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

NCT07555132 | Not Yet Recruiting

• 1 other identifier: 2025-02452_kt26ChristCrain2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder

Keywords

Oxytocin (OT); 3,4-methylenedioxymethamphetamine (MDMA)

Outcome Measures

Primary Outcomes (1)

• Change in area under the concentration time curve in plasma neurophysin I

  Change in area under the concentration time curve in plasma neurophysin I after a single dose administration of MDMA (100mg) as compared to placebo in the same individuals and compared between ASD patients and healthy controls.

  From baseline (before intake) to 5 hours after a single dose administration of MDMA or placebo

Secondary Outcomes (14)

• Peak change in plasma oxytocin/neurophysin-I level

  From baseline (before intake) to 5 hours after a single dose administration of MDMA or placebo

• Time course of plasma oxytocin/neurophysin-I levels

  From baseline (before intake) to 5 hours after a single dose administration of MDMA or placebo

• Time course of plasma MDMA concentration

  From baseline (before intake) to 5 hours after a single dose administration of MDMA or placebo

• Time course of pituitary hormone

  From baseline (before intake) to 5 hours after a single dose administration of MDMA or placebo

• Change in subjective emotional effects assessed on Subjective effects questionnaire Numeric Analog Scales (NAS)

  Throughout the treatment visit (timepoint 0, 30, 60, 90, 120, 150, 180, 240, and 300 minutes)

Study Arms (2)

Patients with ASD

ACTIVE COMPARATOR

MDMA 100 mg versus placebo, within-subject comparison; randomized to be given MDMA 100 mg or a placebo first in random order. Each participant will present at the study site for two experimental visits.

Diagnostic Test: MDMA; Diagnostic Test: Placebo

Healthy controls

ACTIVE COMPARATOR

MDMA 100 mg versus placebo, within-subject comparison; randomized to be given MDMA 100 mg or a placebo first in random order. Each participant will present at the study site for two experimental visits.

Diagnostic Test: MDMA; Diagnostic Test: Placebo

Interventions

MDMA DIAGNOSTIC_TEST

MDMA will be prepared as gelatine capsules containing 25 mg of pharmaceutically pure MDMA hydrochloride (Lipomed AG, Arlesheim, Switzerland) and mannitol filler. MDMA will be administered in a single dose of 100 mg (4 capsules of 25 mg MDMA)

Healthy controls; Patients with ASD

Placebo DIAGNOSTIC_TEST

Placebos will be prepared as identical gelatine capsules containing only mannitol filler.

Healthy controls; Patients with ASD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Endocrinology, Diabetes and Metabolism

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Mirjam Christ-Crain, Prof. Dr. med.

  University Hospital Basel, Endocrinology, Diabetes and Metabolism

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mirjam Christ-Crain, Prof. Dr. med.

CONTACT

+41 61 265 25 25; mirjam.christ-crain@usb.ch

Talitha Hildebrandt

CONTACT

+41 61 556 5075; talithanatalja.hildebrandt@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants, study investigators and study nurses will be blinded to the study intervention.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, cross-over (MDMA vs. placebo, within- individual comparison) study in patients versus healthy controls (between-individual comparison)

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

CH (1)