ACTRN12616000267459
Completed
Phase 1
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
Swinburne University of Techology0 sites40 target enrollmentFebruary 29, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Swinburne University of Techology
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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