Trial Outcomes & Findings for Cannabis Effects on Driving-related Skills of Young Drivers (NCT NCT01592409)
NCT ID: NCT01592409
Last Updated: 2019-02-11
Results Overview
The driving simulator will objectively measure driving behaviour during a number of pre-programmed driving scenarios. Zone/ Hazard performance measure: Mean Speed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
Approximate: at baseline (30 minutes before smoking), 30 minutes after smoking
Results posted on
2019-02-11
Participant Flow
Recruitment was by media ads and research postings in Toronto.
Screened over the telephone n=1024. Assessed for eligibility (n=178). Excluded: Not meeting inclusion criteria n=45, Declined to participate or lost interest n=32, Did not receive IP (did not return after practice session) n=2. Pilots (received active cannabis, not randomized) n=5. Randomized n=94.
Participant milestones
| Measure |
Active Cannabis
In this condition, participants will receive a cigarette containing 12.5% active THC.
delta-9-tetrahydrocannabinol: A single cannabis cigarette (potency 12.5% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose.
|
Placebo
In this condition, participants will receive a cannabis cigarette where the active THC has been removed (contains 0% THC).
Placebo: A single placebo cannabis cigarette (0% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose (as this is a double-blind study).
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
32
|
|
Overall Study
COMPLETED
|
67
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Active Cannabis
In this condition, participants will receive a cigarette containing 12.5% active THC.
delta-9-tetrahydrocannabinol: A single cannabis cigarette (potency 12.5% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose.
|
Placebo
In this condition, participants will receive a cannabis cigarette where the active THC has been removed (contains 0% THC).
Placebo: A single placebo cannabis cigarette (0% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose (as this is a double-blind study).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Cannabis Effects on Driving-related Skills of Young Drivers
Baseline characteristics by cohort
| Measure |
Active Cannabis
n=67 Participants
In this condition, participants will receive a cigarette containing 12.5% active THC.
delta-9-tetrahydrocannabinol: A single cannabis cigarette (potency 12.5% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose.
|
Placebo
n=31 Participants
In this condition, participants will receive a cannabis cigarette where the active THC has been removed (contains 0% THC).
Placebo: A single placebo cannabis cigarette (0% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose (as this is a double-blind study).
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.22 years
STANDARD_DEVIATION 1.88 • n=5 Participants
|
21.97 years
STANDARD_DEVIATION 2.24 • n=7 Participants
|
22.14 years
STANDARD_DEVIATION 1.995 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
67 participants
n=5 Participants
|
31 participants
n=7 Participants
|
98 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximate: at baseline (30 minutes before smoking), 30 minutes after smokingPopulation: Zone/Hazard performance measure: Mean Speed (Change from drug-free baseline to 30 minutes after smoking cannabis in kilometres per hour (kph)
The driving simulator will objectively measure driving behaviour during a number of pre-programmed driving scenarios. Zone/ Hazard performance measure: Mean Speed.
Outcome measures
| Measure |
Active Cannabis
n=67 Participants
In this condition, participants will receive a cigarette containing 12.5% active THC.
delta-9-tetrahydrocannabinol: A single cannabis cigarette (potency 12.5% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose.
|
Placebo
n=31 Participants
In this condition, participants will receive a cannabis cigarette where the active THC has been removed (contains 0% THC).
Placebo: A single placebo cannabis cigarette (0% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose (as this is a double-blind study).
|
|---|---|---|
|
Psychomotor Impairment (Driving)
|
3.38 change in kph
Standard Deviation 9.75
|
-1.54 change in kph
Standard Deviation 7.36
|
Adverse Events
Active Cannabis
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Cannabis
n=67 participants at risk
In this condition, participants will receive a cigarette containing 12.5% active THC.
delta-9-tetrahydrocannabinol: A single cannabis cigarette (potency 12.5% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose.
|
Placebo
n=32 participants at risk
In this condition, participants will receive a cannabis cigarette where the active THC has been removed (contains 0% THC).
Placebo: A single placebo cannabis cigarette (0% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose (as this is a double-blind study).
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
injury
|
0.00%
0/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
6.2%
2/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
Skin and subcutaneous tissue disorders
bruising
|
1.5%
1/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
3.1%
1/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
Immune system disorders
allergies
|
0.00%
0/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
3.1%
1/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
Psychiatric disorders
anxiety/nervousness
|
1.5%
1/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
6.2%
2/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
Respiratory, thoracic and mediastinal disorders
common cold
|
4.5%
3/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
3.1%
1/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
General disorders
dizziness/faintness
|
7.5%
5/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
6.2%
2/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
General disorders
diaphoresis
|
1.5%
1/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
0.00%
0/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
General disorders
difficulty falling asleep
|
1.5%
1/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
0.00%
0/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
Reproductive system and breast disorders
genital discomfort
|
1.5%
1/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
3.1%
1/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
General disorders
headache
|
14.9%
10/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
6.2%
2/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
Ear and labyrinth disorders
earache
|
1.5%
1/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
0.00%
0/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
Gastrointestinal disorders
food poisoning
|
1.5%
1/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
0.00%
0/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
General disorders
insomnia
|
9.0%
6/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
0.00%
0/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
Metabolism and nutrition disorders
increased appetite
|
0.00%
0/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
3.1%
1/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
Vascular disorders
low blood pressure
|
6.0%
4/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
3.1%
1/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
Skin and subcutaneous tissue disorders
itching
|
1.5%
1/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
0.00%
0/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
Vascular disorders
loss of consciousness
|
3.0%
2/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
0.00%
0/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
Musculoskeletal and connective tissue disorders
muscle/bone/joint pain
|
4.5%
3/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
6.2%
2/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
Gastrointestinal disorders
nausea
|
1.5%
1/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
3.1%
1/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
General disorders
nasal infection
|
1.5%
1/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
0.00%
0/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
Cardiac disorders
rapid heartbeat
|
3.0%
2/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
0.00%
0/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
Skin and subcutaneous tissue disorders
rash
|
6.0%
4/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
0.00%
0/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
Ear and labyrinth disorders
simulation sickness
|
1.5%
1/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
6.2%
2/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
General disorders
somnolence
|
6.0%
4/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
3.1%
1/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
0.00%
0/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
3.1%
1/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
Gastrointestinal disorders
stomach/abdominal discomfort
|
3.0%
2/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
0.00%
0/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
General disorders
tiredness/fatigue
|
7.5%
5/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
9.4%
3/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
3.1%
1/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
|
Gastrointestinal disorders
abdominal pain
|
4.5%
3/67 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
0.00%
0/32 • Collected from session 1 (eligibility assessment) to session 2 (practice) (approx. 3 months); from session 2 to 3 (approx. 24 hours), from session 3 to 4 (approx. 24 hours), session 4 to session 5 (approx. 24 hours).
|
Additional Information
Dr. Robert Mann, Senior Scientist
Centre for Addiction and Mental Health
Phone: 416-535-8501
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place