TerminatedPhase 1psilocybin

Prophylactic Effects of Psilocybin on Chronic Cluster Headache

Sponsored by Gitte Moos Knudsen

NCT ID
NCT04280055
Target Enrollment
10 participants
Start Date
2020-01-21
Est. Completion
2022-06-01

About This Study

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.

Conditions Studied

Cluster Headache

Interventions

  • Psilocybin

Eligibility

Age:18 Years - 65 Years
Healthy Volunteers:No
View full eligibility 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)

Study Locations (1)

Neurobiology Research Unit, Rigshospitalet
Copenhagen, Denmark

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source