Effects of Psilocybin in Concussion Headache
Post-Traumatic Headache
About this trial
This is an interventional treatment trial for Post-Traumatic Headache focused on measuring psilocybin
Eligibility 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
Sites / Locations
- VA Connecticut Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo/Low Dose Psilocybin
Placebo/High Dose Psilocybin
Low Dose Psilocybin/Placebo
High Dose Psilocybin/Placebo
High Dose Psilocybin/Low Dose Psilocybin
Low Dose Psilocybin/High Dose Psilocybin
Subjects in this arm receive placebo in the first session and low dose psilocybin in the second session.
Subjects in this arm receive placebo in the first session and high dose psilocybin in the second session.
Subjects in this arm receive low dose psilocybin in the first session and placebo in the second session.
Subjects in this arm receive high dose psilocybin in the first session and placebo in the second session.
Subjects in this arm receive high dose psilocybin in the first session and low dose psilocybin in the second session.
Subjects in this arm receive low dose psilocybin in the first session and high dose psilocybin in the second session.