Effects of Low-Dose MDMA Compared to Placebo on Plasma Oxytocin in Adults with Central Diabetes Insipidus and Healthy Adults

What this Trial Is About

Researchers are studying how low-dose MDMA 3,4-methylenedioxymethamphetamine affects plasma oxytocin levels in people with arginine vasopressin deficiency, also known as central diabetes insipidus, and in healthy individuals. They aim to confirm previous findings that MDMA triggers oxytocin release in healthy controls but not significantly in patients, while also collecting important safety information about low-dose MDMA use. The study uses a randomized, double-blind design where participants receive both MDMA and placebo in two different treatment periods separated by at least 10 days. MDMA is given as a single dose of either 25 mg or 50 mg in capsule form, while the placebo capsules contain only filler. Participants are assigned to one of two groups one receives MDMA first and then placebo, the other receives placebo first and then MDMA. During the study, researchers measure the oxytocin levels in plasma over up to six weeks, along with many other biological and psychological outcomes such as hormone levels, emotional recognition tasks, anxiety assessments, and general health questionnaires. Safety is closely monitored through clinical measures like blood pressure, heart rate, and laboratory tests. The total participation time includes the treatment visits and follow-up assessments over several weeks.

Plasma Oxytocin Changes in Response to Low-dose MDMA vs. Placebo in Patients With Arginine Vasopressin Deficiency and Healthy Controls