- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05305105
Effects of Psilocybin in Post-Treatment Lyme Disease
August 9, 2023 updated by: Johns Hopkins University
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).
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
Detailed Description
This pilot study will evaluate the therapeutic potential of psilocybin in people with well-documented current Post-Treatment Lyme Disease (PTLD).
Study measures will assess the impact of psilocybin-assisted treatment on overall symptom burden and quality of life in 20 people with PTLD.
This is an open-label proof-of-concept trial in which participants will complete an 8-week course of study treatment including two psilocybin sessions (15mg in week 4 and 15 or 25mg in week 6) with psychological support, and follow-up assessments 1, 3, and 6 months after the final psilocybin session.
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21224
- Behavioral Pharmacology Research Unit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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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Dosing at the first session will be 15mg.
For the second session participants will either remain at the initial dose, or increase to 25mg.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Baseline, 2 weeks after final psilocybin dose, 1 month after final psilocybin dose
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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
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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).
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Baseline, 2 weeks after final psilocybin dose, 1 month after final psilocybin dose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Baseline, 1 week after final psilocybin dose, 1 month after final psilocybin dose
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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
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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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Baseline, 1 week after final psilocybin dose, 1 month after final psilocybin dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Albert Garcia-Romeu, PhD, Johns Hopkins University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Fallon BA, Zubcevik N, Bennett C, Doshi S, Rebman AW, Kishon R, Moeller JR, Octavien NR, Aucott JN. The General Symptom Questionnaire-30 (GSQ-30): A Brief Measure of Multi-System Symptom Burden in Lyme Disease. Front Med (Lausanne). 2019 Dec 6;6:283. doi: 10.3389/fmed.2019.00283. eCollection 2019.
- Rebman AW, Bechtold KT, Yang T, Mihm EA, Soloski MJ, Novak CB, Aucott JN. The Clinical, Symptom, and Quality-of-Life Characterization of a Well-Defined Group of Patients with Posttreatment Lyme Disease Syndrome. Front Med (Lausanne). 2017 Dec 14;4:224. doi: 10.3389/fmed.2017.00224. eCollection 2017.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2022
Primary Completion (Estimated)
September 30, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
March 22, 2022
First Submitted That Met QC Criteria
March 22, 2022
First Posted (Actual)
March 31, 2022
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 9, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Disease Attributes
- Vector Borne Diseases
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Tick-Borne Diseases
- Borrelia Infections
- Spirochaetales Infections
- Chronic Disease
- Post-Infectious Disorders
- Lyme Disease
- Post-Lyme Disease Syndrome
- Physiological Effects of Drugs
- Psychotropic Drugs
- Hallucinogens
- Psilocybin
Other Study ID Numbers
- IRB00281685
- 132642 (Other Identifier: Steven & Alexandra Cohen Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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