Status:
TERMINATED
Effects of Psilocybin in Concussion Headache
Lead Sponsor:
Yale University
Conditions:
Post-Traumatic Headache
Eligibility:
All Genders
21-65 years
Phase:
PHASE1
Brief 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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03806985
Start Date
March 28 2019
End Date
June 27 2023
Last Update
October 12 2023
Active Locations (1)
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1
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516