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Effects of Psilocybin in Post-Treatment Lyme Disease

Primary Purpose

Post-Treatment Lyme Disease, Chronic Lyme Disease, Lyme Disease, Chronic

Status
Enrolling by invitation
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Psilocybin
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Treatment Lyme Disease focused on measuring Psilocybin, Hallucinogen, Psychedelic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Behavioral Pharmacology Research Unit

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psilocybin

Arm Description

Participants will complete an 8-week course of study treatment including two doses of psilocybin with psychological support administered approximately 2 weeks apart.

Outcomes

Primary Outcome Measures

Change in multi-system symptom burden as assessed by the General Symptom Questionnaire (GSQ-30) score
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
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).

Secondary Outcome Measures

Change in fatigue as assessed by the Fatigue Severity Scale (FSS) score
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)
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.

Full Information

First Posted
March 22, 2022
Last Updated
August 9, 2023
Sponsor
Johns Hopkins University
Collaborators
Steven & Alexandra Cohen Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05305105
Brief Title
Effects of Psilocybin in Post-Treatment Lyme Disease
Official Title
Effects of Psilocybin in Post-Treatment Lyme Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Steven & Alexandra Cohen Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Treatment Lyme Disease, Chronic Lyme Disease, Lyme Disease, Chronic
Keywords
Psilocybin, Hallucinogen, Psychedelic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psilocybin
Arm Type
Experimental
Arm Description
Participants will complete an 8-week course of study treatment including two doses of psilocybin with psychological support administered approximately 2 weeks apart.
Intervention Type
Drug
Intervention Name(s)
Psilocybin
Intervention Description
Dosing at the first session will be 15mg. For the second session participants will either remain at the initial dose, or increase to 25mg.
Primary Outcome Measure Information:
Title
Change in multi-system symptom burden as assessed by the General Symptom Questionnaire (GSQ-30) score
Description
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.
Time Frame
Baseline, 2 weeks after final psilocybin dose, 1 month after final psilocybin dose
Title
Change in functional health and well-being as assessed by the Short Health Form, Version 2 (SF-36v2) score
Description
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).
Time Frame
Baseline, 2 weeks after final psilocybin dose, 1 month after final psilocybin dose
Secondary Outcome Measure Information:
Title
Change in fatigue as assessed by the Fatigue Severity Scale (FSS) score
Description
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.
Time Frame
Baseline, 1 week after final psilocybin dose, 1 month after final psilocybin dose
Title
Change in pain as assessed by the Short-Form McGill Pain Questionnaire (SF-MPQ)
Description
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.
Time Frame
Baseline, 1 week after final psilocybin dose, 1 month after final psilocybin dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Garcia-Romeu, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioral Pharmacology Research Unit
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31867334
Citation
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.
Results Reference
background
PubMed Identifier
29312942
Citation
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.
Results Reference
background
Links:
URL
http://hopkinspsychedelic.org/lyme
Description
Online Study Screener

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