Trials / Recruiting
RecruitingNCT06464367
Mechanistic Studies of Psilocybin in Headache Disorders
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Yale University · Academic / Other
- Sex
- All
- Age
- 21 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
In previous clinical trial work, the investigators observed lasting reductions in headache burden after limited dosing of psilocybin. This purpose of this study is to examine potential sources for this observed effect. This study will measure brain resting state functional connectivity (fMRI), central synaptic density (SV2A PET), peripheral markers of inflammation, circadian rhythm (actigraphy), and sleep (sleep EEG) in both migraine and healthy control participants before and one week after the administration of psilocybin or an active control agent.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Psilocybin | synthetic psilocybin 10 mg (oral) |
| DRUG | Placebo | synthetic THC 2.5 mg (oral) |
Timeline
- Start date
- 2025-05-19
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2024-06-18
- Last updated
- 2025-07-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06464367. Inclusion in this directory is not an endorsement.