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.
The study will compare the effects of a single dose of MDMA (100mg) to placebo in both groups. The primary outcome measure is the area under the concentration time curve in oxytocin level from baseline to 6 hours after administration of MDMA, comparing patients with central diabetes insipidus and healthy volunteers.
Secondary outcome measures include peak change in oxytocin plasma level, time course of plasma OT levels, time course of plasma MDMA concentration, time course of cortisol levels, time course of prolactin levels, time course of copeptin levels, time course of adrenocorticotropic hormone (ACTH) levels, subjective/emotional effects, recognition of negative emotions, empathy, anxiety level, level of alexithymia, level of depression, and level of general physical and mental health. The study started on February 5, 2021, and was completed on April 11, 2022. The study was conducted at the University Hospital in Basel, Switzerland.
Trial Details
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.NCT Number NCT04648137
Sponsors & Collaborators
University of BaselThe University of Basel Department of Biomedicine hosts the Liechti Lab research group, headed by Matthias Liechti.
Papers
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 trialThis double-blind, placebo-controlled study (n=30) explores oxytocin deficiency in patients with arginine vasopressin deficiency (central diabetes insipidus), using MDMA as a biochemical and psychoactive provocation test. The participants included patients with vasopressin deficiency and healthy controls, who were given either MDMA or placebo in a randomized order over two sessions.