Study: Could Psilocybin-Assisted Therapy Help Fibromyalgia
Last reviewed and updated: August 20, 2026.
Key Takeaways
| The study | An open-label pilot trial at the University of Michigan tested psilocybin-assisted therapy in adults with fibromyalgia, published in early 2025. |
| Very small sample | The trial included only 5 participants and had no control group, so it is a preliminary signal rather than evidence of effectiveness. |
| Safety findings | No serious adverse events occurred. Some participants had transient increases in blood pressure or heart rate, and four of five reported temporary headaches. |
| Reported benefits | Participants generally reported improvements in overall symptoms, including pain severity and sleep disturbance. |
| What comes next | The authors called for larger, controlled studies. Psilocybin is not an approved or established treatment for fibromyalgia. |
Fibromyalgia, a chronic condition marked by widespread pain, fatigue, and cognitive disturbances, affects millions worldwide. Traditional treatments often fall short, prompting researchers to seek alternative therapies. A small pilot study investigated the potential of psilocybin-assisted therapy (PAT) for individuals with fibromyalgia. It enrolled just five people.
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Study Overview
Conducted by the University of Michigan, this open-label trial involved five participants diagnosed with fibromyalgia. Each received two doses of oral psilocybin (15 mg and 25 mg) two weeks apart, alongside psychotherapy sessions. The primary aim was to assess safety, while secondary objectives focused on evaluating pain severity, interference, and sleep disturbances.
Safety Findings
Participants experienced transient increases in blood pressure and heart rate during dosing, which normalized by the end of treatment. No serious adverse events were reported. Four participants noted brief headaches following dosing.
Effectiveness Outcomes
One month post-treatment, the five participants reported improvements on the study’s outcome measures:
- Pain Severity: Reported decrease of 2.1 points on a 10-point scale.
- Pain Interference: Reported reduction of 1.8 points.
- Sleep Disturbance: Reported improvement of 2.5 points.
With five participants and no control group, these numbers cannot show that PAT relieves fibromyalgia symptoms. They only justify running a larger, controlled trial.
Participant Feedback
Using the Patient Global Impression of Change scale, one participant reported their symptoms as “very much improved,” two as “much improved,” and two as “minimally improved.”
Implications and Future Research
While this pilot study provides promising insights, its small sample size and open-label design limit generalizability. The researchers advocate for larger, randomized controlled trials to further evaluate the efficacy and safety of PAT for fibromyalgia.
This study contributes to the growing body of research exploring psychedelic-assisted therapies for chronic pain conditions. If subsequent trials confirm these findings, PAT could become a valuable addition to fibromyalgia treatment options.
For more detailed information, refer to the full study published in Frontiers in Pain Research.
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What the Fibromyalgia Pilot Study Actually Shows
The pilot was an open-label proof-of-concept trial of psilocybin-assisted therapy in adults with fibromyalgia. Researchers at the University of Michigan ran it, and Frontiers in Pain Research published the results in early 2025. Two design limits shape everything that follows. The trial enrolled only 5 participants, and it had no control group.
Participants generally reported improvements in overall symptoms, including pain severity and sleep disturbance. The safety results were also reassuring at this scale. No serious adverse events occurred. Some participants had transient increases in blood pressure or heart rate during dosing, and those readings normalized by the end of treatment. Four of the five reported temporary headaches afterward. These findings speak to safety and feasibility. A pilot trial of this size is built to test exactly that, and little else.
With 5 participants and no control group, the trial cannot establish that psilocybin treats fibromyalgia. Improvements in an open-label study can reflect expectation and clinical attention as much as the drug itself. Every participant knew what they were receiving, and every participant also received psychotherapy alongside the dosing. The authors themselves called for larger, controlled studies before anyone draws conclusions. Psilocybin is not an approved or established treatment for fibromyalgia, and patients should not read this pilot as a green light.
Frequently Asked Questions
- Does psilocybin help fibromyalgia?
- It is far too early to say. A small open-label pilot trial at the University of Michigan found that participants reported improvements in pain severity and sleep, but it enrolled only 5 people and had no control group. That makes it a preliminary safety and feasibility signal, not evidence that psilocybin treats fibromyalgia.
- How big was the fibromyalgia psilocybin study?
- Very small. The trial included just 5 participants and was open-label, meaning everyone knew they were receiving psilocybin and there was no comparison group. Studies this size cannot separate a real drug effect from expectation or extra clinical attention, which is why the authors called for larger, controlled research.
- Was psilocybin safe for the fibromyalgia participants?
- In this small trial, yes. No serious adverse events occurred. Some participants had transient increases in blood pressure or heart rate during dosing that normalized by the end of treatment, and four of five reported temporary headaches afterward. These findings are reassuring at this scale but come from only 5 people.
- Can I get psilocybin treatment for fibromyalgia?
- Not as an approved treatment. Psilocybin remains a Schedule I substance federally and is not approved for fibromyalgia or any other condition. Research access would be through a clinical trial. Oregon and Colorado have licensed psilocybin programs, but those are not fibromyalgia treatment programs, and the evidence here remains preliminary.
