A study on the safety and effects of the drug DMT in healthy smoking individuals

Adaptive, randomized, double-blind, placebo-controlled single ascending dose study evaluating safety, pharmacodynamics and pharmacokinetics of a 90-minute target-controlled intravenous infusion of DMT in healthy regular smokers.

Primary outcomes assess treatment-emergent (S)AEs, vital signs, respiratory rate, ECG, laboratory tests, psychotic symptoms (BPRS), serotonergic toxicity (Hunter criteria) and suicidality (C-SSRS); secondary measures include Neurocart battery, PK sampling, EEG and subjective psychedelic rating scales (HRS, MEQ, 5D-ASC).