RecruitingPhase 1NCT06450210

Safety for Home Administration of Microdose Psilocybin Use

Sponsor

Johns Hopkins University

Enrollment

20 participants

Start Date

Dec 6, 2024

Study Type

INTERVENTIONAL

Conditions

Psychedelic Experiences

Summary

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

Min Age: 21 YearsMax Age: 60 Years

Inclusion Criteria9

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
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 (PRN) 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.
Licensed to drive (for driving simulator test).

Exclusion Criteria13

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
Currently taking psychoactive drugs (prescribed or not) on a daily basis. This includes nicotine but excepts caffeine.
Currently taking on a regular (e.g. daily) basis any medications having a centrally-acting serotonergic effect, including monoamine oxidase inhibitors (MAOIs). For individuals who have intermittent or PRN 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
History of schizophrenia spectrum disorder
History of bipolar I disorder
History of substance induced psychotic disorder
Current history of meeting Diagnostic and Statistical Manual (DSM)-5 criteria for a moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine)
Have a first degree relative with bipolar I disorder, or schizophrenia spectrum disorder.
Cardiovascular screening: To qualify for the study, blood pressure at screening will be less than 130 mmHg systolic, 80 mmHg diastolic, and 90 beats per minute; mean heart rate must also be no less than 40 beats per minute. Blood pressure will be taken while subjects are at rest and have been seated or supine for at least 5 minutes.