Study design
In a single-blind, placebo-controlled study using a within-subjects repeated measures design, 11 healthy volunteers received up to four different doses of bolus plus slow-rate infusions of DMT over 30 min. Dosing sessions were separated by at least 2 weeks. On dosing visits, EEG activity as well as subjective and autonomic effects were measured acutely and retrospectively, and blood samples were collected for pharmacokinetic purposes (EEG findings and pharmacokinetic modelling will be published elsewhere). The study was approved by the National Research Ethics Service Committee London – Brent and the Health Research Authority and was conducted in accordance with the revised Declaration of Helsinki (2013), the International Committee on Harmonization Guidelines in Good Clinical Practice, and the National Health Service Research Governance Framework. The study was sponsored and approved by Imperial College London’s Joint Research and Compliance Office and the National Institute for Health Research/Wellcome Trust Imperial Clinical Research Facility gave site-specific approval for the study. The study was conducted under a Home Office licence for research with Schedule 1 drugs.