Overview

Shifting Brain Excitation-Inhibition Balance in Autism Spectrum Disorder

Status:
Unknown status
Trial end date:
2019-04-27
Target enrollment:
0
Participant gender:
Male
Summary
This study investigates brain response to single acute dose of cannabidiol, cannabidivarin, and placebo in healthy men with and without autism spectrum disorder
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
King's College London
Treatments:
Cannabidiol
Criteria
Inclusion Criteria:

- men

- pass diagnostic threshold for ASD on the ADI-R (if informant is available)

- currently symptomatic on ADOS

- age 18-50 years

- can give informed consent

- IQ>70 (on a standard instrument such as WASI)

- medication-free in the month preceding participation (but regular medication with
drug, which does not affect glutamate or GABA directly may be permitted)

- willing to provide urine samples to screen for use of illicit substances prior to each
scan

Exclusion Criteria:

- IQ<70

- history of psychosis, co-morbid major mental illness, significant physical illness
(heart disease, high blood pressure, seizures)

- habitual substance misuse (including alcohol)

- known allergy to cannabis

- ASD caused by a known genetic syndrome e.g. Fragile X or 22q11 deletion syndrome,

- past/present treatment for epilepsy

- Women will be excluded from this pilot study to reduce heterogeneity in a small
sample; avoid the issues around exposing women of reproductive age to a drug; and
because pregnancy is a routine exclusion criteria for research MRI. Lastly, ASD is
more common in men.