Effects of Psilocybin on Behavior, Psychology and Brain Function in Long-term Meditators

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Moderately-high dose of psilocybin; Drug: Moderately-low dose of psilocybin; Drug: Very-low dose of psilocybin; Drug: Placebo

• Registration Number: NCT02145091
• Lead Sponsor: Johns Hopkins University

Brief Summary

This is a double-blind placebo-controlled study investigating the acute and persisting effects of psilocybin on meditation, spirituality, health, well-being, prosocial attitudes, and brain functioning.

Detailed Description

This study will use questionnaires and functional magnetic resonance imaging (fMRI) to examine the acute and persisting effects of psilocybin on brain function, meditation, spirituality, and psychology. The majority of the study procedures -- including screening, preparatory meetings, placebo and psilocybin sessions, and a large battery of behavioral and psychological measures -- will be conducted at the investigator's laboratory at the Behavioral Pharmacology Research Unit (BPRU) on the Johns Hopkins Bayview campus. The brain imaging procedures will be conducted at F.M. Kirby Research Center at the Kennedy Krieger Institute (KKI).

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-05-20
• Study First Posted: 2014-05-22
• Status Verified: 2019-12
• Primary Completion: 2019-12-26
• Study Completion: 2019-12-26
• Last Update Submitted: 2019-12-26
• Last Update Posted: 2019-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

• Current or past history of meeting Diagnostic and Statistical Manual (DSM)-IV 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-IV criteria for alcohol or drug dependence (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
One all-day session	Moderately-high dose of psilocybin	Participants will complete on all-day study session with a moderately-high dose of psilocybin. Preparation will include two days of screening, and an additional 8 hours of session preparation over at least 2 days. Follow-up will consist of an interview and MRI scan one day after the all-day session, a questionnaire follow-up 2 months after the all-day session, and a final follow-up 12-18 months after the all-day session.
MRI of the acute effects of psilocybin	Very-low dose of psilocybin	This is an optional arm consisting of two sessions where either placebo, a very-low dose of psilocybin, or a moderately-low dose of psilocybin will be administered. During each session, participants will undergo MRI scanning shortly after the administration of each dose. Study sessions may occur over one or two days. Participants who have previously completed an all-day session with psilocybin in this study will be eligible to volunteer for this arm.
One all-day session	Placebo	Participants will complete on all-day study session with a moderately-high dose of psilocybin. Preparation will include two days of screening, and an additional 8 hours of session preparation over at least 2 days. Follow-up will consist of an interview and MRI scan one day after the all-day session, a questionnaire follow-up 2 months after the all-day session, and a final follow-up 12-18 months after the all-day session.
Three all-day sessions	Moderately-high dose of psilocybin	Participants will complete three all-day study sessions, the first two with placebo and the third with a moderately-high dose of psilocybin. The majority of participants (over 90%) will be assigned to either one or two all-day sessions. A small minority of participants (less than 10%) will be assigned to three all-day sessions. Preparation will include two days of screening and 8 hours of session preparation over at least 2 days, before the first all-day session. Follow-up will consist of an interview and MRI scan one day after each all-day session, a questionnaire follow-up 2 months after each all-day session, and a final follow-up 12-18 months after the third all-day session.
Three all-day sessions	Placebo	Participants will complete three all-day study sessions, the first two with placebo and the third with a moderately-high dose of psilocybin. The majority of participants (over 90%) will be assigned to either one or two all-day sessions. A small minority of participants (less than 10%) will be assigned to three all-day sessions. Preparation will include two days of screening and 8 hours of session preparation over at least 2 days, before the first all-day session. Follow-up will consist of an interview and MRI scan one day after each all-day session, a questionnaire follow-up 2 months after each all-day session, and a final follow-up 12-18 months after the third all-day session.
MRI of the acute effects of psilocybin	Placebo	This is an optional arm consisting of two sessions where either placebo, a very-low dose of psilocybin, or a moderately-low dose of psilocybin will be administered. During each session, participants will undergo MRI scanning shortly after the administration of each dose. Study sessions may occur over one or two days. Participants who have previously completed an all-day session with psilocybin in this study will be eligible to volunteer for this arm.
Two all-day sessions	Moderately-high dose of psilocybin	Participants will complete two all-day study sessions, the first with placebo and the second with a moderately-high dose of psilocybin. Preparation will include two days of screening and 8 hours of session preparation over at least 2 days, before the first all-day session. Follow-up will consist of an interview and MRI scan one day after each all-day session, a questionnaire follow-up 2 months after each all-day session, and a final follow-up 12-18 months after the second all-day session.
Two all-day sessions	Placebo	Participants will complete two all-day study sessions, the first with placebo and the second with a moderately-high dose of psilocybin. Preparation will include two days of screening and 8 hours of session preparation over at least 2 days, before the first all-day session. Follow-up will consist of an interview and MRI scan one day after each all-day session, a questionnaire follow-up 2 months after each all-day session, and a final follow-up 12-18 months after the second all-day session.
MRI of the acute effects of psilocybin	Moderately-low dose of psilocybin	This is an optional arm consisting of two sessions where either placebo, a very-low dose of psilocybin, or a moderately-low dose of psilocybin will be administered. During each session, participants will undergo MRI scanning shortly after the administration of each dose. Study sessions may occur over one or two days. Participants who have previously completed an all-day session with psilocybin in this study will be eligible to volunteer for this arm.

Primary Outcome Measures

Name	Time	Method
Hood Mysticism Scale	End of session day.	This measures subjective experiences associated with classical mystical experiences.
States of Consciousness Questionnaire	End of session day	Measures subjective experience associated with classical mystical experiences.
Persisting Effects Questionnaire	2 months and 12-18 months post-session	This is a measure of changes in spirituality, personal well-being, relationships, and emotions.
fMRI Resting State Functional Connectivity	2 months pre and 1 day post session	Measures change in activity in brain regions that have been previously shown to be modulated by either psilocybin or meditation.

Trial Locations

Locations (1)

Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States