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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
Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of psilocybin session days. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on session days.
Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, 24 hours before and after each drug administration. The exception is caffeine. Participants will be required to be either a non-smoker or a non-daily smoker.
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 below
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I agree to keep my caffeine intake the same on the days I have psilocybin sessions.
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I agree not to use psychoactive substances or smoke regularly around my treatment times.
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I take prescribed mental health medication daily.
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I haven't had major heart issues like a stroke or uncontrolled high blood pressure in the past year.
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I agree not to take any non-prescribed drugs or supplements before drug sessions, except for approved exceptions.
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I agree not to take any 'as needed' medications on the mornings I receive treatment.
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I have diabetes and use insulin without experiencing low blood sugar.
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I agree not to take any 'as needed' medications on the mornings I receive treatment.
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I agree not to take any erectile dysfunction medication 72 hours before each treatment.
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I have epilepsy with a history of seizures.
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My weight is more than 20% over or under the ideal range for my height.
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I am not pregnant, nursing, or if capable of becoming pregnant, I am using effective birth control.
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A close family member has Schizophrenia, Psychotic Disorder, or Bipolar I/II.
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I am not currently taking daily medications that affect serotonin or are MAO inhibitors.
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I am healthy and mentally stable, confirmed by medical tests and interviews.
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I agree not to take any 'as needed' medications on the mornings I receive treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after enrollment for reporting.

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 • NCT02061293
44%
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

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
~770

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
2,242 Previous Clinical Trials
14,816,617 Total Patients Enrolled
Roland R Griffiths, Ph.D.Principal InvestigatorJHUSOM
7 Previous Clinical Trials
300 Total Patients Enrolled

Media Library

Psilocybin Clinical Trial Eligibility Overview. Trial Name: NCT02243813 — Phase 1
Healthy Subjects Research Study Groups: Immediate Participation, Delayed Participation
Healthy Subjects Clinical Trial 2023: Psilocybin Highlights & Side Effects. Trial Name: NCT02243813 — Phase 1
Psilocybin 2023 Treatment Timeline for Medical Study. Trial Name: NCT02243813 — Phase 1
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
~0 spots leftby May 2024