Clinical trial NCT06789705: Plasma Oxytocin Changes in Response to Low-dose MDMA vs. Placebo in Patients With Arginine Vasopressin Deficiency and Healthy Controls
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Central Diabetes Insipidus
Keywords: MDMA
oxytocin
arginin vasopressin
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Case-control study with a randomized, double-blind, controlled, cross-over design
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Area under the concentration-time curve in plasma oxytocin level
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Peak change in oxytocin plasma level
timeFrame: up to 6 weeks
measure: Time course of plasma oxytocin levels
timeFrame: up to 6 weeks
measure: Time course of plasma MDMA concentration
timeFrame: up to 6 weeks
measure: Subjective/emotional effects assessed on numeric analogue scales (NASs)
timeFrame: up to 6 weeks
measure: Recognition of emotions and body expressions in the Emotion from Body expression and Emotion from Face (EmBody/EmFace) task
timeFrame: up to 6 weeks
measure: Recognition of emotions and body expressions in the face emotion recognition task (FERT)
timeFrame: up to 6 weeks
measure: Anxiety level with the State-Trait Anxiety Inventory (STAI-S)
timeFrame: up to 6 weeks
measure: Anxiety level with the State-Trait Anxiety Inventory (STAI-T)
timeFrame: at baseline
measure: Number of complaints
timeFrame: up to 6 weeks
measure: Number of adverse effects
timeFrame: up to 6 weeks
measure: Time course of plasma copeptin
timeFrame: up to 6 weeks
measure: Time course of plasma Adrenocorticotropic hormone (ACTH)
timeFrame: up to 6 weeks
measure: Time course of plasma cortisol
timeFrame: up to 6 weeks
measure: Time course of plasma prolactin
timeFrame: up to 6 weeks
measure: Time course of plasma neurophysin I
timeFrame: up to 6 weeks
measure: Alexithymia level using the Toronto-Alexithymia-Scale 20 (TAS-20)
timeFrame: up to 6 weeks
measure: Depression level using the Beck-Depressions-Inventory II (BDI-II)
timeFrame: up to 6 weeks
measure: General physical & mental health using the posterior-pituitary quality of life questionnaire (PP-QoL)
timeFrame: up to 6 weeks
measure: General physical & mental health using the Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: up to 6 weeks
measure: Autistic traits level using the Autism-Spectrum Quotient Test (AQ)
timeFrame: up to 6 weeks
measure: Eating disturbances level using the Three-Factor Eating Questionnaire-Revised 18 Item (TFEQ-R18)
timeFrame: up to 6 weeks
measure: 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.
timeFrame: up to 6 weeks
measure: Time course of plasma glucose
timeFrame: up to 6 weeks
measure: Time course of plasma insulin
timeFrame: up to 6 weeks
measure: Time course of plasma c-peptide
timeFrame: up to 6 weeks
measure: Subjective saturation effects
timeFrame: up to 6 weeks
measure: Assessments of clinical variable blood pressure
timeFrame: up to 6 weeks
measure: Assessments of clinical variable heart rate
timeFrame: up to 6 weeks
measure: Assessments of clinical variable body temperature
timeFrame: up to 6 weeks
measure: Assessments of laboratory variable plasma sodium
timeFrame: up to 6 weeks
measure: Assessments of laboratory variable potassium
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Mirjam Christ-Crain, Prof.
role: PRINCIPAL_INVESTIGATOR
References: