A Phase I clinical trial evaluating the pharmacokinetics, pharmacodynamics and safety profile of DMT will further research into the compound’s therapeutic potential.
Psychedelics research company Entheon Biomedical has received approval from the Dutch ethics committee for its trial – EBRX-101. The trial will be the basis for future Phase II trial exploring the efficacy of DMT for smoking cessation and the treatment of other substance addictions.
The study will be conducted at the Centre for Human Drug Research, in Leiden, Netherlands, with patient screening scheduled to begin this month.
Dr Andrew Hegle, chief science officer of Entheon, said: “DMT’s unique metabolic and neuroprotective properties, together with its record of safe human use in the scientific literature, suggests that it is an ideal candidate for therapeutic administration.
“However, it is crucial that we thoroughly investigate the pharmacological properties and safety profile of infused DMT in a clinical setting, and fully characterise its effects on the central nervous system.
“These results will form the basis for Entheon’s Phase II efficacy trials for nicotine cessation and the treatment of other substance use disorders.”
The study is the core research focus of Entheon Rx™, one of the Company’s business divisions, which is focused on advancing the therapeutic potential of DMT and DMT-based drug analogues.
It will use an adaptive, randomised, double-blind, placebo-controlled design with a single ascending dose of intravenous DMT to be administered via continuous-controlled infusion to a population of otherwise healthy smokers.
CEO of Entheon, Timothy Ko, commented: “Approval of this study is a significant achievement for the company, marking the culmination of months of rigorous work.
“In our estimation and based on our review of existing literature, EBRX-101 is the most comprehensive studies of DMT to date. This clinical trial will serve as a benchmark for further investigation into the development of DMT as a treatment for addiction disorders.”
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