PAPAYA: Pharmacologically-Assisted Psychotherapy for social Anxiety in Young people with Autism
Pharmacologically-Assisted Psychotherapy for social Anxiety in Young people with Autism
Orygen
156 participants
Apr 28, 2025
Interventional
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 16-25 years old at consent;
- ASD diagnosed in the past year or as assessed with the Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2) Module 4;
- Current diagnosis of DSM-5 Social Anxiety Disorder (using the SCID 5);
- Ability to provide informed consent (sufficient English and IQ>70 assessed with the Weschler Test of Adult Reading).
Exclusion Criteria9
- Unable to safely abstain from alcohol for 48 hours before medication-assisted therapy sessions;
- Unable to abstain from cannabis for 48 hours before medication-assisted therapy sessions;
- Use of any illicit drug other than cannabis on average > 2 days per week over the past 4 weeks at screening;
- Unstable medical conditions or contraindications for study medications, assessed with medical exam, electrocardiogram, and clinical blood tests, and as determined by the trial doctor;
- Current treatment with contraindicated medications that cannot be safely discontinued as determined by the trial doctor;
- Current or past DSM-5 psychotic or bipolar illness, as assessed by the SCID-5;
- Acute suicidality or severe disturbance likely to interfere with the ability to comply with the study protocol;
- Significant speech, visual, or auditory impairment likely to interfere with treatment; and
- Pregnancy, breast feeding or, if sexually active, no effective contraception (participants capable of becoming pregnant only).
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Interventions
MDMA-ASSISTED PSYCHOTHERAPY: Individual psychotherapy is manualized and adapted from Cognitive Behavioral Therapy for social anxiety in autism. Participants undergo three 90-minute preparatory psychotherapy sessions, approximately a week apart. Following the prep sessions, each participant will attend two 8-hour MDMA-assisted psychotherapy sessions separated by 4 weeks. There will be four 60-90 minute integration psychotherapy sessions in the 4 weeks after each MDMA session, equalling a total of 8 integration sessions. Therapy is delivered by allied health practitioners (e.g. psychologists) trained in this method. MDMA-assisted sessions and most other psychotherapy sessions are delivered face-to-face. Some preparatory and/or integration sessions may be delivered via telehealth. Preparatory sessions will focus on developing a collaborative relationship between participant and therapist, setting therapy expectations and developing a safety plan. Medication-assisted psychotherapy sessions will include periods of quiet introspection and will employ the cognitive behavioural framework to discuss material arising during these periods, as well as reflecting on cognitions identified as related to social anxiety, and some exposure activities. Integration sessions will include reflecting on experiences and learnings in the medication-assisted sessions and generalising these learnings into everyday life using cognitive behavioural techniques. MDMA DOSE: Session 1, Initial Dose 1.0 mg/kg (Administered at the beginning of the session once baseline checks (e.g., medical review; biochemical tests for pregnancy and recent drug and alcohol use; adverse events) are completed; oral) Session 1, Supplemental Dose 0.5mg/kg (Administered 2.5-3 hours post initial dose if indicated; oral) Session 2, Initial Dose 1.5 mg/kg if Session 1 dose well tolerated, or 1.0 mg/kg (Administered at the beginning of the session once baseline checks (e.g., medical review; biochemical tests for pregnancy and recent drug and alcohol use; adverse events) are completed; oral) Session 2, Supplemental Dose 0.5mg/kg (Administered 2.5-3 hours post initial dose if indicated; oral) MDMA doses are rounded to the nearest 40 mg with a maximum initial dose of 120 mg. STUDY SETTING The study will be conducted at Orygen Clinical Trials Unit in Melbourne and the Brain and Mind Centre at the University of Sydney. FIDELITY All participants will be asked for permission to video record sessions for ongoing clinician training and fidelity assessment. ALLIED HEALTH PRACTITIONERS All therapists will be clinically experienced allied health providers. Study specific clinician training will be delivered by study PIs who are experts in the field (clinical psychologists and psychiatrists). Training (between five and ten, 2-hour training sessions) will include didactic training, guided reading, discussion, and role plays and be delivered before the first trial participant is randomised.
Locations(1)
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ACTRN12624001474549