Skip to content
CompletedNot applicable

Psilocybin in Adults With and Without Autism Spectrum Disorder

NCT05651126 · PSILAUT · King's College London

Closed to entry
Status
Not accepting participants
Not applicable
Phase
67
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

This study will test the hypothesis that brain systems are differentially regulated by serotonin in individuals with and without Autism Spectrum Disorder.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Brain activation and connectivity response to serotonergic stimulation as assessed by functional magnetic resonance imaging.

    Measured over Data collected on up to 3 visit days per participant.

  • Brain electrophysiological activity task-free electroencephalography (EEG)

    Measured over Data collected on up to 3 visit days per participant.

  • Brain electrophysiological activity electroencephalography (EEG) during visual stimulation

    Measured over Data collected on up to 3 visit days per participant.

  • Brain electrophysiological activity electroencephalography (EEG) during auditory stimulation

    Measured over Data collected on up to 3 visit days per participant.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 60 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: For all participants: * Calendar age above 18 years * Working knowledge of English * Able to give informed consent * Not pregnant or breastfeeding * Individuals should be in good physical health, prescription medication free during the 2-week period preceding a study visit. However, occasional use of over-the-counter medication (e.g. painkillers) on an as needed basis (and not on the day of study visit) may be permitted. In addition, regular prescription medication (use of a stable dose over the two months preceding participation) with a drug that does not affect 5HT directly may be permitted. Also permitted is topical medication without systemic exposure For individuals with ASD: * Diagnosis of ASD by recognised clinical service supported by the Autism Diagnostic Interview-Revised (ADI-R) if a relative is available. Current symptom level assessed using the Autism Diagnostic Observation Schedule (ADOS-2) Exclusion Criteria: For all participants: * History of allergy/idiosyncrasy to psilocybin or chemically related compounds or excipients which may be employed in the study or to any other drug used in the past * Clinically relevant history or presence of any medical disorder, potentially interfering with this study * Clinically relevant abnormality at screening as judged by the investigator * History of or current abuse of drugs (including prescription medication) or alcohol or solvents * Participation in a research study involving a pharmacological probe or drug trial within last month * Subjects with current epilepsy, seizures or episodes of unexplained and unprovoked loss of consciousness * Anyone with a history or examination which indicates laboratory testing is needed will be excluded from the study * Intelligence Quotient below 70 * Currently taking prescription medications of propranolol or pindolol * Individuals with major mental illness * Individuals who have a current or past history of meeting diagnostic criteria for schizophrenia or other psychotic disorders or bipolar I or II disorder Reproductive safety: * Pregnancy or breastfeeding (is a routine exclusion for research MRI scanning) * Female study participants must be willing to use one form of highly effective non-hormonal contraception for one week after study drug administration. This would include a vasectomised partner (sole partner), tubal occlusion, intrauterine system \[IUS\]/hormonal coil or copper containing intrauterine device or copper containing IUD, or true abstinence (when this is in line with the preferred and usual lifestyle of the subject). Women should have been stable on their chosen method of birth control for a minimum of 2 months before entering the study. Participants must agree to undergo a pregnancy test prior to each administration of study drug For individuals with ASD: ASD caused by a known genetic syndrome, e.g. Fragile X, 22q11 deletion syndrome. Currently treated for epilepsy

Where

1 study site

FacilityCityRegionCountry
King's College LondonLondonUnited Kingdom

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05651126 on ClinicalTrials.gov →

Last updated in the registry 2025-07-28. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits