Clinical TrialHealthy VolunteersPsilocybinPlaceboRecruiting

Effects of Psilocybin on Electrophysiology and the Dynamic Content of Thought

This double-blind, placebo-controlled, full cross-over trial (n=30) will study the effects of psilocybin (10mg/70kg) on brain activity and thought dynamics in healthy volunteers.

Target Enrollment
30 participants
Study Type
Phase I/II interventional
Design
Randomized, quadruple Blind

Detailed Description

This double-blind, placebo-controlled, within-subject crossover study in healthy volunteers uses EEG and MRI during cognitive tasks and naturalistic stimuli to examine acute effects of psilocybin (10 mg/70 kg) on thought dynamics, creativity, memory, and shared versus individual brain responses.

Psilocybin and matching placebo are administered as size 0 blue gelatin capsules; sessions last approximately 6 hours with a washout between visits. Primary outcomes include electrophysiological measures, MRI responses, and behavioural task performance.

Study Protocol

Preparation

sessions

Dosing

2 sessions
360 min each

Integration

sessions

Study Arms & Interventions

Psilocybin

experimental

Single oral dose of psilocybin (10 mg/70 kg) in a full crossover design.

Interventions

  • Psilocybin10 mg
    via Oral• single dose• 1 doses total

    10 mg per 70 kg; encapsulated cGMP, size 0 blue gelatin capsule; acute effects ~6 hours.

Placebo

inactive

Matching inert placebo capsule in crossover.

Interventions

  • Placebo
    via Oral• single dose• 1 doses total

    Microcrystalline cellulose in size 0 blue gelatin capsule.

Participants

Ages
18 – 75
Sexes
Male & Female

Inclusion 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

  • 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)

Study Details

  • Status
    Recruiting
  • Phase
    Phase IPhase II
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment30 participants
  • Timeline
    Start: 2022-03-03
    End: 2024-12-31
  • Compounds
    PsilocybinPlacebo
  • Topic
    Healthy Volunteers

Locations

Johns Hopkins Center for Psychedelic and Consciousness Research — Baltimore, Maryland, United States

Your Library