NCT07555132Not yet recruiting
Circulating Oxytocin Changes in Response to MDMA vs. Placebo in Adult Patients With Autism Spectrum Disorder and Matched Healthy Controls
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 15 Apr 2026
- Start date
- Jun 2026
- Primary completion date
- Jun 2028
- Lead sponsor
- University Hospital, Basel, Switzerland
- Diseases
- Autism
- NCT number
- NCT07555132
What you commit to
- Study type: Interventional
- Planned participants: 40
- From Jun 2026 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Current or previous major psychiatric disorder (e.g., major depression, schizophrenia spectrum disorder)
Other illness
- Uncontrolled arterial hypertension (>140/90 mmHg) or hypotension (<85mmHg)
- Psychotic disorder in first-degree relatives
- Confirmed epilepsy diagnosis
- Diagnosed autism spectrum disorder level 2 or 3 (according to DSM V criteria)
Lab values
- 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)
- Diagnosed CKD > grade III (GFR < 30ml/min)
Other
- Consumption of alcoholic beverages >15 drinks/week
- Tobacco smoking >10 cigarettes/day
- Pregnancy and breastfeeding
- Diagnosed liver cirrhosis or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) levels 2.5 times above the normal range
Who the study is looking for
- Adult patients with a confirmed diagnosis of autism spectrum disorder level 1 according to Diagnostic and Statistical Manual (DSM) V
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Basel, Endocrinology, Diabetes and Metabolism Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.