Safety and tolerability of inhaled N,N-Dimethyltryptamine (BMND01 candidate): A phase I clinical trial

This open-label, single-ascending, fixed-order dose-response study (n=27) investigates the safety and tolerability of inhaled DMT. The healthy volunteers received varying doses of inhaled DMT (5-60mg). Preliminary findings indicate dose-dependent increases in intensity, valence, and perceptual ratings, with no significant safety concerns, suggesting inhaled DMT as a potentially efficient and safe administration method.

Abstract of Safety and tolerability of inhaled N,N-Dimethyltryptamine

“Psychedelics are being increasingly examined for their therapeutic potential in mood disorders. While the acute effects of ayahuasca, psilocybin, and lysergic acid diethylamide (LSD) last over several hours, inhaled N,N-Dimethyltryptamine (DMT) effects last around 10 min, which might provide a cost- and time-effective alternative to the clinical application of oral psychedelics. We aimed at investigating the safety and tolerability of inhaled DMT (BMND01 candidate). We recruited 27 healthy volunteers to receive a first, lower dose and a second, higher dose (5/20 mg, 7.5/30 mg, 10/40 mg, 12.5/50 mg, or 15/60 mg) of inhaled DMT in an open-label, single-ascending, fixed-order, dose-response study design. We investigated subjective experiences (intensity, valence, and phenomenology), physiological effects (blood pressure, heart rate, respiratory rate, blood oxygen saturation, body temperature), biochemical markers (liver, kidney, and metabolic functions), and adverse events during the acute and post-acute effects of DMT. DMT dose-dependently increased intensity, valence and perceptual ratings. There was a mild, transient, and self-limited increase in blood pressure and heart rate. There were no changes in safety blood biomarkers and no serious adverse events. DMT dose-dependently enhanced subjective experiences and positive valence. Inhaled DMT might be an efficient, non-invasive, safe route of administration, which might simplify the clinical use of this substance. This is the first clinical trial to test the effects of inhaled DMT (BMND01 candidate).”

Authors: Marcelo Falchi-Carvalho, Isabel Wießner, Sérgio Ruschi B. Silva, Lucas O. Maia, Handersson Barros, Sophie Laborde, Flávia Arichelle, Sam Tullman, Natan Silva-Costa, Aline Assunção, Raissa Almeida, Érica J. Pantrigo, Raynara Bolcont, José Victor Costa-Macedo, Emerson Arcoverde, Nicole Galvão-Coelho, Draulio B. Araujo & Fernanda Palhano-Fontes

Summary of Safety and tolerability of inhaled N,N-Dimethyltryptamine