Effects of Psilocybin in Concussion Headache

  • STATUS
    Recruiting
  • End date
    Jul 15, 2023
  • participants needed
    24
  • sponsor
    Yale University
Updated on 4 October 2022

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.

Details
Condition Post-Traumatic Headache
Treatment Placebo oral capsule, High Dose Psilocybin, Low Dose Psilocybin
Clinical Study IdentifierNCT03806985
SponsorYale University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of post-traumatic headache
Typical pattern of headache attacks with approximately two attacks or more weekly
Attacks are managed by means involving no more than twice weekly triptan use

Exclusion Criteria

Axis I psychotic disorder (e.g. schizophrenia, bipolar I, depression with psychosis)
Axis I psychotic disorder in first degree relative
Unstable medical condition, severe renal, cardiac or hepatic disease, pacemaker, or serious central nervous system pathology
Pregnant, breastfeeding, lack of adequate birth control
History of intolerance to psilocybin, LSD, or related compounds
Drug or alcohol abuse within the past 3 months (excluding tobacco)
Urine toxicology positive to drugs of abuse
Use of vasoconstrictive medications (i.e. sumatriptan, pseudoephedrine, midodrine) within 5 half-lives of test days
Use of serotonergic antiemetics (i.e. ondansetron) in the past 2 weeks
Use of antidepressant medication (i.e. TCA, MAOI, SSRI) in the past 6 weeks
Use of steroids or certain other immunomodulatory agents (i.e. azathioprine) in the past 2 weeks
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