Not Yet RecruitingN/AMDMA

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

Sponsored by University Hospital, Basel, Switzerland

NCT ID
NCT07555132
Target Enrollment
40 participants
Start Date
2026-06
Est. Completion
2028-06

About This Study

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.

Conditions Studied

Autism Spectrum Disorder

Interventions

  • MDMA
  • Placebo

Eligibility

Age:18 Years - N/A
Healthy Volunteers:Yes
View full eligibility criteria
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)

Study Locations (1)

University Hospital Basel, Endocrinology, Diabetes and Metabolism
Basel, Switzerland

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Mirjam Christ-Crain, Prof. Dr. med.
CONTACT
+41 61 265 25 25mirjam.christ-crain@usb.ch
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source