RecruitingACTRN12621001205820

Medicinal Cannabis Detection Trial

Detectability of THC in the oral fluid of patients prescribed medical cannabis


Sponsor

Swinburne University of Technology

Enrollment

50 participants

Start Date

Jul 21, 2021

Study Type

Observational

Conditions

Summary

The introduction of legal medical cannabis in Australia presents a unique challenge for the current roadside drug testing (RDT) approach which was designed to deter driving after illicit drug use and mitigate associated road safety risks. Having a legal prescription for a THC-containing medical cannabinoid product is not at present a valid legal defence against the charge of driving with a detectable concentration of a prescribed illicit drug, which means that medical cannabis patients are effectively prohibited from driving. Understanding the detectability of medical cannabis products using the Securetec DrugWipe® TWIN and investigating the driving-related effects of medical cannabis use, are important research priorities that can help to inform effective road safety policy and law enforcement strategy in this area. This project will examine whether THC in medicinal cannabis products is detectable (present/absent) with commonly used single-use oral fluid drug detection devices among people who routinely use this medication, and for how long it might be present after consumption. We will assess this in a group of patients who are currently using medicinal cannabis products at different concentrations and in different preparations (e.g., oil and spray, THC dominant and THC/CBD-equivalent). We will also be assessing whether there are any changes to driving or cognitive ability due to using medicinal cannabis products that contain varying concentrations of THC and CBD.


Eligibility

Sex: Both males and femalesMin Age: 21 Yearss

Inclusion Criteria10

  • Aged 21 years or older
  • Have a full driver licence (current or expired/lapsed in past 12 months)
  • Patients who have been prescribed medicinal cannabis under the Special Access Scheme B (SAS-B) containing predominately THC or that is THC/CBD equivalent for a refractory condition including, but not limited to:
  • o Chronic pain conditions
  • o Sleep disorders
  • o Inflammatory conditions
  • o Gastrointestinal disorders
  • o Movement disorders
  • o Respiratory conditions
  • Able to attend a 7-hour session without using medical cannabis more than once

Exclusion Criteria4

  • Patient is unable to provide written informed consent
  • Patient is pregnant or lactating
  • Patient has been previously enrolled in the study
  • Patient is unable to abstain for illicit drug use for 7 days prior to testing

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Interventions

This project will examine whether THC in medicinal cannabis products is detectable (present/absent) with commonly used single-use oral fluid drug detection devices among people who routinely use this

This project will examine whether THC in medicinal cannabis products is detectable (present/absent) with commonly used single-use oral fluid drug detection devices among people who routinely use this medication, and for how long it might be present after consumption. We will assess this in a group of patients who are currently using medicinal cannabis products at different concentrations and in different preparations (e.g., oil and spray, THC dominant and THC/CBD-equivalent). We will also be assessing whether there are any changes to driving or cognitive ability due to using medicinal cannabis products that contain varying concentrations of THC and CBD. All research activities will take place at Swinburne University of Technology. Participants will be required to attend a single 7-hour session involving providing 5x saliva and blood and 2x urine samples over the course of the session. Participants will also complete 3x driving simulation tests (~30 mins) and 3x CANTAB cognitive tests (~30 mins), including a baseline test and two further tests at 2.4h and 5h post medicine consumption. participants will also complete a series of questionnaires (5x) taking approximately 10 mins in total each time. Assessments will be conducted by a research assistant and a research nurse. In the session, participants will supply and self-administer a single dose of their prescribed medical cannabis product. This will be witnessed by a member of the research team who will also cite that patients' script for accuracy in dosing.


Locations(1)

VIC, Australia

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ACTRN12621001205820