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 UniversityThe 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 trialThis 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.