Skip to content

Trial · Interventional

CompletedNot applicableRegistry data

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

Short name OxyMA

NCTNCT04648137 (opens ClinicalTrials.gov in a new tab)Other id2020-02147; me20ChristCrain4
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures Oxytocin, does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Not applicable
Enrollment
30 participants (actual)
Sponsor
University Hospital, Basel, Switzerland · Other
Design
Randomized · Double masking
Countries
1 country

Switzerland

Start
5 Feb 2021
Primary completion
11 Apr 2022
Completion
11 Apr 2022
First posted
1 Dec 2020
Last update posted
13 Apr 2022
Conditions
Diabetes Insipidus

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. N/A

    OxyMA

    NCT04648137

    5 Feb 2021 to 11 Apr 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • study intervention: 3,4-methylenedioxymethamphetamine (MDMA, ecstasy)Diagnostic test
  • Control intervention: PlaceboDiagnostic test

Arms2

  • Experimental

    Patients with central diabetes insipidus

  • Experimental

    Healthy volunteers

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. area under the concentration time curve in oxytocin level

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

    Registry description

    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.

Secondary outcomes(14)

  1. Peak change in oxytocin (OT) plasma level

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

    Registry description

    Peak change in OT plasma level

  2. Time course of plasma OT levels

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

    Registry description

    Time course of plasma OT levels

  3. Time course of plasma MDMA concentration

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

    Registry description

    Time course of plasma MDMA concentration

  4. Time course of cortisol levels

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

    Registry description

    Time course of cortisol levels

  5. Time course of prolactin levels

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

    Registry description

    Time course of prolactin levels

  6. Time course of copeptin levels

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

    Registry description

    Time course of copeptin levels

  7. Time course of adrenocorticotropic hormone (ACTH) levels

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

    Registry description

    Time course of ACTH levels

  8. Subjective/emotional effects

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

    Registry description

    Subjective/emotional effects assessed on a 10-point visual analog scale (e.g., feelings of anxiety, pleasure, fear, 0 = better outcome,10 = worst outcome)

  9. Recognition of negative emotions in the face emotion recognition task (FERT)

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

    Registry description

    Recognition of negative emotions in the face emotion recognition task (FERT)

  10. Empathy in the multifaceted empathy task (MET)

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

    Registry description

    Empathy in the multifaceted empathy task (MET)

  11. Anxiety level with the State-Trait Anxiety Inventory (STAI)

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

    Registry description

    Anxiety level with the State-Trait Anxiety Inventory (STAI)

  12. Level of Alexithymia using the Toronto-Alexithymia-Scale 20 (TAS-20)

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

    Registry description

    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

  13. Level of depression using the Beck-Depressions-Inventory II (BDI-II)

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

    Registry description

    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.

  14. Level of general physical & mental health using the short form health survey (SF-36)

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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2023

3 results

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.

Atila et al. 2023The lancet. Diabetes & endocrinologycited by 56

PMID 37192642DOI 10.1016/s2213-8587(23)00120-1PUB-37192642

Full text at the publisher3 results
Publisher pageSee results (3)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria diabetes insipidus: * Confirmed diagnosis of central diabetes insipidus Inclusion criteria healthy volunteers: * Matched for age, sex, BMI and estrogen replacement/menopause/hormonal contraceptives to patients with central diabetes insipidus * No medication, except hormonal contraception- Exclusion Criteria: * 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

PepBank is a research reference. Talk to a doctor before you use any peptide.