Clinical TrialAnxiety DisordersMDMANot yet recruiting

Pharmacologically-Assisted Psychotherapy for social Anxiety in Young people with Autism

This randomised controlled parallel group Phase III trial (n=156) evaluated the safety and efficacy of mdma for social anxiety disorder autism spectrum disorder using 70mg/70kg mdma.

Target Enrollment
156 participants
Study Type
Phase III interventional
Design
Randomized, triple Blind

Detailed Description

The aim of this study is to test whether MDMA-assisted psychotherapy reduces social anxiety in young autistic people, compared with medication-assisted psychotherapy using:
• Dexamfetamine
• Lorazepam
• Diphenhydramine hydrochloride, and
• placebo.
We hypothesise that MDMA-assisted psychotherapy will reduce social anxiety more than medication psychotherapy with placebo or the active control medications.

Young people with autism, aged 16 to 25 years and experiencing social anxiety can take part in this research. The study will involve assessment for autism if participants have not been diagnosed in the past year. Participation will involve taking part in a medication-assisted psychotherapy program over a period of 12 weeks in addition to participating in a number of research assessments for approximately one year.

Study Arms & Interventions

Experimental Arm

experimental

Interventions

  • MDMA

Participants

Inclusion Criteria

  • 1. 16-25 years old at consent;
  • 2. ASD diagnosed in the past year or as assessed with the Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2) Module 4;
  • 3. Current diagnosis of DSM-5 Social Anxiety Disorder (using the SCID 5);
  • 4. Ability to provide informed consent (sufficient English and IQ>70 assessed with the Weschler Test of Adult Reading).

Exclusion Criteria

  • 1. Unable to safely abstain from alcohol for 48 hours before medication-assisted therapy sessions;
  • 2. Unable to abstain from cannabis for 48 hours before medication-assisted therapy sessions;
  • 3. Use of any illicit drug other than cannabis on average > 2 days per week over the past 4 weeks at screening;
  • 4. Unstable medical conditions or contraindications for study medications, assessed with medical exam, electrocardiogram, and clinical blood tests, and as determined by the trial doctor;
  • 5. Current treatment with contraindicated medications that cannot be safely discontinued as determined by the trial doctor;
  • 6. Current or past DSM-5 psychotic or bipolar illness, as assessed by the SCID-5;
  • 7. Acute suicidality or severe disturbance likely to interfere with the ability to comply with the study protocol;
  • 8. Significant speech, visual, or auditory impairment likely to interfere with treatment; and
  • 9. Pregnancy, breast feeding or, if sexually active, no effective contraception (participants capable of becoming pregnant only).

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase III
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment156 participants
  • Timeline
    Start: 2025-04-28
    End: 2027-01-15
  • Compound
    MDMA
  • Topic
    Anxiety Disorders

Locations

Unknown facility — Australia

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