Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000872639
Ethics application status
Approved
Date submitted
27/07/2023
Date registered
15/08/2023
Date last updated
29/09/2024
Date data sharing statement initially provided
15/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of cannabidiol (CBD) on psychosocial stress, situational anxiety and nausea experienced in a virtual reality environment
Scientific title
A randomised, double-blind, placebo-controlled, parallel-group trial exploring the effect of purified oral cannabidiol (CBD) on psychosocial stress, situational anxiety, acute motion sickness and cybersickness experienced in a virtual reality environment in healthy individuals.
Secondary ID [1] 310168 0
CT-2023-CTN-03182-1
Universal Trial Number (UTN)
U1111-1295-6610
Trial acronym
CAPSTAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychosocial stress
 330755 0
Situational anxiety 330756 0
Motion sickness 330757 0
Cybersickness 330758 0
Condition category
Condition code
Mental Health 327589 327589 0 0
Anxiety
Mental Health 327808 327808 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be an acute dose of cannabidiol (CBD). Specifically, it will be 2 x soft-gel capsules of CBD (150mg total) in an oil-based formulation. The capsules will be consumed (once only) via oral ingestion under the supervision of an investigator 90-minutes prior to exposure to a series of three customised virtual reality (VR) experiences using the Vive Pro Eye VR headset including (1) a 15-minute simulated public speaking task, the "Public Speaking" task (2) a 5-minute task of walking a narrow virtual plank above a sheer drop, the "Walk the Plank" task; and (3) a 5-minute virtual reality rollercoaster ride, the "Rollercoaster Ride". Each VR task will be separated by a rest period of 10-minutes. Each participant will complete all three VR tasks after treatment (i.e., CBD or placebo) during individual "Test Days".
Intervention code [1] 326565 0
Treatment: Drugs
Intervention code [2] 326781 0
Treatment: Devices
Comparator / control treatment
The control will be a placebo. Specifically, it will be 2 x soft-gel capsules containing an oil-based formulation (only). The capsules will not contain any cannabinoids or other cannabis constituents.
Control group
Placebo

