Effects of low-dose MDMA on oxytocin levels in patients with vasopressin deficiency and healthy controls

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

This study is testing whether low-dose MDMA can increase oxytocin levels in people with a vasopressin deficiency and healthy individuals to see how it affects them differently.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Basel, Switzerland (Academic / other)
• Locations: 1 site (Basel)
• Trial ID: NCT06789705 on ClinicalTrials.gov

What this trial studies

This study investigates how low-dose MDMA affects oxytocin levels in patients with arginine vasopressin deficiency, specifically those with central diabetes insipidus, compared to healthy controls. The researchers hypothesize that MDMA will stimulate oxytocin production in healthy individuals but not in patients with the deficiency. The study aims to confirm previous findings and gather safety data regarding low-dose MDMA use. Participants will include both patients and matched healthy controls, with careful monitoring of their health status.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with arginine vasopressin deficiency or anterior pituitary deficiency.

Not a fit: Patients with significant cardiovascular disease or uncontrolled hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the hormonal responses in patients with vasopressin deficiency and inform future treatment strategies.

How similar studies have performed: Previous studies have indicated potential effects of MDMA on oxytocin levels, but this specific approach in patients with vasopressin deficiency is novel.

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

Where this trial is running

Basel

• University Hospital Basel — Basel, Switzerland (Recruiting)

Study contacts

• Principal investigator: Mirjam Christ-Crain, Prof. — University Hospital, Basel, Switzerland
• Study coordinator: Mirjam Christ-Crain, Prof.

Conditions Central Diabetes Insipidus; MDMA; oxytocin; arginin vasopressin