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

NCT04648137 | Completed

• 1 other identifier: 2020-02147; me20ChristCrain4
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate oxytocin levels in response to MDMA administration as compared to placebo in patients with diabetes insipidus and healthy volunteers.

Conditions

Diabetes Insipidus

Keywords

central diabetes insipidus; oxytocin levels; 3,4-methylenedioxymethamphetamine (MDMA); hypothalamic-pituitary axis; hypopituitarism; vasopressin

Outcome Measures

Primary Outcomes (1)

• area under the concentration time curve in oxytocin level

  area under the concentration time curve in oxytocin level from baseline oxytocin measurement (before intake) to 6 hours after a single administration of MDMA (100mg) as compared to placebo in the same subjects between patients with central diabetes insipidus and healthy volunteers.

  from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA

Secondary Outcomes (14)

• Peak change in oxytocin (OT) plasma level

  from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA

• Time course of plasma OT levels

  from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA

• Time course of plasma MDMA concentration

  from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA

• Time course of cortisol levels

  from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA

• Time course of prolactin levels

  from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA

Study Arms (2)

Patients with central diabetes insipidus

EXPERIMENTAL

Diagnostic Test: study intervention: 3,4-methylenedioxymethamphetamine (MDMA, ecstasy); Diagnostic Test: Control intervention: Placebo

Healthy volunteers

EXPERIMENTAL

Diagnostic Test: study intervention: 3,4-methylenedioxymethamphetamine (MDMA, ecstasy); Diagnostic Test: Control intervention: Placebo

Interventions

study intervention: 3,4-methylenedioxymethamphetamine (MDMA, ecstasy) DIAGNOSTIC_TEST

single administration of MDMA (100mg): 3,4-methylenedioxymethamphetamine (MDMA, ecstasy) will be prepared as gelatin capsules with mannitol as the filler. MDMA will be administered in a single absolute dose of 100 mg corresponding to a medium high dose of (mean ± SD) 1.3 ± 0.3 mg/kg body weight.

Healthy volunteers; Patients with central diabetes insipidus

Control intervention: Placebo DIAGNOSTIC_TEST

Identical placebo (only mannitol) capsules

Healthy volunteers; Patients with central diabetes insipidus

Eligibility Criteria

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

You may qualify if:

• Confirmed diagnosis of central diabetes insipidus
• Matched for age, sex, BMI and estrogen replacement/menopause/hormonal contraceptives to patients with central diabetes insipidus
• No medication, except hormonal contraception-

You may not qualify if:

• 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/flatter, Wolff-Parkinson-White syndrome (WPW)-Syndrome)
• Uncontrolled arterial hypertension (\>140/90 mmHg) or hypotension (syst blood pressure \<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 inhibitor (SSRI), monoamine oxidase (MAO)-Inhibitors
• Pregnancy and breastfeeding
• Diagnosed chronic kidney disease (CKD) \> grade III (GRF \< 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, Endocrinology, Diabetes and Metabolism

Basel, 4031, Switzerland

Location

Related Publications (1)

• Atila C, Holze F, Murugesu R, Rommers N, Hutter N, Varghese N, Sailer CO, Eckert A, Heinrichs M, Liechti ME, Christ-Crain M. Oxytocin in response to MDMA provocation test in patients with arginine vasopressin deficiency (central diabetes insipidus): a single-centre, case-control study with nested, randomised, double-blind, placebo-controlled crossover trial. Lancet Diabetes Endocrinol. 2023 Jul;11(7):454-464. doi: 10.1016/S2213-8587(23)00120-1. Epub 2023 May 13.

  PMID: 37192642 DERIVED

MeSH Terms

Conditions

Diabetes Insipidus; Diabetes Insipidus, Neurogenic; Hypopituitarism

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mirjam Christ-Crain, Prof. Dr. med.

  Endocrinology, Diabetes and Metabolism, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, cross-over (MDMA versus placebo, within subject comparison) study in patients with central diabetes insipidus versus healthy controls (between-subject comparison). Participants will be randomized to receive either first placebo or first MDMA, respectively.

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 1, 2020
• Study Start: February 5, 2021
• Primary Completion: April 11, 2022
• Study Completion: April 11, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-04

Locations

CH (1)