Speaker Bio
Marcelo Falchi currently serves as a temporary professor of psychiatry at the School of Medicine of the Federal University of Rio Grande do Norte (UFRN). Also, he attends to patients in his private practice. His academic and professional journey is centered around the field of psychedelic science, particularly at the Brain Institute in Natal and the University of Campinas (UNICAMP), both in Brazil. He has been instrumental in pioneering research, notably in conducting scientific studies using psychedelics. His work extends to various areas of psychopharmacology and phenomenology, with a particular interest in substances like LSD, DMT, and ayahuasca. In addition to his research, Dr. Falchi is committed to medical education, having served as a preceptor in the psychiatric residency program at institutions such as Pontifical Catholic University (PUC) in Campinas and Edivaldo Orsi Hospital Complex. His combined roles in teaching, research, and clinical practice reflect a deep commitment to advancing understanding and care in the realm of psychiatry and psychedelic medicine.
ICPR 2024 Abstract
Safety and Tolerability of vaporized DMT: a phase I trial
Background: The resurgence of interest in psychedelics for treating mood disorders has led to exploring the therapeutic potential of various compounds, including N,N-Dimethyltryptamine (DMT). Unlike longer-acting psychedelics like ayahuasca, psilocybin, and LSD, vaporized DMT has a rapid onset and short duration, potentially offering a more practical option in clinical settings.
Research Question and Hypothesis: This Phase I trial aimed to investigate the safety and tolerability of vaporized DMT. The hypothesis was that inhaled DMT would be safe and well-tolerated in controlled doses among healthy volunteers, providing a basis for further clinical applications.
Methods: The study followed an open-label, single-ascending, fixed-order, dose-response design with 27 healthy participants. They received a lower and then a higher dose of vaporized DMT, ranging from 5/20 mg to 15/60 mg. The trial evaluated subjective experiences, physiological effects, biochemical markers, and adverse events during both acute and post-acute phases.
Findings: DMT administration resulted in dose-dependent enhancements in subjective experience intensity and positive valence. Physiological responses included mild, transient increases in blood pressure and heart rate. There were no significant changes in safety blood biomarkers or serious adverse events. Higher doses in the second session were associated with increased comfort and control, indicating a possible acclimation effect.
Conclusion: Vaporized DMT was found to be safe and well-tolerated in a controlled clinical setting. The study supports the feasibility of inhaled DMT as a potential therapeutic tool, offering a shorter, more manageable alternative to traditional oral psychedelics.