This pre-print, open-label, proof-of-concept trial (n=5) of psilocybin-assisted therapy (15mg/25mg x 2) for fibromyalgia finds the treatment to be well-tolerated, with only transient blood pressure elevations and headaches reported. Secondary outcomes show clinically meaningful improvements in pain severity, pain interference, and sleep disturbance one month after treatment, with all participants reporting some degree of symptom improvement.
Abstract of Preliminary safety and effectiveness of psilocybin-assisted therapy in adults with fibromyalgia
“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.“
Authors: Jacob S. Aday, Jenna McAfee, Deirdre A. Conroy, Avinash Hosanagar, Vijay Tarnal, Cody Weston, Katharine Scott, Dana Horowitz, Steven E. Harte, Niloufar Pouyan, Nicolas G. Glynos, Anne K. Baker, Jeffrey Guss, Alan K. Davis, Helen J. Burgess, George A. Mashour, Daniel J. Clauw & Kevin F. Boehnke
Summary of Preliminary safety and effectiveness of psilocybin-assisted therapy in adults with fibromyalgia
Fibromyalgia (FM) is a chronic, nociplastic pain condition affecting 2–4% of the population, characterised by widespread pain, sleep disturbances, fatigue, and cognitive challenges. Often, FM manifests with a complex blend of physical and mental health symptoms, creating significant personal and economic burdens. Conventional treatment approaches, including pharmacotherapy and physical interventions, provide limited relief, highlighting a critical need for new, effective therapeutic options.
Psilocybin-assisted therapy (PAT), which combines psilocybin with psychotherapy, has shown promise in managing various psychological conditions, such as depression and end-of-life distress. Psilocybin, a compound found in certain mushrooms, affects serotonin receptors, leading to altered cognition, mood, and sensory perception. These changes may modify neural connectivity and promote psychological flexibility, potentially improving symptoms in conditions like FM, which involve centralised pain processing. Given these potential benefits, this study aimed to explore the safety and effectiveness of PAT in adults with FM through a small open-label trial.
Methods
Study Design and Participants
This open-label trial was conducted at the University of Michigan, recruiting five participants aged 25-64 who met specific FM criteria. Exclusion criteria included severe cardiovascular conditions, epilepsy, and recent substance use. To ensure participant safety, extensive pre-screening was conducted, resulting in five individuals completing the study. Recruitment methods included flyers, online research platforms, and health record searches. The study focused on safety as its primary outcome and monitored adverse effects throughout the trial.
Therapy Structure
Find this paper
https://doi.org/10.31234/osf.io/j8zb5
Open Access | Google Scholar | Backup | 🕊
Cite this paper (APA)
Aday, J. S., McAfee, J., Conroy, D. A., Hosanagar, A., Tarnal, V., Weston, C., … Boehnke, K. F. (2024, November 4). Preliminary safety and effectiveness of psilocybin-assisted therapy in adults with fibromyalgia: An open-label, pilot clinical trial. https://doi.org/10.31234/osf.io/j8zb5
Study details
Compounds studied
Psilocybin
Topics studied
Fibromyalgia
Pain
Study characteristics
Original
Open-Label
Theory Building
Participants
5
Humans
Compound Details
The psychedelics given at which dose and how many times
Psilocybin 15 - 25mg | 2x