Preliminary safety and effectiveness of psilocybin-assisted therapy in adults with fibromyalgia: An open-label, proof-of-concept clinical trial
In an open-label proof-of-concept trial (N=5), psilocybin-assisted therapy was well tolerated in adults with fibromyalgia, producing only transient elevations in blood pressure/heart rate and non-serious post-dose headaches. Participants showed clinically meaningful improvements in pain severity, pain interference and sleep disturbance one month after treatment, supporting progression to larger randomised controlled trials.
Authors
- Alan Davis
- James Guss
- Jordan Aday
Published
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 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 d): pain severity [d = -2.1, 95% CI(-3.7 to -0.49)], pain interference [d = -1.8, 95% CI (-3.27 to -0.24)], and sleep disturbance [d = -2.5, 95% CI (-4.21 to -0.75)]. Using the Patient Global Impression of Change, one participant reported their symptoms "very much improved," two reported "much improved," and two reported "minimally improved." We stopped recruitment early because of concerns about generalizability and changes in FDA guidance for psychedelic clinical trials that occurred data collection.
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.
Research Summary of 'Preliminary safety and effectiveness of psilocybin-assisted therapy in adults with fibromyalgia: An open-label, proof-of-concept clinical trial'
Introduction
Fibromyalgia (FM) is described as a common chronic nociplastic pain condition affecting about 2-4% of the population, characterised by widespread pain, disturbed sleep, fatigue and cognitive difficulties. Existing treatments, including pharmacological and physical interventions, show limited and heterogeneous effectiveness, leaving substantial clinical and economic burden. Previous research suggests that psilocybin produces substantial alterations in cognition, mood and neural functional connectivity and that psychedelic-assisted therapy can increase psychological flexibility; early clinical and preclinical studies as well as survey reports have hinted at analgesic effects of psilocybin for certain pain conditions, but no clinical trials had directly evaluated psilocybin-assisted therapy (PAT) for FM prior to this study. Aday and colleagues therefore conducted an open-label, proof-of-concept trial to evaluate the preliminary safety and effectiveness of PAT in people with fibromyalgia. The investigators aimed to assess acute physiological safety during dosing and adverse events over the treatment period as primary endpoints, and to explore changes in pain severity, pain interference, sleep disturbance and related psychosocial outcomes as secondary and exploratory endpoints in a small sample of participants undergoing a structured PAT protocol.
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Study Details
- Study Typeindividual
- Journal
- Compound
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- APA Citation
Aday, J. S., McAfee, J., Conroy, D. A., Hosanagar, A., Tarnal, V., Weston, C., Scott, K., Horowitz, D., Harte, S. E., Pouyan, N., Glynos, N. G., Baker, A. K., Guss, J., Davis, A. K., Burgess, H. J., Mashour, G. A., Clauw, D. J., & Boehnke, K. F. (2024). Preliminary safety and effectiveness of psilocybin-assisted therapy in adults with fibromyalgia: An open-label, proof-of-concept clinical trial. https://doi.org/10.31234/osf.io/j8zb5
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