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Autism Spectrum DisorderNCT03537950

Shifting Brain Excitation-Inhibition Balance in Autism Spectrum Disorder

A study testing PLC, CBD and CBDV in people with Autism Spectrum Disorder, run by King's College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study investigates brain response to single acute dose of cannabidiol, cannabidivarin, and placebo in healthy men with and without autism spectrum disorder Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
PLC, CBD and CBDV
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited Kingdom
Study dates
22 Aug 2016to 1 Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • King's College London

    London, SE5 8AF

Other trials in United Kingdom

About this study

Official title: Shifting Brain Excitation-Inhibition Balance Through the Endocannabinoid System in Men With Autism Spectrum Disorder (ASD) and in Healthy Controls

This study investigates brain response to single acute dose of cannabidiol, cannabidivarin, and placebo in healthy men with and without autism spectrum disorder

Read the detailed description

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.

Being tested
PLC, CBD, CBDV
Keywords
Cannabidiol, Cannabidivarin, E-I balance, pharmacological imaging
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PLCDrug

    Also called Placebo

    Single oral dose of PLC.

  • CBDDrug

    Also called Cannabidiol

    Single oral dose of cannabidiol (CBD) - 600mg.

  • CBDVDrug

    Also called Cannabidivarin

    Single oral dose of cannabidivarin (CBDV) - 600mg.

Study groups in NCT03537950
Study groupRoleWhat they receive
PLC, CBD, CBDVExperimentalDose order: PLC, CBD, CBDV
Receives: Drug: PLC; Drug: CBD; Drug: CBDV
PLC, CBDV, CBDExperimentalDose order: PL, CBDV, CBD
Receives: Drug: PLC; Drug: CBD; Drug: CBDV
CBD, PLC, CBDVExperimentalDose order: CBD, PLC, CBDV
Receives: Drug: PLC; Drug: CBD; Drug: CBDV
CBD, CBDV, PLCExperimentalDose order: CBD, CBDV, PLC
Receives: Drug: PLC; Drug: CBD; Drug: CBDV
CBDV, PLC, CBDExperimentalDose order: CBDV, PLC, CBD
Receives: Drug: PLC; Drug: CBD; Drug: CBDV
CBDV, CBD, PLCExperimentalDose order: CBDV, CBD, PLC
Receives: Drug: PLC; Drug: CBD; Drug: CBDV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: In the months 1-2 following the last day of scanning.

Secondary outcomes (2)

  1. 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.

    Measured: In the months 3-4 following the last day of scanning

  2. 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.

    Measured: In the months 5-6 following the last day of scanning

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2018
  2. Study start22 Aug 2016
  3. Primary completion16 Feb 2017
  4. Study completion1 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Repeated-measures cross-over study, where each subject received each of three pharmacological probes once (order of drug administration was pseudorandomised)
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03537950
Sponsor's protocol ID
HR15-162744
Status last verified
Mar 2024
First submitted
17 Apr 2018
Last updated
5 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34210360

Questions about this trial

What is this clinical trial studying?

A study testing PLC, CBD and CBDV in people with Autism Spectrum Disorder, run by King's College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain biochemistry response to pharmacological stimulation (time frame: In the months 1-2 following the last day of scanning.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03537950, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.

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