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Home/Research/Psilocybin/Headache Disorders (Cluster & Migraine)

Psilocybin for Headache Disorders (Cluster & Migraine)

44 papers and 7 clinical trials exploring psilocybin as a treatment for headache disorders (cluster & migraine).

CompoundClassic Psychedelic

Psilocybin

Psilocybin is a naturally occurring tryptamine psychedelic that acts as a prodrug to psilocin, a potent 5-HT2A receptor agonist. It is the furthest advanced psychedelic in clinical development, with two positive Phase III trials in treatment-resistant depression and expanding regulated access in Australia, Germany, and US states.

Full Psilocybin profile
IndicationOver 3 billion people globally.

Headache Disorders (Cluster & Migraine)

Psychedelics are being researched as potential treatments for headache disorders, including migraines and cluster headaches, which affect a significant portion of the global population. Early findings indicate that psychedelics may modulate pain perception and offer novel therapeutic pathways for those suffering from these debilitating conditions.

Full Headache Disorders (Cluster & Migraine) profile

Academic Research

44 papers
Open Accessindividual

Pilot study of psilocybin in patients with post-treatment lyme disease

In an open‑label, single‑arm pilot study of 20 patients with post‑treatment Lyme disease, two psilocybin sessions with psychological support produced significant, sustained reductions in symptom burden (40% decrease in GSQ‑30 at six months) and improvements in both physical and mental quality of life. The intervention was feasible and well-tolerated with no serious related adverse events, supporting further controlled trials of psilocybin‑assisted therapy for PTLD.

Published
February 25, 2026
Journal
Scientific Reports
Authors
Garcia-Romeu, A., Naudé, G. P., Rebman, A. W., So, S., Yaffe, A., Geithner, I., Kozero, E. A., Yang, T., Soloski, M. J., Aucott, J. N.
Open Accessindividual

Efficacy and Safety of the Neuroplastogen TSND-201 for the Treatment of PTSD A Randomized Clinical Trial

In a multicentre, double‑blind, placebo‑controlled phase 2 trial of 65 adults with chronic PTSD, once‑weekly oral TSND‑201 produced significantly greater reductions in clinician‑rated PTSD severity (CAPS‑5; LS mean difference 9.64, P = .01) and improvements in self‑reported symptoms, functioning and depression versus placebo. TSND‑201 was generally well tolerated — common adverse events included headache, decreased appetite, nausea, dizziness and transient blood‑pressure increases — supporting its potential as a rapid‑acting, durable treatment for PTSD.

Published
February 18, 2026
Journal
JAMA Psychiatry
Authors
Jones, A., Warner-Schmidt, J., Kwak, H., Stogniew, M., Mandell, B., Ching, T. H., Stein, M. B., Kelmendi, B.
Open Accessindividual

Comparing single- and repeat-dose psilocybin with active placebo for migraine prevention in an exploratory randomized controlled clinical trial

In an exploratory randomised, double‑blind trial in adults with frequent migraine, single or two‑dose psilocybin produced reductions in migraine frequency similar to an active diphenhydramine placebo and no serious adverse events were observed. Incomplete blinding and nonsignificant between‑group differences despite large effect sizes in psilocybin arms indicate the need for larger, better‑controlled trials with headache‑specialist input to separate drug and non‑drug effects.

Published
December 29, 2025
Journal
Headache
Authors
Schindler, E. A. D., Gottschalk, C. H., Pittman, B. P., D'Souza, D. C.
Open Accessindividual

Psilocybin-assisted psychotherapy for methamphetamine use disorder: A pilot open-label safety and feasibility study

In a single‑arm, open‑label pilot of 15 people with methamphetamine use disorder, outpatient psilocybin‑assisted psychotherapy (single 25 mg oral dose with preparatory and integration sessions) was feasible and well tolerated with no serious adverse events, and was associated with reductions in self‑reported methamphetamine use and craving at 28 and 90 days; a larger randomised trial is required to confirm efficacy and safety.

