This randomized, double-blind, placebo-controlled crossover trial (n=30) called OxyMA aims to investigate the changes in circulating oxytocin levels in response to the oxytocin system stimulator MDMA in patients with diabetes insipidus and healthy controls.
Randomized, double-blind, placebo-controlled crossover study comparing single 100 mg MDMA versus placebo in 30 participants (patients with central diabetes insipidus and matched healthy volunteers) to measure acute changes in circulating oxytocin.
Primary purpose is basic science; MDMA administered as gelatin capsule with mannitol filler. Outcomes include plasma oxytocin response; standard safety exclusions applied (cardiovascular disease, psychiatric disorders, interacting medications).
Single 100 mg MDMA capsule (within-subject crossover)
Absolute dose 100 mg (~1.3 ± 0.3 mg/kg) administered in gelatin capsule with mannitol.
Identical mannitol placebo capsule (within-subject crossover)
Identical placebo capsule containing only mannitol.
In a double‑blind, placebo‑controlled, randomised crossover trial of 15 healthy adults, a single 100 mg oral dose of MDMA acutely and robustly activated the HPA axis, producing significant increases in plasma ACTH and cortisol. Together with its known effect on oxytocin, this suggests MDMA could serve as a novel simultaneous stimulation test for oxytocin and HPA axis function, pending validation in larger studies.