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

NCT07555132 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-29

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

MDMA

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)

DIAGNOSTIC_TEST

Placebo

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

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Mirjam Christ-Crain, Prof. Dr. med. · University Hospital Basel, Endocrinology, Diabetes and Metabolism

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07555132 on ClinicalTrials.gov