Not Yet RecruitingNot Applicable

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

Switzerland40 participantsStarted 2026-06

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT07555132

SponsorUniversity Hospital, Basel, Switzerland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06

Contact for this trial

Mirjam Christ-Crain, Prof. Dr. med.

+41 61 265 25 25 mirjam.christ-crain@usb.ch

View on ClinicalTrials.gov More Autism Spectrum Disorder trials