The Effects of Psilocybin-Facilitated Experience on the Psychology and Effectiveness of Religious Professionals
Condition: Religious or Spiritual Problem
Study type: Interventional
Phase: Phase 1

Summary: 
      The current protocol is a pilot study of the effects and possible utility of
      psilocybin-facilitated experiences for professional religious leaders. We hypothesize that
      religious professionals, given their interests, training, and life experience, will be able
      to make nuanced discriminations of their psilocybin experiences, thus contributing to the
      scientific understanding of mystical-type experience. As we better characterize the
      phenomenology of psilocybin-induced mystical experiences, we may apply this knowledge to
      improve potential treatment studies in the future. A primary objective is to investigate
      changes in psychological functioning, spirituality, health, well-being, prosocial attitudes
      and behavior in professional religious leaders that may occur after receiving psilocybin
      under supportive conditions. A secondary objective is to determine whether participants who
      report having had the strongest mystical-type effects during psilocybin sessions will show
      the largest positive changes in the Interim Questionnaire.
    

Detailed description: 
      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.
    

Intervention name(s): Psilocybin
Intervention type(s): Drug
Intervention description(s): Participants will receive 20 mg/70 kg of psilocybin in the first session and will receive either 20 or 30 mg/70 kg in the second session.
Intervention MeSH terms: Psilocybin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Psilocybin; Pharmacologic Actions; Psychotropic Drugs