- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00802282
Psilocybin and Spiritual Practice
February 23, 2016 updated by: Roland Griffiths, Johns Hopkins University
Effects of Psilocybin and Spiritual Practice on Persisting Changes in Attitudes and Behavior
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
First of 5 groups, as described in the protocol and to which volunteers are blinded
|
dose manipulation as described in the protocol and to which volunteers are blinded
Volunteers will be assigned to standard or high support, as described in the protocol
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
|
dose manipulation as described in the protocol and to which volunteers are blinded
Volunteers will be assigned to standard or high support, as described in the protocol
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
|
dose manipulation as described in the protocol and to which volunteers are blinded
Volunteers will be assigned to standard or high support, as described in the protocol
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
|
dose manipulation as described in the protocol and to which volunteers are blinded
Volunteers will be assigned to standard or high support, as described in the protocol
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
|
dose manipulation as described in the protocol and to which volunteers are blinded
Volunteers will be assigned to standard or high support, as described in the protocol
Volunteers will be assigned to either 2 or 3 sessions, as described in the protocol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hood Mysticism Scale
Time Frame: At end of sessions
|
At end of sessions
|
States of Consciousness Questionnaire
Time Frame: At end of sessions
|
At end of sessions
|
Persisting Effects Questionnaire
Time Frame: 3 weeks after each session
|
3 weeks after each session
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Daily spiritual experiences scale
Time Frame: Baseline, 3 weeks after second session, 6 months, and 3 weeks after the third session
|
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
|
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
|
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
|
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
|
Baseline, 6 months, and 3 weeks after the third session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Roland R Griffiths, Ph.D., Johns Hopkins University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Griffiths RR, Richards WA, McCann U, Jesse R. Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance. Psychopharmacology (Berl). 2006 Aug;187(3):268-83; discussion 284-92. doi: 10.1007/s00213-006-0457-5. Epub 2006 Jul 7.
- Griffiths R, Richards W, Johnson M, McCann U, Jesse R. Mystical-type experiences occasioned by psilocybin mediate the attribution of personal meaning and spiritual significance 14 months later. J Psychopharmacol. 2008 Aug;22(6):621-32. doi: 10.1177/0269881108094300. Epub 2008 Jul 1.
- Johnson M, Richards W, Griffiths R. Human hallucinogen research: guidelines for safety. J Psychopharmacol. 2008 Aug;22(6):603-20. doi: 10.1177/0269881108093587. Epub 2008 Jul 1.
- Griffiths RR, Johnson MW, Richards WA, Richards BD, Jesse R, MacLean KA, Barrett FS, Cosimano MP, Klinedinst MA. Psilocybin-occasioned mystical-type experience in combination with meditation and other spiritual practices produces enduring positive changes in psychological functioning and in trait measures of prosocial attitudes and behaviors. J Psychopharmacol. 2018 Jan;32(1):49-69. doi: 10.1177/0269881117731279. Epub 2017 Oct 11.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
December 3, 2008
First Submitted That Met QC Criteria
December 3, 2008
First Posted (Estimate)
December 4, 2008
Study Record Updates
Last Update Posted (Estimate)
February 24, 2016
Last Update Submitted That Met QC Criteria
February 23, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00020767
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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