Clinical TrialCrossoverAutism Spectrum Disorder (ASD)MDMAPlaceboMDMAPlaceboNot yet recruiting

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

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.

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Target Enrollment
40 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

Detailed Description

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.

Study Arms & Interventions

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.

Interventions

  • MDMA100 mg
    via Oral• single dose• 1 doses total
  • 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.

Interventions

  • MDMA100 mg
    via Oral• single dose• 1 doses total
  • Placebo

Participants

Ages
18 – ?
Sexes
Male & Female

Inclusion Criteria

  • for patients:
  • Adult patients with a confirmed diagnosis of autism spectrum disorder level 1 according to Diagnostic and Statistical Manual (DSM) V
  • Inclusion criteria for healthy controls:
  • 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

Exclusion Criteria

  • 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)

Study Details

Study Team

Sponsors & Collaborators

Locations

University Hospital Basel, Endocrinology, Diabetes and Metabolism — Basel, Switzerland