The present study is a modern randomized cross-over trial, investigating different continuous intravenous DMT dose rates over a broad dose range.
Randomized, double-blind, placebo-controlled 5-period crossover in healthy volunteers (n=24) testing IV DMT at 0.6, 1.2, 1.8 and 2.4 mg/min with a placebo arm; a sixth session permits patient-guided titration.
Primary aim is to characterise dose–response relationships for subjective and autonomic effects using continuous IV infusion regimens and relate doses to acute safety and physiological measures.
IV infusion of DMT at 0.6 mg/min (single session).
Total dose ~54 mg (infusion).
IV infusion of DMT at 1.2 mg/min (single session).
Total dose ~108 mg (infusion).
IV infusion of DMT at 1.8 mg/min (single session).
Total dose ~162 mg (infusion).
IV infusion of DMT at 2.4 mg/min (single session).
Total dose ~216 mg (infusion).
Saline infusion (placebo comparator).
Saline infusion.
IV infusion at 1.2 mg/min with an additional patient-guided titration session.
Patient-guided dose titration in a sixth session; total dose ~108 mg before titration.