Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000609358
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
30/04/2026
Date registered
Help: Date registered
18/05/2026
Date last updated
Help: Date last updated
18/05/2026
Date data sharing statement initially provided
Help: Data sharing statement date
18/05/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the neuromodulatory effects of cannabidiol in healthy adults
Scientific title
Examining the neuromodulatory effects of cannabidiol in healthy adults: A randomised, double-blind, placebo-controlled, cross-over trial
Additional trial identifiers [1] 317153 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CBD-EEG
Related trial records

Health condition
Health condition(s) studied:
Anxiety 341737 0
Autism 341944 0
Condition category
Condition code
Mental Health 337991 337991 0 0
Anxiety
Mental Health 338009 338009 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
- 600mg cannabidiol (CBD) suspended in 6ml of medium-chain triglyceride (MCT) oil plus flavouring.
- Single dose, administered oralorally (oil held under tongue for 1 minute).
- Adherence will be monitored by trial staff observing participants hold the oil in their mouth for 1 minute (timed by trial staff) before swallowing.
- 2-week washout between active and placebo interventions.
Intervention code [1] 333923 0
Treatment: Drugs
Description of the comparator or control
6ml of MCT oil, plus flavouring, matched on colour and taste
Single dose
Oral administration, hold oil under tongue for 1 minute
Control group
Placebo

Outcomes
Primary outcome [1] 345262 0
Change in resting state aperiodic slope across the cortex following CBD compared to placebo
Timepoint [1] 345262 0
2 hours post-dose
Secondary outcome [1] 461130 0
Change in EEG oscillatory power in the gamma band across brain regions following CBD
Timepoint [1] 461130 0
2 hours post-dose
Secondary outcome [2] 461131 0
Change in resting state EEG functional connectivity following CBD
Timepoint [2] 461131 0
2 hours post-dose
Secondary outcome [3] 461132 0
Change in mismatch negativity amplitude following CBD
Timepoint [3] 461132 0
2 hours post-dose
Secondary outcome [4] 461311 0
Change in mismatch negativity latency following CBD
Timepoint [4] 461311 0
2 hours post-dose

Eligibility
Key inclusion criteria
• Age 18-40 years
• Male or female
• Fluent in written and spoken English
• Normal or corrected-to-normal vision
• Normal hearing
• No intellectual disability
• Willing to undergo urine and blood sample collection
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
• Known hypersensitivity to CBD, THC, cannabis or excipients used in product manufacture (MCT oil)
• Medicinal cannabis (on prescription) or illicit cannabis use (including unregulated CBD products) in the past 6 months
• Pregnant, breastfeeding or planning to become pregnant during the trial
• Current psychiatric, developmental, substance use, genetic, and neurological conditions
• Intellectual disability
• Currently taking psychoactive medications (e.g., benzodiazepines)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Non-participant-facing investigator will conduct the blinding and participant allocation, and hold the blinding codes confidentially
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random sequence generator with variable block size
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis
As the primary endpoint is a within-subject comparison (CBD vs placebo) at a single post-dose window, power was calculated using a paired samples t-test (mathematically equivalent to a two-level repeated-measures model). Based on conservative, moderate within-subject effects observed for acute CBD neurophysiology (Cohen’s d = 0.5)(Pretzsch, Freyberg, et al., 2019b; Pretzsch, Voinescu, et al., 2019)), n = 34 completers are required for 80% power at a = 0.05 (two-tailed). To allow for ~15–20% attrition and EEG data exclusions, we will recruit a total of N = 40 participants.

To test the hypothesis that E–I will be modulated by acute CBD, the primary endpoint will be the aperiodic slope (1/f exponent) of resting-state EEG recorded ~2 h post-dose. The planned analysis is a linear mixed-effects model with intervention (CBD, placebo) as a fixed effect, and period (visit 1, visit 2) and sequence (CBD-placebo, placebo-CBD) included as covariates, plus a random intercept for participant to account for within-subject dependence (a = 0.05, two-tailed). The model will estimate the adjusted mean difference (CBD–placebo) with 95% CIs.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2026
Actual
Date of last participant enrolment
Anticipated
30/11/2026
Actual
Date of last data collection
Anticipated
17/12/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 321736 0
University
Name [1] 321736 0
Deakin University
Country [1] 321736 0
Australia
Funding source category [2] 321742 0
Commercial sector/Industry
Name [2] 321742 0
Medigrowth Australia
Country [2] 321742 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 324580 0
None
Name [1] 324580 0
Address [1] 324580 0
Country [1] 324580 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320276 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 320276 0
Ethics committee country [1] 320276 0
Australia
Date submitted for ethics approval [1] 320276 0
11/02/2026
Approval date [1] 320276 0
31/03/2026
Ethics approval number [1] 320276 0
2026/HE000008

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 149958 0
Dr Talitha Ford
Address 149958 0
Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125
Country 149958 0
Australia
Phone 149958 0
+6192468730
Fax 149958 0
Email 149958 0
[email protected]
Contact person for public queries
Name 149959 0
Talitha Ford
Address 149959 0
Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125
Country 149959 0
Australia
Phone 149959 0
+6192468730
Fax 149959 0
Email 149959 0
[email protected]
Contact person for scientific queries
Name 149960 0
Talitha Ford
Address 149960 0
Deakin University, 221 Burwood Hwy, Burwood, Victoria, 3125
Country 149960 0
Australia
Phone 149960 0
+6192468730
Fax 149960 0
Email 149960 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.