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

Last updated: February 18, 2025
Sponsor: University Hospital, Basel, Switzerland
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hormone Deficiencies

Treatment

Placebo

MDMA

Clinical Study ID

NCT06789705
2024-01105; kt24ChristCrain3
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion criteria patients:

  1. Adult patients with confirmed diagnosis of Arginine Vasopressin deficiency (centraldiabetes 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/hormonalcontraceptives to patients

  3. No medication, except hormonal contraception

Exclusion

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 anytime 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 ventricularejection 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 oxidaseinhibitors

  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 aspartateaminotransferase (ASAT) levels 2.5 times above the normal range

Study Design

Total Participants: 24
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
January 27, 2025
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • University Hospital Basel

    Basel, 4031
    Switzerland

    Active - Recruiting

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