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NCT03806985 · ClinicalTrials.gov registry record · Phase 1
Effects of Psilocybin in Concussion Headache
A Phase 1 study, sponsored by Yale University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03806985 is a Phase 1 study that was terminated before completion, run by Yale University. The registered enrollment target is 12 participants.
The verdict
NCT03806985, a Phase 1 study, was terminated before completion, sponsored by Yale University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the effects of oral psilocybin in post-traumatic headache. Subjects will be randomized to receive placebo, low dose psilocybin, or high dose psilocybin on two separate test days approximately 14 days apart. 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. Blood samples will be drawn at various timepoints to measure levels of inflammatory peptides.
Interventions
- DRUG Placebo oral capsule
- DRUG Low Dose Psilocybin
- DRUG High Dose Psilocybin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-03-28 |
| Est. Completion | 2023-06-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03806985
The ClinicalTrials.gov registry entry for NCT03806985 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 12 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 oral capsule is the first listed.
NCT03806985 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03806985 about?
NCT03806985 is a clinical study titled "Effects of Psilocybin in Concussion Headache". The purpose of this study is to investigate the effects of oral psilocybin in post-traumatic headache. Subjects will be randomized to receive placebo, low dose psilocybin, or high dose psilocybin on two separate test days approximately 14 days apart. Subjects will maintain a headache diary prior to,...
What is the current status of trial NCT03806985?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2019-03-28. Estimated completion is 2023-06-27.
What interventions are being tested in trial NCT03806985?
The interventions under investigation include: Placebo oral capsule (DRUG), Low Dose Psilocybin (DRUG), High Dose Psilocybin (DRUG).
Who is sponsoring clinical trial NCT03806985?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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