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Circulating Oxytocin Changes in Response to MDMA vs. Placebo in Adult Patients With Autism Spectrum Disorder and Matched Healthy Controls

NCT07555132 · OxySPECTRUM · University Hospital, Basel, Switzerland

Closed to entry
Status
Not accepting participants
Not applicable
Phase
40
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

This study is to investigate the physiological mechanism of oxytocin system stimulation using 3,4-methylenedioxymethamphetamine (MDMA) as a physiological tool (acute oxytocin releases), not as a medication. This study seeks to test whether the oxytocin response after MDMA administration is different between individuals with autism spectrum disorder and matched healthy controls.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in area under the concentration time curve in plasma neurophysin I

    Measured over From baseline (before intake) to 5 hours after a single dose administration of MDMA or placebo

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria for patients: * Adult patients with a confirmed diagnosis of autism spectrum disorder level 1 according to Diagnostic and Statistical Manual (DSM) V Inclusion criteria for healthy controls: * Adult healthy controls * Matched for age, sex, BMI, and oestrogen replacement/menopause/hormonal contraceptives to patients * No medication, except hormonal contraception * A score of \<32 in the Autism Spectrum Quotient Exclusion Criteria: * Participation in a trial with investigational drugs within 30 days * Illicit substance use (except for 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/flutter, Wolff-Parkinson-White (WPW)-Syndrome) * Uncontrolled arterial hypertension (\>140/90 mmHg) or hypotension (\<85mmHg) * Current or previous major psychiatric disorder (e.g., major depression, schizophrenia spectrum disorder) * Psychotic disorder in first-degree relatives * Pregnancy and breastfeeding * Diagnosed CKD \> grade III (GFR \< 30ml/min) * Diagnosed liver cirrhosis or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) levels 2.5 times above the normal range * Confirmed epilepsy diagnosis * Diagnosed autism spectrum disorder level 2 or 3 (according to DSM V criteria)

Where

1 study site

FacilityCityRegionCountry
University Hospital Basel, Endocrinology, Diabetes and MetabolismBaselSwitzerland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07555132 on ClinicalTrials.gov →

Last updated in the registry 2026-04-29. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits