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Psychedelic
Psilocybin for Post-Treatment Lyme Disease
Phase 1
Waitlist Available
Led By Albert Garcia-Romeu, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 week after final psilocybin dose, 1 month after final psilocybin dose
Awards & highlights
Study Summary
This trial will study the effects of the drug psilocybin on Lyme disease symptoms and quality of life in people who have already completed treatment for the disease.
Who is the study for?
Adults over 18 with Post-Treatment Lyme Disease (PTLD) symptoms like pain, fatigue, or cognitive issues after standard antibiotic treatment for Lyme disease. Participants must have a documented CDC-confirmed diagnosis of early or late Lyme disease and be medically stable. Pregnant individuals, those not using contraception, non-English speakers, and people with certain medical conditions or on specific medications are excluded.Check my eligibility
What is being tested?
The trial is studying the impact of psilocybin on symptom burden and quality of life in PTLD patients. It aims to understand if this substance can alleviate persistent symptoms associated with Lyme disease after conventional treatments have been completed.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of psilocybin may include nausea, headache, dizziness, increased heart rate and blood pressure changes. Psychological effects could range from altered perception to anxiety or mood swings.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a documented diagnosis of Lyme disease according to CDC guidelines.
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I have symptoms like pain, fatigue, or thinking problems after Lyme disease treatment.
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I have completed a prescribed course of antibiotics.
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I am medically stable based on recent health screenings and tests.
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I am 18 years old or older.
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My health is stable as confirmed by recent medical exams and tests.
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I have a documented diagnosis of Lyme disease according to CDC guidelines.
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I have completed a prescribed course of antibiotics.
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I am 18 years old or older.
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I have symptoms like pain, fatigue, or thinking problems after Lyme disease treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 week after final psilocybin dose, 1 month after final psilocybin dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 week after final psilocybin dose, 1 month after final psilocybin dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in functional health and well-being as assessed by the Short Health Form, Version 2 (SF-36v2) score
Change in multi-system symptom burden as assessed by the General Symptom Questionnaire (GSQ-30) score
Secondary outcome measures
Change in fatigue as assessed by the Fatigue Severity Scale (FSS) score
Change in pain as assessed by the Short-Form McGill Pain Questionnaire (SF-MPQ)
Side effects data
From 2021 Phase 2 trial • 95 Patients • NCT0206129344%
Headache
21%
Nausea
15%
Anxiety
8%
Suicidal Ideation
6%
Insomnia
6%
Depressed mood
4%
Abdominal pain upper
4%
Vomiting
4%
Corona virus infection
4%
Upper respiratory tract infection
4%
Viral upper resp. tract infection
4%
Alcohol poisoning
4%
Depression
4%
Pneumonia
2%
Urinary incontinence
2%
Illusion
2%
Biopsy cervix
2%
Palpitations
2%
Cataract
2%
Abdominal pain
2%
Toothache
2%
Pain
2%
Limb injury
2%
Muscle strain
2%
Blood pressure diastolic increased
2%
Blood pressure increased
2%
Back pain
2%
Musculoskeletal pain
2%
Myalgia
2%
Dizziness
2%
Psychomotor hyperactivity
2%
Alcohol withdrawal syndrome
2%
Dysphoria
2%
Testicular pain
2%
Hyperventilation
2%
Food poisoning
2%
Food allergy
2%
Dyspepsia
2%
Influenza
2%
Nasal congestion
2%
Skin cosmetic procedure
2%
Photopsia
2%
Diverticulitis
2%
Asthenia
2%
Fatigue
2%
Gingivitis
2%
Dyspnea
2%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Psilocybin
Diphenhydramine
Trial Design
1Treatment groups
Experimental Treatment
Group I: PsilocybinExperimental Treatment1 Intervention
Participants will complete an 8-week course of study treatment including two doses of psilocybin with psychological support administered approximately 2 weeks apart.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~770
Who is running the clinical trial?
Steven & Alexandra Cohen FoundationOTHER
6 Previous Clinical Trials
204 Total Patients Enrolled
1 Trials studying Lyme Disease
40 Patients Enrolled for Lyme Disease
Johns Hopkins UniversityLead Sponsor
2,242 Previous Clinical Trials
14,816,617 Total Patients Enrolled
1 Trials studying Lyme Disease
100 Patients Enrolled for Lyme Disease
Steven and Alexandra Cohen FoundationUNKNOWN
1 Previous Clinical Trials
56 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have dementia or related disorders like Alzheimer's.I have a documented diagnosis of Lyme disease according to CDC guidelines.I am able to have children and am not using birth control.You are able to provide written informed consent for participation into the study.I had chronic pain, fatigue, fibromyalgia, autoimmune disease, or unexplained neurological symptoms before Lyme disease symptoms.You have recently had thoughts of hurting yourself or have tried to hurt yourself in the past three years.I am currently taking medication that affects my brain's serotonin levels.You have been diagnosed with schizophrenia, a psychotic disorder (unless caused by drugs or a medical condition), or bipolar disorder (type I or II).I use insulin for my diabetes and haven't had low blood sugar with pills.I have symptoms like pain, fatigue, or thinking problems after Lyme disease treatment.I have completed a prescribed course of antibiotics.I am medically stable based on recent health screenings and tests.I am currently on antidepressants, antipsychotics, or MAOIs.I have had cancer within the last 2 years.I have a documented diagnosis of Lyme disease according to CDC guidelines.My kidney function is reduced with a creatinine clearance below 40 ml/min.I am 18 years old or older.I do not have severe heart issues like uncontrolled high blood pressure, recent stroke, or irregular heartbeat.I am not fluent in English.My health is stable as confirmed by recent medical exams and tests.I have a close family member with Schizophrenia, Psychotic Disorder, or Bipolar I.I have epilepsy with a history of seizures.I have completed a prescribed course of antibiotics.I am 18 years old or older.I have or had a major illness that affects my immune system.I have symptoms like pain, fatigue, or thinking problems after Lyme disease treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Psilocybin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What cautions should be taken when administering Psilocybin to patients?
"Due to the preliminary nature of this trial, our team at Power has assigned Psilocybin a safety rating of 1. This is because Phase 1 trials typically lack sufficient data on both efficacy and security."
Answered by AI
Is there still room to enroll in this clinical investigation?
"According to clinicaltrials.gov, the trial that was initially posted on July 1st 2022 is not currently enrolling patients. However, there are seven other medical studies with open recruitment at this time."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Maryland
Pennsylvania
Other
How old are they?
65+
18 - 65
What site did they apply to?
Behavioral Pharmacology Research Unit
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I’ve been experiencing much fatigue and cognitive decline since my diagnosis, despite taking doxycycline treatments as prescribed.
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- Behavioral Pharmacology Research Unit: < 48 hours
Typically responds via
Email
Average response time
- < 2 Days
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