Clinical TrialHealthy VolunteersMDMAPlaceboRecruiting

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

This double-blind, placebo-controlled crossover trial (n=24) will investigate low-dose MDMA (25 mg or 50 mg) effects on oxytocin in patients with arginine vasopressin deficiency and matched healthy controls.

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

Detailed Description

Randomized, double-blind, placebo-controlled crossover (two sessions, washout ≥10 days) testing single low doses of MDMA (25 mg or 50 mg) versus placebo in patients with arginine vasopressin deficiency and matched healthy controls.

Primary outcome is change in plasma oxytocin; study will confirm prior findings and provide safety data for low-dose MDMA stimulation testing, with monitoring of vitals and adverse events.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

MDMA

experimental

Single-dose MDMA (25 mg or 50 mg) in a randomized double-blind crossover with placebo; washout ≥10 days.

Interventions

  • MDMA50 mg
    via Oral• single dose

    Single dose 25 mg or 50 mg (capsule composition as described)

Placebo

inactive

Identical placebo capsules administered in crossover.

Interventions

  • Placebo
    via Oral• single dose

    Placebo contains mannitol filler, identical gelatin capsules

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion criteria — patients:
  • 1. Adult patients with confirmed diagnosis of Arginine Vasopressin deficiency (central diabetes insipidus) or with 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 cannabis) more than 10 times in lifetime or any use within the previous 2 months
  • 3. Consumption of alcoholic beverages >15 drinks/week
  • 4. Tobacco smoking >10 cigarettes/day
  • 5. Cardiovascular disease (coronary artery disease, heart failure with LVEF <40%, stroke in last 3 months, atrial fibrillation/flutter, Wolff–Parkinson–White syndrome)
  • 6. Uncontrolled arterial hypertension (>140/90 mmHg) or hypotension (<85 mmHg)
  • 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 SSRIs or MAOIs
  • 10. Pregnancy and breastfeeding
  • 11. Diagnosed chronic kidney disease > grade III (GFR <30 ml/min)
  • 12. Diagnosed liver cirrhosis or ALAT/ASAT levels >2.5× normal range

Study Details

  • Status
    Recruiting
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment24 participants
  • Timeline
    Start: 2025-01-01
    End: 2026-12-01
  • Compounds
    MDMAPlacebo
  • Topic
    Healthy Volunteers

Locations

University Hospital Basel — Basel, Switzerland

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