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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 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 25 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02981173
The ClinicalTrials.gov registry entry for NCT02981173 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02981173 reports 0 study locations.
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.
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