Summary
A Johns Hopkins pilot study found that psilocybin, given with psychological support, was safe and well tolerated in adults with post-treatment Lyme disease and was associated with significant, lasting reductions in multi-system symptom burden, including improved mood, fatigue, sleep, pain, and quality of life for up to six months. Prior brain imaging and immunological research indicate that post-treatment Lyme disease is a biologically based condition with no currently accepted treatments. These findings suggest psilocybin-assisted treatment may offer a promising new approach for managing this debilitating neurologic disorder.
Why was this study done?
Many people treated for Lyme disease continue to experience long lasting symptoms such as fatigue, pain, cognitive problems, sleep disturbance, anxiety, and depression that impair daily functioning. Researchers wanted to test whether psilocybin-assisted treatment, which has shown antidepressant, anti-anxiety, and possible anti-inflammatory effects in other settings, could safely reduce symptoms and improve quality of life patients with post-treatment Lyme disease.
How was this study done?
This was an open label pilot study of 20 carefully screened adults with well documented Lyme disease and persistent symptoms, meeting the research criteria for post-treatment Lyme disease, a defined subgroup of Lyme disease patients with ongoing health complaints after treatment. Over eight weeks, participants received two doses of psilocybin with psychological support (15mg in week four, then 15 or 25 mg in week six), along with regular weekly preparation and aftercare visits. Follow-up assessments occurred one month, three months, and six months after the second dose. Researchers tracked overall symptom burden, quality of life, mood, fatigue, sleep, and pain using validated questionnaires, monitored safety including blood pressure and heart rate, and collected blood samples for future inflammatory cytokine and other biomarker analysis.
What were the major findings?
Psilocybin treatment was feasible and generally well tolerated in this group, with no serious adverse events related to the study drug. All 20 participants completed the full treatment and attended all dosing sessions and follow-up visits. The most common study related side effects were short lived increases in blood pressure and heart rate, headache, pain, and fatigue during or shortly after dosing sessions. On average, participants showed relatively large and statistically significant improvements in overall symptom burden and health related quality of life one month after the second dose, and these benefits were largely maintained through the six month follow up, with general symptom scores about forty percent lower and mental and physical quality of life scores roughly thirteen percent higher than at baseline. Measures of depression, fatigue, sleep disturbance, and pain also improved substantially and remained better than baseline across all follow ups, which is notable because a placebo response in a chronic illness trial may diminish over time rather than continue for six months such as in this study.
What is the impact of this work?
Psilocybin treatment was feasible and generally well tolerated in this group, with no serious adverse events related to the study drug. All 20 participants completed the full treatment and attended all dosing sessions and follow-up visits. The most common study related side effects were short lived increases in blood pressure and heart rate, headache, pain, and fatigue during or shortly after dosing sessions. On average, participants showed relatively large and statistically significant improvements in overall symptom burden and health related quality of life one month after the second dose, and these benefits were largely maintained through the six month follow up, with general symptom scores about forty percent lower and mental and physical quality of life scores roughly thirteen percent higher than at baseline. Measures of depression, fatigue, sleep disturbance, and pain also improved substantially and remained better than baseline across all follow ups, which is notable because a placebo response in a chronic illness trial may diminish over time rather than continue for six months such as in this study.
Study team members:
Albert Garcia-Romeu, Ph.D.1*, Gideon P. Naudé, Ph.D.1, Alison W. Rebman, M.P.H.2, Sara So, M.H.S., M.S., L.C.P.C., Abigail Yaffe, B.A., M.A., Ian Geithner, M.P.S., L.P.A.1, Erica A. Kozero, B.S. 2, Ting Yang, Ph.D.2, Mark J. Soloski, Ph.D.2, & John N. Aucott, M.D.2*
1 Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, MD, 21224, U.S.A.
2 Lyme Disease Research Center, Division of Rheumatology, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD, 21205, U.S.A.
This research was supported by:
Support for this study was provided through the Johns Hopkins Center for Psychedelic and Consciousness Research with funding from Tim Ferriss, Matt Mullenweg, Blake Mycoskie, Craig Nerenberg, and the Steven & Alexandra Cohen Foundation.
