Recruiting
NA
INTERVENTIONAL
NCT06789705
Plasma Oxytocin Changes in Response to Low-dose MDMA vs. Placebo in Patients With Arginine Vasopressin Deficiency and Healthy Controls
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
MDMA
Type:
DRUG
Description:
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.
Name:
Placebo
Type:
OTHER
Description:
Placebo will be prepared as identical gelatin capsules containing only mannitol filler and given at treatment visit.
Primary Outcomes
Measure:
Area under the concentration-time curve in plasma oxytocin level
TimeFrame:
up to 6 weeks
Description:
Area under the concentration-time curve in plasma oxytocin level from baseline oxytocin measurement (before MDMA intake) to 5 hours after a single administration of 25 mg or 50 mg MDMA in patients with Arginine Vasopressin deficiency as compared to healthy controls.
Trial Information
NCT ID
NCT06789705
Status
Recruiting
Study Type
INTERVENTIONAL
Phases
NA
Sponsor
University Hospital, Basel, Switzerland
Last Updated
December 15, 2025