Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000142831
Ethics application status
Approved
Date submitted
3/11/2020
Date registered
12/02/2021
Date last updated
12/02/2021
Date data sharing statement initially provided
12/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Do blood, saliva and urine levels of THC and cannabidiol (chemicals found in cannabis) relate to their effects on personality and perception
Scientific title
Tissue Levels of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) and Effects on Perception and Personality in healthy volunteers
Secondary ID [1] 302499 0
CT-2020-CTN-03921-1 v1
Universal Trial Number (UTN)
U1111-1260-6993
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
psychosis 319603 0
Schizophrenia 320335 0
Condition category
Condition code
Mental Health 317543 317543 0 0
Psychosis and personality disorders
Mental Health 317544 317544 0 0
Schizophrenia
Mental Health 317545 317545 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will be administered one dose of one drug on one day only, either Delta-9-tetrahydrocannabinol (THC, 5 mg, perioral, once, in a capsule with an olive oil incipient) or Cannabidiol (CBD, 500 mg, perioral, once., in a capsule with an olive oil incipient), while under observation, prescribing by a psychiatrist with Medicinal Cannabis Product Prescribing Authorisation. Blood, urine and saliva samples will be taken for analysis of levels of the drugs and their primary metabolite(s). Several personality and psychosis-proneness measures will be taken before and after treatment. Blood will be taken just before drug treatment, and then one hour every hour after for 5 hours (total 6 collections). Saliva and urine samples will be taken twice: once before drug treatment and once 2 hours after drug treatment. Personality and psychosis proneness tests will be done twice, just after each saliva/urine collection.
Intervention code [1] 318969 0
Treatment: Drugs
Comparator / control treatment
Pre-treatment tests will be the control. CBD will be a comparator to THC.
Control group
Active

Outcomes
Primary outcome [1] 325587 0
levels of delta-9-tetrahydrocannabinol, 11-hydroxy-tetrahydrocannabinol, 11-nor-9-carboxy-tetrahydrocannabinol, cannabidol, cannabidiol-D3
Timepoint [1] 325587 0
Blood: hourly for 6 hours.
Urine and saliva: before and 2 hours after treatment
Primary outcome [2] 325588 0
Psychosis proneness assessed by a composite of:
Schizotypal Personality Questionnaire, Marteau-Bekker Anxiety Scale, Perceptual Aberration Scale, Launay-Slade Hallucination Scale, Magical Ideation Scale, Scale for the Assessment of Positive Symptoms, Autism Spectrum Quotient
Timepoint [2] 325588 0
before and 2.5 hours after treatment
Primary outcome [3] 325589 0
Stimulus binding Will be assessed with the rubber hand illusion while manipulating both the interstimulus time and distance intervals.
Timepoint [3] 325589 0
before treatment and 2 hours after treatment
Secondary outcome [1] 388471 0
Heart rate assessed by automated monitor
Timepoint [1] 388471 0
before drug administration and every hour after until 5 hours post-drug
Secondary outcome [2] 388472 0
Alerting, orienting, and executive attention assessed by Attention Network Test
Timepoint [2] 388472 0
before drug administration and once between 2 and 4 hours after.
Secondary outcome [3] 390655 0
body temperature, measured with a contactless infrared thermoprobe.
Timepoint [3] 390655 0
before drug administration and every hour after until 5 hours post-drug
Secondary outcome [4] 391754 0
blood pressure measured by automated monitor
Timepoint [4] 391754 0
before drug administration and every hour after until 5 hours post-drug
Secondary outcome [5] 391755 0
blood oxygen level by oxymeter
Timepoint [5] 391755 0
before drug administration and every hour after until 5 hours post-drug

Eligibility
Key inclusion criteria
Healthy unmedicated people (with the exceptions of acne and contraceptive medications)
Minimum age
18 Years
Maximum age
59 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
pregnant or breast-feeding;
fertile, sexually active and not using contraceptives;
ingesting caffeine or any other stimulants on the day of each testing session;
using current prescription medications other than oral contraceptives or acne medication;
using over-the-counter medications or “natural” therapies in the 48 hours before each testing session;
using "recreational drugs" including alcohol in the 48 hours before each testing session;
Any medical condition, including mental illness, requiring treatment other than acne;
a history of substance abuse disorder;
a family history in first degree relatives of any psychotic disorder (e.g., schizophrenia, bipolar disorder, schizoaffective disorder);
a history of sensitivity to cannabis (e.g., nausea, dizziness, anxiety).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed by drugs being in identical gelatin capsules, and neither experimenters nor participants know which drug is administered (double blind)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation by 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
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed-Model Analysis of Variance with trend analysis with post-hoc t-Tests using the exact Bonferroni correction will be used to analyse parametric data. Non-parametric data will be analysed using kernel density analysis and permutation tests. All analyses will be performed with R Statistics and R Studio with the ‘ez’ and ‘sm’ pack-ages for parametric and non-parametric tests respectively.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2021
Actual
Date of last participant enrolment
Anticipated
30/11/2022
Actual
Date of last data collection
Anticipated
30/11/2022
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 306927 0
University
Name [1] 306927 0
University of Western Australia
Country [1] 306927 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Highway, Crawley, WA, 6009
Country
Australia
Secondary sponsor category [1] 307487 0
None
Name [1] 307487 0
None
Address [1] 307487 0
None
Country [1] 307487 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307074 0
University of Western Australia Human Ethics
Ethics committee address [1] 307074 0
Ethics committee country [1] 307074 0
Australia
Date submitted for ethics approval [1] 307074 0
05/02/2020
Approval date [1] 307074 0
23/06/2020
Ethics approval number [1] 307074 0
RA/4/20/6008

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

Contacts
Principal investigator
Name 105938 0
Prof Mathew Martin-Iverson
Address 105938 0
Prof Mathew Martin-Iverson
Head of Pharmacology and Honours Coordinator, School of Biomedical Sciences
University of Western Australia, 35 Stirling Highway, Crawley, Western Australia, 6009

Office: 1.41, M Block, Queen Elizabeth II Medical Centre, Nedlands, 6009
8 6457 2982 (office)
Country 105938 0
Australia
Phone 105938 0
+61 8 6457 2982
Fax 105938 0
Email 105938 0
[email protected]
Contact person for public queries
Name 105939 0
Mathew Martin-Iverson
Address 105939 0
Prof Mathew Martin-Iverson
Head of Pharmacology and Honours Coordinator, School of Biomedical Sciences
University of Western Australia, 35 Stirling Highway, Crawley, Western Australia, 6009

Office: 1.41, M Block, Queen Elizabeth II Medical Centre, Nedlands, 6009
8 6457 2982 (office)
Country 105939 0
Australia
Phone 105939 0
+61 8 6457 2982
Fax 105939 0
Email 105939 0
[email protected]
Contact person for scientific queries
Name 105940 0
Mathew Martin-Iverson
Address 105940 0
Prof Mathew Martin-Iverson
Head of Pharmacology and Honours Coordinator, School of Biomedical Sciences
University of Western Australia, 35 Stirling Highway, Crawley, Western Australia, 6009

Office: 1.41, M Block, Queen Elizabeth II Medical Centre, Nedlands, 6009
8 6457 2982 (office)
Country 105940 0
Australia
Phone 105940 0
+61 8 6457 2982
Fax 105940 0
Email 105940 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.