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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03106363
Other study ID # 123-2015
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date July 4, 2017
Est. completion date January 17, 2020

Study information

Verified date February 2020
Source Centre for Addiction and Mental Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Alcohol and cannabis are the two most widely used substances of abuse in the world and are the psychoactive substances most often found in seriously and fatally injured drivers. In a recent study, it was observed that individuals who reported both driving under the influence of alcohol (DUIA) and the influence of cannabis (DUIC) experienced collision risk that was nearly 4 times that of individuals who reported driving after using only one of these drugs. Recent research in the United States and Canada indicates that the prevalence of DUIC among young drivers of high school and university age, and young adults is similar to, or higher than, the prevalence of DUIA. This is a serious public health issue, since motor vehicle collisions are the leading cause of death in this age group. Given the frequency with which alcohol and cannabis are consumed together, it is important to understand their combined effects on driver behaviour. The current study will examine the acute effects of a moderate dose of cannabis (12.5% THC) combined with an intoxicating amount of alcohol (BAC=0.08) on driving simulator performance of young drivers. Following an eligibility screening and practice session, a total of 70 participants aged 19 to 29 years will each complete 4 experimental sessions. During each session, participants will drink alcohol or placebo alcohol and smoke an active or placebo cannabis cigarette. The effects of alcohol and cannabis on the performance of driving-related skills will be assessed using a high-fidelity driving simulator. Cognitive, psychomotor, and mood effects will also be assessed.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
delta 9 tetrahydrocannabinol
A single cannabis cigarette (potency 12.5% delta 9 tetrahydrocannabinol) will be given to participants to smoke over a 10 minute period, ad libitum. If the cannabis cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose.
placebo delta 9 tetrahydrocannabinol
A single placebo cannabis cigarette (<0.03% delta 9 tetrahydrocannabinol) will be given to participants to smoke over a 10 minute period, ad libitum. If the placebo cannabis cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose (as this is a double-blind study).
Alcohol
A single oral administration of an alcoholic beverage mixed in a 1:3 ratio of alcohol to tonic water to obtain a target blood alcohol content of 0.08mg%.
Placebo alcohol
A single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage.

Locations

Country Name City State
Canada Centre for Addiction and Mental Health Toronto Ontario

Sponsors (3)

Lead Sponsor Collaborator
Centre for Addiction and Mental Health Canadian Institutes of Health Research (CIHR), Health Canada

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Downey LA, King R, Papafotiou K, Swann P, Ogden E, Boorman M, Stough C. The effects of cannabis and alcohol on simulated driving: Influences of dose and experience. Accid Anal Prev. 2013 Jan;50:879-86. doi: 10.1016/j.aap.2012.07.016. Epub 2012 Aug 4. — View Citation

Lenné MG, Dietze PM, Triggs TJ, Walmsley S, Murphy B, Redman JR. The effects of cannabis and alcohol on simulated arterial driving: Influences of driving experience and task demand. Accid Anal Prev. 2010 May;42(3):859-66. doi: 10.1016/j.aap.2009.04.021. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Psychomotor impairment: Standard deviation of lateral position The driving simulator will objectively measure changes in driving behavior after alcohol and/or cannabis exposure. Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur within 2 hours before and approximately 45 minutes after Time 0.
Secondary Psychomotor impairment: Mean speed, standard deviation of speed, and maximum speed The driving simulator will objectively measure changes in driving behavior after alcohol and/or cannabis exposure. Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur within 2 hours before and approximately 45 minutes after Time 0.
Secondary Psychomotor impairment: Minimum time to collision and brake latency The driving simulator will objectively measure changes in driving behavior after alcohol and/or cannabis exposure. Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur within 2 hours before and approximately 45 minutes after Time 0.
Secondary Psychomotor impairment: Number of collisions The driving simulator will objectively measure changes in driving behavior after alcohol and/or cannabis exposure. Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur within 2 hours before and approximately 45 minutes after Time 0.
Secondary Subjective alcohol and cannabis effects Visual analogue scale measures how participants feel before and after alcohol and/or cannabis exposure. Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Visual analogue scales are administered within 2 hours before as well as approximately 15, 30, 45, and 75 minutes and 2, 3, 4, and 5 hours after Time 0.
Secondary Cognitive testing Measures changes in performance related to attention, memory, field of view, and dexterity before and after alcohol and/or cannabis exposure. Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Cognitive testing is administered within 2 hours before Time 0 as well as approximately 75 minutes after Time 0.
Secondary Breath alcohol content Changes in BAC after drinking alcohol. Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Breath alcohol content is measured within 2 hours before Time 0 as well as approximately 15, 30, 45, and 75 minutes and 2, 3, 4, and 5 hours after Time 0.
Secondary Blood concentration for delta 9 tetrahydrocannabinol, carboxy-tetrahydrocannabinol, and 11 hydroxy tetrahydrocannabinol. Changes in concentration of delta 9 tetrahydrocannabinol (THC) , carboxy-tetrahydrocannabinol (THC-COOH), and 11 hydroxy tetrahydrocannabinol (11-OH-THC) in blood. Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Blood concentration for THC, THC-COOH, and 11-OH-THC is assessed within 2 hours before Time 0 as well approximately 45 minutes after Time 0.
Secondary Urine cannabinoids corrected for creatinine Determination of the ratio of excreted THC metabolite carboxy-THC to creatinine will determine whether participants have used cannabis between testing days, and hence will be excluded from further participation. Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Ratio of excreted THC metabolite carboxy-THC to creatinine is assessed within 2 hours before Time 0 as well as approximately 5 hours after Time 0.
Secondary Vital signs: blood pressure Changes in blood pressure (systolic/diastolic) Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Vital signs are assessed within 2 hours before as well as approximately 15, 30, 45, and 75 minutes and 2, 3, 4, and 5 hours after Time 0.
Secondary Vital signs: pulse Changes in pulse Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Vital signs are assessed within 2 hours before as well as approximately 15, 30, 45, and 75 minutes and 2, 3, 4, and 5 hours after Time 0.
Secondary Vital signs: temperature Changes in temperature Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Vital signs are assessed within 2 hours before as well as approximately 15, 30, 45, and 75 minutes and 2, 3, 4, and 5 hours after Time 0.
Secondary Vital signs: respiration Changes in respiration Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Vital signs are assessed within 2 hours before as well as approximately 15, 30, 45, and 75 minutes and 2, 3, 4, and 5 hours after Time 0.
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