Preliminary safety and effectiveness of psilocybin-assisted therapy in adults with fibromyalgia: an open-label pilot clinical trial.
Study Goal
The researchers aimed to investigate the safety and preliminary efficacy of psilocybin-assisted therapy (PAT) for treating fibromyalgia (FM) symptoms.
Results Summary
The study found PAT was well-tolerated with transient side effects (elevated blood pressure, heart rate, and headaches). Participants reported clinically meaningful improvements in pain severity, pain interference, and sleep disturbance one month post-treatment.
Population
Adults with fibromyalgia (N=5).
Effective Dosage
Two oral doses (15 mg and 25 mg) administered two weeks apart.
Duration
Intervention spanned approximately two weeks (dosing period), with follow-up assessments one month post-treatment.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Psilocybin-assisted therapy (PAT) | no change | safety | people with FM | - | well-tolerated | #1 |
oral psilocybin | increase | blood pressure | participants | - | transient elevations | #2 |
oral psilocybin | increase | heart rate | participants | - | transient elevations | #3 |
oral psilocybin | increase | transient headaches | Four of five participants | - | reported | #4 |
Psilocybin-assisted therapy (PAT) | decrease | pain severity | participants | d = -2.1, 95% CI(-3.7 to -0.49) | clinically meaningful improvements | #5 |
Psilocybin-assisted therapy (PAT) | decrease | pain interference | participants | d = -1.8, 95% CI (-3.27 to -0.24) | clinically meaningful improvements | #6 |
Psilocybin-assisted therapy (PAT) | decrease | sleep disturbance | participants | d = -2.5, 95% CI (-4.21 to -0.75) | clinically meaningful improvements | #7 |
Psilocybin-assisted therapy (PAT) | decrease | symptoms | one participant | very much improved | reported | #8 |
Psilocybin-assisted therapy (PAT) | decrease | symptoms | two participants | much improved | reported | #9 |
Psilocybin-assisted therapy (PAT) | decrease | symptoms | two participants | minimally improved | reported | #10 |
INTRODUCTION: 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. METHODS: Here, we report findings from an open-label, pilot clinical trial of PAT for FM (N = 5). In conjunction with psychotherapy (two preparatory, four integration sessions), participants received two doses of oral psilocybin (15 mg and 25 mg) delivered two weeks apart. RESULTS: 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." We stopped recruitment early because of concerns about generalizability and changes in FDA guidance for psychedelic clinical trials that occurred data collection. DISCUSSION: This small open-label trial preliminarily supports that PAT is well-tolerated by people with FM, establishing a basis for larger randomized controlled trials. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, identifier, (NCT05128162).