Clinical TrialHeadache Disorders (Cluster & Migraine)PsilocybinPsilocybinPlaceboCompleted

Psilocybin for the Treatment of Migraine Headache

Randomised, double-blind, crossover study (n=14) comparing low (0.0143 mg/kg) and high (0.143 mg/kg) oral psilocybin versus placebo in adults with migraine.

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

Detailed Description

Randomised, double-blind, crossover design in adults with migraine: each subject receives placebo and a psilocybin dose approximately 14 days apart with randomised order and assignment to low or high dose.

Participants maintain headache diaries to record frequency, intensity and associated symptoms; this preliminary study will inform design of larger trials.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Psilocybin

experimental

Crossover comparing low and high dose oral psilocybin versus placebo; subjects receive placebo and psilocybin ~14 days apart in randomised order.

Interventions

  • Psilocybin0.143 mg/kg
    via Oral• single dose• 1 doses total

    High dose psilocybin capsule (0.143 mg/kg).

  • Psilocybin0.0143 mg/kg
    via Oral• single dose• 1 doses total

    Low dose psilocybin capsule (0.0143 mg/kg).

Placebo

inactive

Microcrystalline cellulose capsule used as placebo in crossover sessions.

Interventions

  • Placebo
    via Oral• single dose• 1 doses total

    Microcrystalline cellulose capsule.

Participants

Ages
21 – 65
Sexes
Male & Female

Inclusion Criteria

  • Diagnosis of migraine headache per ICHD-3beta criteria
  • Typical pattern of migraine attacks with approximately two migraines or more weekly
  • Attacks are managed by means involving no more than twice weekly triptan use
  • Age 21 to 65

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 Campus — West Haven, Connecticut, United States

Your Library