Effects of Psilocybin-facilitated Experience on the Psychology and Effectiveness of Professional Leaders in Religion

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Psilocybin

• Registration Number: NCT02243813
• Lead Sponsor: Johns Hopkins University

Brief Summary

The current protocol is a pilot study of the effects and possible utility of psilocybin-facilitated experiences for professional religious leaders.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-09-16
• Study First Posted: 2014-09-18
• Study Start: 2015-03
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

• Current or past history of meeting Diagnostic and Statistics Manual (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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Participation	Psilocybin	Participants will begin psilocybin intervention immediately after study enrollment.
Delayed Participation	Psilocybin	Participants will begin the psilocybin intervention 6 months after study enrollment.

Primary Outcome Measures

Name	Time	Method
Interim Questionnaire	6 months after enrollment	This questionnaire asks about experiences and changes in attitudes, mood and behavior that occurred during the past 5 months. The questionnaire includes questions about salient spiritual experiences, changes in spiritual practices, changes in attitudes, moods, social interactions, and other behaviors related to participants' religious/spiritual vocation.

Trial Locations

Locations (1)

Behavioral Biology Research Center, Johns Hopkins Bayview; 🇺🇸 Baltimore, Maryland, United States