Actively Recruiting
Plasma Oxytocin Changes in Response to Low-dose MDMA vs. Placebo in Patients With Arginine Vasopressin Deficiency and Healthy Controls
Led by University Hospital, Basel, Switzerland · Updated on 2025-02-19
24
Participants Needed
1
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Plasma Oxytocin Changes in Response to Low-dose MDMA vs. Placebo in Patients With Arginine Vasopressin Deficiency and Healthy Controls
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with confirmed diagnosis of Arginine Vasopressin deficiency (central diabetes insipidus) or with only anterior pituitary deficiency
- Adult healthy controls matched for age, sex, body mass index, and hormonal status (oestrogen replacement, menopause, or hormonal contraceptives)
- Healthy controls taking no medication except hormonal contraception
You will not qualify if you...
- Participation in a trial with investigational drugs within 30 days
- Illicit substance use (except cannabis) more than 10 times in lifetime or any use within the last two months
- Consumption of more than 15 alcoholic drinks per week
- Smoking more than 10 cigarettes per day
- Cardiovascular disease including coronary artery disease, heart failure with left ventricular ejection fraction below 40%, stroke within last 3 months, atrial fibrillation/flutter, or Wolff-Parkinson-White syndrome
- Uncontrolled high blood pressure (above 140/90 mmHg) or low blood pressure (below 85 mmHg)
- Current or previous major psychiatric disorders such as major depression or schizophrenia spectrum disorder
- Psychotic disorder in first-degree relatives
- Regular use of selective serotonin reuptake inhibitors or monoamine oxidase inhibitors
- Pregnancy or breastfeeding
- Chronic kidney disease grade III or worse (glomerular filtration rate below 30 ml/min)
- Diagnosed liver cirrhosis or liver enzyme levels (ALAT or ASAT) 2.5 times above normal range
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
Research Team
M
Mirjam Christ-Crain, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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