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NCT03341689 · ClinicalTrials.gov registry record · Phase 1
Psilocybin for the Treatment of Migraine Headache
A Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT03341689: Completed Phase 1 study, sponsored by Yale University.
NCT03341689 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03341689, a Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the effects of oral psilocybin in migraine headache. Subjects will each receive a dose of placebo and a dose of psilocybin approximately 14 days apart. Subjects will be randomized to the order of treatment and they will be randomized to receive either low or high dose psilocybin. Subjects will maintain a headache diary prior to, during, and after the treatments in order to document headache frequency and intensity, as well as associated symptoms. This preliminary study will inform on the basic effects of psilocybin in migraine headache and inform on the design of larger, more definitive studies.
Primary Outcome
Average days (number of days per week)
Interventions
- DRUG Placebo
- DRUG Low Dose Psilocybin
- DRUG High Dose Psilocybin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2017-11-01 |
| Est. Completion | 2021-10-31 |
| Phase | Phase 1 |
What the finished NCT03341689 record still lists
NCT03341689 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03341689 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03341689 about?
NCT03341689 is a clinical study titled "Psilocybin for the Treatment of Migraine Headache". The purpose of this study is to investigate the effects of oral psilocybin in migraine headache. Subjects will each receive a dose of placebo and a dose of psilocybin approximately 14 days apart. Subjects will be randomized to the order of treatment and they will be randomized to receive either low ...
What is the current status of trial NCT03341689?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2017-11-01. Estimated completion is 2021-10-31.
What interventions are being tested in trial NCT03341689?
The interventions under investigation include: Placebo (DRUG), Low Dose Psilocybin (DRUG), High Dose Psilocybin (DRUG).
Who is sponsoring clinical trial NCT03341689?
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 NCT03341689's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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