Outcomes
Primary outcome [1] 335424 0
The change in subjective ratings of stress on a 100 mm Visual Analog Scale
Timepoint [1] 335424 0
Stress will be measured on 11 instances as described below:
Prior to drug administration (pre-treatment measurement)
Approximately 75-minutes post-drug administration (baseline measurement)
Immediately before delivery of instructions for all three virtual reality tasks, commencing 90-minutes post-drug administration
Immediately after delivery of instructions for the ‘Public Speaking’ and ‘Walk the Plank’ tasks (i.e., before performance of the tasks)
Immediately after completion of all three virtual reality tasks
At the study close, approximately 10-minutes after completion of the ‘Rollercoaster Ride’ task
Primary outcome [2] 335425 0
The change in subjective ratings of nausea on a 100 mm Visual Analog Scale
Timepoint [2] 335425 0
Nausea will be measured on 11 instances as described below:
Prior to drug administration (pre-treatment measurement)
Approximately 75-minutes post-drug administration (baseline measurement)
Immediately before delivery of instructions for all three virtual reality tasks, commencing 90-minutes post-drug administration
Immediately after delivery of instructions for the ‘Public Speaking’ and ‘Walk the Plank’ tasks (i.e., before performance of the tasks)
Immediately after completion of all three virtual reality tasks
At the study close, approximately 10-minutes after completion of the ‘Rollercoaster Ride’ task
Secondary outcome [1] 424479 0
Salivary cortisol
Timepoint [1] 424479 0
Immediately before drug administration, approximately 75-minutes post-drug administration (baseline measurement) and during each of the three rest periods following the virtual reality tasks.
Secondary outcome [2] 424480 0
Skin conductance of the fingers using a Galvanic Skin Response (GSR) measurement device.
Timepoint [2] 424480 0
Immediately before drug administration (pre-treatment measurement), and continuously throughout all three virtual reality tasks commencing 75-minutes post-drug administration (baseline measurement)
Secondary outcome [3] 424481 0
Skin conductance of the forehead using a Galvanic Skin Response (GSR) measurement device.
Timepoint [3] 424481 0
Immediately before drug administration (pre-treatment measurement), and continuously throughout all three virtual reality tasks commencing 75-minutes post-drug administration (baseline measurement)
Secondary outcome [4] 424482 0
Heart rate using a chest belt heart rate monitor.
Timepoint [4] 424482 0
Immediately before drug administration (pre-treatment measurement), and continuously throughout all three virtual reality tasks commencing 75-minutes post-drug administration (baseline measurement)
Secondary outcome [5] 424483 0
Vomiting or near-vomiting episodes using participant self-reports to the investigator.
Timepoint [5] 424483 0
Throughout the test session commencing immediately post-drug administration
Secondary outcome [6] 424484 0
The change in subjective ratings of anxiety on a negative affect 100 mm Visual Analog Scale
Timepoint [6] 424484 0
Anxiety on a negative affect Visual Analog Scale will be measured on 11 instances as described below:
Prior to drug administration (pre-treatment measurement)
Approximately 75-minutes post-drug administration (baseline measurement)
Immediately before delivery of instructions for all three virtual reality tasks, commencing 90-minutes post-drug administration
Immediately after delivery of instructions for the ‘Public Speaking’ and ‘Walk the Plank’ tasks (i.e., before performance of the task)
Immediately after completion of all three virtual reality tasks
At the study close, approximately 10-minutes after completion of the ‘Rollercoaster Ride’ task
Secondary outcome [7] 424485 0
The change in subjective ratings of anxiety on a positive affect 100 mm Visual Analog Scale
Timepoint [7] 424485 0
Anxiety on a positive affect Visual Analog Scale will be measured on 11 instances as described below:
Prior to drug administration (pre-treatment measurement)
Approximately 75-minutes post-drug administration (baseline measurement)
Immediately before delivery of instructions for all three virtual reality tasks, commencing 90-minutes post-drug administration
Immediately after delivery of instructions for the ‘Public Speaking’ and ‘Walk the Plank’ tasks (i.e., before performance of the task)
Immediately after completion of all three virtual reality tasks
At the study close, approximately 10-minutes after completion of the ‘Rollercoaster Ride’ task
Secondary outcome [8] 424486 0
The change in subjective anxiety ratings on a positive activation 100 mm Visual Analog Scale.
Timepoint [8] 424486 0
Anxiety on a positive activation Visual Analog Scale will be measured in 11 instances as described below:
Prior to drug administration (pre-treatment measurement)
Approximately 75-minutes post-drug administration (baseline measurement)
Immediately before delivery of instructions for all three virtual reality tasks, commencing 90-minutes post-drug administration
Immediately after delivery of instructions for the ‘Public Speaking’ and ‘Walk the Plank’ tasks (i.e., before performance of the task)
Immediately after completion of all three virtual reality tasks
At the study close, approximately 10-minutes after completion of the ‘Rollercoaster Ride’ task
Secondary outcome [9] 424487 0
The change in subjective anxiety ratings on a negative deactivated 100 mm Visual Analog Scale.
Timepoint [9] 424487 0
Anxiety on a negative deactivated Visual Analog Scale will be measured on 11 instances as described below:
Prior to drug administration (pre-treatment measurement)
Approximately 75-minutes post-drug administration (baseline measurement)
Immediately before delivery of instructions for all three virtual reality tasks, commencing 90-minutes post-drug administration
Immediately after delivery of instructions for the ‘Public Speaking’ and ‘Walk the Plank’ tasks (i.e., before performance of the task)
Immediately after completion of all three virtual reality tasks
At the study close, approximately 10-minutes after completion of the ‘Rollercoaster Ride’ task

Eligibility
Key inclusion criteria
a) Healthy adults aged between 18-50 years.
b) Proficient in English (able to provide informed consent).
c) Residing in Greater Sydney NSW Australia.
d) Willing to follow the protocol requirements.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
a) Self-reported regular use (i.e., more than twice weekly) of any cannabis or cannabinoid-containing products including CBD in the past two weeks.
b) Self-reported regular use (i.e., more than twice weekly) use of psychotropic drugs (licit or illicit) (e.g., cannabis, amphetamines, cocaine, ecstasy (MDMA), LSD (acid), antidepressants, opioids, benzodiazepines) within the past two weeks.
c) Self-reported regular use (i.e., more than twice weekly) of medication that may affect the stress response (e.g., corticosteroids, beta-blockers) within the past two weeks
d) Self-reported history of allergic reactions (e.g., urticaria or anaphylaxis) to cannabis or cannabis-based products.
e) Self-reported history of liver disease, renal disease, epilepsy or heart disease (currently (i.e., within the past 2-weeks) controlled high blood pressure <140/90mmHg is acceptable)
f) Current (i.e., within the past 2-weeks) otologic (vestibular) disease
g) A history of repeated episodes of syncope
h) Pregnant, lactating, or trying to conceive.
i) Self-reported drug and/or alcohol dependence (or suspected drug and/or alcohol dependence as determined by the trial physician)
j) A medically diagnosed anxiety disorder (e.g., social anxiety disorder) within the past 12 months
k) Current suicide ideation (i.e., a score >0 on Question 9 of the Patient Health Questionnaire) or suspected suicide ideation as determined by the trial physician.
l) Current depression, anxiety, and stress scores outside the healthy range of the Depression Anxiety Stress Scale-21 (> moderate on DASS-21 for depression, anxiety and stress).
m) An uncontrolled chronic medical condition (mental or physical)
n) Self-reported high vulnerability to cybersickness or motion sickness.
o) Frequent (> weekly) use of VR technologies, which tends to produce desensitisation towards motion sickness.
p) Self-reported intense fear of heights.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed using numbered containers (or 'sachets').

