Repeat Dosing of Psilocybin in Migraine Headache

Brief Summary

In seeking to understand the capacity for psilocybin to reduce migraine headache burden, this study will investigate single and repeated dosing of psilocybin up to two doses. In seeking to identify an underlying mechanism in psilocybin's effects, neuroinflammatory markers for migraine headache will be measured.

Intervention / Treatment

  • Drug: Psilocybin
  • Drug: Placebo

Condition or Disease

  • Migraine Headache

Phase

Study Design

Study type: Interventional
Status: Recruiting
Study results: No Results Available
Age: 21 Years to 65 Years   (Adult, Older Adult)
Enrollment: 24 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Aug 10, 2021
Primary Completion: Jul 15, 2022
Completion Date: Jul 15, 2023
Study First Posted: Jan 06, 2020
Results First Posted: Aug 30, 2020
Last Updated: Oct 25, 2021

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Migraine headache is a common medical condition and a top cause of disability worldwide. Treatment options for migraine headache are many and varied, though an approximated 10% of migraineurs is refractory to medication and thus, there is a need to develop alternative treatments. There is anecdotal evidence supporting lasting therapeutic effects after limited dosing of psilocybin and related compounds in headache disorders. The cause of this unique effect remains unknown, though the drug class has demonstrable anti-inflammatory activity, a biological process relevant to migraine and other headache disorders. In seeking to understand the capacity for psilocybin to reduce migraine headache burden, this study will investigate single and repeated dosing of psilocybin up to two doses. In seeking to identify an underlying mechanism in psilocybin's effects, neuroinflammatory markers for migraine headache will be measured. The results from this study will serve in the development of larger investigations seeking to understand the effects of psilocybin and related compounds in headache disorders.

Eligibility Criteria

Sex: All
Minimum Age: 21
Maximum Age: 65

This clinical trial is recruiting

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More Details

NCT Number: NCT04218539
Other IDs: 2000026974
Study URL: https://ClinicalTrials.gov/show/NCT04218539
Last updated: Jun 16, 2022