Preliminary safety and effectiveness of psilocybin-assisted therapy in adults with fibromyalgia: an open-label pilot clinical trial

Summary & key facts

This small, early study gave psilocybin with therapy to five adults who have fibromyalgia, a long-term pain condition. Each person had two psychotherapy visits before, four after, and two oral psilocybin doses (15 mg then 25 mg) two weeks apart. One month after the second dose, people reported large improvements in pain and sleep. There were some short-lived side effects like higher blood pressure or heart rate during dosing and headaches afterward, but no serious harms. Because only five people took part and the trial was not blinded or randomized, these results are only preliminary and need testing in larger, controlled studies.

Key facts:

• Five adults with fibromyalgia took part in an open-label pilot trial of psilocybin-assisted therapy.
• Each participant had two preparatory therapy sessions, two psilocybin doses (15 mg then 25 mg) two weeks apart, and four integration therapy sessions afterward.
• One month after the second dose, participants reported large improvements in pain severity, pain interference with daily life, and sleep disturbance compared to before treatment.
• On a global measure of change, one person said their symptoms were very much improved, two said much improved, and two said minimally improved.
• During dosing, some people had short, temporary rises in blood pressure or heart rate that returned to normal by the end of treatment.
• Four of the five participants reported temporary headaches after dosing, and there were no serious adverse events reported.
• The study stopped early because of concerns about how well the results would apply to other people and because rules from regulators changed, so the findings are preliminary.

Abstract

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).

Topics

Forensic Toxicology and Drug Analysis Pain Management and Placebo Effect Psychedelics and Drug Studies

Categories

Clinical Psychology Psychology Social Sciences

Tags

Clinical trial Fibromyalgia Hallucinogen Internal medicine Medicine Open label Physical therapy Pilot trial Psilocybin Psychiatry Psychology Randomized controlled trial

Substances

Psilocybin

Conditions & symptoms

Chronic Pain Chronic pain Lack of energy or motivation Poor sleep