Clinical TrialHeadache Disorders (Cluster & Migraine)PsilocybinPsilocybinPlaceboCompleted

Psilocybin for the Treatment of Cluster Headache

Randomised, triple-blind, crossover Phase I study (n=25 actual) testing three oral sessions of placebo, low-dose or high-dose psilocybin (three sessions 5 days apart) for cluster headache.

Target Enrollment
25 participants
Study Type
Phase I interventional
Design
Randomized, triple Blind

Detailed Description

Randomised, triple-masked crossover study in participants with cluster headache comparing three-session pulse regimens of high-dose, low-dose and placebo psilocybin; sessions occur approximately 5 days apart.

Participants maintain a headache diary before, during and after the pulse regimen to document frequency and intensity; participants may be invited for a second round after at least six months and will be randomised to low or high dose.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

High dose psilocybin

experimental

High-dose psilocybin (weight-based or fixed-dose) given on each of three test days in a crossover design.

Interventions

  • Psilocybin0.143 mg/kg
    via Oral• three sessions (5 days apart)• 3 doses total

    Weight-based option 0.143 mg/kg or fixed 10 mg option.

Low dose psilocybin

experimental

Low-dose psilocybin (weight-based or fixed-dose) given on each of three test days in a crossover design.

Interventions

  • Psilocybin0.0143 mg/kg
    via Oral• three sessions (5 days apart)• 3 doses total

    Weight-based option 0.0143 mg/kg or fixed 1 mg option.

Placebo

inactive

Placebo capsule given on each of three test days in crossover.

Interventions

  • Placebo
    via Oral• three sessions (5 days apart)• 3 doses total

    Microcrystalline cellulose capsule.

Participants

Ages
21 – 65
Sexes
Male & Female

Inclusion Criteria

  • Chronic cluster headache with at least one attack daily
  • Episodic cluster headache with periods that are predictable and have a duration of approximately 2 months
  • Attacks are managed by means involving no more than twice weekly triptan use (e.g., high-flow oxygen, heat/cold pack)

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, lysergic acid diethylamide (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 five half-lives of test days
  • Use of serotonergic antiemetics (i.e. ondansetron) in the past 2 weeks
  • Use of antidepressant medications (i.e. amitriptyline, isocarboxazid, fluoxetine, citalopram) 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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