NCT06789705

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

Plasma Oxytocin Changes in Response to Low-dose MDMA vs. Placebo in Patients With Arginine Vasopressin Deficiency (Central Diabetes Insipidus) and Healthy Controls - the OxyMAX Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The investigator hypothesize that low-dose MDMA (3,4-methylenedioxymethamphetamine) will produce a sufficiently strong oxytocin stimulation in healthy controls and no relevant increase in patients. This study will confirm previously published data and provide important safety data with low-dose MDMA stimulation testing.

Conditions

• Central Diabetes Insipidus

Interventions

Type	Name	Description
DRUG	MDMA	MDMA will be administered in a single dose of 50 mg (2 capsules of 25 mg MDMA) or 25mg (1 capsule of 25 mg MDMA, 1 capsule containing only mannitol filler) and given at treatment visit.
OTHER	Placebo	Placebo will be prepared as identical gelatin capsules containing only mannitol filler and given at treatment visit.

Timeline

• Start date: 2025-01-27
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-01-23
• Last updated: 2025-02-19

Locations

1 site across 1 country: Switzerland