Circulating Oxytocin Changes in Response to MDMA vs. Placebo in Adult Patients With Autism Spectr… (NCT07555132) | Clinical Trial Compass
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 range18 Years
SexALL
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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 …
What they're measuring
1
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