Prophylactic Effects of Psilocybin on Chronic Cluster Headache

NCT04280055 | Terminated Phase 1 DMC

• 1 other identifier: H-18040896
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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. 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

Cluster Headache

Keywords

Cluster Headache; Psilocybin; Prophylactic; Treatment; Hallucinogens

Outcome Measures

Primary Outcomes (2)

• Headache frequency

  Change in headache frequency in number of attacks/week

  Week 6-10 (post drug observation) compared to week 0-4 (baseline observation)

• Resting state FC fMRI analyses

  Resting state FC fMRI analyses, including hypothalamic FC, comparing baseline and rescan, comparison with healthy control sample, and evaluation of correlation between headache frequency changes and FC changes.

  Day 1 of first psilocybin session to 1 week after last psilocybin session (3 weeks)

Secondary Outcomes (12)

• Proportion of reduced frequency

  Week 6-10 (post drug observation) compared to week 0-4 (baseline observation)

• Headache intensity

  Week 6-10 (post drug observation) compared to week 0-4 (baseline observation)

• Need of acute therapy

  Week 6-10 (post drug observation) compared to week 0-4 (baseline observation)

• Sideeffects

  Whole observation period (10 weeks)

• Remission

  Day 1 after first psilocybin session until 12 month follow up (1 year).

Study Arms (1)

Psilocybin

EXPERIMENTAL

Drug: Psilocybin

Interventions

Psilocybin DRUG

0.14 mg/kg p.o. in three sessions spaced by one week

Psilocybin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gitte Moos Knudsen: lead

Study Sites (1)

Neurobiology Research Unit, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Links

• Online preprint of the outcome of the study. Positive!

MeSH Terms

Conditions

Cluster Headache

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Gitte Moos Knudsen, MD, DMSc

  Neurobiology Research Unit, Rigshospitalet

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair, Professor, MD, DMSc

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 21, 2020
• Study Start: January 21, 2020
• Primary Completion: November 1, 2020
• Study Completion: June 1, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)