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

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.

Intervention / Treatment

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

Condition or Disease

  • Diabetes Insipidus

Phase

Study Design

Study type: Interventional
Status: Completed
Study results: No Results Available
Age: 18 Years to 65 Years   (Adult, Older Adult)
Enrollment: 30 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Feb 05, 2021
Primary Completion: Apr 11, 2022
Completion Date: Apr 11, 2022
Study First Posted: Dec 01, 2020
Last Updated: Apr 13, 2022

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Disruption of the hypothalamic-pituitary axis due to congenital abnormalities, tumors or head trauma may cause anterior and/or posterior pituitary deficiency also known as partial or panhypopituitarism. Patients with hypopituitarism, especially those with panhypopituitarism (i.e., anterior and posterior insufficiency) often report residual symptoms and lower quality of life despite adequate substitution treatment of deficient pituitary hormones. A recent study identified a potential oxytocin deficient state in men with combined anterior and posterior deficiency. Due to the close proximity of vasopressin and oxytocin, disruption of the vasopressin system leading to diabetes insipidus could as well disturb the oxytocin system leading to low oxytocin levels. It is therefore possible that the increased psychopathology and reduced quality of life as observed in patients with central diabetes insipidus is caused by an oxytocin deficiency. Several studies documented marked acute increases in circulating oxytocin levels in response to 3,4-methylenedioxymethamphetamine (MDMA) administration as compared to placebo in healthy volunteers.

MDMA could therefore be useful as a provocation test to detect an oxytocin deficiency in patients with central diabetes insipidus. This study is to investigate if oxytocin provocation following a single dose administration of MDMA is reduced in patients with central diabetes insipidus as compared to healthy volunteers.

Eligibility Criteria

Sex: All

More Details

NCT Number: NCT04648137
Acronym: OxyMA
Other IDs: 2020-02147; me20ChristCrain4
Study URL: https://ClinicalTrials.gov/show/NCT04648137
Last updated: Jun 17, 2022