HealthyPhase 1NCT02145091
Effects of Psilocybin on Behavior, Psychology and Brain Function in Long-term Meditators
A Phase 1 study testing Moderately-high dose of psilocybin, Moderately-low dose of psilocybin and Very-low dose of psilocybin in people with Healthy, run by Johns Hopkins University at 1 site in United States.
Trial summary
This is a double-blind placebo-controlled study investigating the acute and persisting effects of psilocybin on meditation, spirituality, health, well-being, prosocial attitudes, and brain functioning. 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?
- Moderately-high dose of psilocybin, Moderately-low dose of psilocybin and Very-low dose of psilocybin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 26 Dec 2019
- 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
- Some college-level education (college degree preferred)
- 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
- 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 participant does not routinely consume caffeinated beverages, he/she must agree not to do so on session days.
- Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration. The exception is caffeine. Participants will be required to be non-smokers.
- Agree not to take any Pro re-nata (PRN) medications on the mornings of drug sessions
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- 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.
- Live within driving distance of Baltimore - out-of-State residents may be eligible if they can provide their own transportation and lodging.
- Have a long-term meditation practice, ideally in a Buddhist tradition, with good familiarity with breath meditation and loving kindness meditation; preference given to those with very long-term practices
Who cannot join
- 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 fibrilation), 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 Monoamine 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.
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- More than 20% outside the upper or lower range of ideal body weight according to Metropolitan Life height and weight table
- Head trauma
- Claustrophobia
- Cardiac pacemaker
- Implanted cardiac defibrillator
- Aneurysm brain clip
- Inner ear implant
- Artificial heart valve (last 6 weeks)
- Prior history as a metal worker and/or certain metallic objects in the body
- Psychiatric Exclusion Criteria:
- Current or past history of meeting Diagnostic and Statistical Manual (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
- Has a psychiatric condition 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
This is a double-blind placebo-controlled study investigating the acute and persisting effects of psilocybin on meditation, spirituality, health, well-being, prosocial attitudes, and brain functioning.
Read the detailed description
This study will use questionnaires and functional magnetic resonance imaging (fMRI) to examine the acute and persisting effects of psilocybin on brain function, meditation, spirituality, and psychology. The majority of the study procedures -- including screening, preparatory meetings, placebo and psilocybin sessions, and a large battery of behavioral and psychological measures -- will be conducted at the investigator's laboratory at the Behavioral Pharmacology Research Unit (BPRU) on the Johns Hopkins Bayview campus. The brain imaging procedures will be conducted at F.M. Kirby Research Center at the Kennedy Krieger Institute (KKI).
- Conditions
- Healthy
- Being tested
- Moderately-high dose of psilocybin, Moderately-low dose of psilocybin, Very-low dose of psilocybin, Placebo
- Keywords
- Psilocybin, Hallucinogens, Pharmacologic Actions, Central Nervous System Agents, Therapeutic Uses, Psychotropic Drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderately-high dose of psilocybinDrug
Also called O-phosphoryl-4-hydroxy-N,N-dimethyltryptamine
Oral dose of a moderately-high dose of psilocybin.
Moderately-low dose of psilocybinDrug
Also called O-phosphoryl-4-hydroxy-N,N-dimethyltryptamine
Oral dose of a moderately-low dose of psilocybin.
Very-low dose of psilocybinDrug
Also called O-phosphoryl-4-hydroxy-N,N-dimethyltryptamine
Oral dose of a very-low dose of psilocybin.
PlaceboDrug
Also called Lactose
An oral placebo (lactose pill).
| Study group | Role | What they receive |
|---|---|---|
| One all-day session | Experimental | Participants will complete on all-day study session with a moderately-high dose of psilocybin.
Preparation will include two days of screening, and an additional 8 hours of session preparation over at least 2 days. Follow-up will consist of an interview and MRI scan one day after the all-day session, a questionnaire follow-up 2 months after the all-day session, and a final follow-up 12-18 months after the all-day session. Receives: Drug: Moderately-high dose of psilocybin; Drug: Placebo |
| Two all-day sessions | Experimental | Participants will complete two all-day study sessions, the first with placebo and the second with a moderately-high dose of psilocybin.
