Skip to content
RecruitingNot applicable

Plasma Oxytocin Changes in Response to Low-dose MDMA vs. Placebo in Patients With Arginine Vasopressin Deficiency and Healthy Controls

NCT06789705 · OxyMAX · University Hospital, Basel, Switzerland

Recruiting
Status
Accepting participants
Not applicable
Phase
24
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

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.

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 plasma oxytocin level

    Measured over up to 6 weeks

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
Ages
All
Sex
Accepted
Healthy volunteers
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

1 study site

FacilityCityRegionCountry
University Hospital BaselBaselSwitzerland

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.

NCT06789705 on ClinicalTrials.gov →

Last updated in the registry 2025-02-19. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits