Preliminary safety and effectiveness of psilocybin-assisted therapy in adults with fibromyalgia: An open-label, pilot clinical trial
OpenAlex – November 04, 2024
Source: OpenAlex
Summary
A compelling new avenue for Fibromyalgia pain management emerges: five individuals undergoing Psilocybin-assisted therapy, guided by a psychotherapist, reported substantial improvements. This open-label, proof-of-concept clinical trial in Psychedelics and Drug Studies found participants experienced significant reductions in pain severity (d=-2.1) and sleep disturbance (d=-2.5) one month post-treatment. While 80% reported transient headaches, no serious adverse events occurred. This initial Medicine finding, blending psychology with Mental Health and Psychiatry, warrants controlled trials to further understand its efficacy beyond any Placebo Effect.
Abstract
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. Here, we report findings from an open-label, proof-of-concept trial of PAT for FM (N=5; NCT05128162). In conjunction with psychotherapy (two preparatory, four integration sessions), participants received two doses of oral psilocybin (15mg and 25mg) delivered two weeks apart. 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.” Compared to baseline, there were improvements in the following exploratory outcomes after the intervention: FM symptoms, anxiety, and fatigue. This small open-label trial preliminarily supports that PAT is well-tolerated by people with FM, establishing a basis for larger randomized controlled trials.