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Recruiting NCT06789705

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

No phase Interventional Central Diabetes Insipidus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MDMA, Placebo.
Who it may be relevant to
Registry conditions: Central Diabetes Insipidus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Drug MDMA
    MDMA will be administered in a single dose of 50 mg (2 capsules of 25 mg MDMA) or 25mg (1 capsule of 25 mg MDMA, 1 capsule containing only mannitol filler) and given at treatment visit.
  • Other Placebo
    Placebo will be prepared as identical gelatin capsules containing only mannitol filler and given at treatment visit.

Primary outcome measures

  • Area under the concentration-time curve in plasma oxytocin level [Time frame: up to 6 weeks]
Secondary outcome measures (12)
  • Peak change in oxytocin plasma level [Time frame: up to 6 weeks]
  • Time course of plasma oxytocin levels [Time frame: up to 6 weeks]
  • Time course of plasma MDMA concentration [Time frame: up to 6 weeks]
  • Subjective/emotional effects assessed on numeric analogue scales (NASs) [Time frame: up to 6 weeks]
  • Recognition of emotions and body expressions in the Emotion from Body expression and Emotion from Face (EmBody/EmFace) task [Time frame: up to 6 weeks]
  • Recognition of emotions and body expressions in the face emotion recognition task (FERT) [Time frame: up to 6 weeks]
  • Anxiety level with the State-Trait Anxiety Inventory (STAI-S) [Time frame: up to 6 weeks]
  • Anxiety level with the State-Trait Anxiety Inventory (STAI-T) [Time frame: at baseline]
  • Number of complaints [Time frame: up to 6 weeks]
  • Number of adverse effects [Time frame: up to 6 weeks]
  • Time course of plasma copeptin [Time frame: up to 6 weeks]
  • Time course of plasma Adrenocorticotropic hormone (ACTH) [Time frame: up to 6 weeks]

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:

  • Adult healthy controls
  • Matched for age, sex, Body mass index, and oestrogen replacement/menopause/hormonal contraceptives to patients
  • No medication, except hormonal contraception

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • University Hospital Basel — Basel

Identifiers

NCT: NCT06789705 · 2024-01105; kt24ChristCrain3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