Shifting Brain Excitation-Inhibition Balance in Autism Spectrum Disorder
NCT ID: NCT03537950
Last Updated: 2024-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2016-08-22
2017-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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PLC, CBD, CBDV
Dose order: PLC, CBD, CBDV
PLC
Single oral dose of PLC.
CBD
Single oral dose of cannabidiol (CBD) - 600mg.
CBDV
Single oral dose of cannabidivarin (CBDV) - 600mg.
PLC, CBDV, CBD
Dose order: PL, CBDV, CBD
PLC
Single oral dose of PLC.
CBD
Single oral dose of cannabidiol (CBD) - 600mg.
CBDV
Single oral dose of cannabidivarin (CBDV) - 600mg.
CBD, PLC, CBDV
Dose order: CBD, PLC, CBDV
PLC
Single oral dose of PLC.
CBD
Single oral dose of cannabidiol (CBD) - 600mg.
CBDV
Single oral dose of cannabidivarin (CBDV) - 600mg.
CBD, CBDV, PLC
Dose order: CBD, CBDV, PLC
PLC
Single oral dose of PLC.
CBD
Single oral dose of cannabidiol (CBD) - 600mg.
CBDV
Single oral dose of cannabidivarin (CBDV) - 600mg.
CBDV, PLC, CBD
Dose order: CBDV, PLC, CBD
PLC
Single oral dose of PLC.
CBD
Single oral dose of cannabidiol (CBD) - 600mg.
CBDV
Single oral dose of cannabidivarin (CBDV) - 600mg.
CBDV, CBD, PLC
Dose order: CBDV, CBD, PLC
PLC
Single oral dose of PLC.
CBD
Single oral dose of cannabidiol (CBD) - 600mg.
CBDV
Single oral dose of cannabidivarin (CBDV) - 600mg.
Interventions
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PLC
Single oral dose of PLC.
CBD
Single oral dose of cannabidiol (CBD) - 600mg.
CBDV
Single oral dose of cannabidivarin (CBDV) - 600mg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
MALE
Yes
Sponsors
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King's College London
OTHER
Responsible Party
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Dr Grainne McAlonan
Deputy head of department
Principal Investigators
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Grainne McAlonan, PhD
Role: PRINCIPAL_INVESTIGATOR
King's College London
Locations
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King's College London
London, , United Kingdom
Countries
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References
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Pretzsch CM, Floris DL, Voinescu B, Elsahib M, Mendez MA, Wichers R, Ajram L, Ivin G, Heasman M, Pretzsch E, Williams S, Murphy DGM, Daly E, McAlonan GM. Modulation of striatal functional connectivity differences in adults with and without autism spectrum disorder in a single-dose randomized trial of cannabidivarin. Mol Autism. 2021 Jul 1;12(1):49. doi: 10.1186/s13229-021-00454-6.
Other Identifiers
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HR15-162744
Identifier Type: -
Identifier Source: org_study_id
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