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NCT02981173 · ClinicalTrials.gov registry record · Phase 1
Psilocybin for the Treatment of Cluster Headache
A Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT02981173: Completed Phase 1 study, sponsored by Yale University.
NCT02981173 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02981173, a Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study 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.
Primary Outcome
Measured in days
Interventions
- DRUG Placebo
- DRUG 0.143 mg/kg Psilocybin or 10 mg Psilocybin
- DRUG 0.0143 mg/kg Psilocybin or 1 mg Psilocybin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2016-12-05 |
| Est. Completion | 2022-10-21 |
| Phase | Phase 1 |
What the finished NCT02981173 record still lists
NCT02981173 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02981173 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02981173 about?
NCT02981173 is a clinical study titled "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. Subjects will maintain a headac...
What is the current status of trial NCT02981173?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2016-12-05. Estimated completion is 2022-10-21.
What interventions are being tested in trial NCT02981173?
The interventions under investigation include: Placebo (DRUG), 0.143 mg/kg Psilocybin or 10 mg Psilocybin (DRUG), 0.0143 mg/kg Psilocybin or 1 mg Psilocybin (DRUG).
Who is sponsoring clinical trial NCT02981173?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02981173's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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