NCT06789705 Plasma Oxytocin Changes in Response to Low-dose MDMA vs. Placebo in Patients With Arginine Vasopressin Deficiency and Healthy Controls
| NCT ID | NCT06789705 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Central Diabetes Insipidus |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-01-27 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2025-01-27 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion criteria patients: 1\. Adult patients with confirmed diagnosis of Arginine Vasopressin deficiency (central diabetes insipidus)2 or with only anterior pituitary deficiency Inclusion criteria healthy controls: 1. Adult healthy controls 2. Matched for age, sex, Body mass index, and oestrogen replacement/menopause/hormonal contraceptives to patients 3. No medication, except hormonal contraception Exclusion Criteria: 1. Participation in a trial with investigational drugs within 30 days 2. Illicit substance use (except for cannabis) more than 10 times in lifetime or any time within the previous two months 3. Consumption of alcoholic beverages \>15 drinks/week 4. Tobacco smoking \>10 cigarettes/day 5. Cardiovascular disease (coronary artery disease, heart failure Left ventricular ejection fraction \<40%, stroke in the last 3 months, atrial fibrillation/flatter, Wolff-Parkinson-White-Syndrome) 6. Uncontrolled arterial hypertension (\>140/90 mmHg) or hypotension (\<85mmHg) 7. Current or previous major psychiatric disorder (e.g., major depression, schizophrenia spectrum disorder) 8. Psychotic disorder in first-degree relatives 9. Regular intake of selective serotonin reuptake inhibitors or Monoamine oxidase inhibitors 10. Pregnancy and breastfeeding 11. Diagnosed Chronic Kidney Disease \> grade III (glomerular filtration rate \< 30ml/min) 12. Diagnosed liver cirrhosis or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) levels 2.5 times above the normal range
Contact & Investigator
Mirjam Christ-Crain, Prof.
PRINCIPAL INVESTIGATOR
University Hospital, Basel, Switzerland
Frequently Asked Questions
Who can join the NCT06789705 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Central Diabetes Insipidus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06789705 currently recruiting?
Yes, NCT06789705 is actively recruiting participants. Contact the research team at Mirjam.Christ-Crain@usb.ch for enrollment information.
Where is the NCT06789705 trial being conducted?
This trial is being conducted at Basel, Switzerland.
Who is sponsoring the NCT06789705 clinical trial?
NCT06789705 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Mirjam Christ-Crain, Prof. at University Hospital, Basel, Switzerland. The trial plans to enroll 24 participants.
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