Clinical TrialHeadache Disorders (Cluster & Migraine)PlaceboPsilocybinPsilocybinTerminated

Effects of Psilocybin in Concussion Headache

Double-blind crossover trial (n=12) investigating repeated oral psilocybin (two sessions; low 0.0143 mg/kg or 1 mg and high 0.143 mg/kg or 10 mg) versus placebo for post-traumatic headache.

Target Enrollment
12 participants
Study Type
Phase I interventional
Design
Randomized, double Blind

Detailed Description

This randomised, double-blind, crossover study evaluates oral psilocybin (low and high dose) versus placebo in participants with post-traumatic headache over two test days separated by approximately 14 days.

Participants maintain a headache diary before, during and after treatments to record frequency, intensity and associated symptoms; blood samples are collected to measure inflammatory peptides.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Psilocybin vs placebo

experimental

Randomised crossover sequences comparing placebo, low-dose and high-dose oral psilocybin across two test days ~14 days apart.

Interventions

  • Placebo
    via Oral• single dose

    Placebo oral capsule (microcrystalline cellulose).

  • Psilocybin0.0143 mg/kg
    via Oral• single dose

    Low dose: 0.0143 mg/kg (weight-based) or 1 mg fixed-dose option.

  • Psilocybin0.143 mg/kg
    via Oral• single dose

    High dose: 0.143 mg/kg (weight-based) or 10 mg fixed-dose option.

Participants

Ages
21 – 65
Sexes
Male & Female

Inclusion 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

  • 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

Study Details

Locations

VA Connecticut Healthcare System — West Haven, Connecticut, United States

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