Safety Study of Home Use of Microdose Psilocybin in Healthy Adults Aged 21 to 60

What this Trial Is About

Researchers are evaluating the safety of administering microdoses of psilocybin trihydrate at home to healthy adults aged 21 to 60 years. The study aims to identify which doses can be safely taken outside a clinical setting by using ascending doses and a randomized placebo in a controlled laboratory environment. This Phase 1 study involves 20 participants and is sponsored by Johns Hopkins University. Participants will receive single oral microdoses of psilocybin trihydrate at 1.2 mg, 2.0 mg, 3.0 mg, and 4.2 mg, as well as a placebo, across five double-blind dosing sessions at the research site. The doses are given in ascending order on separate days. Baseline questionnaires and safety assessments will be completed before and during each dosing session. The study will determine the highest dose that meets safety criteria for at-home use for each participant. Participants will undergo an initial medical and psychological screening lasting about 4 hours, which may be partly remote. During each dosing visit, safety checks including blood pressure, heart rate, field sobriety tests, and psychological status exams will be conducted at specific intervals post-dose. Driving performance will be assessed at baseline and after dosing using a simulation. The total participation includes screening and five dosing sessions with monitoring to evaluate safety outcomes related to vital signs, sobriety, psychology, and driving ability.

Safety for Home Administration of Microdose Psilocybin Use