Psilocybin and Spiritual Practice

Summary

This study will investigate the effects of psilocybin dose and the frequency and intensity of support activities for spiritual practice (e.g., meditation) on a battery of attitudinal and behavioral outcome measures in 75 healthy volunteers who are interested in pursuing a program of spiritual practices with the intention applying spiritual insights and knowledge to everyday life. After screening and study enrollment, each volunteer will be assigned to one of five groups that vary in dose, frequency and intensity of support for spiritual practice, and number of psilocybin sessions (either 2 or 3 sessions). The psilocybin dose manipulation will be double-blind. Volunteers will be told that in each of sessions 1, 2, and 3, he/she could receive a very low, low, moderate, moderately high, or high dose of psilocybin. They will be told that each participant will receive 2 or more dose levels of psilocybin over the 2 or 3 sessions, and all participants will have one or more sessions in which he or she receives a moderately high or high dose of psilocybin. The duration of each volunteer's participation will be approximately 6 to 8 months. Each volunteer will receive several hours of preparation with the study guides in the month prior to the first psilocybin session; the first two sessions will be separated by one month. Various measures will be assessed before, during and immediately after sessions. A battery of longitudinal measures will be evaluated immediately after study enrollment, 3 weeks after the second psilocybin session, and 4 months after the second psilocybin session (6 months after study enrollment). For purposes of controlling expectancies through the 6 month follow-up evaluation, volunteers and guides will not know which volunteers or how many volunteers will be scheduled for a third session.

Conditions

• Healthy

Interventions

DRUG

psilocybin

dose manipulation as described in the protocol and to which volunteers are blinded

BEHAVIORAL

Intensity of support for spiritual practice

Volunteers will be assigned to standard or high support, as described in the protocol

BEHAVIORAL

Number of sessions

Volunteers will be assigned to either 2 or 3 sessions, as described in the protocol

Sponsors & Collaborators

• Fetzer Institute

  collaborator OTHER

• The CSP Fund of the San Francisco Foundation

  collaborator UNKNOWN

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Roland R Griffiths, Ph.D. · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-08-31

Primary Completion

2014-02-28

Completion

2014-05-31

Countries

• United States

Study Locations