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
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
⁃ 1\. Adult patients with confirmed diagnosis of Arginine Vasopressin deficiency (central diabetes insipidus)2 or with only anterior pituitary deficiency
• Adult healthy controls
• Matched for age, sex, Body mass index, and oestrogen replacement/menopause/hormonal contraceptives to patients
• No medication, except hormonal contraception
Locations
Other Locations
Switzerland
University Hospital Basel
RECRUITING
Basel
Contact Information
Primary
Mirjam Christ-Crain, Prof.
Mirjam.Christ-Crain@usb.ch
+41 61 265 25 25
Time Frame
Start Date: 2025-01-27
Estimated Completion Date: 2026-12
Participants
Target number of participants: 24
Treatments
Experimental: 3,4-methylenedioxymethamphetamine (MDMA) and Placebo
In this arm, first MDMA is given and after a wash-out phase of at least 10 days, Placebo will be administered.
Experimental: Placebo and 3,4-methylenedioxymethamphetamine (MDMA)
In this arm, first Placebo is given and after a wash-out phase of at least 10 days, MDMA will be administered.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Basel, Switzerland