Current 5-MeO-DMT Clinical Trials
Usona has recently been granted IND approval to conduct a phase 1, first-in-human, double-blind, placebo-controlled, randomized, single and multiple ascending dose study to determine the safety, tolerability, and pharmacokinetics of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) administered by intramuscular injection in healthy volunteers.
This study is in the start-up phase and not yet open to enrollment. Please check back soon for updates.
5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) is a psychoactive indolealkylamine that is produced by a number of plants and animals, but is best known to be present, along with its active, O-demethylated metabolite bufotenine, in the skin glands of a certain toxic desert toad (Incilius alvarius, formerly Bufo alvarius).
5-MeO-DMT, first synthesized in 1936 (Hoshino 1936), is closely related in structure to serotonin (5-hydroxytryptamine [5-HT]), and therefore has a similar molecular structure to the classic psychedelics DMT (N,N-dimethyltryptamine) and psilocybin. However, its pharmacological activity may be distinct. 5-MeO-DMT works mainly as a selective serotonin receptor agonist at the 5-HT1A and 5-HT2A receptors, with functional dominance of the 5‑HT1A subtype being suggested by numerous researchers (Spencer 1987, Winter 2000, Krebs-Thomson 2006, Shen 2010a).
The therapeutic efficacy of psychedelic drugs is unknown but hypothesized to occur in part through pharmacological action on serotonergic functioning, stimulation of neurotrophic growth factors and neuroplastic changes (Bogenschutz & Johnson 2016, Barrett 2020), and through psychological mechanisms such as reprocessing of traumatic content, emotional breakthroughs, mystical-type experiences, and fostering adaptive changes in personality (Mithoefer 2016, Mithoefer 2018, MacLean 2011, Wagner 2017). Previous research with other psychoactive tryptamines has demonstrated a possible predictive correlation between psychedelic experience and a positive therapeutic response in patients suffering from various psychiatric conditions (Roseman 2018, Romeo 2021, Ross 2016, Griffiths 2016).
As a potentially potent, fast-acting agent with short duration of psychedelic effect in humans, 5-MeO-DMT may have significant health care implications due to cost-savings and increased patient accessibility.