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

NCT06789705 | Recruiting

• 1 other identifier: 2024-01105; kt24ChristCrain3
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Diabetes Insipidus

Keywords

MDMA; oxytocin; arginin vasopressin

Outcome Measures

Primary Outcomes (1)

• Area under the concentration-time curve in plasma oxytocin level

  Area under the concentration-time curve in plasma oxytocin level from baseline oxytocin measurement (before MDMA intake) to 5 hours after a single administration of 25 mg or 50 mg MDMA in patients with Arginine Vasopressin deficiency as compared to healthy controls.

  up to 6 weeks

Secondary Outcomes (31)

• Peak change in oxytocin plasma level

  up to 6 weeks

• Time course of plasma oxytocin levels

  up to 6 weeks

• Time course of plasma MDMA concentration

  up to 6 weeks

• Subjective/emotional effects assessed on numeric analogue scales (NASs)

  up to 6 weeks

• Recognition of emotions and body expressions in the Emotion from Body expression and Emotion from Face (EmBody/EmFace) task

  up to 6 weeks

Study Arms (2)

3,4-methylenedioxymethamphetamine (MDMA) and Placebo

EXPERIMENTAL

In this arm, first MDMA is given and after a wash-out phase of at least 10 days, Placebo will be administered.

Drug: MDMA; Other: Placebo

Placebo and 3,4-methylenedioxymethamphetamine (MDMA)

EXPERIMENTAL

In this arm, first Placebo is given and after a wash-out phase of at least 10 days, MDMA will be administered.

Drug: MDMA; Other: Placebo

Interventions

MDMA DRUG

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.

3,4-methylenedioxymethamphetamine (MDMA) and Placebo; Placebo and 3,4-methylenedioxymethamphetamine (MDMA)

Placebo OTHER

Placebo will be prepared as identical gelatin capsules containing only mannitol filler and given at treatment visit.

3,4-methylenedioxymethamphetamine (MDMA) and Placebo; Placebo and 3,4-methylenedioxymethamphetamine (MDMA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Adult patients with confirmed diagnosis of Arginine Vasopressin deficiency (central diabetes insipidus)2 or with only anterior pituitary deficiency
• Adult healthy controls
• Matched for age, sex, Body mass index, and oestrogen replacement/menopause/hormonal contraceptives to patients
• No medication, except hormonal contraception

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Diabetes Insipidus, Neurogenic

Interventions

N-Methyl-3,4-methylenedioxyamphetamine

Condition Hierarchy (Ancestors)

Diabetes Insipidus; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Mirjam Christ-Crain, Prof.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mirjam Christ-Crain, Prof.

CONTACT

+41 61 265 25 25; Mirjam.Christ-Crain@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The order of the two MDMA doses is predefined in a randomization list. The randomization list is not known to the participants, the investigators and the study nurses involved in the trial. Participants and study personnel involved in supervising the session will be blinded to treatment order. The order is balanced.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Case-control study with a randomized, double-blind, controlled, cross-over design

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: January 27, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

CH (1)