CompletedNot applicable

Circulating Oxytocin Changes in Response to the Oxytocin System Stimulator MDMA in Patients With Diabetes Insipidus and Healthy Controls

NCT04648137 · OxyMA · University Hospital, Basel, Switzerland

Closed to entry

Status

Not accepting participants

Not applicable

Phase

Target enrolment

Study sites

Outside the US

What it is testing

Summary

This study is to evaluate oxytocin levels in response to MDMA administration as compared to placebo in patients with diabetes insipidus and healthy volunteers.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

area under the concentration time curve in oxytocin level
Measured over from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years

Ages

All

Sex

Accepted

Healthy volunteers

Inclusion Criteria diabetes insipidus: * Confirmed diagnosis of central diabetes insipidus Inclusion criteria healthy volunteers: * Matched for age, sex, BMI and estrogen replacement/menopause/hormonal contraceptives to patients with central diabetes insipidus * No medication, except hormonal contraception- Exclusion Criteria: * Familial central diabetes insipidus * Participation in a trial with investigational drugs within 30 days * Illicit substance use (with the exception of 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 ( LVEF) \<40%, stroke in the last 3 months, atrial fibrillation/flatter, Wolff-Parkinson-White syndrome (WPW)-Syndrome) * Uncontrolled arterial hypertension (\>140/90 mmHg) or hypotension (syst blood pressure \<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 inhibitor (SSRI), monoamine oxidase (MAO)-Inhibitors * Pregnancy and breastfeeding * Diagnosed chronic kidney disease (CKD) \> grade III (GRF \< 30ml/min) * Diagnosed liver cirrhosis or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) levels 2.5 times above the normal range

Where

1 study site

Facility	City	Region	Country
University Hospital Basel, Endocrinology, Diabetes and Metabolism	Basel	—	Switzerland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04648137 on ClinicalTrials.gov →

Last updated in the registry 2022-04-13. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

MDMA

All 48 trials from University Hospital, Basel, Switzerland →