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Trial registered on ANZCTR


Registration number
ACTRN12616000267459
Ethics application status
Approved
Date submitted
24/02/2016
Date registered
29/02/2016
Date last updated
18/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of two concentrations of delta-9 tetrahydrocannabinol (THC, the active ingredient in Cannabis) on saliva-based drug detection systems and driving performance
Scientific title
A randomised controlled trial investigating the sensitivity and specificity of a single-use saliva based drug test in detecting two doses of orally admistered delta-9 tetrahydrocannabinol (THC) oil and the effect on driving performance
Secondary ID [1] 287290 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Drugged drivers 297784 0
Condition category
Condition code
Other 296187 296187 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Over the three week experimental period, participation will receive all of the experimental doses. One dose will be taken at each session (i.e. high, low THC or placebo) and the order of dosing will be randomised.
1. THC (high dose), comprising 20mg/kg of THC (0.092mg THC per 5ml dose) in 5 ml bearer oil.
2. THC (low dose), comprising 10mg/kg of THC (0.046mg THC per 5ml dose) in 5 ml bearer oil.
Each dose is complete and is not weight related, i.e. participants will not have repeated doses .of the THC oil. The dose will be administered orally in the form of a 5ml bearer sesame oil, to be delivered in an unmarked amber coloured vial. Adherence to the treatment protocol will be confirmed by assessing an empty treatment vial, which will be returned to the research nurse. The dose (high, low THC or placebo) will be randomised and will be provided once to participants at baseline at each of the three testing sessions (to occur one week apart).

The saliva tests employed are the same as those currently used in Policing practice during random roadside drug tests; The Securetec Drugwipe (registered trademark) TWIN oral drug test. Saliva will be obtained using Securetec Drugwipe (registered trademark) TWIN and will be taken at six time points during each experimental session. The Securetec Drugwipe (registered trademark) TWIN drug screen requires an absorbent pad to be placed over the tongue for approximately 20 seconds. 1ml of saliva will be taken per sample, therefore approximately 6ml in total over each of the three experimental sessions. A sample volume of less than 10 micro litres is sufficient for analysis. The device is wiped on the tongue, when the colour has changed from pink to yellow there is the required amount of saliva to obtain the results. The first saliva sample will be used to test for the presence of drugs (baseline sample), and the other samples will be used to test for the concentration of the treatment (or placebo) over time as part of the testing session. Saliva testing will occur at baseline (prior to dosing), immediately post dosing (5 minutes post dosing), 30 minutes post dosing, 1 hour post dosing, 3 ours post dosing and at 4 hours post dosing.

Driving performance will be assessed using the Forum 8 driving simulator, and driving performance will be assessed three times each study session. The simulator consists of a car unit with adjustable car seats and a dashboard and includes a steering wheel, turn sign indicators, gear lever, brake and accelerator pedals for vehicle control. The system generates realistic roadway scenery which is presented on three integrated TV screens 1.90 meters in front of the centre of the steering wheel. The speed and gear number are displayed on the dashboard and screen. Auditory feedback is provided by speakers and included the sound of the engine, braking, speeding in curves, and driving off-road. Driving assessment will take place at baseline (prior to dosing), and at 30 minutes and at 3 hours post dosing.
Intervention code [1] 292611 0
Treatment: Drugs
Comparator / control treatment
THC negative solution in 5 ml bearer sesame oil.
Control group
Placebo

