Safety for Home Administration of Microdose Psilocybin Use
ConditionPsychedelic Experiences
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-60
SponsorJohns Hopkins University
About this trial
The goal of this laboratory study is to establish whether and which microdoses of psilocybin are safe to administer at home to healthy participants.
Eligible participants will be given ascending doses of psilocybin trihydrate and a single, interspersed, randomized placebo on separate days in double-blind fashion. The participants will be asked to complete questionnaires and undergo safety assessments.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
21 to 60 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
Disqualifiers
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 fibrillation, corrected QT interval (QTc) > 450 msec), artificial heart valve, or transient ischemic attack (TIA) in the past year
Epilepsy
Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
Trial design
Design model
Sequential
Treatments tested in this trial
psilocybin trihydrate
DrugMicrodoses of psilocybin trihydrate will be administered to participants (1.2 mg, 2.0 mg, 3.0 mg, and 4.2 mg).
Placebo
DrugParticipants will receive a capsule identical in appearance to the active drug that contains an inactive substance.
Treatment groups
20 Participants
are divided into 5 treatment groupsGroup A: 1.2 mg psilocybin trihydrate microdoseExperimental treatment 1 intervention
Group B: 2.0 mg psilocybin trihydrate microdoseExperimental treatment 1 intervention
Group C: 3.0 mg psilocybin trihydrate microdoseExperimental treatment 1 intervention
Group D: 4.2 mg psilocybin trihydrate microdoseExperimental treatment 1 intervention
Group E: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Systolic and Diastolic Blood pressure (mmHg)
Blood pressure will be measured at 60, 120, 180, and 240 minutes. A dose will be deemed safe for home dosing if participants do not have elevations in blood pressure beyond threshold values; systolic blood pressure \> 150 mmHg, diastolic blood pressure \> 90mmHg) at any timepoint.
Time frame
Baseline, 1-4 hours post dose2
Heart rate in beats per minute (bpm)
Heart rate will be measured at 60, 120, 180, and 240 minutes. A dose will be deemed safe for home dosing if participants do not have elevations in heart rate beyond threshold value of \> 110 bpm
Time frame
Baseline; 1-4 hours post dose3
Field sobriety testing
The standardized battery of field sobriety tests includes: The Walk-and-Turn (W\&T), One-Leg Stand (OLS), Horizontal Gaze Nystagmus (HGN). A dose will be deemed safe for home dosing if participants pass field sobriety testing at time of expected peak psilocybin effects. The cumulative amount of clues observed across these tasks (out of a possible 22 clues) will be reported.
Time frame
Baseline; 90 minutes post dose4
Number of participants with normal or abnormal psychological status as assessed by a psychiatric mental status exam
The Psychiatric Mental Status Exam will be a clinical interview identical to that performed by psychiatrists in daily clinical practice and will assess and document the participant's mood, affect, thought process (including the presence of formal thought disorder), paranoia, delusions, hallucinations, other perceptual alterations, speech (including rate, volume, prosody, whether or not speech is pressured), suicidal thoughts, and orientation to person, place and time. A dose will be deemed safe for home dosing if there is no evidence of abnormal psychological status on a psychiatric mental status exam performed by a blinded study psychiatrist. There is no formal scoring rubric for this outcome. A psychiatrist will use their clinical judgment to evaluate whether a participant has normal or abnormal psychological status based on a clinical interview.
Time frame
120 minutes post doseSecondary outcomes
1
Driving Performance as assessed by The Systems Technology, Inc. Simulation (STISIM) Drive® M4000-R Console
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. Specific driving outcomes include: lateral control (i.e., SDLP), longitudinal control (i.e., standard deviation of speed (SDSP), mean speed, number of speed exceedances), total accidents (sum of number of collisions, pedestrians hit, etc.), total rule violations (sum of number of missed stop signs, illegal turns, etc.), and distance to lead vehicles. Scores range from 0 to no upper limit. Higher scores represent higher magnitude of driving impairment.
Time frame
Baseline; 60 minutes post doseSponsors and contacts
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Johns Hopkins University
Lead sponsor
Private Philanthropic Funds
Collaborator
Source ClinicalTrials.gov