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NCT00802282 · ClinicalTrials.gov registry record · Phase 1
Psilocybin and Spiritual Practice
A Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT00802282: Completed Phase 1 study, sponsored by Johns Hopkins University.
NCT00802282 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 75 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00802282, a Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study 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.
Interventions
- DRUG psilocybin
- BEHAVIORAL Intensity of support for spiritual practice
- BEHAVIORAL Number of sessions
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2009-08 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00802282
The ClinicalTrials.gov registry entry for NCT00802282 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which psilocybin is the first listed.
NCT00802282 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00802282 about?
NCT00802282 is a clinical study titled "Psilocybin and Spiritual Practice". 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 practi...
What is the current status of trial NCT00802282?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2009-08. Estimated completion is 2014-05.
What interventions are being tested in trial NCT00802282?
The interventions under investigation include: psilocybin (DRUG), Intensity of support for spiritual practice (BEHAVIORAL), Number of sessions (BEHAVIORAL).
Who is sponsoring clinical trial NCT00802282?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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