Outcomes
Primary outcome [1] 295860 0
The sensitivity (positive or negative reading) of the Securetec Drugwipe (Registered Trademark) TWIN oral drug test as a function of the treatment.
Timepoint [1] 295860 0
After randomisation and administration of treatment (low or high THC or placebo). Specifically, this will occur at 5 mins, 30 mins, 1 hour, 2 hour and 4 hours post treatment administration.
Primary outcome [2] 297490 0
To assess the specificity (positive reading as a function of high or low dose) of the Securetec Drugwipe (Registered Trademark) TWIN oral drug test..
Timepoint [2] 297490 0
After randomisation and administration of treatment ((low or high THC or placebo). Specifically, this will occur at 5 mins, 30 mins, 1 hour, 2 hour and 4 hours post treatment administration.
Secondary outcome [1] 316734 0
Associations between the treatment (low, high dose of THC oil or placebo) and driving performance . This will be assessed using the Forum 8 driving simulator. Weaving of the car, expressed as standard deviation of the lateral position (SDLP), standard deviation of speed (SDS, km/h) and lapses will be assessed.
Timepoint [1] 316734 0
After randomisation and administration of treatment (low or high THC or placebo). Specifically, this will occur at 30 mins and 3 hours post treatment administration.
Secondary outcome [2] 316735 0
Concentration of the treatment (low, high dose of THC oil or placebo) in blood and urine samples across time
Timepoint [2] 316735 0
After randomisation and administration of treatment (low or high THC or placebo. Specifically, for blood assessment this will occur at 30 mins, 2 hours and 4 hours post treatment administration. For urine analysis, this will occur at 4 hours post treatment administration..
Secondary outcome [3] 316736 0
Association between treatment concentrations (low, high dose of THC oil or placebo) across time and driving simulator performance, measured as Standard Deviation of the Lateral Position (SDLP), Standard Deviation of Speed km/h (SDS) and lapses as assessed by the Forum 8 driving simulator. This will be assessed in the blood and urine samples.
Timepoint [3] 316736 0
After randomisation and administration of treatment (low or high THC or placebo. Specifically, for blood assessment this will occur at 30 mins, 2 hours and 4 hours post treatment administration. For urine analysis, this will occur at 4 hours post treatment administration. This will be statistically compared to performance on the driving simulator to assess treatment-concentration effects. After dosing, driving performance is assessed 30 mins and 3 hours post treatment administration.

Eligibility
Key inclusion criteria
Aged between 21 and 55 years

2. Hold a full drivers licence (no ‘P’ plates)

3. Participants will also be required to have experimented with cannaboids previously (self-disclosure).

4 Have no history of past substance abuse or current abuse of illicit drugs

5. Have no pre-existing physical or neurological conditions, no previous or current history of severe psychiatric, cardiac, endocrine, gastrointestinal, or bleeding disorders

6. Not currently pregnant or lactating
Minimum age
21 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Inability to speak or read English

2. History of drug or substance abuse or current illicit drug abuse

3. History of neurological conditions or previous or current history of psychiatric, cardiac, endocrine, gastrointestinal, or bleeding disorders

4 Taking any form of medication within 5 days of admission (except for prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication throughout the study

5. Current participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit

6. Unable to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol

7. Unable to provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial.

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)
Randomization of participants to treatment groups will be determined by random allocation. Eligible, recruited participants will be assigned a participant number. The randomisation order that has been placed next to the participant’s number will be the allocated treatment order for that individual.

Blinding will be achieved by enlisting a person outside of the project to code the treatments, and maintain the key to this code until data collection is completed. The codes will only be broken in an emergency, such as an SAE that requires knowledge of the treatment being taken in order to manage a participant’s condition. The principle investigator and ethics committee will be informed within 24 hours of the code-break envelope being opened.
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
Crossover
Other design features
Repeated measures
Phase
Phase 1 / Phase 2
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis
Participants will be 40 men and women aged between 21-40 years. As this is a pilot exploratory study, no formal power calculation is being conducted. No research is available assessing the ability of new generation (Securetec Drugwipe (registered trademark) TWIN single-use saliva-based drug tests to detect the presence of THC, however limited clinical studies have utilised similar, albeit typically smaller samples. Approximately 60 participants will be screened; approximately 50 participants will be randomised with the aim of having 40 participants complete (evaluable population).

All statistical tests will be performed two tailed at the 5% significance level and performed using IBM SPSS statistical package. Z scores for the distribution will be calculated for each variable and displayed in histogram form. Out of range values will be recoded as missing values.

