Safety and tolerability of inhaled N,N-Dimethyltryptamine (BMND01 candidate): A phase I clinical trial.
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
European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology March 1, 2024 DOI: 10.1016/j.euroneuro.2023.12.006 via PubMed
Summary
AI-generated from the abstractInhaled N,N-Dimethyltryptamine (DMT) produces dose-dependent increases in the intensity, positive valence, and perceptual effects of subjective experiences, with only mild, transient, and self-limited increases in blood pressure and heart rate. No changes in safety blood biomarkers or serious adverse events occurred. The acute effects last around 10 minutes, offering a potentially cost- and time-effective alternative to longer-acting oral psychedelics for clinical use in mood disorders. This open-label, single-ascending, fixed-order, dose-response study in 27 healthy volunteers tested five dose pairs (5/20 mg through 15/60 mg) of inhaled DMT (BMND01 candidate).
Study at a glance
| Characteristics | Open-label, single-ascending, fixed-order, dose-response study Peer reviewed |
|---|---|
| Sample size | 27 |
| Population | Healthy volunteers |
| Intervention | Inhaled DMT (BMND01 candidate) |
| Dose | 5/20 mg, 7.5/30 mg, 10/40 mg, 12.5/50 mg, or 15/60 mg |
| Topics | 5-MeO-DMT DMT |
| Keywords | Entheogens Clinical trial Dose-response study Mood disorders N,N-Dimethyltryptamine |
| Citations | 25 |
| Key finding | Inhaled DMT dose-dependently increased subjective intensity, valence, and perceptual ratings with only mild, transient cardiovascular effects and no serious adverse events. |
Abstract
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).