Effects of Psilocybin in Post-Treatment Lyme Disease
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ClinicalTrials.gov Identifier: NCT05305105 |
Recruitment Status :
Enrolling by invitation
First Posted : March 31, 2022
Last Update Posted : August 14, 2023
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Condition or disease | Intervention/treatment | Phase |
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Post-Treatment Lyme Disease Chronic Lyme Disease Lyme Disease, Chronic | Drug: Psilocybin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effects of Psilocybin in Post-Treatment Lyme Disease |
Actual Study Start Date : | July 1, 2022 |
Estimated Primary Completion Date : | September 30, 2024 |
Estimated Study Completion Date : | December 31, 2024 |
Arm | Intervention/treatment |
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Experimental: Psilocybin
Participants will complete an 8-week course of study treatment including two doses of psilocybin with psychological support administered approximately 2 weeks apart.
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Drug: Psilocybin
Dosing at the first session will be 15mg. For the second session participants will either remain at the initial dose, or increase to 25mg. |
- Change in multi-system symptom burden as assessed by the General Symptom Questionnaire (GSQ-30) score [ Time Frame: Baseline, 2 weeks after final psilocybin dose, 1 month after final psilocybin dose ]The GSQ-30 is a validated and reliable instrument developed to assess multi-system symptom burden among patients with Lyme Disease. Total score ranges from 0 to 120, with higher scores indicating greater symptom burden.
- Change in functional health and well-being as assessed by the Short Health Form, Version 2 (SF-36v2) score [ Time Frame: Baseline, 2 weeks after final psilocybin dose, 1 month after final psilocybin dose ]The SF-36, version 2 (SF-36v2) is a multi-purpose, short form health survey that yields an 8-domain profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures. The number of questions contributing to each domain varies from 2 to 10. Domain scores range from 0 (poorest health status) to 100 (best health status).
- Change in fatigue as assessed by the Fatigue Severity Scale (FSS) score [ Time Frame: Baseline, 1 week after final psilocybin dose, 1 month after final psilocybin dose ]The FSS was designed to detect and evaluate changes in fatigue over time in persons with chronic illness. Its research utility rests with its ability to measure fatigue severity and identify features that distinguish fatigue between other clinical features of chronic medical disorders, such as depression. Scores on the FSS range from a minimum of 9 to a maximum of 63, with higher scores indicating greater fatigue severity.
- Change in pain as assessed by the Short-Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: Baseline, 1 week after final psilocybin dose, 1 month after final psilocybin dose ]The Short-Form McGill Pain Questionnaire (SF-MPQ) was designed to provide a quantitative measure of pain that can be tested statistically and includes major classes of word descriptors used by patients to specify subjective pain experience. The SF-MPQ 15-item pain metric has summary scores ranging from 0 to 45 with a higher score indicating worse pain.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 SSRIs, SNRIs, and/or bupropion is allowed if the type and frequency of the therapy has been stable for at least two months prior to screening. Allowable bupropion doses for participants will be ≤300mg/day.
Exclusion Criteria:
- Meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for moderate or severe substance use disorder (excluding tobacco) within the past 5 years.
- Currently taking antipsychotics, MAO inhibitors, or antidepressant medications other than SSRIs, SNRIs, or bupropion. Allowable bupropion doses for participants will be ≤300mg/day.
- Currently taking lithium or other primary centrally-acting serotonergic medications, whether over-the-counter or prescription (e.g., efavirenz, 5-hydroxytryptophan, St. John's wort).
- Cardiovascular conditions: angina, a clinically significant ECG abnormality (e.g. atrial fibrillation or QTc >450msec), transient ischaemic attack (TIA) in the last 6 months, stroke, artificial heart valves, or uncontrolled hypertension with resting blood pressure systolic >139 or diastolic >89, or heart rate >90 bpm.
- Renal disease (creatinine clearance < 40 ml/min using the Cockcroft-Gault equation).
- Current or past history of meeting DSM-5 criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I or II Disorder.
- Family (i.e., 1st degree relative) history of Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I Disorder.
- Past-year hallucinogen use
- Received the Lyme vaccine when it was available (1998-2002).
- Development of unexplained chronic pain, chronic fatigue syndrome, fibromyalgia, autoimmune disease, or unexplained neurologic symptoms before first evidence of Lyme disease.
- Cancer or malignancy in the past 2 years.
- Epilepsy with history of seizures.
- Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia.
- Current dementia or related disorders including but not limited to, Alzheimer's Disease, vascular dementia, Lewy body dementia, and frontotemporal disorders.
- Current or past major immunosuppressive illness or medications.
- Currently pregnant or nursing.
- Currently of childbearing potential and not using effective methods of contraception.
- Not fluent in English.
- High risk for suicidal ideation or behavior (i.e., individuals who report suicidal ideation with intent or behavior on the Columbia-Suicide Severity Rating Scale [C-SSRS] at screening, or individuals with a suicide attempt within the past 3 years).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05305105
United States, Maryland | |
Behavioral Pharmacology Research Unit | |
Baltimore, Maryland, United States, 21224 |
Principal Investigator: | Albert Garcia-Romeu, PhD | Johns Hopkins University |
Publications:
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT05305105 |
Other Study ID Numbers: |
IRB00281685 132642 ( Other Identifier: Steven & Alexandra Cohen Foundation ) |
First Posted: | March 31, 2022 Key Record Dates |
Last Update Posted: | August 14, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Psilocybin Hallucinogen Psychedelic |
Lyme Disease Post-Lyme Disease Syndrome Chronic Disease Disease Attributes Pathologic Processes Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections |
Borrelia Infections Spirochaetales Infections Tick-Borne Diseases Vector Borne Diseases Post-Infectious Disorders Psilocybin Hallucinogens Physiological Effects of Drugs Psychotropic Drugs |