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Psilocybin for Healthy Subjects in Professional Leadership Roles in Religion
Phase 1
Waitlist Available
Led By Roland R Griffiths, Ph.D.
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
Currently taking on a regular (e.g., daily) basis any medications having a primary centrally-acting pharmacological effect on serotonin neurons or medications that are Mono amine Oxidase (MAO) inhibitors. For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up6 months after enrollment
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is testing whether psilocybin can help religious leaders have more meaningful experiences.
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have a history of seizures caused by epilepsy.
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Your close family member (like a parent or sibling) has been diagnosed with schizophrenia, psychotic disorder, or bipolar disorder.
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You are taking medication for mental health issues regularly.
Select...
You hold a high position in a religious organization and spend a lot of time helping people seeking spiritual guidance or support.
Select...
You agree not to take medications like Viagra or Cialis within 72 hours of each study drug administration.
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You have heart-related health problems like blocked arteries, high blood pressure that is not under control, or recent heart attack or stroke.
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You have been diagnosed with schizophrenia or bipolar disorder, except if it was caused by drugs or a medical condition.
Select...
You have had a problem with alcohol or drug abuse in the past 5 years or have had severe depression.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months after enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Interim Questionnaire
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%
Biopsy cervix
2%
Illusion
2%
Urinary incontinence
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Immediate ParticipationExperimental Treatment1 Intervention
Participants will begin psilocybin intervention immediately after study enrollment.
Group II: Delayed ParticipationExperimental Treatment1 Intervention
Participants will begin the psilocybin intervention 6 months after study enrollment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~720
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,191 Previous Clinical Trials
14,803,337 Total Patients Enrolled
Roland R Griffiths, Ph.D.Principal InvestigatorJHUSOM
7 Previous Clinical Trials
311 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of seizures caused by epilepsy.The applicant must have a college degree or equivalent, and be a graduate or professional.The subject agrees not to take any nonprescription medication, nutritional supplement, or herbal supplement for one week before each drug session, except when approved by the study investigatorsThere is no foreseeable likelihood for a major life-altering event for her or himself or a close family member during the next year.Your close family member (like a parent or sibling) has been diagnosed with schizophrenia, psychotic disorder, or bipolar disorder.You are taking medication for mental health issues regularly.I have given my written permission.You agree to avoid taking medications like Viagra or Cialis for three days before each drug administration.You are a leader in a well-known religious organization and spend a lot of time helping people seeking spiritual guidance or support.On the mornings of the psilocybin session days, the participant should agree to consume approximately the same amount of caffeine as they would on a usual morningWe ask that you refrain from using any mind-altering substances, including alcohol and nicotine, for 24 hours before and after each drug administrationYou hold a high position in a religious organization and spend a lot of time helping people seeking spiritual guidance or support.You agree not to take medications like Viagra or Cialis within 72 hours of each study drug administration.You have heart-related health problems like blocked arteries, high blood pressure that is not under control, or recent heart attack or stroke.You have been diagnosed with schizophrenia or bipolar disorder, except if it was caused by drugs or a medical condition.You have had a problem with alcohol or drug abuse in the past 5 years or have had severe depression.
Research Study Groups:
This trial has the following groups:- Group 1: Immediate Participation
- Group 2: Delayed Participation
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.
Healthy Subjects Patient Testimony for trial: Trial Name: NCT02243813 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have any other experiments utilized Psilocybin in their research?
"Currently, there are 33 ongoing Psilocybin trials. 0 of these clinical studies have reached the Phase 3 stage yet. While a majority of them originate in Vancouver, Washington, they span across 36 different locations worldwide."
Answered by AI
What criteria make someone a suitable candidate for this research?
"This clinical trial is open to healthy adults between the ages of 25 and 80. Up to 20 participants can be included in this medical study."
Answered by AI
To what extent has participation in this medical experiment been extended?
"Sadly, this trial is no longer open to patients. It was initially listed on March 1st 2015 and the last update occurred May 31st 2022. However, there are currently 840 trials for healthy subjects (hs) that admit participants as well as 33 studies involving psilocybin actively recruiting patients."
Answered by AI
Does this trial have an age restriction and, if so, is it open to persons above the age of 18?
"According to the trial's guidelines, applicants aged between 25 and 80 are eligible. Additionally, there are 50 spots reserved for participants younger than 18 years old and 401 vacancies available for individuals over 65."
Answered by AI
Are there still opportunities to participate in this research protocol?
"At this moment, the study is not seeking out new participants. The research was initially launched on March 1st 2015 and most recently updated on May 31 2022. However, if you wish to look into other trials there are currently 840 studies recruiting healthy subjects (hs) as well 33 clinical experiments exploring psilocybin treatments actively searching for patients."
Answered by AI
What safeguards are in place to ensure the safe use of Psilocybin?
"Taking into account the limited evidence related to Psilocybin's efficacy and safety, our team at Power assigned it a score of 1."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
Maryland
Pennsylvania
Other
How old are they?
65+
18 - 65
What site did they apply to?
Behavioral Biology Research Center, Johns Hopkins Bayview
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
0
What questions have other patients asked about this trial?
How long do screening visit take?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
Personal Enlightenment and therefore help others in their path. I am a high religious leader and believe we could find out answers!
PatientReceived no prior treatments
Im seeking personal enlightenment and possibly be able to expand consciousness that will help others in their path.
PatientReceived 2+ prior treatments
I’ve tried medications and programs and neither were sustainable. My motivation stems from recent discoveries on psilocybin and the positive neurological affects.
PatientReceived 1 prior treatment
I have a history of self examination which I have discussed with my doctor. I have been prescribed numerous medications over the years that purport to be helpful with psychological discomfort. None of them have had any lasting effect.
PatientReceived 1 prior treatment
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