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

Sponsor
University Hospital, Basel, Switzerland
Study ID
NCT07555132
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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)
  • Placebo — DIAGNOSTIC_TEST
    Placebos will be prepared as identical gelatine capsules containing only mannitol filler.

Study Details

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.

Key Dates

First listed
Apr 29, 2026
Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Patients with ASD
    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.
  • Active Comparator: Healthy controls
    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.

Primary Outcome Measure

Change in area under the concentration time curve in plasma neurophysin I [ Time Frame: From baseline (before intake) to 5 hours after a single dose administration of MDMA or placebo ]

Central Contacts

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