An interventional study of PLC and CBD in Autism Spectrum Disorder, sponsored by King's College London. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by King's College London · Not applicable, Interventional, and Basic science
This study investigates brain response to single acute dose of cannabidiol, cannabidivarin, and placebo in healthy men with and without autism spectrum disorder
Previous research suggests that cannabidiol (CBD) and cannabidivarin (CBDV) could have the potential to shift brain excitation and inhibition (E-I) in the healthy brain and in neurodevelopmental psychiatric conditions, where this balance is disrupted, such as autism spectrum disorder (ASD). However, no study to date has investigated this. Therefore, in this study, we invited 20 healthy men with and without ASD. Each participant received each drug once (600mg CBD/CBDV, or matched placebo) and magnetic resonance imaging was used to obtain measures of brain biochemistry, activity, and connectivity. We further obtained questionnaires, task data, saliva, urine and blood samples, and conducted visual tasks using eye tracking, electroencephalography, and retinal imaging.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 38 is below the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →King's College London is the lead sponsor of 506 studies on the registry; 125 are open to participants now.
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Dose order: PLC, CBD, CBDV
Drug: PLC · Drug: CBD · Drug: CBDV
Dose order: PL, CBDV, CBD
Drug: PLC · Drug: CBD · Drug: CBDV
Dose order: CBD, PLC, CBDV
Drug: PLC · Drug: CBD · Drug: CBDV
Dose order: CBD, CBDV, PLC
Drug: PLC · Drug: CBD · Drug: CBDV
Dose order: CBDV, PLC, CBD
Drug: PLC · Drug: CBD · Drug: CBDV
Dose order: CBDV, CBD, PLC
Drug: PLC · Drug: CBD · Drug: CBDV
Single oral dose of PLC.
Also known as: Placebo
Single oral dose of cannabidiol (CBD) - 600mg.
Also known as: Cannabidiol
Single oral dose of cannabidivarin (CBDV) - 600mg.
Also known as: Cannabidivarin
Brain biochemistry response to pharmacological stimulation
The measure of brain biochemistry response to PLC, CBD, and CBDV includes the following: Assessment of the ratio of brain excitation and inhibition (measured as the balance of excitatory and inhibitory neurotransmitters) using using proton magnetic resonance spectroscopy \[1H\]MRS.
Time frame: In the months 1-2 following the last day of scanning.
Measurement of low frequency brain activity using resting state fMRI
In the third and fourth month following the day of the last scan, we will measure whole brain low frequency brain activity using resting state functional magnetic resonance imaging. Measure of activity: fractional amplitude of low frequency fluctuations.
Time frame: In the months 3-4 following the last day of scanning
Measurement of brain functional connectivity using resting state fMRI
In the fifth and sixth month following the day of the last scan, we will measure whole brain resting state functional connectivity using resting state functional magnetic resonance imaging. Measure of connectivity: correlation between pairs of regions.
Time frame: In the months 5-6 following the last day of scanning
Plan to share: No
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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King's College London