MDMA as a Stimulation Test for Possible Oxytocin Deficiency in Adults with Autism Spectrum Disorder and Healthy Controls
Résumé de l'étude
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 étudiée
MDMA (3,4-methylenedioxymethamphetamine, 100mg) as a stimulation test.
(BASEC)
Maladie en cours d'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)
Critères d'exclusion
• 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)
Lieu de l’étude
Bâle
(BASEC)
Sponsor
Mirjam Christ-Crain (University Hospital Basel)
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Mirjam Christ-Crain
+4161 265 25 25
mirjam.christ-crain@clutterusb.chUniversitätsspital Basel Dept. für Endokrinologie Petersgraben 4 4031 Basel
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
02.02.2026
(BASEC)
Identifiant de l'essai ICTRP
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Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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