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Effects of Psilocybin in Post-Treatment Lyme Disease

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ClinicalTrials.gov Identifier: NCT05305105
Recruitment Status : Not yet recruiting
First Posted : March 31, 2022
Last Update Posted : June 24, 2022
Sponsor:
Collaborator:
Steven and Alexandra Cohen Foundation
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE March 22, 2022
First Posted Date  ICMJE March 31, 2022
Last Update Posted Date June 24, 2022
Estimated Study Start Date  ICMJE July 30, 2022
Estimated Primary Completion Date September 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2022)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2022)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Psilocybin in Post-Treatment Lyme Disease
Official Title  ICMJE Effects of Psilocybin in Post-Treatment Lyme Disease
Brief 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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Post-Treatment Lyme Disease
  • Chronic Lyme Disease
  • Lyme Disease, Chronic
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Drug: Psilocybin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 22, 2022)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date September 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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 antidepressants of any drug class, antipsychotics, or Monoamine oxidase inhibitors (MAOIs).
  • 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.
  • 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Abigail S Yaffe 443-470-6189 ayaffe5@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05305105
Other Study ID Numbers  ICMJE IRB00281685
132642 ( Other Identifier: Steven & Alexandra Cohen Foundation )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Johns Hopkins University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Johns Hopkins University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Steven and Alexandra Cohen Foundation
Investigators  ICMJE
Principal Investigator: Albert Garcia-Romeu, PhD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP