Methods

Screening and Protocol

A pre-screening questionnaire was utilized to select appropriate candidates for enrollment. Potential subjects were provided the questionnaire via email. Qualifying subjects were referred to clinic locations in either Denver or Basalt, CO for a single, half-day visit. Non-qualifying subjects received a thank-you for completing the questionnaire. Non-qualifying subject information was not retained.

Upon arrival at the clinic for the study, subjects completed the Informed Consent process, and were interviewed about health conditions, and medications and supplements they take. A baseline WAVi QEEG, or quantitative electro-encephalogram, aka “brain-mapping” scan was performed. WAVi is an objective diagnostic tool that measures electrical activity in the brain.

Subjects were then given a 1mg tested microdose of psilocybin administered as powder from a capsule mixed with hot tea. By mixing the contents of the 1mg capsule with hot tea, the chiton surrounding the mushroom cells is dissolved, releasing the fungal beta glucans and functional alkaloids, including psilocybin, more quickly than swallowing the capsule and waiting for it to be digested prior to absorption.

Following administration of the study medication, the subject had another brief interview about past psychedelic use, and an emotional state questionnaire. Then the Stroop Cognition baseline test was explained and completed by the subject with a volunteer timing the test. Every 30 minutes, the subject was asked if they felt any effects from the study medication. One subject requested additional study medication, which was provided.

When subjects reported they were ready, a second WAVi scan was performed. The Stroop Cognition test and emotional state questionnaire were repeated. All subjects were questioned about mental state, side-effects experienced, and adverse events prior to release. 24 hours after study day, participants were telephoned and asked if any additional side-effects or adverse events occurred. None were reported.

Data

Results By Study Assessment Tools

WAVi QEEG – This forms the bulk of the objective data. The 3 right-most scores are the high-dose psilocybin user followed by 2 football players for comparison. The 3 very high P300 initial scores are persons with previous concussions or TBIs; 2 psilocybin subjects and a football player control subject. Those with the worst initial scores showed the greatest improvements in WAVi voltages, P300 scores, and reaction times, following the study drug.

Stroop Cognition Test – the most commonly reported side effect of psilocybin and other hallucinogens is distorted vision and/or visual disturbances. Thus, we chose the Stroop visual cognition test where the names of colors are spelled out in different colored ink at our Denver clinic. Our Basalt clinic lacks a color printer, so that location used the colorblind version of the Stroop test. That version has black and white shapes with the name of another shape inside it. With one notable exception, all subjects had slightly faster Stroop times and zero errors after the microdose. The exception subject had a recent biotoxin exposure. She had 1 error before the dose and 11 after; however her speech went from aphasic to fluid after microdosing.

Clinical Data – Subjective assessment questions were asked at baseline and after. All subjects stated they felt “happier” and had “greater awareness of the clinic environment” following the microdose.

Results

Two WAVi tests were used as controls: a psychedelic guide who has taken high doses of psilocybin for 20 years and a retired NFL player with multiple previous concussions. After comparing, “Don’t play football” would be our conclusion. But pilot studies only assess safety. Every subject reported improved mood and mental focus. Two subjects had striking results. One began the day visibly stressed and tense, the other with moderate aphasia making communication difficult. Both left in a much improved state following a very small dose of psilocybin.

We would like a larger cohort study in the future to further test our hypothesis that a 1-5mg dose of psilocybin is a safe range for self-administered microdosing.