CompletedPhase 2ACTRN12616000267459

The effect of two concentrations of delta-9 tetrahydrocannabinol (THC, the active ingredient in Cannabis) on saliva-based drug detection systems and driving performance

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


Sponsor

Swinburne University of Techology

Enrollment

40 participants

Start Date

Jul 13, 2016

Study Type

Interventional

Conditions

Summary

This study aims to test the whether legally permissible levels of THC available in foodstuff is detected by a commonly used single-use saliva-based drug test when compared to a placebo and if this differs when given in different concentrations (high and low). We will also be assessing whether there are any changes to driving ability as a result of ingesting hempseed oil.


Eligibility

Sex: Both males and femalesMin Age: 21 YearssMax Age: 55 Yearss

Inclusion Criteria6

  • Aged between 21 and 55 years
  • Hold a full drivers licence (no ‘P’ plates)
  • Participants will also be required to have experimented with cannaboids previously (self-disclosure).
  • Have no history of past substance abuse or current abuse of illicit drugs
  • Have no pre-existing physical or neurological conditions, no previous or current history of severe psychiatric, cardiac, endocrine, gastrointestinal, or bleeding disorders
  • Not currently pregnant or lactating

Exclusion Criteria7

  • Inability to speak or read English
  • History of drug or substance abuse or current illicit drug abuse
  • History of neurological conditions or previous or current history of psychiatric, cardiac, endocrine, gastrointestinal, or bleeding disorders
  • 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
  • Current participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit
  • Unable to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol
  • Unable to provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial.

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Interventions

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 b

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.


Locations(1)

VIC, Australia

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ACTRN12616000267459


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