Low-dose MDMA as a stimulation test for a possible oxytocin deficiency in patients with vasopressin deficiency and healthy controls

Switzerland (ICTRP)

ICTRP Trial ID
NCT06789705 (ICTRP)

Official title (approved by ethics committee)
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 (BASEC)

Academic title
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 (ICTRP)

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

Disease under investigation
Central Diabetes Insipidus (ICTRP)

Intervention under investigation
Drug: MDMAOther: Placebo (ICTRP)

Type of trial
Interventional (ICTRP)

Trial design
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). (ICTRP)

Inclusion/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 (ICTRP)

not available

Primary and secondary end points
Area under the concentration-time curve in plasma oxytocin level (ICTRP)

Peak change in oxytocin plasma level;Time course of plasma oxytocin levels;Time course of plasma MDMA concentration;Subjective/emotional effects assessed on numeric analogue scales (NASs);Recognition of emotions and body expressions in the Emotion from Body expression and Emotion from Face (EmBody/EmFace) task;Recognition of emotions and body expressions in the face emotion recognition task (FERT);Anxiety level with the State-Trait Anxiety Inventory (STAI-S);Anxiety level with the State-Trait Anxiety Inventory (STAI-T);Number of complaints;Number of adverse effects;Time course of plasma copeptin;Time course of plasma Adrenocorticotropic hormone (ACTH);Time course of plasma cortisol;Time course of plasma prolactin;Time course of plasma neurophysin I;Alexithymia level using the Toronto-Alexithymia-Scale 20 (TAS-20);Depression level using the Beck-Depressions-Inventory II (BDI-II);General physical & mental health using the posterior-pituitary quality of life questionnaire (PP-QoL);General physical & mental health using the Patient-Reported Outcomes Measurement Information System (PROMIS);Autistic traits level using the Autism-Spectrum Quotient Test (AQ);Eating disturbances level using the Three-Factor Eating Questionnaire-Revised 18 Item (TFEQ-R18);Resting energy expenditure (REE) in kcal per 24 hours, time course of plasma glucose, insulin and c-peptide, subjective saturation effects assessed on a 10-point NAS.;Time course of plasma glucose;Time course of plasma insulin;Time course of plasma c-peptide;Subjective saturation effects;Assessments of clinical variable blood pressure;Assessments of clinical variable heart rate;Assessments of clinical variable body temperature;Assessments of laboratory variable plasma sodium;Assessments of laboratory variable potassium (ICTRP)

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
not available

Additional contacts
Mirjam Christ-Crain, Prof.;Mirjam Christ-Crain, Prof.;Mirjam Christ-Crain, Prof., Mirjam.Christ-Crain@usb.ch, +41 61 265 25 25;+41 61 265 25 25, University Hospital, Basel, Switzerland, (ICTRP)

Secondary trial IDs
2024-01105, kt24ChristCrain3 (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06789705 (ICTRP)