Diabetes InsipidusOxyMANCT04648137
Circulating Oxytocin Changes in Response to the Oxytocin System Stimulator MDMA in Patients With Diabetes Insipidus and Healthy Controls
A study testing study intervention: 3,4-methylenedioxymethamphetamine (MDMA, ecstasy) in people with Diabetes Insipidus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Insipidus
- What is being tested?
- study intervention: 3,4-methylenedioxymethamphetamine (MDMA, ecstasy)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Feb 2021to 11 Apr 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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-
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Endocrinology, Diabetes and Metabolism
Basel, 4031
About this study
This study is to evaluate oxytocin levels in response to MDMA administration as compared to placebo in patients with diabetes insipidus and healthy volunteers.
Read the detailed description
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.
- Conditions
- Diabetes Insipidus
- Being tested
- study intervention: 3,4-methylenedioxymethamphetamine (MDMA, ecstasy), Control intervention: Placebo
- Keywords
- central diabetes insipidus, oxytocin levels, 3,4-methylenedioxymethamphetamine (MDMA), hypothalamic-pituitary axis, hypopituitarism, vasopressin
- Medical subject headings
- Diabetes Insipidus, Diabetes Insipidus, Neurogenic, Hypopituitarism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Control intervention: PlaceboDiagnostic test
Identical placebo (only mannitol) capsules
| Study group | Role | What they receive |
|---|---|---|
| Patients with central diabetes insipidus | Experimental | Not described Receives: Diagnostic Test: study intervention: 3,4-methylenedioxymethamphetamine (MDMA, ecstasy); Diagnostic Test: Control intervention: Placebo |
| Healthy volunteers | Experimental | Not described Receives: Diagnostic Test: study intervention: 3,4-methylenedioxymethamphetamine (MDMA, ecstasy); Diagnostic Test: Control intervention: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA
Secondary outcomes (14)
Peak change in oxytocin (OT) plasma level
Peak change in OT plasma level
Measured: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA
Time course of plasma OT levels
Time course of plasma OT levels
Measured: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA
Time course of plasma MDMA concentration
Time course of plasma MDMA concentration
Measured: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA
Time course of cortisol levels
Time course of cortisol levels
Measured: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA
Time course of prolactin levels
Time course of prolactin levels
Measured: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA
Time course of copeptin levels
Time course of copeptin levels
Measured: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA
Time course of adrenocorticotropic hormone (ACTH) levels
Time course of ACTH levels
Measured: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA
Subjective/emotional effects
Subjective/emotional effects assessed on a 10-point visual analog scale (e.g., feelings of anxiety, pleasure, fear, 0 = better outcome,10 = worst outcome)
Measured: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA
Recognition of negative emotions in the face emotion recognition task (FERT)
Recognition of negative emotions in the face emotion recognition task (FERT)
Measured: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA
Empathy in the multifaceted empathy task (MET)
Empathy in the multifaceted empathy task (MET)
Measured: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA
Anxiety level with the State-Trait Anxiety Inventory (STAI)
Anxiety level with the State-Trait Anxiety Inventory (STAI)
Measured: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA
Level of Alexithymia using the Toronto-Alexithymia-Scale 20 (TAS-20)
Level of Alexithymia using the Toronto-Alexithymia-Scale 20 (TAS-20); total scores can range from 20-100, with higher scores indicating greater impairment/challenges
Measured: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA
Level of depression using the Beck-Depressions-Inventory II (BDI-II)
Level of depression using the Beck-Depressions-Inventory II (BDI-II); 21-question multiple-choice self-report inventory. Higher total scores indicate more severe depressive symptoms.
Measured: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA
Level of general physical & mental health using the short form health survey (SF-36)
Level of general physical \& mental health using the short form health survey (SF-36); 36-item, patient-reported survey of patient health; the higher the score, the more favourable the health state.
Measured: from baseline oxytocin measurement (before intake) to 6 hours after administration of MDMA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start5 Feb 2021
- Primary completion11 Apr 2022
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes InsipidusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirjam Christ-Crain, Prof. Dr. med., Principal investigator, Endocrinology, Diabetes and Metabolism, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648137
- Sponsor's protocol ID
- 2020-02147; me20ChristCrain4
- Acronym
- OxyMA
- Status last verified
- Apr 2022
- First submitted
- 23 Nov 2020
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37192642