This double-blind, placebo-controlled crossover trial (n=24) will investigate low-dose MDMA (25 mg or 50 mg) effects on oxytocin in patients with arginine vasopressin deficiency and matched healthy controls.
Randomized, double-blind, placebo-controlled crossover (two sessions, washout ≥10 days) testing single low doses of MDMA (25 mg or 50 mg) versus placebo in patients with arginine vasopressin deficiency and matched healthy controls.
Primary outcome is change in plasma oxytocin; study will confirm prior findings and provide safety data for low-dose MDMA stimulation testing, with monitoring of vitals and adverse events.
Single-dose MDMA (25 mg or 50 mg) in a randomized double-blind crossover with placebo; washout ≥10 days.
Single dose 25 mg or 50 mg (capsule composition as described)
Identical placebo capsules administered in crossover.
Placebo contains mannitol filler, identical gelatin capsules