Effects of Psilocybin in Concussion Headache

• Status: Recruiting
• Trial end date: 2022-06-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Psilocybin

Criteria

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