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

University Hospital Basel

Status: Enrolling

Conditions: Central Diabetes Insipidus

Treatments: Drug: MDMA; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06789705

2024-01105 kt24ChristCrain3;

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups

3,4-methylenedioxymethamphetamine (MDMA) and Placebo

Experimental group

Description:

In this arm, first MDMA is given and after a wash-out phase of at least 10 days, Placebo will be administered.

Treatment:

Other: Placebo

Drug: MDMA

Placebo and 3,4-methylenedioxymethamphetamine (MDMA)

Experimental group

Description:

In this arm, first Placebo is given and after a wash-out phase of at least 10 days, MDMA will be administered.

Treatment:

Other: Placebo

Drug: MDMA