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COMPLETEDPHASE1

Psilocybin for the Treatment of Cluster Headache

Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders

NCT02981173•Yale University

Summary

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. 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.

Eligibility

Age

21 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Chronic cluster headache with at least one attack daily
•Episodic cluster headache with periods that are predictable and have a duration of approximately 2 months
•Attacks are managed by means involving no more than twice weekly triptan use (e.g., high-flow oxygen, heat/cold pack)

Exclusion Criteria

•Axis I psychotic disorder (e.g. schizophrenia, bipolar I, depression with psychosis)
•Axis I psychotic disorder in first degree relative
•Unstable medical condition, severe renal, cardiac or hepatic disease, pacemaker, or serious central nervous system pathology
•Pregnant, breastfeeding, lack of adequate birth control
•History of intolerance to psilocybin, lysergic acid diethylamide (LSD), or related compounds
•Drug or alcohol abuse within the past 3 months (excluding tobacco)
•Urine toxicology positive to drugs of abuse
•Use of vasoconstrictive medications (i.e. sumatriptan, pseudoephedrine, midodrine) within five half-lives of test days
•Use of serotonergic antiemetics (i.e. ondansetron) in the past 2 weeks
•Use of antidepressant medications (i.e. amitriptyline, isocarboxazid, fluoxetine, citalopram) in the past 6 weeks
+1 more criteria

Locations (1)

VA Connecticut Healthcare System

West Haven, Connecticut, United States

Key Dates

Start Date

December 5, 2016

Primary Completion Date

June 30, 2022

Completion Date

October 21, 2022

Last Updated

December 15, 2023

Enrollment

ACTUAL participants

Conditions

Cluster Headache

Interventions

0.143 mg/kg Psilocybin or 10 mg Psilocybin

DRUG

0.0143 mg/kg Psilocybin or 1 mg Psilocybin

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 15, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Psilocybin for the Treatment of Cluster Headache

Inclusion Criteria

Exclusion Criteria

China Headache and Vertigo Registry Study

Sphenopalatine Ganglion Pulsed Radiofrequency Treatment Outcomes

Osteopathic Manual Therapy (OMT) and Brain Structure and Function in Primary Headache Patients: A Pilot Study

Personalised Process-based Psychological Interventions for Paediatric Headaches

Hydration in Children and Adolescents With Primary Headaches

GON-injection for a Sooner and Better Treatment of Cluster Headache