Three psilocybin doses (5–20 mg) in healthy volunteers showed dose-dependent functional connectivity changes.
This randomized controlled trial (RCT) enrolled 10 healthy volunteers to assess the effects of psilocybin on functional connectivity. Participants received three psilocybin doses ranging between 5 and 20 mg administered in a randomized and blinded order, with at least one week between doses. The comparator was baseline measurements. Follow-up assessments occurred one week after a single dose.
Main results demonstrated dose-dependent changes in edges, with 77 edges (76 increases, 1 decrease) of 1275 possible showing alteration. Specifically, one of 21 possible between-network increases was observed, while one of seven possible within-network increases survived correction. Additionally, many network-level associations survived correction regarding the positive association between alterations in conscious state and connectivity changes. Dose level and acute subjective effects were positively associated with multiple functional connectivity changes.
Safety and tolerability data were not reported, as were serious adverse events, discontinuations, and overall tolerability. A key limitation is that the study included healthy volunteers only, and none of the edge-level changes survived multiple-comparison correction. The study phase and publication type were not reported, and funding or conflicts were not reported.
Further research is warranted to characterize these sustained effects and their therapeutic relevance to inform studies adopting similar dosing regimens in clinical cohorts. The current evidence does not establish therapeutic efficacy or safety profiles for clinical populations.
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