Clinical TrialHealthy VolunteersMDMAPlaceboCompleted

Circulating Oxytocin Changes in Response to the Oxytocin System Stimulator MDMA in Patients With Diabetes Insipidus and Healthy Controls

This randomized, double-blind, placebo-controlled crossover trial (n=30) called OxyMA aims to investigate the changes in circulating oxytocin levels in response to the oxytocin system stimulator MDMA in patients with diabetes insipidus and healthy controls.

Target Enrollment
30 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

Detailed Description

Randomized, double-blind, placebo-controlled crossover study comparing single 100 mg MDMA versus placebo in 30 participants (patients with central diabetes insipidus and matched healthy volunteers) to measure acute changes in circulating oxytocin.

Primary purpose is basic science; MDMA administered as gelatin capsule with mannitol filler. Outcomes include plasma oxytocin response; standard safety exclusions applied (cardiovascular disease, psychiatric disorders, interacting medications).

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

MDMA

experimental

Single 100 mg MDMA capsule (within-subject crossover)

Interventions

  • MDMA100 mg
    via Oral• single dose• 1 doses total

    Absolute dose 100 mg (~1.3 ± 0.3 mg/kg) administered in gelatin capsule with mannitol.

Placebo

inactive

Identical mannitol placebo capsule (within-subject crossover)

Interventions

  • Placebo
    via Oral• single dose• 1 doses total

    Identical placebo capsule containing only mannitol.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria diabetes insipidus:
  • Confirmed diagnosis of central diabetes insipidus
  • Inclusion criteria healthy volunteers:
  • Matched for age, sex, BMI and estrogen replacement/menopause/hormonal contraceptives to patients with central diabetes insipidus
  • No medication, except hormonal contraception

Exclusion Criteria

  • Exclusion Criteria:
  • Familial central diabetes insipidus
  • Participation in a trial with investigational drugs within 30 days
  • Illicit substance use (with the exception of 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 (LVEF) <40%, stroke in the last 3 months, atrial fibrillation/flutter, Wolff-Parkinson-White syndrome)
  • Uncontrolled arterial hypertension (>140/90 mmHg) or hypotension (systolic blood pressure <85 mmHg)
  • 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 inhibitor (SSRI), monoamine oxidase (MAO) inhibitors
  • Pregnancy and breastfeeding
  • Diagnosed chronic kidney disease > grade III (eGFR < 30 ml/min)
  • Diagnosed liver cirrhosis or ALT/AST levels 2.5 times above the normal range

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment30 participants
  • Timeline
    Start: 2021-02-05
    End: 2021-12-10
  • Compounds
    MDMAPlacebo
  • Topic
    Healthy Volunteers

Locations

University Hospital Basel, Endocrinology, Diabetes and Metabolism — Basel, Switzerland

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