Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 1 study, sponsored by Yale University.
NCT03806985 is a Phase 1 study that was terminated before completion, run by Yale University. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
4-tiered pain score (0=none, 1=mild, 2=moderate, 3=severe)
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 |
Why NCT03806985 stopped before completion
NCT03806985 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo oral capsule is the first listed.
NCT03806985 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03806985's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02602769 · 12 participants
Whole Transcriptome Profiling and Metabolic Phenotyping in Children With ROHHAD Syndrome
- NCT02605421 · 12 participants · Phase 2
Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma
- NCT02619448 · 12 participants · Early Phase 1
Concurrent Chemotherapy Plus HFR Radiation Therapy in Inoperable NSCLC
- NCT03311503 · 12 participants · Phase 1
Phase I/II Trial of Lentiviral Gene Transfer for SCID-X1 With Low Dose Targeted Busulfan Conditioning
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI