ArticleFrontiers in pain research (Lausanne, Switzerland)2025
Preliminary safety and effectiveness of psilocybin-assisted therapy in adults with fibromyalgia: an open-label pilot clinical trial.
Article in Frontiers in pain research (Lausanne, Switzerland), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05128162 (A Phase 2a, Open-label, Pilot Study to Assess the Safety and Efficacy of Psilocybin Administration in Concert With Psychotherapy Among Adult Patients With Fibromyalgia), which is not on this map. Cited by 10 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2a, Open-label, Pilot Study to Assess the Safety and Efficacy of Psilocybin Administration in Concert With Psychotherapy Among Adult Patients With Fibromyalgia
Who cites it
10 citing papers in PubMed.
- Medical and Psychiatric Consultation for Patients Considering State-Regulated Psilocybin Services: A Risk-Reduction Model and Two Illustrative Cases.Research square · 2026Article
- Review
- Trials, trips, and tribulations: pathways for implementing psychedelic therapy in Ireland.The international journal of neuropsychopharmacology · 2026Review
- Pilot study of psilocybin in patients with post-treatment lyme disease.Scientific reports · 2026Article
- Cognitive control as a transdiagnostic mechanism of action in psychedelic effects.Cognitive, affective & behavioral neuroscience · 2026Review
- No evidence of immediate or persistent analgesic effect from a single dose of psilocybin in three mouse models of pain.Nature communications · 2026Article
- Psilocybin and Chronic Pain: A New Perspective for Future Pain Therapists?Medical sciences (Basel, Switzerland) · 2025Review
- Review
- Psilocybin has no immediate or persistent analgesic effect in acute and chronic mouse pain models.bioRxiv : the preprint server for biology · 2025Article
- Classic Psychedelics in Pain Modulation: Mechanisms, Clinical Evidence, and Future Perspectives.ACS chemical neuroscience · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
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 ( Results: Regarding safety (primary outcome), there were transient elevations of blood pressure or heart rate during dosing which normalized by the end of treatment, with no serious adverse events. Four of five participants reported transient headaches following dosing. Compared to baseline, participants reported clinically meaningful improvements in the following secondary outcomes one month following their second psilocybin dose (reported as Cohen's Discussion: This small open-label trial preliminarily supports that PAT is well-tolerated by people with FM, establishing a basis for larger randomized controlled trials. Clinical Trial Registration: ClinicalTrials.gov, identifier, (NCT05128162).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.