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Psilocybin for Religious Leaders' Experiential Enhancement
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
Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing an effective means of birth control.
Have a first or second-degree relative with Schizophrenia, Psychotic Disorder (unless substance induced or due to a medical condition), or Bipolar I or II Disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after enrollment
Awards & highlights
Study Summary
This trial is testing whether psilocybin can help religious leaders have more meaningful experiences.
Who is the study for?
This trial is for healthy, psychologically stable religious leaders with professional training who interact with seekers of spiritual guidance. They must not be pregnant, nursing, or have a history of seizures, serious mental health conditions, substance abuse within the last 5 years, or cardiovascular issues. Participants should not be on psychoactive medications and agree to dietary restrictions before sessions.Check my eligibility
What is being tested?
The study explores how psilocybin (a psychedelic compound) affects religious professionals' psychology and effectiveness in their roles. It's a pilot study meaning it's an initial small-scale experiment to see if further research is warranted.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects from psilocybin can include nausea, headache, increased heart rate and blood pressure, altered perception of time and reality which could lead to anxiety or distress during the experience.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant, nursing, or if capable of becoming pregnant, I am using effective birth control.
Select...
A close family member has Schizophrenia, Psychotic Disorder, or Bipolar I/II.
Select...
I agree not to take any 'as needed' medications on the mornings I receive treatment.
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 • NCT020612939%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Pyrexia
2%
Oedema
2%
Vomiting
2%
Rhinorrhea
2%
Musculoskeletal pain
2%
Hypoesthesia
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin
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
~730
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
2,267 Previous Clinical Trials
14,837,587 Total Patients Enrolled
Roland R Griffiths, Ph.D.Principal InvestigatorJHUSOM
7 Previous Clinical Trials
300 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree not to use psychoactive substances or smoke regularly around my treatment times.My weight is more than 20% over or under the ideal range for my height.I take prescribed mental health medication daily.I agree to keep my caffeine intake the same on the days I have psilocybin sessions.I agree not to take any erectile dysfunction medication 72 hours before each treatment.I agree not to take any non-prescribed drugs or supplements before each drug session, except for approved exceptions.I agree not to take medications like Viagra within 72 hours of each treatment.I agree not to take any over-the-counter meds, supplements, or herbs before each drug session, except when allowed.You have had a problem with alcohol or drug abuse in the past 5 years or have had severe depression.I haven't had major heart issues or strokes in the past year.I agree not to use psychoactive substances or smoke regularly around my treatment times.I agree to keep my caffeine intake the same on the days I have psilocybin sessions.There is no foreseeable likelihood for a major life-altering event for her or himself or a close family member during the next year.I have epilepsy with a history of seizures.I am not pregnant, nursing, or if capable of becoming pregnant, I am using effective birth control.I am not currently taking daily medications that affect serotonin or are MAO inhibitors.You have been diagnosed with schizophrenia or bipolar disorder, except if it was caused by drugs or a medical condition.I am healthy and mentally stable, confirmed by medical exams and tests.You are a leader in a well-known religious organization and spend a lot of time helping people seeking spiritual guidance or support.I have given my written permission.I am not pregnant, nursing, or if capable of becoming pregnant, I am using effective birth control.A close family member has Schizophrenia, Psychotic Disorder, or Bipolar I/II.I am not currently taking daily medications that affect serotonin or are MAO inhibitors.I have diabetes and use insulin without experiencing low blood sugar.I agree not to take any 'as needed' medications on the mornings I receive treatment.The applicant must have a college degree or equivalent, and be a graduate or professional.
Research Study Groups:
This trial has the following groups:- Group 1: Delayed Participation
- Group 2: Immediate 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
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
What questions have other patients asked about this trial?
How long do screening visit take?
PatientReceived 1 prior treatment
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