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

Summary

Researchers conducted a small pilot study examining whether psilocybin (the active compound in certain mushrooms) combined with therapy could help treat fibromyalgia, a chronic pain condition. Five participants received two doses of psilocybin along with supportive therapy sessions. The treatment was well-tolerated with only minor side effects, and participants reported significant improvements in pain, sleep quality, and overall functioning. These promising preliminary results suggest larger studies should be conducted to further test this innovative treatment approach.

Background

Fibromyalgia is a common chronic pain condition affecting 2-4% of the population characterized by widespread pain and nociplastic pain processing. Current treatment options have limited effectiveness. Psilocybin-assisted therapy is an emerging intervention that combines psychotherapy with psilocybin administration and has shown promise for various psychiatric and pain conditions.

Objective

To evaluate the preliminary safety and effectiveness of psilocybin-assisted therapy in adults with fibromyalgia through an open-label pilot clinical trial.

Results

No serious adverse events occurred. Transient headaches occurred in four of five participants and resolved within two days. Participants reported clinically meaningful improvements in pain severity (d = -2.1), pain interference (d = -1.8), and sleep disturbance (d = -2.5). Via Patient Global Impression of Change, one participant reported symptoms ‘very much improved,’ two reported ‘much improved,’ and two reported ‘minimally improved.’

Conclusion

This open-label pilot trial preliminarily supports that psilocybin-assisted therapy is well-tolerated by people with fibromyalgia with promising effectiveness outcomes. Findings establish a basis for larger randomized controlled trials to further evaluate PAT for fibromyalgia treatment.
  • Published in:Front Pain Res (Lausanne),
  • Study Type:Clinical Trial,
  • Source: PMC11958999, PMID: 40171515
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