This randomised, triple-blind, placebo-controlled Phase I crossover trial (n=24) will compare the acute effects of two enantiomers of MDMA—R-MDMA (300 mg) and S-MDMA (100 mg)—in healthy adult participants.
Randomised, triple-blind, placebo-controlled 3-period crossover in healthy volunteers to compare acute subjective and physiological effects of single oral doses of R-MDMA (300 mg) and S-MDMA (100 mg) against placebo.
Primary aim is basic science characterisation of enantiomer-specific pharmacology and subjective effects; outcomes include vital signs, adverse events and standard psychometric instruments.
Each participant receives three single-dose sessions (R-MDMA, S-MDMA, placebo) with washout between periods; estimated enrollment 24 at University Hospital Basel.
Single oral dose of R-MDMA 300 mg in crossover period.
R-MDMA (300 mg)
Single oral dose of S-MDMA 100 mg in crossover period.
S-MDMA (100 mg)
Placebo (mannitol) comparator in crossover period.
Placebo (mannitol)