CompletedPhase 1

Psilocybin for the Treatment of Cluster Headache

NCT02981173 · Yale University

Closed to entry

Status

Not accepting participants

Phase 1

Phase

Target enrolment

Study sites

1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Time to first attack after completion of pulse regimen
Measured over Two months following the completion of pulse regimen (after completion of experimental sessions 1, 2, and 3)
Time to last attack after completion of pulse regimen
Measured over Six months following the completion of pulse regimen (after completion of experimental sessions 1, 2, and 3)
Change in frequency of attacks
Measured over Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
Change in intensity of attacks
Measured over Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
Change in duration of attacks
Measured over Measured from 2 weeks before to 2 months after completion of pulse regimen using a headache diary
Change in cluster period duration compared to typical cluster period (episodic subjects only)
Measured over Measured from 2 weeks before pulse regimen to 6 months following the completion of pulse regimen, then comparing to historical average duration of cluster periods
Difference in the change in cluster attack frequency between 1st and 2nd round
Measured over Measured from 2 weeks before to 2 months after completion for each of the two pulse regimens using a headache diary
Difference in the change in cluster attack intensity between 1st and 2nd round
Measured over Measured from 2 weeks before to 2 months after completion for each of the two pulse regimens using a headache diary
Difference in the change in the duration of attacks between 1st and 2nd round
Measured over Measured from 2 weeks before to 2 months after completion for each of the two pulse regimens using a headache diary

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 65 Years

Ages

All

Sex

Not accepted

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 * Use of steroids or certain other immunomodulatory agents (i.e. azathioprine) in the past 2 weeks

Where

1 study site

Facility	City	Region	Country
VA Connecticut Healthcare System	West Haven	Connecticut	United States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT02981173 on ClinicalTrials.gov →

Last updated in the registry 2023-12-15. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Psilocybin

Indication

Cluster Headache4

Recruiting in

Connecticut77

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