Psilocybin and Spiritual Practice

This study has been completed.
Sponsor:
Collaborators:
Fetzer Institute
The CSP Fund of the San Francisco Foundation
Information provided by (Responsible Party):
Roland Griffiths, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00802282
First received: December 3, 2008
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: psilocybin
Behavioral: Intensity of support for spiritual practice
Behavioral: Number of sessions
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Psilocybin and Spiritual Practice on Persisting Changes in Attitudes and Behavior

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Hood Mysticism Scale [ Time Frame: At end of sessions ] [ Designated as safety issue: No ]
  • States of Consciousness Questionnaire [ Time Frame: At end of sessions ] [ Designated as safety issue: No ]
  • Persisting Effects Questionnaire [ Time Frame: 3 weeks after each session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Daily spiritual experiences scale [ Time Frame: Baseline, 3 weeks after second session, 6 months, and 3 weeks after the third session ] [ Designated as safety issue: No ]
  • A battery assessing various measures of gratitude, forgiveness, religious coping, death attitude, life purpose, life satisfaction, and psychological functioning [ Time Frame: Baseline, 3 weeks after second session, 6 months, and 3 weeks after the third session ] [ Designated as safety issue: No ]
  • Blood markers of stress and immune function [ Time Frame: Baseline, 3 weeks after second session, 6 months, and 3 weeks after the third session ] [ Designated as safety issue: No ]
  • Brief symptom inventory [ Time Frame: Baseline, one week after each session, and at 6 months ] [ Designated as safety issue: Yes ]
  • Visual effects questionnaire [ Time Frame: Baseline, 6 months, and 3 weeks after the third session ] [ Designated as safety issue: Yes ]

Enrollment: 75
Study Start Date: August 2009
Study Completion Date: May 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
First of 5 groups, as described in the protocol and to which volunteers are blinded
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
Experimental: 2
Second of 5 groups, as described in the protocol and to which volunteers are blinded
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
Experimental: 3
Third of 5 groups, as described in the protocol and to which volunteers are blinded
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
Experimental: 4
Fourth of 5 groups, as described in the protocol and to which volunteers are blinded
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
Experimental: 5
Fifth of 5 groups as described in the protocol and to which volunteers are blinded
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

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Eligibility criteria for volunteers who will receive psilocybin

Inclusion Criteria:

  • 21 to 70 years old
  • Have given written informed consent
  • Have a high school level of education
  • Be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests.
  • Have an active interest in exploring and developing their spiritual lives
  • Cigarette smokers must agree to abstain from smoking on psilocybin session days from 1 hour before psilocybin administration until at least 6 hours after psilocybin administration.
  • Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of drug session days. If the volunteer does not routinely consume caffeinated beverages, he or she must agree not to do so on session days.
  • Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of each psilocybin administration. Exceptions include caffeine and nicotine.
  • Agree not to take any PRN medications on the mornings of psilocybin sessions
  • Agree that for one week before each psilocybin session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.

Exclusion Criteria:

General medical exclusion criteria:

  • Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing an effective means of birth control
  • Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrillation), or TIA in the past year
  • Epilepsy with history of seizures
  • Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
  • Currently taking psychoactive prescription medication on a regular (e.g., daily) basis
  • Currently taking on a regular (e.g., daily) basis any medications having a primary centrally-acting pharmacological effect on serotonin neurons or medications that are MAO inhibitors. For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.
  • More than 20% outside the upper or lower range of ideal body weight

Psychiatric Exclusion Criteria:

  • Current or past history of meeting 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.
  • Currently meets DSM-IV criteria for Anorexia Nervosa, Bulimia Nervosa, or other psychiatric conditions judged to be incompatible with establishment of rapport or safe exposure to psilocybin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802282

Locations
United States, Maryland
Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Fetzer Institute
The CSP Fund of the San Francisco Foundation
Investigators
Principal Investigator: Roland R Griffiths, Ph.D. Johns Hopkins University
  More Information

Additional Information:
Publications:
Responsible Party: Roland Griffiths, Professor, Department of Psychiatry, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00802282     History of Changes
Other Study ID Numbers: NA_00020767
Study First Received: December 3, 2008
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
healthy volunteers
spirituality
psilocybin
meditation

Additional relevant MeSH terms:
Psilocybine
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 24, 2014