Prophylactic Effects of Psilocybin on Chronic Cluster Headache

• Status: Recruiting
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the prophylactic effects of psilocybin in chronic cluster headache. Subjects will receive a low dose of psilocybin during 3 sessions spaced by one week. Subjects will maintain a headache diary prior to, during, and after the administrations in order to document headache frequency, intensity and duration. Subjects will undergo a fMRI scanning before the first and after the last psilocybin session.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gitte Moos Knudsen
• Treatments: Psilocybin

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:

• 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)