale University
The Yale Psychedelic Science Group was established in 2016.

American Psychiatric Association
This company doesn't have a full profile yet, it is linked to a clinical trial.

National Institute of Mental Health
This company doesn't have a full profile yet, it is linked to a clinical trial.

Papers

Psilocybin pulse regimen reduces cluster headache attack frequency in the blinded extension phase of a randomized controlled trial
This double-blind, placebo-controlled study (n=10) assesses the safety and efficacy of repeated pulse administration of psilocybin (10mg/70kg, 3x in 15 days) in cluster headache patients. Following the initial trial, eligible participants received a psilocybin pulse at least 6 months later and kept headache diaries for 8 weeks. Results indicate a significant reduction in cluster attack frequency following the psilocybin pulse, suggesting potential therapeutic benefits.

Exploratory investigation of a patient-informed low-dose psilocybin pulse regimen in the suppression of cluster headache: Results from a randomized, double-blind, placebo-controlled trial
This double-blind placebo-controlled study (n=14) finds that psilocybin (10mg/70kg, 3x) reduced the frequency of cluster headaches by 3 (from a baseline of 10), but this effect was not significant. The intensity of the acute experience didn't impact the outcome. A study with more participants might find a significant treatment effect.

Data attribution

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