Psilocybin and Spiritual Practice

Brief 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.

Intervention / Treatment

  • Drug: Psilocybin
  • Behavioral: Intensity of support for spiritual practice
  • Behavioral: Number of sessions

Condition or Disease

  • Healthy

Phase

Study Design

Study type: Interventional
Status: Completed
Study results: No Results Available
Age: 21 Years to 70 Years   (Adult, Older Adult)
Enrollment: 75 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Aug 01, 2009
Primary Completion: Feb 01, 2014
Completion Date: May 01, 2014
Study First Posted: Dec 04, 2008
Results First Posted: Aug 30, 2020
Last Updated: Feb 24, 2016

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Eligibility Criteria

Sex: All
Minimum Age: 21
Maximum Age: 70

More Details

NCT Number: NCT00802282
Other IDs: NA_00020767
Study URL: https://ClinicalTrials.gov/show/NCT00802282
Last updated: Jun 16, 2022