Preparation will include two days of screening and 8 hours of session preparation over at least 2 days, before the first all-day session. Follow-up will consist of an interview and MRI scan one day after each all-day session, a questionnaire follow-up 2 months after each all-day session, and a final follow-up 12-18 months after the second all-day session. Receives: Drug: Moderately-high dose of psilocybin; Drug: Placebo |
| Three all-day sessions | Experimental | Participants will complete three all-day study sessions, the first two with placebo and the third with a moderately-high dose of psilocybin. The majority of participants (over 90%) will be assigned to either one or two all-day sessions. A small minority of participants (less than 10%) will be assigned to three all-day sessions.
Preparation will include two days of screening and 8 hours of session preparation over at least 2 days, before the first all-day session. Follow-up will consist of an interview and MRI scan one day after each all-day session, a questionnaire follow-up 2 months after each all-day session, and a final follow-up 12-18 months after the third all-day session. Receives: Drug: Moderately-high dose of psilocybin; Drug: Placebo |
| MRI of the acute effects of psilocybin | Experimental | This is an optional arm consisting of two sessions where either placebo, a very-low dose of psilocybin, or a moderately-low dose of psilocybin will be administered. During each session, participants will undergo MRI scanning shortly after the administration of each dose. Study sessions may occur over one or two days. Participants who have previously completed an all-day session with psilocybin in this study will be eligible to volunteer for this arm. Receives: Drug: Moderately-low dose of psilocybin; Drug: Very-low dose of psilocybin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persisting Effects Questionnaire
This is a measure of changes in spirituality, personal well-being, relationships, and emotions.
Measured: 2 months and 12-18 months post-session
Hood Mysticism Scale
This measures subjective experiences associated with classical mystical experiences.
Measured: End of session day.
States of Consciousness Questionnaire
Measures subjective experience associated with classical mystical experiences.
Measured: End of session day
fMRI Resting State Functional Connectivity
Measures change in activity in brain regions that have been previously shown to be modulated by either psilocybin or meditation.
Measured: 2 months pre and 1 day post session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startMay 2014
- Primary completion26 Dec 2019
- Study completion26 Dec 2019
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145091
- Sponsor's protocol ID
- NA_00047665-2
- Status last verified
- Dec 2019
- First submitted
- 20 May 2014
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Psilocybin on Behavior, Psychology and Brain Function in Long-term Meditators
- ClinicalTrials.gov ID
- NCT02145091
- Acronym / sponsor ID
- NA_00047665-2
- Conditions
- Healthy
- Keywords
- Psilocybin, Hallucinogens, Pharmacologic Actions, Central Nervous System Agents, Therapeutic Uses, Psychotropic Drugs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- 26 Dec 2019 (actual)
- Study completion
- 26 Dec 2019 (actual)
- First posted
- 22 May 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.
This is a double-blind placebo-controlled study investigating the acute and persisting effects of psilocybin on meditation, spirituality, health, well-being, prosocial attitudes, and brain functioning.
