Clinical TrialSingle-armHeadache Disorders (Cluster & Migraine)PsilocybinTerminated

Phase 1b Study in Patients With Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)

This exploratory open-label Phase Ib, ascending dose study evaluates the effects of psilocybin on cognition in patients with chronic SUNHA.

Ask Blossom about this trial
Target Enrollment
4 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

Open-label Phase 1b single-group study administering psilocybin in three ascending oral doses to patients with chronic Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA).

Primary aims are safety and tolerability; secondary aims include effects on cognition and exploratory change in attack frequency, duration, and intensity.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

Psilocybin

experimental

Open-label, single-group ascending-dose psilocybin capsules, three dose levels.

Interventions

  • Psilocybin
    via Oral• ascending doses• 3 doses total

    Dry-filled capsules administered orally in three ascending single-dose sessions.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Diagnosed with chronic SUNHA

Exclusion Criteria

  • Exclusion Criteria:
  • Other comorbidities

Study Protocol, Arms & Participants

Go Pro to access detailed study protocol timelines, treatment arms, dosing schedules, and participant eligibility criteria.

See Pro Plans

Study Details

Locations

King's College London — London, United Kingdom

Related Publications

Open AccessindividualPrimary

Low-dose psilocybin in short-lasting unilateral neuralgiform headache attacks: results from an open-label phase Ib ascending dose study

In an open-label phase Ib ascending-dose study terminated early after enrolling four patients (three completers), low-dose oral psilocybin with psychological support was well tolerated and induced strong subjective altered states and psychological insights, with two participants showing >50% reductions in attack frequency but overall limited effects on headache severity or duration. Cognition could not be assessed acutely due to high subjective dose intensity, and the small sample prevents any conclusive evidence for psilocybin in SUNHA, though the findings suggest psychological factors may be an important treatment target.

Published
Journal
Headache
Authors
Rucker, J., Butler, M., Hambleton, S., Bird, C., Seynaeve, M., Cheema, S., Campbell-Coker, K., Maggio, C., Dunbar, F., Lambru, G., Matharu, M.

Your Personal Research Library

Go Pro to save trials, add notes, rate research, and organize custom shelves.

See Pro Plans