Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-24 @ 5:04 PM
NCT ID:
NCT03537950
Eligibility 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.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03537950
Study Brief:
Protocol Section:
NCT03537950