Effects of Psilocybin-facilitated Experience on the Psychology and Effectiveness of Professional Leaders in Religion



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:25 - 80
Updated:10/13/2018
Start Date:March 2015
End Date:July 2020
Contact:Mary Cosimano
Email:mcosima1@jhmi.edu
Phone:410-550-5990

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The current protocol is a pilot study of the effects and possible utility of
psilocybin-facilitated experiences for professional religious leaders.


Inclusion criteria:

- Have given written informed consent

- College graduation or equivalent and graduate/professional training.

- Recognized leadership position in a well-established religious organization;
professional activities must include significant time interacting with those seeking
religious/spiritual guidance or support.

- Be healthy and psychologically stable as determined by screening for medical and
psychiatric problems via a personal interview, a medical questionnaire, a physical
examination, an electrocardiogram (ECG), and routine medical blood and urinalysis
laboratory tests

- During the next year there is no foreseen likelihood for a major potentially
life-altering event for her or himself or a close family member (e.g. retirement or
major career change for the volunteer; life-threatening illness of a spouse or child
of the volunteer)

- 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.

- Agree not to take any Pro-re-nata (PRN) medications on the mornings of drug sessions

- Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72
hours of each drug administration.

- Agree that for one week before each drug session, he/she will refrain from taking any
nonprescription medication, nutritional supplement, or herbal supplement except when
approved by the study investigators. Exceptions will be evaluated by the study
investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs,
and common doses of vitamins and minerals.

General medical exclusion criteria:

- 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.

- Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled
hypertension, a clinically significant Electrocardiogram (ECG) abnormality (e.g.,
symptomatic atrial fibrillation), or Transient Ischemic Attack (TIA) in the past year

- Epilepsy with history of seizures

- Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of
hypoglycemia

- Currently taking psychoactive prescription medication on a regular (e.g., daily) basis

- 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.

- More than 20% outside the upper or lower range of ideal body weight according to
Metropolitan Life height and weight table

Psychiatric Exclusion Criteria:

- Current or past history of meeting Diagnostic and Statistics Manual (DSM)-5 criteria
for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical
condition), or Bipolar I or II Disorder

- Current or past history within the last 5 years of meeting DSM-5 criteria for alcohol
or substance use disorder (excluding caffeine and nicotine) or severe major depression

- 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

- Has a psychiatric condition judged to be incompatible with establishment of rapport or
safe exposure to psilocybin
We found this trial at
1
site
Baltimore, Maryland 21224
Principal Investigator: Roland R Griffiths, Ph.D.
Phone: 410-550-5990
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mi
from
Baltimore, MD
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