Published
September 20, 2025
Journal
Addiction
Authors
Knock, E., Siefried, K. J., Gill Bedi, |., Albert, S., Day, R. O., Ezard, N., Ross, M., Liknaitzky, P., Brett, J., Bedi, G.
Open Accessindividual

Investigating the safety and tolerability of single-dose psilocybin for post-traumatic stress disorder: A nonrandomized open-label clinical trial

In a Phase 2, non-randomised open-label trial of 22 adults with PTSD, a single 25 mg dose of psilocybin administered with psychological support was generally well tolerated with no serious adverse events and mostly transient side-effects, and was associated with large, clinically meaningful reductions in PTSD symptoms and improvements in functioning and quality of life sustained to 12 weeks. These results indicate single-dose psilocybin may be safe and potentially efficacious for PTSD, warranting further controlled investigation.

Published
August 29, 2025
Journal
Journal of Psychopharmacology
Authors
Mcgowan, N. M., Rucker, J. J., Yehuda, R., Agrawal, M., Modlin, N. L., Simmons, H., Tofil-Kaluza, A., Das, S., Goodwin, G. M.
Open Accessindividual

An open-label, dose-escalation trial of psilocybin-assisted therapy for bipolar 2 depression

In an open-label, single-arm dose-escalation pilot (n=14) of psilocybin-assisted therapy for bipolar II depression, psilocybin (10 mg, with 25 mg if needed) was generally well tolerated and produced significant, sustained reductions in depressive symptoms and improved quality of life up to 90 days, with adverse events (including transient anxiety, nausea, headache and three notable psychiatric events) broadly comparable to other psilocybin studies. The authors conclude that randomised, placebo-controlled trials are needed to confirm efficacy and refine dosing protocols in this vulnerable population.

Published
July 7, 2025
Journal
OSF Preprints
Authors
Downey, A. E., Szigeti, B., Bradley, E. R., Fernandes-Osterhold, G., Sakai, K., Llerena, K., Nerayo, J., Fredenburg, L., Nielsen, B., Krystal, A. D., O'donovan, A., Gard, D. E., Woolley, J. D.

Clinical Trials

7 trials
RecruitingPhase I

Mechanistic Studies of Psilocybin in Headache Disorders

This interventional trial (n=50) will explore mechanisms of psilocybin in migraine and healthy controls using a randomized, parallel, quadruple-blind design with oral psilocybin 10 mg versus 2.5 mg THC control.

Started
September 1, 2024
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT06464367
CompletedPhase I

Repeat Dosing of Psilocybin in Migraine Headache

Randomised, Phase I parallel study (n=18) testing single and repeated oral psilocybin (10 mg) vs diphenhydramine placebo across two sessions ~7 days apart to assess effects on migraine headache burden and mechanisms.

Started
July 15, 2021
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT04218539
TerminatedPhase I

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.

Started
May 21, 2021
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT04905121
TerminatedPhase I/II

Prophylactic Effects of Psilocybin on Chronic Cluster Headache

Open-label, single-group pilot study (n=10) assessing prophylactic effects of low-dose psilocybin (0.14 mg/kg oral) given in three weekly sessions for chronic cluster headache with fMRI and psilocin sampling.

Started
January 21, 2020
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT04280055
TerminatedPhase I

Effects of Psilocybin in Concussion Headache

Double-blind crossover trial (n=12) investigating repeated oral psilocybin (two sessions; low 0.0143 mg/kg or 1 mg and high 0.143 mg/kg or 10 mg) versus placebo for post-traumatic headache.

Started
March 28, 2019
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
NCT03806985
CompletedPhase I

Psilocybin for the Treatment of Migraine Headache

Randomised, double-blind, crossover study (n=14) comparing low (0.0143 mg/kg) and high (0.143 mg/kg) oral psilocybin versus placebo in adults with migraine.

Started
January 11, 2017
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
NCT03341689

Explore further

Search all Psilocybin papers Search all Headache Disorders (Cluster & Migraine) trials Full Psilocybin profile Full Headache Disorders (Cluster & Migraine) profile