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Safety and tolerability of inhaled N,N-Dimethyltryptamine (BMND01 candidate): A phase I clinical trial.
Falchi-Carvalho, Marcelo; Wießner, Isabel; Silva, Sérgio Ruschi B; O Maia, Lucas; Barros, Handersson; Laborde, Sophie; Arichelle, Flávia; Tullman, Sam; Silva-Costa, Natan; Assunção, Aline; Almeida, Raissa; Pantrigo, Érica J; Bolcont, Raynara; Costa-Macedo, José Victor; Arcoverde, Emerson; Galvão-Coelho, Nicole; Araujo, Draulio B; Palhano-Fontes, Fernanda.
Afiliação
  • Falchi-Carvalho M; Biomind Labs, Brookfield Place, 181 Bay Street, Suite 1800, Toronto, ON M5J 2T9, Canada; Department of Clinical Medicine, Health Science Center, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.
  • Wießner I; Brain Institute, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.
  • Silva SRB; Brain Institute, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.
  • O Maia L; Brain Institute, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.
  • Barros H; Graduate Program in Health Sciences, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.
  • Laborde S; Graduate Program in Health Sciences, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.
  • Arichelle F; Brain Institute, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.
  • Tullman S; Brain Institute, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.
  • Silva-Costa N; Brain Institute, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.
  • Assunção A; Brain Institute, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.
  • Almeida R; Department of Physiology and Behavior, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.
  • Pantrigo ÉJ; Brain Institute, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.
  • Bolcont R; Brain Institute, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.
  • Costa-Macedo JV; Brain Institute, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.
  • Arcoverde E; University Hospital Onofre Lopes, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.
  • Galvão-Coelho N; Department of Physiology and Behavior, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.
  • Araujo DB; Brain Institute, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil; Graduate Program in Health Sciences, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil. Electronic address: draulio@neuro.ufrn.br.
  • Palhano-Fontes F; Brain Institute, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil. Electronic address: fernandapalhano@neuro.ufrn.br.
Eur Neuropsychopharmacol ; 80: 27-35, 2024 Mar.
Article em En | MEDLINE | ID: mdl-38141403
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).
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: N,N-Dimetiltriptamina / Alucinógenos Limite: Humans Idioma: En Revista: Eur Neuropsychopharmacol Assunto da revista: PSICOFARMACOLOGIA Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Brasil País de publicação: Holanda
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: N,N-Dimetiltriptamina / Alucinógenos Limite: Humans Idioma: En Revista: Eur Neuropsychopharmacol Assunto da revista: PSICOFARMACOLOGIA Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Brasil País de publicação: Holanda