HealthyPhase 1NCT00802282
Psilocybin and Spiritual Practice
A Phase 1 study testing psilocybin, Intensity of support for spiritual practice and Number of sessions in people with Healthy, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- psilocybin, Intensity of support for spiritual practice and Number of sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to May 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- psilocybin, Intensity of support for spiritual practice, Number of sessions
- Keywords
- healthy volunteers, spirituality, psilocybin, meditation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psilocybinDrug
dose manipulation as described in the protocol and to which volunteers are blinded
Intensity of support for spiritual practiceBehavioural
Volunteers will be assigned to standard or high support, as described in the protocol
Number of sessionsBehavioural
Volunteers will be assigned to either 2 or 3 sessions, as described in the protocol
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | First of 5 groups, as described in the protocol and to which volunteers are blinded Receives: Drug: psilocybin; Behavioral: Intensity of support for spiritual practice; Behavioral: Number of sessions |
| 2 | Experimental | Second of 5 groups, as described in the protocol and to which volunteers are blinded Receives: Drug: psilocybin; Behavioral: Intensity of support for spiritual practice; Behavioral: Number of sessions |
| 3 | Experimental | Third of 5 groups, as described in the protocol and to which volunteers are blinded Receives: Drug: psilocybin; Behavioral: Intensity of support for spiritual practice; Behavioral: Number of sessions |
| 4 | Experimental | Fourth of 5 groups, as described in the protocol and to which volunteers are blinded Receives: Drug: psilocybin; Behavioral: Intensity of support for spiritual practice; Behavioral: Number of sessions |
| 5 | Experimental | Fifth of 5 groups as described in the protocol and to which volunteers are blinded Receives: Drug: psilocybin; Behavioral: Intensity of support for spiritual practice; Behavioral: Number of sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hood Mysticism Scale
Measured: At end of sessions
States of Consciousness Questionnaire
Measured: At end of sessions
Persisting Effects Questionnaire
Measured: 3 weeks after each session
Secondary outcomes (5)
Daily spiritual experiences scale
Measured: 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
Measured: Baseline, 3 weeks after second session, 6 months, and 3 weeks after the third session
Blood markers of stress and immune function
Measured: Baseline, 3 weeks after second session, 6 months, and 3 weeks after the third session
Brief symptom inventory
Measured: Baseline, one week after each session, and at 6 months
Visual effects questionnaire
Measured: Baseline, 6 months, and 3 weeks after the third session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startAug 2009
- Primary completionFeb 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Fetzer Institute, The CSP Fund of the San Francisco Foundation
- Responsible party
- Principal investigator, Roland Griffiths, Johns Hopkins University
- Investigators
- Roland R Griffiths, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802282
- Sponsor's protocol ID
- NA_00020767
- Status last verified
- Feb 2016
- First submitted
- 3 Dec 2008
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 16826400Griffiths 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.
PubMed 18593735Johnson 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.
PubMed 18593734Griffiths 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.
PubMed 29020861
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Psilocybin and Spiritual Practice on Persisting Changes in Attitudes and Behavior
- ClinicalTrials.gov ID
- NCT00802282
- Acronym / sponsor ID
- NA_00020767
- Conditions
- Healthy
- Keywords
- healthy volunteers, spirituality, psilocybin, meditation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Fetzer Institute, The CSP Fund of the San Francisco Foundation
- Study start
- Aug 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 4 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: psilocybin, Behavioral: Intensity of support for spiritual practice, Behavioral: Number of sessionsFirst of 5 groups, as described in the protocol and to which volunteers are blinded |
| 2 | Experimental | Drug: psilocybin, Behavioral: Intensity of support for spiritual practice, Behavioral: Number of sessionsSecond of 5 groups, as described in the protocol and to which volunteers are blinded |
| 3 | Experimental | Drug: psilocybin, Behavioral: Intensity of support for spiritual practice, Behavioral: Number of sessionsThird of 5 groups, as described in the protocol and to which volunteers are blinded |
| 4 | Experimental | Drug: psilocybin, Behavioral: Intensity of support for spiritual practice, Behavioral: Number of sessionsFourth of 5 groups, as described in the protocol and to which volunteers are blinded |
| 5 | Experimental | Drug: psilocybin, Behavioral: Intensity of support for spiritual practice, Behavioral: Number of sessionsFifth of 5 groups as described in the protocol and to which volunteers are blinded |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psilocybindose manipulation as described in the protocol and to which volunteers are blinded | Drug | 1, 2, 3, 4, 5 |
| Intensity of support for spiritual practiceVolunteers will be assigned to standard or high support, as described in the protocol | Behavioural | 1, 2, 3, 4, 5 |
| Number of sessionsVolunteers will be assigned to either 2 or 3 sessions, as described in the protocol | Behavioural | 1, 2, 3, 4, 5 |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Background: PubMed 16826400Griffiths 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.
- Background: PubMed 18593735Griffiths 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.
- Background: PubMed 18593734Johnson 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.
- Derived from this study: PubMed 29020861Griffiths 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 WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland R Griffiths, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing psilocybin, Intensity of support for spiritual practice and Number of sessions in people with Healthy, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hood Mysticism Scale (time frame: At end of sessions). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00802282, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.