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New treatment option for Central Diabetes Insipidus
Official title Plasma Oxytocin Changes in Response to Low-dose MDMA vs. Placebo in Patients With Arginine Vasopressin Deficiency and Healthy Controls
ClinicalTrials.gov ID: NCT06789705
What this study is testing
What is MDMA?
MDMA is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for central diabetes insipidus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- patients: 1\. Adult patients with confirmed diagnosis of Arginine Vasopressin deficiency (central diabetes insipidus)2 or with only anterior...
- Adult healthy controls
- Matched for age, sex, Body mass index, and oestrogen replacement/menopause/hormonal contraceptives to patients
- No medication, except hormonal contraception
You likely can't join if
- Participation in a trial with investigational drugs within 30 days
- Illicit substance use (except for 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 \<40%, stroke in the last 3 months, atrial...
- Uncontrolled arterial hypertension (\>140/90 mmHg) or hypotension (\<85mmHg)
See the full eligibility criteria
- patients: 1\. Adult patients with confirmed diagnosis of Arginine Vasopressin deficiency (central diabetes insipidus)2 or with only anterior pituitary deficiency healthy controls:
- Adult healthy controls
- Matched for age, sex, Body mass index, and oestrogen replacement/menopause/hormonal contraceptives to patients
- No medication, except hormonal contraception
- Participation in a trial with investigational drugs within 30 days
- Illicit substance use (except for 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 \<40%, stroke in the last 3 months, atrial fibrillation/flatter, Wolff-Parkinson-White-Syndrome)
- Uncontrolled arterial hypertension (\>140/90 mmHg) or hypotension (\<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 inhibitors or Monoamine oxidase inhibitors
- Pregnancy and breastfeeding
- Diagnosed Chronic Kidney Disease \> grade III (glomerular filtration rate \< 30ml/min)
- Diagnosed liver cirrhosis or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) levels 2.5 times above the normal range
The study team makes the final eligibility decision.
Where it's taking place
- Basel, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basel, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.