Participants and screening procedures
psychedelic drug, psychiatric, suicide ideation
Fifteen healthy participants (8 females and 7 males, age (mean ± SD): 32.4 ± 7.5 years, range 24–48 years) completed four study visits. Participants gave written informed consent before beginning the study in accordance with the ethical review of the Advarra IRB (#Pro00059548), which approved this study, and the Declaration of Helsinki. Pre-screening eligibility determination included the following inclusion criteria: adults between the ages of 21–50; in good general health (as ascertained by medical and psychiatric history and physical examination including vital sign measurements); prior experience (at least once but not more than 20 times) with a classical psychedelic drug (e.g., LSD, psilocybin, mescaline, etc.) or ketamine (if known, no more than seven previous 60 mg daily doses) as confirmed by the study clinician; body mass index between 18 and 30 kg/mParticipants received monetary compensation. Once participants consented to participate in the study, they underwent a physical exam, medical history, psychiatric history, and assessment for suicide ideation by the study clinician. Vitals, height, and weight were also measured, and demographic information was collected. Participants then did a short breathing challenge while wearing the Kernel Flow1 TD-fNIRS headset to simulate what future study visits would feel like. Lab tests (complete metabolic panel, pregnancy test, and drug screen) were completed and reviewed by the study clinician no more than 14 days before the first dosing visit. A total of 15 participants completed all of the study visits. Participants were given the option for an additional meeting with the study clinician to ask more detailed questions about what to expect and how to prepare for dosing visits.