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Psilocybin’s Effects on Headache Frequency are Not Related to Acute Psychedelic Effects or Measures of Mental Health: Secondary Analysis of Clinical Trials in Migraine and Cluster Headache (P7-12.001)

Emmanuelle A. D. Schindler, Christopher Gottschalk, Deepak Cyril D’souza

Neurology April 7, 2025 DOI: 10.1212/wnl.0000000000210945 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Observational analysis of clinical trial data Peer reviewed
Population Patients with migraine or cluster headache in clinical trials of psilocybin
Intervention Psilocybin
Topics Psilocybin
Keywords Migraine Cluster headache Clinical trial Anesthesia Hallucinogen
Citations 2
Key findings Acute psychedelic effects and mental health improvements were not associated with reduced headache frequency in psilocybin trials for migraine and cluster headache.

Abstract

To examine the relationship of acute psychedelic effects and measures of mental health with headache frequency in clinical trials of psilocybin in migraine and cluster headache.

Comparable studies

Other non-randomized and open-label trials on psilocybin, most cited first.

Study Year Design Participants
Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study. Patients with moderate-to-severe, unipolar, treatment-resistant major depression 2016 Open-label feasibility trial n = 12
Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Patients with severe, unipolar, treatment-resistant major depression 2017 Open-label trial n = 20
Pilot study of the 5-HT2AR agonist psilocybin in the treatment of tobacco addiction Psychiatrically healthy nicotine-dependent smokers 2014 Open-label pilot study n = 15
Quality of Acute Psychedelic Experience Predicts Therapeutic Efficacy of Psilocybin for Treatment-Resistant Depression Patients with treatment-resistant depression 2018 Clinical trial n = 20
Safety, Tolerability, and Efficacy of Psilocybin in 9 Patients With Obsessive-Compulsive Disorder Subjects with obsessive-compulsive disorder (OCD) 2006 Controlled clinical trial

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