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Home/Research/Psilocybin/Fibromyalgia

Psilocybin for Fibromyalgia

3 papers and 6 clinical trials exploring psilocybin as a treatment for fibromyalgia.

CompoundClassic Psychedelic

Psilocybin

Psilocybin is a naturally occurring tryptamine psychedelic that acts as a prodrug to psilocin, a potent 5-HT2A receptor agonist. It is the furthest advanced psychedelic in clinical development, with two positive Phase III trials in treatment-resistant depression and expanding regulated access in Australia, Germany, and US states.

Full Psilocybin profile
IndicationApproximately 300 million worldwide are affected by fibromyalgia.

Fibromyalgia

Fibromyalgia is a complex, multifaceted condition affecting individuals through chronic pain and associated symptoms such as depression and anxiety. Emerging research suggests the potential of psychedelics in managing this condition, although robust clinical evidence is still limited.

Full Fibromyalgia profile

Academic Research

3 papers
Open Accessindividual

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.

Published
March 18, 2025
Journal
Frontiers in Pain Research
Authors
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.
Open Accessindividual

Potential analgesic effects of psychedelics on select chronic pain conditions: A survey study

A survey of patients with fibromyalgia, arthritis, migraine, tension‑type headache and sciatica found that psychedelic use—especially full doses—was reported to give greater pain relief than conventional medications in all conditions except sciatica; microdoses improved migraine and matched conventional treatment for the other non‑sciatica conditions. These results suggest full and microdoses of classical psychedelics may merit further investigation as treatments for select chronic pain disorders.

Published
August 20, 2023
Journal
European Journal of Pain
Authors
Cavarra, M., Mason, N. L., Kuypers, K. P. C., Bonnelle, V., Smith, W. J., Feilding, A., Kryskow, P., Ramaekers, J. G.
Paywallindividual

Knowledge, Perceptions, and Use of Psychedelics among Individuals with Fibromyalgia

This survey study (n=354) sought to characterize the knowledge, perceptions and past use of psychedelics among people with fibromyalgia (FM). It was found that 29.9% of respondents reported past use of a psychedelic, and perceptions of benefit from use were generally neutral (59.4%) or positive (36.8%). Less than 3% reported that using psychedelics negatively impacted their overall health or pain symptoms. 11 out of 12 patients using psychedelics specifically to treat pain reported improvements in their symptoms.

Published
January 10, 2022
Journal
Journal of Psychoactive Drugs
Authors
Glynos, N. G., Pierce, J., Davis, A. K., Mcafee, J., Boehnke, K. F.

Clinical Trials

6 trials
Not yet recruitingPhase I

A Phase 1, Open-label, Single-arm Basket Trial of the Intravenously Administered Psilocin (TRP-8803): Safety, Anxiety, and Quality of Life Across Health Conditions Characterised by Cognitive Inflexibility, Emotional Distress, and Persistent Bodily Symptom Burden

This Phase 1, open‑label, single‑arm basket trial (N=66) tests the safety and early clinical effects of intravenous psilocin (TRP‑8803) administered in two dosing sessions alongside psychotherapy over a 6‑week treatment period, with a 12‑week follow‑up. Conducted in Australia and sponsored by Tryp Therapeutics, the study enrols participants across ten diagnostic cohorts — anorexia nervosa, body dysmorphic disorder, chronic fatigue, fibromyalgia, generalised anxiety disorder, irritable bowel syndrome, long COVID, major depressive disorder, obsessive–compulsive disorder and post‑traumatic stress disorder — to evaluate tolerability and signals of benefit in anxiety and quality of life. As a Phase 1 trial the primary outcomes focus on safety and tolerability (adverse events, vital signs and treatment‑emergent effects), with secondary or exploratory outcomes assessing changes in anxiety symptoms and health‑related quality of life using standardised, validated instruments. The single‑arm, open‑label design means there is no placebo or active comparator, and efficacy assessments are intended to generate preliminary, hypothesis‑generating data to inform the design of subsequent controlled studies. The study began recruitment in November 2025.

Started
November 3, 2025
Type
interventional
Blinding
none
Randomized
Yes
Registry ID
ACTRN12625000949482
RecruitingPhase NA

The Impact of Psilocybin on Pain in Fibromyalgia Patients (PsiloFM)

This double-blind, randomized, placebo-controlled trial (n=35) will investigate the impact of psilocybin (5–10 mg) on pain perception in fibromyalgia patients.

Started
April 1, 2024
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
NCT06368492
Unknown statusPhase NA

Psilocybin in Patients With Fibromyalgia: EEG-measured Brain Biomarkers of Action (Psilopain)

This open-label trial (n=20) will take EEG measures on participants who receive two doses of psilocybin (up to 25mg). Next to the brain measures, participants will be studied up to six months later.

Started
August 15, 2022
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT05548075
CompletedPhase II

Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia

Open-label single-group study (n=17) assessing two oral psilocybin doses (15 mg, then 25 mg at 2 weeks) plus psychotherapy for adults with fibromyalgia.

Started
May 3, 2022
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT05128162
RecruitingPhase I

Psilocybin-facilitated Treatment for Chronic Pain

Randomised, double-blind, parallel-group study (n=30) testing a single oral dose of psilocybin (0.36 mg/kg) versus active placebo (dextromethorphan 2.6 mg/kg) for fibromyalgia.

Started
January 1, 2022
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT05068791
RecruitingPhase II

The Impact of Psilocybin on Pain in Fibromyalgia Patients and Healthy Volunteers: a Multicenter Trial

Double-blind, randomised Phase II trial (n=44) comparing single oral low doses of psilocybin (5 mg, 10 mg) versus placebo to assess effects on pain tolerance and painfulness in fibromyalgia patients and healthy volunteers.

Started
December 22, 2021
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
2021-002909-10

Explore further

Search all Psilocybin papers Search all Fibromyalgia trials Full Psilocybin profile Full Fibromyalgia profile