The Effects of Psilocybin-Facilitated Experience on the Psychology and Effectiveness of Religious Professionals

This randomized-controlled pilot study uses a wait-list control design. A wait-list design
includes a control group that is assigned to a waiting list to receive an intervention after
the active treatment group does. In this study, the active group will receive the psilocybin
at weeks 5 and 9 and the wait-list control group will receive psilocybin at weeks 30 and 34.
The wait-list control group serves the purpose of providing an untreated comparison for the
active treatment group, while at the same time allowing the wait-list participants an
opportunity to obtain the intervention at a later date.

This study's procedures include screening, preparatory meetings, psilocybin sessions, and
follow-up assessments. A large battery of behavioral and psychological measures will be
assessed throughout. The study team will consent and enroll up to 86 subjects to obtain a
total of 12 completer participants as well as 2-3 family members or friends per study
participant who can assess said completers on the Observer Rating Form (COM-R). This number
will account for screen-failures and dropouts as well. The 12 participants will be randomly
assigned to either an immediate participation group (N=6) or a 6-month delayed participation
group (N=6). Although statistical power calculations show that 12 participants will be
sufficient to detect the major effects anticipated in this study, the sponsor of this study
(The Council on Spiritual Practices) is concurrently funding Johns Hopkins University School
of Medicine to conduct a methodologically identical study with 12 additional participants
(IND #59009). This will permit the two sites to collaborate post study completion and combine
the data from the two studies to provide statistical power to detect even more subtle effects
of the psilocybin intervention. Twelve volunteers (6 from each group) will participate at
Johns Hopkins and 12 at New York University. Randomization and data analysis will be
conducted at New York University.

Inclusion Criteria:

- Inclusion criteria for religious professionals:

- 25 to 76 years old

- 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.

- During the next two years 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 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.

- Have no or limited lifetime use of hallucinogens. Preference will be given to
enrolling volunteers with no prior use. If we decide to enroll a volunteer with
prior use, preference will be given for those who report the fewest exposures or
the least enduring effects from such use.

Exclusion Criteria:

- General medical exclusion criteria for religious professionals:

- 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 ECG abnormality (e.g., symptomatic atrial
fibrilation), or 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 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 for religious professionals:

- Current or past history of meeting 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

- History of violent or suicidal behavior

- Family history of completed suicide