The primary outcome to be measured will be the scores on the drug screening device as a function of treatment group and will be presented as a binary outcome (detection yes/no). A binary logistic regression model will be used, with detection status (present/absent) as the outcome, and treatment group (high or low hempseed oil or placebo) used as the categorical predictor variable. Baseline data and demographic information will be entered sequentially to assess for possible effect-modification.

Results for the dose-relative concentration of THC in samples of blood, urine and saliva for both low and high doses of hempseed oil will analysed using mixed design analysis of variance (MANCOVA), with treatment group (high, low or placebo) as the between-subject variable, time (individual sessions) as the within-subjects variable, and baseline score as the covariate.

Results for the driving simulator (SDLP, SPS and lapses) will also be compared using a mixed design analysis of variance (MANCOVA), with treatment group (high, low or placebo) as the between-subject variable, time as the within-subjects variable, and baseline score as the covariate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2016
Actual
13/07/2016
Date of last participant enrolment
Anticipated
28/10/2016
Actual
5/12/2016
Date of last data collection
Anticipated
Actual
13/12/2016
Sample size
Target
40
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291854 0
Government body
Name [1] 291854 0
Department of Health, Health Protection Branch, State Government of Victoria.
Country [1] 291854 0
Australia
Primary sponsor type
University
Name
Swinburne University of Techology
Address
John Street, Hawthorn, Victoria, 3122
Country
Australia
Secondary sponsor category [1] 290518 0
None
Name [1] 290518 0
Address [1] 290518 0
Country [1] 290518 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293365 0
Belberry Limited
Ethics committee address [1] 293365 0
Ethics committee country [1] 293365 0
Australia
Date submitted for ethics approval [1] 293365 0
01/03/2016
Approval date [1] 293365 0
07/06/2016
Ethics approval number [1] 293365 0
Ethics committee name [2] 295855 0
Swinburne University Human Research Ethics Committee (SUHREC)
Ethics committee address [2] 295855 0
Ethics committee country [2] 295855 0
Australia
Date submitted for ethics approval [2] 295855 0
22/06/2016
Approval date [2] 295855 0
22/06/2016
Ethics approval number [2] 295855 0
SHR Project 2016/168

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

Contacts
Principal investigator
Name 59586 0
Prof Con Stough
Address 59586 0
Swinburne University of Technology,
Faculty of Health, Arts and Design
School of Health Sciences
Centre for Human Psychopharmacology
Mail H24
PO Box 218
Hawthorn, Victoria, 3122
Australia
Country 59586 0
Australia
Phone 59586 0
+61 3 9214 8167
Fax 59586 0
Email 59586 0
cstough@swin.edu.au
Contact person for public queries
Name 59587 0
Amie C Hayley
Address 59587 0
Mail H20
Swinburne University of Technology,
Faculty of Health, Arts and Design
School of Health Sciences
Centre for Human Psychopharmacology
PO Box 218
Hawthorn, Victoria, 3122
Australia
Country 59587 0
Australia
Phone 59587 0
+61 3 9214 5585
Fax 59587 0
Email 59587 0
ahayley@swin.edu.au
Contact person for scientific queries
Name 59588 0
Amie C Hayley
Address 59588 0
Mail H20
Swinburne University of Technology,
Faculty of Health, Arts and Design
School of Health Sciences
Centre for Human Psychopharmacology
PO Box 218
Hawthorn, Victoria, 3122
Australia
Country 59588 0
Australia
Phone 59588 0
+61 3 9214 5585
Fax 59588 0
Email 59588 0
ahayley@swin.edu.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseDetection of delta-9-tetrahydrocannabinol (THC) in oral fluid, blood and urine following oral consumption of low-content THC hemp oil.2018https://dx.doi.org/10.1016/j.forsciint.2017.12.033
N.B. These documents automatically identified may not have been verified by the study sponsor.