Effects of psilocybin on brain activity and thought processes
Effects of Psilocybin on Electrophysiology and the Dynamic Content of Thought
This study tests how psilocybin from mushrooms affects brain activity and thinking in healthy people to see if it can improve creativity and memory.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05301608 on ClinicalTrials.gov |
What this trial studies
This research investigates how psilocybin, a compound found in certain mushrooms, influences brain activity and thought dynamics in healthy individuals. The study employs a double-blind, placebo-controlled, within-subject design, utilizing computerized tasks alongside electroencephalography (EEG) and magnetic resonance imaging (MRI) to assess the drug's effects on creativity, memory, and brain responses. Participants will receive a moderate dose of psilocybin and undergo various assessments to understand its acute psychological and neural impacts, potentially paving the way for advancements in psychedelic medicine and consciousness studies.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 18 to 75 who are psychologically stable and fluent in English.
Not a fit: Patients with significant medical or psychiatric issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of consciousness and lead to optimized applications of psychedelic medicine.
How similar studies have performed: Other studies have shown promising results in understanding the effects of psychedelics on brain function, suggesting this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 to 75 years old * Have given written informed consent * Have at least a high-school level of education or equivalent (e.g. GED) and be fluent in English * 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 morning of the drug session day. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on the session day. * Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration. The exception is caffeine. * Agree not to take any "as-needed" 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. * Have used a psychedelic drug (e.g. lysergic acid diethylamide(LSD)/acid, psilocybin mushrooms, ayahuasca) at least five times in their lifetime. * Proof of COVID-19 vaccination 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 fibrilation), artificial heart valve, or heart attack 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 serotonergic effect, including mono-amine oxidase inhibitors (MAOIs). For individuals who have intermittent or "as needed" use of such medications, psilocybin sessions will not be conducted until at least five 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 * Current or past history of meeting Diagnostic and Statistical Manual, version 5 (DSM-5) criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition) * Current or past history within the last five years of meeting DSM-5 criteria for a moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine) * Have a first or second-degree relative with bipolar I disorder, schizophrenia spectrum, or other psychotic disorders (except substance/medication-induced or due to another medical condition) * Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin * Has history of migraine, tension, or other recurring headaches. * Head trauma, traumatic brain injury, or concussion with loss of consciousness for \>2 minutes * Contraindications for magnetic resonance imaging (MRI) (e.g. claustrophobia incompatible with MRI scanning, medical device or implant incompatible with MRI, prior history as a metal worker and/or certain metallic objects in the body) * Left-handedness (assessed by the Edinburgh Handedness Inventory)
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Center for Psychedelic and Consciousness Research — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Frederick S Barrett, PhD — Johns Hopkins University
- Study coordinator: Gabi Lofland
- Email: gloflan1@jhmi.edu
- Phone: (410) 550-2253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.