Clinical TrialHeadache Disorders (Cluster & Migraine)PsilocybinTerminated

Prophylactic Effects of Psilocybin on Chronic Cluster Headache

Open-label, single-group pilot study (n=10) assessing prophylactic effects of low-dose psilocybin (0.14 mg/kg oral) given in three weekly sessions for chronic cluster headache with fMRI and psilocin sampling.

Target Enrollment
10 participants
Study Type
Phase I/II interventional
Design
Non-randomized

Detailed Description

Prospective open-label pilot evaluating whether three low-dose psilocybin administrations (0.14 mg/kg p.o., one week apart) reduce attack frequency, intensity and duration in people with chronic cluster headache.

Participants complete a headache diary over a 10-week period including a 4-week baseline, three dosing weeks and a 4-week follow-up; acute treatments are permitted and recorded, prophylactic medications must be washed out prior to inclusion.

Outcomes include change in headache frequency, duration and intensity, correlation of clinical response with plasma psilocin and estimated 5-HT2A receptor occupancy, and pre/post fMRI measures of brain network connectivity; participants contacted at 3, 6 and 12 months for remission data.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

Psilocybin

experimental

Low-dose psilocybin administered in three outpatient sessions spaced one week apart for prophylaxis of chronic cluster headache.

Interventions

  • Psilocybin0.14 mg/kg
    via Oral• weekly• 3 doses total

    Blood sampling for psilocin during first session; fMRI before first and after last dose.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Age between 18 and 65
  • A diagnosis of chronic cluster headache according to IHCD-III.
  • Ability to separate cluster headache attacks from other types of headache.
  • A history of at least 4 attacks/week in the last 4 weeks before inclusion

Exclusion Criteria

  • Exclusion Criteria:
  • A history of using a serotonergic hallucinogen for CH.
  • Participation in any clinical trials within 30 days preceding study enrollment.
  • Use of other prophylactic CH medication within the last two weeks.
  • Current use of drugs suspected to interfere with treatment (e.g. antipsychotic medication) or to be hazardous in combination with psilocybin.
  • Presence of other trigeminal autonomic cephalalgias.
  • Known hypersensitivity/allergy to multiple drugs (including psilocybin).
  • A history or presence of any medical and psychiatric condition that might render patient unsuitable for participation.
  • Present or previous manic or psychotic disorder or critical psychiatric disorder.
  • Current drug or alcohol abuse.
  • MRI Contraindications.
  • Pregnancy or breastfeeding
  • Not using safe contraception (if fertile woman)
  • Stroke (<1 year from inclusion)
  • Myocardial infarction (<1 year from inclusion)
  • Hypertension (> 140/90 mmHg at inclusion)
  • Clinically significant arrhythmia (<1 year from inclusion)

Study Details

Locations

Neurobiology Research Unit, Rigshospitalet — Copenhagen, Denmark

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