This randomised, double-blind, crossover interventional trial (n=40) will assess whether a single 100 mg dose of MDMA changes circulating oxytocin signalling differently in adults with autism spectrum disorder (ASD) and matched healthy controls. The study (OxySPECTRUM) is designed to explore the physiological oxytocin response to MDMA, using plasma neurophysin I as an equimolar surrogate marker for oxytocin. Participants in both the ASD and healthy control groups will receive MDMA 100 mg and placebo in within-subject comparisons over two experimental visits, with the order randomised. MDMA will be given as four 25 mg gelatine capsules, while placebo will be identical capsules containing mannitol only. The main outcome is change in the area under the concentration-time curve for plasma neurophysin I from baseline to 5 hours after dosing.
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.
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.
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.