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Psilocybin and Spiritual Practice

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ClinicalTrials.gov Identifier: NCT00802282
Recruitment Status : Completed
First Posted : December 4, 2008
Last Update Posted : February 24, 2016
Sponsor:
Collaborators:
Fetzer Institute
The CSP Fund of the San Francisco Foundation
Information provided by (Responsible Party):
Roland Griffiths, Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE December 3, 2008
First Posted Date  ICMJE December 4, 2008
Last Update Posted Date February 24, 2016
Study Start Date  ICMJE August 2009
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2008)
  • Hood Mysticism Scale [ Time Frame: At end of sessions ]
  • States of Consciousness Questionnaire [ Time Frame: At end of sessions ]
  • Persisting Effects Questionnaire [ Time Frame: 3 weeks after each session ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2008)
  • Daily spiritual experiences scale [ Time Frame: Baseline, 3 weeks after second session, 6 months, and 3 weeks after the third session ]
  • 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 ]
  • Blood markers of stress and immune function [ Time Frame: Baseline, 3 weeks after second session, 6 months, and 3 weeks after the third session ]
  • Brief symptom inventory [ Time Frame: Baseline, one week after each session, and at 6 months ]
  • Visual effects questionnaire [ Time Frame: Baseline, 6 months, and 3 weeks after the third session ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psilocybin and Spiritual Practice
Official Title  ICMJE Effects of Psilocybin and Spiritual Practice on Persisting Changes in Attitudes and Behavior
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1
    First of 5 groups, as described in the protocol and to which volunteers are blinded
    Interventions:
    • Drug: psilocybin
    • Behavioral: Intensity of support for spiritual practice
    • Behavioral: Number of sessions
  • Experimental: 2
    Second of 5 groups, as described in the protocol and to which volunteers are blinded
    Interventions:
    • Drug: psilocybin
    • Behavioral: Intensity of support for spiritual practice
    • Behavioral: Number of sessions
  • Experimental: 3
    Third of 5 groups, as described in the protocol and to which volunteers are blinded
    Interventions:
    • Drug: psilocybin
    • Behavioral: Intensity of support for spiritual practice
    • Behavioral: Number of sessions
  • Experimental: 4
    Fourth of 5 groups, as described in the protocol and to which volunteers are blinded
    Interventions:
    • Drug: psilocybin
    • Behavioral: Intensity of support for spiritual practice
    • Behavioral: Number of sessions
  • Experimental: 5
    Fifth of 5 groups as described in the protocol and to which volunteers are blinded
    Interventions:
    • Drug: psilocybin
    • Behavioral: Intensity of support for spiritual practice
    • Behavioral: Number of sessions
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2008)
75
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00802282
Other Study ID Numbers  ICMJE NA_00020767
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roland Griffiths, Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE
  • Fetzer Institute
  • The CSP Fund of the San Francisco Foundation
Investigators  ICMJE
Principal Investigator: Roland R Griffiths, Ph.D. Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP