Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000030976
Ethics application status
Approved
Date submitted
9/02/2010
Date registered
10/01/2011
Date last updated
18/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effects of Delta 9-tetrahydrocannabinol (THC) on Driving Performance, Cognition, Fatigue and Stress.
Scientific title
The Effects of Delta 9-tetrahydrocannabinol (THC) on Driving Performance, Cognition, Fatigue and Stress on Healthy Volunteers.
Secondary ID [1] 1395 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The acute and residual effects of THC consumption will be explored in healthy volunteers (who are experienced, but non-chronic cannabis smokers). 256788 0
Condition category
Condition code
Mental Health 256935 256935 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The level of THC administered will be 2x 3.2% THC cigarettes over a period of 12-15 minutes (16 puffs or less in total). This will be a one-off intervention undertaken during one of two testing conditions, spaced exactly 1 week apart.
Intervention code [1] 255992 0
Not applicable
Comparator / control treatment
2x non-THC placebo (herbal) cigarettes will be administered over a period of 12-15 minutes (16 puffs or less in total). Once again, this will be a one-off intervention undertaken during one of two testing conditions spaced exactly 1 week apart.
Control group
Placebo

Outcomes
Primary outcome [1] 257807 0
Performance on a computer-based driving simulator and sustained vigilance task.
Timepoint [1] 257807 0
30 minutes, 1.5 hours & 4.5 hours post treatment.
Primary outcome [2] 257808 0
Physiological measures of fatigue during computerised driving simulation and sustained vigilance task. Participants will wear specialised glasses designed to measure the number and type of blinks and saccadic eye movements made during the computer-based tasks (which then give a physiologically determined fatigue score).
Timepoint [2] 257808 0
30 minutes, 1.5 hours & 4.5 hours post treatment.
Primary outcome [3] 257809 0
Performance on a battery of computer-based cognitive measures (attention, reaction time, tracking, motor coordination, etc.).
Timepoint [3] 257809 0
1 hour 10 minutes; 2 hours 10 minutes & 4 hours 10 minutes post treatment.
Primary outcome [4] 257810 0
Performance on a computer-based cognitive battery measuring response inhibition, decision making & time perception tasks.
Timepoint [4] 257810 0
2.5 hours post treatment.
Secondary outcome [1] 263227 0
THC levels in blood and saliva.

Blood will be taken via an intravenous cannula (administered by a relevantly qualified Division 1 Nurse) and THC levels will be determined via Gas chromatography-mass spectrometry (GCMS) analysis.
Saliva will collected in polypropene tubes and THC levels will be determined via Liquid chromatography-mass spectrometry (LCMS) analysis.
Timepoint [1] 263227 0
Baseline, 15 minutes, 1 hour, 2 hours, 4 hours & 6 hours post treatment.
Secondary outcome [2] 263228 0
Salivary Cortisol levels.

Saliva will be collected in Polypropene tubes and Cortisol levels will be analysed via Enzyme-linked immunosorbent assay (ELISA) analysis.
Timepoint [2] 263228 0
Baseline, 15 minutes, 1 hour, 2 hours, 4 hours & 6 hours post treatment.
Secondary outcome [3] 263229 0
Estimated autonomic nervous system activity. Physiological measures including respiration, heart rate, sweating and temperature will be measured using a specialised ambulatory vest containing electrodes that are secured into place.

The device measures (via electrodes and a portable data collection device) components of heart rate variability and auxiliary measure of sympathetic function such as sweating. It measures respiratory parameters via plethysmography.
Timepoint [3] 263229 0
Physiological data will be recorded continuously from baseline through to 6 hours post treatment.

Eligibility
Key inclusion criteria
Experienced cannabis smoker
Holder of full Driver's License
Minimum age
21 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of substance abuse or dependence for any drug; Known allergic reaction to cannabis in the past ; Chronic Cannabis user; Wears glasses or spectacles to read/use a computer (contact lenses okay);
History of psychiatric illnesses, especially Anxiety/Depression, Schizophrenia, Bipolar Disorder &/or Psychosis; Pregnant, lactating, or potentially pregnant; History of the following medical conditions: Cardiovascular conditions, Respiratory conditions, Endocrine conditions, Gastrointestinal conditions, Bleeding disorders, Neurological disorders, Liver or kidney conditions, Brain injury or Traumatic Head Injury or prolonged periods of unconsciousness; Currently taking prescription medication (other than a contraceptive pill)

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
3/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256496 0
University
Name [1] 256496 0
Swinburne University of Techology
Country [1] 256496 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Securetec
Address
Eugen-Sanger Ring 1
D-85649 Brunnthal
Country
Germany
Secondary sponsor category [1] 255806 0
Commercial sector/Industry
Name [1] 255806 0
VicRoads
Address [1] 255806 0
60 Denmark Street
Kew, Vic, 3101
Country [1] 255806 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258542 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 258542 0
Ethics committee country [1] 258542 0
Australia
Date submitted for ethics approval [1] 258542 0
Approval date [1] 258542 0
02/02/2010
Ethics approval number [1] 258542 0

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

Contacts
Principal investigator
Name 30821 0
Address 30821 0
Country 30821 0
Phone 30821 0
Fax 30821 0
Email 30821 0
Contact person for public queries
Name 14068 0
Rita Brien
Address 14068 0
Brain Sciences Institute
Mail H99
PO Box 218
Hawthorn Vic 3122
Country 14068 0
Australia
Phone 14068 0
61 3 9214 4444
Fax 14068 0
61 3 9214 5525
Email 14068 0
[email protected]
Contact person for scientific queries
Name 4996 0
Professor Con Stough
Address 4996 0
Brain Sciences Institute
Mail H99
PO Box 218
Hawthorn Vic 3122
Country 4996 0
Australia
Phone 4996 0
61 3 9214 8167
Fax 4996 0
61 3 9214 5525
Email 4996 0
[email protected]

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
No additional documents have been identified.