Status:
TERMINATED
Prophylactic Effects of Psilocybin on Chronic Cluster Headache
Lead Sponsor:
Gitte Moos Knudsen
Conditions:
Cluster Headache
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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. Sub...
Detailed Description
Cluster headache (CH) is one of the most painful conditions known. CH affects 1 out 1000 and exists in two well-defined forms: episodic (ECH) and chronic (CCH). Ten to fifteen percent of patients have...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04280055
Start Date
January 21 2020
End Date
June 1 2022
Last Update
August 10 2022
Active Locations (1)
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1
Neurobiology Research Unit, Rigshospitalet
Copenhagen, Denmark, 2100