Study of Psilocybin Effects on Self-awareness in Healthy Adults Aged 21 to 60

What this Trial Is About

Researchers are studying how psilocybin, a psychedelic substance, affects self-awareness in healthy adults aged 21 to 60. The study explores changes in various components of self-awareness and brain connectivity, which may help understand the clinical potential of psychedelics for conditions like depression, OCD, and anxiety. It is a randomized, triple-blind early phase 1 trial comparing psilocybin with an active placebo. Participants will be randomly assigned to receive either 15 mg of psilocybin or 100 mg of niacin as a placebo. Assessments will be conducted one week before, immediately after, and one week after dosing. Those initially receiving placebo may be invited to receive psilocybin later in an open-label extension, depending on availability. The study uses tasks, questionnaires, and near-infrared spectroscopy to measure changes in self-awareness and brain activity. Participants will complete various tasks and questionnaires measuring self-awareness, emotional regulation, interoceptive awareness, and ego dissolution before and after substance administration. Near-infrared spectroscopy will assess brain activity related to self-awareness. The main outcome is the change in global metacognitive judgment from baseline to one week post-dose. Safety and adherence are monitored, and the entire study period spans several weeks with follow-up assessments.

Changes in Self-awareness Induced by Psychoactive Substances: an Experimental Study With Psilocybin.