MDMA as a Stimulation Test for Possible Oxytocin Deficiency in Adults with Autism Spectrum Disorder and Healthy Controls
Summary description of the study
Oxytocin is a hormone produced in the brain and released into the bloodstream by the pituitary gland. It is involved in important psychosocial aspects and has a positive influence on mother-child relationships or partnership relationships, as well as on feelings such as love, trust, and relaxation. Among laypeople, the hormone is also referred to as the cuddle or love hormone. Changes in the oxytocin system have been studied for many years in connection with autism spectrum disorder, as some affected individuals exhibit peculiarities in social perception and interaction. There is scientific evidence that in some adult individuals with autism spectrum disorder, the release or effect of oxytocin may be altered. However, individual measurements of hormone levels in the blood are not sufficient to reliably assess the function of the oxytocin system. A new approach is to test how well the oxytocin system responds to a targeted stimulus. Such a response is called a "stimulation test." The substance MDMA (3,4-methylenedioxymethamphetamine) is known to trigger a strong, short-term increase in oxytocin levels. This effect has been confirmed multiple times in healthy individuals. With this study, we aim to find out how strongly the oxytocin system of adult individuals with autism spectrum disorder responds to MDMA compared to healthy controls. This will help us better understand whether a portion of adult individuals with autism spectrum disorder may have impaired oxytocin release.
(BASEC)
Intervention under investigation
MDMA (3,4-methylenedioxymethamphetamine, 100mg) as a stimulation test.
(BASEC)
Disease under investigation
Autism Spectrum Disorder
(BASEC)
Inclusion Criteria – Patients
• Adults (18–65 years) with a confirmed diagnosis of autism spectrum disorder according to DSM-5, validated by ADOS and/or ADI-R.
Inclusion Criteria – Healthy Controls
• Healthy participants,
• matched by age, gender, BMI, and ovarian hormone status (menopause/estrogen therapy/hormonal contraceptives),
• no medication except hormonal contraception,
• Autism Spectrum Quotient <32.
(BASEC)
Exclusion criteria
• Illegal substances (except cannabis) >10 times in life or use in the last 2 months.
• Alcohol >15 standard drinks/week.
• Smoking >10 cigarettes/day.
• Cardiovascular diseases (CAD, heart failure LVEF <40%, stroke <3 months, atrial fibrillation/flutter, WPW syndrome).
• Uncontrolled hypertension (>140/90 mmHg) or hypotension (systole <85 mmHg).
• Current or former severe psychiatric illness (e.g., depression, schizophrenia).
• Psychotic illness in first-degree relatives.
• Pregnancy or breastfeeding.
• Chronic kidney insufficiency stage >III (GFR <30 ml/min).
• Liver cirrhosis or ALAT/ASAT >2.5× above normal.
• Confirmed epilepsy.
(BASEC)
Trial sites
Basel
(BASEC)
Sponsor
Mirjam Christ-Crain (University Hospital Basel)
(BASEC)
Contact
Contact Person Switzerland
Mirjam Christ-Crain
+4161 265 25 25
mirjam.christ-crain@clutterusb.chUniversitätsspital Basel Dept. für Endokrinologie Petersgraben 4 4031 Basel
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
02.02.2026
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Circulating Oxytocin Changes in Response to MDMA vs. Placebo in Adult Patients with Autism Spectrum Disorder and Matched Healthy Controls – A Randomized Placebo-Controlled Cross-Over Trial – The OxySPECTRUM Study (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
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Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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