PES

Safety and tolerability of multiple sublingual microdoses of 5-MeO-DMT in adults with moderate symptoms of depression and/or anxiety: a randomized, double-blind, placebo-controlled study

This Phase I clinical trial (n=36) of sublingual 5-MeO-DMT (6-12 mg weekly doses over four weeks) in adults with moderate to high anxiety/depression demonstrated good safety and tolerability with no significant adverse events, rapid absorption with peak plasma concentrations at 20 minutes, dose-dependent neurophysiological modulation without full psychedelic effects, and maintenance of normal cognitive and behavioral function.

Published

July 15, 2025

Journal

Neuropsychopharmacology

Authors

Beatriz, M., Millón, B., Noguera, L., Bruno, D., Vita, L., Zanino, M., Kassuha, D. E., Ortiz, J. E., Feresin, G. E., Díaz-Dellavalle, P., Orosco, L., Garcés, M. A., Diez, P., Albarracín, S. G., Bruno, M. A.