NCT05651126

Psilocybin in Adults With and Without Autism Spectrum Disorder

Modulation of Serotonin Pathways Using Psilocybin in Adults With and Without Autism Spectrum Disorder (ASD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

To do this, the brain response to two single acute doses of partial serotonin (5HT)1A/2A receptor agonist psilocybin (COMP360) relative to a single dose of placebo (baseline serotonin activity) will be compared in healthy autistic and non-autistic adults. Brain function will be assessed using a range of MRI (fMRI and MRS), EEG and sensory tasks. Unimodal and multimodal analyses will be conducted. Please note that this study uses psilocybin as a probe of the serotonin system in a Case-Control science study and, following Scope protocol review, the U.K. MHRA confirmed that it is not a 'Clinical Trial of an Investigational Medicinal Product' (IMP) as defined by the EU Directive 2001/20/EC.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Psilocybin 5 mg	Partial Serotonin (5HT) 1A/2A Receptor Agonist Psilocybin
DRUG	Psilocybin 2 mg	Partial Serotonin (5HT) 1A/2A Receptor Agonist Psilocybin
DRUG	Placebo	Inactive placebo

Timeline

• Start date: 2022-12-12
• Primary completion: 2024-08-23
• Completion: 2024-08-23
• First posted: 2022-12-14
• Last updated: 2025-07-28

Locations

1 site across 1 country: United Kingdom