Actively Recruiting
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
Led by University Hospital, Basel, Switzerland · Updated on 2025-02-19
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how low-dose MDMA (3,4-methylenedioxymethamphetamine) affects plasma oxytocin levels in people with arginine vasopressin deficiency, also known as central diabetes insipidus, and in healthy individuals. They aim to confirm previous findings that MDMA triggers oxytocin release in healthy controls but not significantly in patients, while also collecting important safety information about low-dose MDMA use. The study uses a randomized, double-blind design where participants receive both MDMA and placebo in two different treatment periods separated by at least 10 days. MDMA is given as a single dose of either 25 mg or 50 mg in capsule form, while the placebo capsules contain only filler. Participants are assigned to one of two groups: one receives MDMA first and then placebo, the other receives placebo first and then MDMA. During the study, researchers measure the oxytocin levels in plasma over up to six weeks, along with many other biological and psychological outcomes such as hormone levels, emotional recognition tasks, anxiety assessments, and general health questionnaires. Safety is closely monitored through clinical measures like blood pressure, heart rate, and laboratory tests. The total participation time includes the treatment visits and follow-up assessments over several weeks.
CONDITIONS
Brief 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, hormonal contraceptives) to patients
- Healthy controls with no medication except hormonal contraception
- Adults aged 18 years or older
You will not qualify if you...
- Participation in any trial with investigational drugs within the past 30 days
- Illicit substance use (except cannabis) more than 10 times in lifetime or any use within the previous two months
- Consumption of more than 15 alcoholic drinks per week
- Tobacco smoking more than 10 cigarettes per day
- Cardiovascular diseases including coronary artery disease, heart failure with left ventricular ejection fraction below 40%, stroke in last 3 months, atrial fibrillation or flutter, 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 disorders
- Psychotic disorders in first-degree relatives
- Regular use of selective serotonin reuptake inhibitors or monoamine oxidase inhibitors
- Pregnancy or breastfeeding
- Diagnosed chronic kidney disease grade III or worse (glomerular filtration rate below 30 ml/min)
- Diagnosed liver cirrhosis or elevated liver enzymes (ALAT or ASAT) more than 2.5 times normal range
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks
Participants receive a single dose of MDMA or placebo during treatment visits, with a wash-out phase of at least 10 days between crossover treatments.
2 treatment visits separated by at least 10 days
Duration - Up to 6 weeks after each treatment
Participants are monitored for changes in plasma oxytocin and other clinical and laboratory measures after treatment.
Multiple assessments during follow-up period
Trial Site Locations
Total: 1 location
1
University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
Research Team
M
Mirjam Christ-Crain, Prof.
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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