Last updated: October 11, 2023
Sponsor: Yale University
Overall Status: Terminated
Phase
1
Condition
Headaches
Pain (Pediatric)
Pain
Treatment
Low Dose Psilocybin
High Dose Psilocybin
Placebo oral capsule
Clinical Study ID
NCT03806985
1607018057.B
Ages 21-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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, orserious 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 thepast 2 weeks
Study Design
Total Participants: 12
Treatment Group(s): 3
Primary Treatment: Low Dose Psilocybin
Phase: 1
Study Start date:
March 28, 2019
Estimated Completion Date:
June 27, 2023
Connect with a study center
VA Connecticut Healthcare System
West Haven, Connecticut 06516
United StatesSite Not Available

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