Each participant will be assigned a unique Randomisation Code (e.g., R001, R002, R003, etc.) that is linked to a sachets (e.g., labeled R001) carrying their assigned treatments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
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
Parallel
Other design features
Not applicable
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary and secondary outcomes will be analysed using generalized linear mixed models (GLMM). Treatment, Time and the Treatment × Time interaction will be included as fixed effects, and the participant will be included as a random effect, with other covartiates included as appropriate to improve goodness of fit (e.g., Sex, Age, Time of day). To refine the models, we will use corrected Akaike Information Criterion. We will calculate ?m between models and exclude models with ?m > 2 as having substantially less support. No covariance structure will be specified (unstructured). To identify the best distribution and link for the GLMM models, the data type, residual plots, Shapiro-Wilk normality test, Levene’s test for Homogeneity of Variance, and Pearson’s dispersion test will be used. Type III Wald chi-square tests will be used to generate main effects p-values. A priori planned uncorrected pairwise comparisons will be performed to compare:

• subjective ratings of stress on a stress VAS (nervous 0-100) across treatments at Timepoint t=125 (i.e., post-instructions for the ‘Public Speaking’ task)
• subjective ratings of stress on a stress VAS (nervous 0-100) across treatments at Timepoint t=147 (i.e., post-instructions for the ‘Walk the Plank’ task)
• subjective ratings of nausea on a nausea VAS (nauseous 0-100) across treatments at Timepoint t=165, (i.e., immediately post-completion of the ‘Rollercoaster Ride’ task)
• subjective ratings of nausea on a nausea VAS (nauseous 0-100) across treatments at Timepoint t=175, (i.e., 10-minutes post-completion of the ‘Rollercoaster Ride’ task)
as these are the primary outcome measures.
Dunn-Šidák corrected pairwise comparisons will be performed where additional significant main and interaction effects are present. Statistical significance will be accepted as p<0.05. The statistical analysis plan will be finalised before the last participant Test Day and will be available on request.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/09/2023
Actual
26/10/2023
Date of last participant enrolment
Anticipated
3/06/2024
Actual
20/06/2024
Date of last data collection
Anticipated
3/06/2024
Actual
20/06/2024
Sample size
Target
74
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 40899 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 314332 0
Other
Name [1] 314332 0
Lambert Initiative for Cannabinoid Therapeutics
Country [1] 314332 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Camperdown, NSW, 2050
Country
Australia
Secondary sponsor category [1] 316280 0
None
Name [1] 316280 0
Address [1] 316280 0
Country [1] 316280 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313433 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 313433 0
Ethics committee country [1] 313433 0
Australia
Date submitted for ethics approval [1] 313433 0
15/02/2023
Approval date [1] 313433 0
14/06/2023
Ethics approval number [1] 313433 0
2023/307

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

Contacts
Principal investigator
Name 128142 0
Prof Iain McGregor
Address 128142 0
Brain and Mind Centre
Level 6, 94 Mallett Street
Missenden Road, Camperdown
NSW, 2050
Country 128142 0
Australia
Phone 128142 0
+61 2 9351 0883
Fax 128142 0
Email 128142 0
[email protected]
Contact person for public queries
Name 128143 0
Zeeta Bawa
Address 128143 0
Brain and Mind Centre
Room 611, Level 6,
94 Mallett Street
Missenden Road, Camperdown
NSW, 2050
Country 128143 0
Australia
Phone 128143 0
+61 420 211 304
Fax 128143 0
Email 128143 0
[email protected]
Contact person for scientific queries
Name 128144 0
Dr Danielle McCartney
Address 128144 0
Brain and Mind Centre
Room 611, Level 6,
94 Mallett Street
Missenden Road, Camperdown
NSW, 2050
Country 128144 0
Australia
Phone 128144 0
+61 404 656 000
Fax 128144 0
Email 128144 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication (via request), no end date
Available to whom?
Only researchers who provide methodologically sound proposal
Available for what types of analyses?
Only to achieve the aims of the approved proposal
How or where can data be obtained?
By contacting the principal investigator, Professor Iain McGregor via email to [email protected]


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.