Plasma Oxytocin Changes in Response to Low-dose MDMA vs. Placebo in Patients With Arginine Vasopressin Deficiency and Healthy Controls
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Central Diabetes Insipidus
In brief
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.
Key facts
- Study ID
- NCT06789705
- Run by
- University Hospital, Basel, Switzerland
- People needed
- 24
- Starts
- 2025-01-27
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-02-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Participation in a trial with investigational drugs within 30 days
- Illicit substance use (except for cannabis) more than 10 times in lifetime or any time within the previous two months
- Consumption of alcoholic beverages >15 drinks/week
- Tobacco smoking >10 cigarettes/day
- 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)
- Uncontrolled arterial hypertension (>140/90 mmHg) or hypotension (<85mmHg)
- Current or previous major psychiatric disorder (e.g., major depression, schizophrenia spectrum disorder)
- Psychotic disorder in first-degree relatives
- Regular intake of selective serotonin reuptake inhibitors or Monoamine oxidase inhibitors
- Pregnancy and breastfeeding
- Diagnosed Chronic Kidney Disease > grade III (glomerular filtration rate < 30ml/min)
- Diagnosed liver cirrhosis or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) levels 2.5 times above the normal range
Where it is running
- University Hospital Basel — Basel, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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