NCT03537950

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2017

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

April 17, 2018

Last Update Submit

March 4, 2024

Conditions

Autism Spectrum Disorder

Keywords

CannabidiolCannabidivarinE-I balancepharmacological imaging

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

  • Measurement of low frequency brain activity using resting state fMRI

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

  • Measurement of brain functional connectivity using resting state fMRI

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

Study Arms (6)

PLC, CBD, CBDV

EXPERIMENTAL

Dose order: PLC, CBD, CBDV

Drug: PLCDrug: CBDDrug: CBDV

PLC, CBDV, CBD

EXPERIMENTAL

Dose order: PL, CBDV, CBD

Drug: PLCDrug: CBDDrug: CBDV

CBD, PLC, CBDV

EXPERIMENTAL

Dose order: CBD, PLC, CBDV

Drug: PLCDrug: CBDDrug: CBDV

CBD, CBDV, PLC

EXPERIMENTAL

Dose order: CBD, CBDV, PLC

Drug: PLCDrug: CBDDrug: CBDV

CBDV, PLC, CBD

EXPERIMENTAL

Dose order: CBDV, PLC, CBD

Drug: PLCDrug: CBDDrug: CBDV

CBDV, CBD, PLC

EXPERIMENTAL

Dose order: CBDV, CBD, PLC

Drug: PLCDrug: CBDDrug: CBDV

Interventions

PLCDRUG

Single oral dose of PLC.

Also known as: Placebo
CBD, CBDV, PLCCBD, PLC, CBDVCBDV, CBD, PLCCBDV, PLC, CBDPLC, CBD, CBDVPLC, CBDV, CBD
CBDDRUG

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

Also known as: Cannabidiol
CBD, CBDV, PLCCBD, PLC, CBDVCBDV, CBD, PLCCBDV, PLC, CBDPLC, CBD, CBDVPLC, CBDV, CBD
CBDVDRUG

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

Also known as: Cannabidivarin
CBD, CBDV, PLCCBD, PLC, CBDVCBDV, CBD, PLCCBDV, PLC, CBDPLC, CBD, CBDVPLC, CBDV, CBD

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, SE5 8AF, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 34210360DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Cannabidiolcannabidivarin

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Grainne McAlonan, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants and investigators were blinded to the drug condition.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Repeated-measures cross-over study, where each subject received each of three pharmacological probes once (order of drug administration was pseudorandomised)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy head of department

Study Record Dates

First Submitted

April 17, 2018

First Posted

May 25, 2018

Study Start

August 22, 2016

Primary Completion

February 16, 2017

Study Completion

March 1, 2017

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)