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In a recent study, psilocybin-assisted therapy was found to be safe and well tolerated in adults with fibromyalgia, with most reporting symptom improvements.

Psilocybin-assisted therapy (PAT) was found to be safe and well tolerated among adults with fibromyalgia (FM), with participants generally reporting improvements in overall symptoms and across multiple FM-related domains, according to findings from a small pilot study published online in Frontiers in Pain Research.

“FM is currently understood as the prototypical nociplastic pain condition, ie, a disorder of pain regulation via altered centralized pain processing,” wrote first author Jacob S. Aday, PhD, of University of Michigan, and study coauthors. “… The heterogeneous nature of FM manifests clinically as varied phenotypic expressions, which makes many treatment options, such as pharmacotherapy and physical interventions, only minimally effective.”

Pioneering Research

PAT, an emerging intervention that combines administration of psilocybin with psychotherapy, has shown promise in recent studies for the treatment of depression, anxiety, end-of-life distress, substance use disorders, and obsessive-compulsive disorder. For this study—the first to date to investigate PAT for FM—researchers investigated the efficacy and safety of PAT in five female adults with FM.

The trial began with two preparatory therapy sessions designed to establish rapport, explore the patients’ lived experiences with FM, and provide education on psychedelics, therapy structure, and safety protocols. Two psilocybin dosing sessions, spaced 2 weeks apart, followed by therapists maintaining a supportive, non-intrusive presence, encouraging inward focus, and assisting participants with comfort or safety needs. Toward the end of the dosing sessions, participants were invited to describe their experiences without the therapist’s interpretation or guidance. Four integration sessions followed each dosing session, focused on processing and reinforcing aspects of the participant’s experience to promote cognitive and behavioral change.

Promising Findings

No serious adverse events were reported. Transient increases in blood pressure and heart rate during dosing remained within predefined ranges and resolved by the end of treatment. Four participants reported mild, short-lived headaches post-dosing.

At 1-month follow-up, participants generally reported improvements in overall symptoms and multiple FM-related symptom domains. Several individuals experienced clinically meaningful reductions in pain severity, pain interference, anxiety, and sleep disturbance, along with modest gains in chronic pain acceptance.

Despite these promising early findings, the authors cautioned, “Given the study limitations, larger, controlled studies with a more clinically translational design are necessary to understand whether [PAT] is safe and effective in the treatment of FM.”