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 March 1, 2024 DOI: 10.1016/j.euroneuro.2023.12.006 (opens in new tab)
Study at a glance
AI-extracted from the abstract| 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 Psychedelics hallucinogens Medical studies Psychedelic drugs Drug trials DMT N |
| Citations | 25 |
| Key points | 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).
Comparable studies
Other non-randomized and open-label trials on 5-MeO-DMT, most cited first.
Citations in the library
Cited by 26
- Rapid and sustained antidepressant effects of vaporized N,N-dimethyltryptamine: a phase 2a clinical trial in treatment-resistant depression. Neuropsychopharmacology May 1, 2025
- Psychedelics in neuroinflammation: Mechanisms and therapeutic potential Progress in Neuro-Psychopharmacology and Biological Psychiatry January 31, 2025
- Benefits and Challenges of Ultra-Fast, Short-Acting Psychedelics in the Treatment of Depression American Journal of Psychiatry 2025
- The Antidepressant Effects of Vaporized N,N-Dimethyltryptamine: An Open-Label Pilot Trial in Treatment-Resistant Depression. Psychedelic Medicine March 1, 2025
- Acute dose-dependent effects and self-guided titration of continuous N,N-dimethyltryptamine infusions in a double-blind placebo-controlled study in healthy participants Neuropsychopharmacology December 19, 2024
and 21 more in the library
Cites 32
- Trial of Psilocybin versus Escitalopram for Depression New England Journal of Medicine April 14, 2021
- Human hallucinogen research: guidelines for safety. Journal of Psychopharmacology July 1, 2008
- Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. New England Journal of Medicine November 3, 2022
- Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Psychopharmacology November 8, 2017
- MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nature Medicine June 1, 2021
and 27 more in the library