Clinical TrialAutism Spectrum Disorder (ASD)PsilocybinPsilocybinPlaceboCompleted

Psilocybin in Adults With and Without Autism Spectrum Disorder (PSILAUT)

Randomised, double-blind, crossover neuroimaging study (n=67) comparing single doses of psilocybin 2 mg and 5 mg versus placebo in adults with and without Autism Spectrum Disorder to probe serotonin system regulation.

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

Detailed Description

Case-control repeated-measures crossover design: each participant receives placebo, psilocybin 2 mg and psilocybin 5 mg in separate visits; order pseudorandomised and participants/investigators blinded.

Primary outcomes evaluate serotonin-modulated brain responses using multimodal neuroimaging (fMRI, MRS), EEG and sensory tasks with unimodal and multimodal analyses.

Psilocybin (COMP360) is used as a probe of the serotonin system; UK MHRA determined this is not an IMP clinical trial under EU Directive definitions.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

Crossover

experimental

Randomised, double-blind, crossover administration of placebo, psilocybin 2 mg and psilocybin 5 mg in separate visits.

Interventions

  • Psilocybin5 mg
    via Oral• single dose• 1 doses total

    COMP360 psilocybin 5 mg.

  • Psilocybin2 mg
    via Oral• single dose• 1 doses total

    COMP360 psilocybin 2 mg.

  • Placebo0 mg
    via Oral• single dose• 1 doses total

    Inactive placebo.

Participants

Ages
18 – 60
Sexes
Male & Female

Inclusion Criteria

  • 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

  • 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

Study Details

Locations

King's College London — London, United Kingdom

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