Detailed description
This study will use questionnaires and functional magnetic resonance imaging (fMRI) to examine the acute and persisting effects of psilocybin on brain function, meditation, spirituality, and psychology. The majority of the study procedures -- including screening, preparatory meetings, placebo and psilocybin sessions, and a large battery of behavioral and psychological measures -- will be conducted at the investigator's laboratory at the Behavioral Pharmacology Research Unit (BPRU) on the Johns Hopkins Bayview campus. The brain imaging procedures will be conducted at F.M. Kirby Research Center at the Kennedy Krieger Institute (KKI).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| One all-day session | Experimental | Drug: Moderately-high dose of psilocybin, Drug: PlaceboParticipants will complete on all-day study session with a moderately-high dose of psilocybin. Preparation will include two days of screening, and an additional 8 hours of session preparation over at least 2 days. Follow-up will consist of an interview and MRI scan one day after the all-day session, a questionnaire follow-up 2 months after the all-day session, and a final follow-up 12-18 months after the all-day session. |
| Two all-day sessions | Experimental | Drug: Moderately-high dose of psilocybin, Drug: PlaceboParticipants will complete two all-day study sessions, the first with placebo and the second with a moderately-high dose of psilocybin. Preparation will include two days of screening and 8 hours of session preparation over at least 2 days, before the first all-day session. Follow-up will consist of an interview and MRI scan one day after each all-day session, a questionnaire follow-up 2 months after each all-day session, and a final follow-up 12-18 months after the second all-day session. |
| Three all-day sessions | Experimental | Drug: Moderately-high dose of psilocybin, Drug: PlaceboParticipants will complete three all-day study sessions, the first two with placebo and the third with a moderately-high dose of psilocybin. The majority of participants (over 90%) will be assigned to either one or two all-day sessions. A small minority of participants (less than 10%) will be assigned to three all-day sessions. Preparation will include two days of screening and 8 hours of session preparation over at least 2 days, before the first all-day session. Follow-up will consist of an interview and MRI scan one day after each all-day session, a questionnaire follow-up 2 months after each all-day session, and a final follow-up 12-18 months after the third all-day session. |
| MRI of the acute effects of psilocybin | Experimental | Drug: Moderately-low dose of psilocybin, Drug: Very-low dose of psilocybin, Drug: PlaceboThis is an optional arm consisting of two sessions where either placebo, a very-low dose of psilocybin, or a moderately-low dose of psilocybin will be administered. During each session, participants will undergo MRI scanning shortly after the administration of each dose. Study sessions may occur over one or two days. Participants who have previously completed an all-day session with psilocybin in this study will be eligible to volunteer for this arm. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have given written informed consent
- Some college-level education (college degree preferred)
- 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
- 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 participant does not routinely consume caffeinated beverages, he/she must agree not to do so on session days.
- Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration. The exception is caffeine. Participants will be required to be non-smokers.
Key exclusion criteria (20 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 fibrilation), 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
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 |
|---|---|---|
| Moderately-high dose of psilocybinAlso: O-phosphoryl-4-hydroxy-N,N-dimethyltryptamineOral dose of a moderately-high dose of psilocybin. | Drug | One all-day session, Three all-day sessions, Two all-day sessions |
| Moderately-low dose of psilocybinAlso: O-phosphoryl-4-hydroxy-N,N-dimethyltryptamineOral dose of a moderately-low dose of psilocybin. | Drug | MRI of the acute effects of psilocybin |
| Very-low dose of psilocybinAlso: O-phosphoryl-4-hydroxy-N,N-dimethyltryptamineOral dose of a very-low dose of psilocybin. | Drug | MRI of the acute effects of psilocybin |
| PlaceboAlso: LactoseAn oral placebo (lactose pill). | Drug | MRI of the acute effects of psilocybin, One all-day session, Three all-day sessions, Two all-day sessions |
Primary outcome
Persisting Effects Questionnaire
Time frame: 2 months and 12-18 months post-session
This is a measure of changes in spirituality, personal well-being, relationships, and emotions.
Hood Mysticism Scale
Time frame: End of session day.
This measures subjective experiences associated with classical mystical experiences.
States of Consciousness Questionnaire
Time frame: End of session day
Measures subjective experience associated with classical mystical experiences.
fMRI Resting State Functional Connectivity
Time frame: 2 months pre and 1 day post session
Measures change in activity in brain regions that have been previously shown to be modulated by either psilocybin or meditation.
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 30 Dec 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Moderately-high dose of psilocybin, Moderately-low dose of psilocybin and Very-low dose of 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 10 inclusion and 20 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 30 Dec 2019. 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?
Persisting Effects Questionnaire (time frame: 2 months and 12-18 months post-session). The study lists 4 primary outcomes in all. 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 30 Dec 2019.