HealthyPhase 1NCT02243813
Effects of Psilocybin-facilitated Experience on the Psychology and Effectiveness of Professional Leaders in Religion
A Phase 1 study testing Psilocybin in people with Healthy, run by Johns Hopkins University at 1 site in United States.
Trial summary
The current protocol is a pilot study of the effects and possible utility of psilocybin-facilitated experiences for professional religious leaders. Read more about this study
- Who is it for?
- Ages 25 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Psilocybin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 31 May 2024
- 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 25 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have given written informed consent
- College graduation or equivalent and graduate/professional training.
- Recognized leadership position in a well-established religious organization; professional activities must include significant time interacting with those seeking religious/spiritual guidance or support.
- 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
- During the next year there is no foreseen likelihood for a major potentially life-altering event for her or himself or a close family member (e.g. retirement or major career change for the volunteer; life-threatening illness of a spouse or child of the volunteer)
- 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 psilocybin session days. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on session days.
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- Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, 24 hours before and after each drug administration. The exception is caffeine. Participants will be required to be either a non-smoker or a non-daily smoker.
- Agree not to take any Pro-re-nata (PRN) medications on the mornings of drug sessions
- Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration.
- Agree that for one week before each drug 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.
- 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 Electrocardiogram (ECG) abnormality (e.g., symptomatic atrial fibrillation), or Transient Ischemic Attack (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 Mono amine Oxidase (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 according to Metropolitan Life height and weight table
- Psychiatric Exclusion Criteria:
- Current or past history of meeting Diagnostic and Statistics Manual (DSM)-5 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-5 criteria for alcohol or substance use disorder (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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral Biology Research Center, Johns Hopkins Bayview
Baltimore, Maryland, 21224
About this study
The current protocol is a pilot study of the effects and possible utility of psilocybin-facilitated experiences for professional religious leaders.
- Conditions
- Healthy
- Being tested
- Psilocybin
- Keywords
- Psilocybin, Pharmacologic Actions, Psychotropic Drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Participants will receive 20 mg/70 kg of psilocybin in the first session and will receive either 20 or 30 mg/70 kg in the second session.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Participation | Experimental | Participants will begin the psilocybin intervention 6 months after study enrollment. Receives: Drug: Psilocybin |
| Immediate Participation | Experimental | Participants will begin psilocybin intervention immediately after study enrollment. Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interim Questionnaire
This questionnaire asks about experiences and changes in attitudes, mood and behavior that occurred during the past 5 months. The questionnaire includes questions about salient spiritual experiences, changes in spiritual practices, changes in attitudes, moods, social interactions, and other behaviors related to participants' religious/spiritual vocation.
Measured: 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startMar 2015
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland R Griffiths, Ph.D., Principal investigator, JHUSOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243813
- Sponsor's protocol ID
- IRB00036973
- Status last verified
- Jun 2024
- First submitted
- 16 Sep 2014
- Last updated
- 18 Jun 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Psilocybin-facilitated Experience on the Psychology and Effectiveness of Professional Leaders in Religion
- ClinicalTrials.gov ID
- NCT02243813
- Acronym / sponsor ID
- IRB00036973
- Conditions
- Healthy
- Keywords
- Psilocybin, Pharmacologic Actions, Psychotropic Drugs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 18 Sep 2014 (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.
The current protocol is a pilot study of the effects and possible utility of psilocybin-facilitated experiences for professional religious leaders.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Participation | Experimental | Drug: PsilocybinParticipants will begin the psilocybin intervention 6 months after study enrollment. |
| Immediate Participation | Experimental | Drug: PsilocybinParticipants will begin psilocybin intervention immediately after study enrollment. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Have given written informed consent
- College graduation or equivalent and graduate/professional training.
- Recognized leadership position in a well-established religious organization; professional activities must include significant time interacting with those seeking religious/spiritual guidance or support.
- 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
- During the next year there is no foreseen likelihood for a major potentially life-altering event for her or himself or a close family member (e.g. retirement or major career change for the volunteer; life-threatening illness of a spouse or child of the volunteer)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PsilocybinParticipants will receive 20 mg/70 kg of psilocybin in the first session and will receive either 20 or 30 mg/70 kg in the second session. | Drug | Delayed Participation, Immediate Participation |
Primary outcome
Interim Questionnaire
Time frame: 6 months after enrollment
This questionnaire asks about experiences and changes in attitudes, mood and behavior that occurred during the past 5 months. The questionnaire includes questions about salient spiritual experiences, changes in spiritual practices, changes in attitudes, moods, social interactions, and other behaviors related to participants' religious/spiritual vocation.
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 18 Jun 2024.
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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
JHUSOM
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 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 23 inclusion and 0 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 18 Jun 2024. 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?
Interim Questionnaire (time frame: 6 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2024.