Preliminary safety and effectiveness of psilocybin-assisted therapy in adults with fibromyalgia: an open-label pilot clinical trial.

ABSTRACT:

Introduction

Fibromyalgia (FM) is the prototypical nociplastic pain condition, characterized by widespread pain and issues with cognition, mood, and sleep. Currently, there are limited treatment options available that effectively treat FM symptoms. Psilocybin-assisted therapy (PAT) is an emerging combined drug-therapy intervention, but no studies to-date have investigated PAT for FM.

Methods

Here, we report findings from an open-label, pilot clinical trial of PAT for FM (N = 5). In conjunction with psychotherapy (two preparatory, four integration sessions), participants received two doses of oral psilocybin (15 mg and 25 mg) delivered two weeks apart.

Results

Regarding safety (primary outcome), there were transient elevations of blood pressure or heart rate dur

SUBMITTER: Aday JS 

PROVIDER: S-EPMC11958999 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature