Effects of Psilocybin in Post-Treatment Lyme Disease

• ClinicalTrials.gov Identifier: NCT05305105
• Recruitment Status: Enrolling by invitation
• First Posted: March 31, 2022
• Last Update Posted: August 14, 2023
• Sponsor: Johns Hopkins University
• Collaborator: Steven & Alexandra Cohen Foundation
• Information provided by (Responsible Party): Johns Hopkins University

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).

Condition or disease	Intervention/treatment	Phase
Post-Treatment Lyme Disease; Chronic Lyme Disease; Lyme Disease, Chronic	Drug: Psilocybin	Phase 1

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 Design

• 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

Arms and Interventions

Arm	Intervention/treatment
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.	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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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).

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

United States, Maryland

Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States, 21224

Sponsors and Collaborators

Johns Hopkins University

Steven & Alexandra Cohen Foundation

Investigators

• Principal Investigator: Albert Garcia-Romeu, PhD; Johns Hopkins University

More Information

Additional Information:

Online Study Screener 

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.

• 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
• 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

Keywords provided by Johns Hopkins University:

Psilocybin; Hallucinogen; Psychedelic

Additional relevant MeSH terms:

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