Effects of Psilocybin in Post-Treatment Lyme Disease (NCT05305105) | Clinical Trial Compass
CompletedPhase 1
Effects of Psilocybin in Post-Treatment Lyme Disease
United States20 participantsStarted 2022-07-01
Plain-language summary
This study will examine the effects of psilocybin on Lyme disease symptom burden and quality of life in people with Post-Treatment Lyme Disease (PTLD).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* ≥ 18 years of age.
* Capable of providing written informed consent for participation into the study.
* Willingness to allow the study team to review past medical records.
* At least one current PTLD-defining symptom (widespread pain, fatigue, or neurocognitive dysfunction) following completion of standard, recommended antibiotic therapy for treatment of Lyme disease, and that appeared in the first two years following first evidence of Lyme disease.
* Medical record documentation of meeting the Centers for Disease Control (CDC) case definition for clear diagnosis and treatment of early or late Lyme disease while living in a Lyme-endemic area. In other words, a history of physician-documented single or disseminated erythema migrans rash, late Lyme arthritis, or late Lyme neuropathy, OR Medical record documentation of meeting the CDC case definition for probable early or late Lyme disease. In other words, a history of abrupt onset of flu-like symptoms with or without a misdiagnosed rash, and concurrent positive serology while living in a Lyme-endemic area.
* Received treatment with a recommended course of antibiotics.
* Be medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests.
* Concurrent pharmacotherapy with selective serotonin reuptake inhibitors (SSRI), serotonin and norepinephrine r…
What they're measuring
1
Change in multi-system symptom burden as assessed by the General Symptom Questionnaire (GSQ-30) score
Timeframe: Baseline, 2 weeks after final psilocybin dose, 1 month after final psilocybin dose
2
Change in functional health and well-being as assessed by the Short Health Form (SF-36) score
Timeframe: Baseline, 2 weeks after final psilocybin dose, 1 month after final psilocybin dose