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
Visit trial
Status Completed
Results Published Yes
Start date 01 November 2016
End date 01 June 2022
Chance of happening 100%
Phase Phase I
Design Blinded
Type Interventional
Generation First
Participants 24
Sex All
Age 21- 65
Therapy No

Trial Details

Subjects will maintain a headache diary prior to, during, and after the pulse regimen in order to document headache frequency and intensity before, during, and after the pulse regimen. After at least 6 months from the last experimental session, subjects may be invited for a second round, in which they will be randomized to receive either low dose or high dose psilocybin.

NCT Number NCT02981173

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

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.