Psychomotor Impairment
Conditions
Brief 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.
Detailed description
The proposed study will pursue the following primary aims: Aim 1: 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. Simulated driving performance, tests of cognition, verbal memory, and mood will be measured concurrently with BAC and levels of cannabinoids in biological fluids before and after acute drug exposure in male and female drivers aged 19 to 29. BAC and biological fluids will be measured up to 5 hours following drug exposure. Aim 2: Explore the effects of driving history, driving attitudes, and individual difference measures (e.g., demographics, drug and alcohol use, etc.) on the acute effects of alcohol and cannabis on driving simulator performance of young drivers. Exploratory analyses will be undertaken to determine if the acute effects of cannabis plus alcohol on the driving simulator task are influenced by these measures. Study Design and Duration This study will be a within-subjects, double-blind, double-dummy, placebo-controlled, counterbalanced, randomized clinical trial assessing the impact of alcohol and cannabis combined on driver behaviour. Although a placebo condition is part of the study, this is not a treatment study. Initial contact with potential participants will be made via telephone, and study personnel will conduct a telephone screen for eligibility. Upon eligibility confirmation by telephone, participants will be asked to attend CAMH for an eligibility assessment. Participants will attend CAMH for a total of 6 study sessions (an eligibility assessment, a practice day, and 4 test sessions). At each of four test sessions, participants will undergo one of these alcohol and cannabis exposure conditions: 1) placebo alcohol and placebo cannabis; 2) intoxicating dose of alcohol and placebo cannabis; 3) placebo alcohol and active cannabis, and; 4) intoxicating dose of alcohol and active cannabis. The order of these conditions will be randomly assigned. Participants will complete the alcohol manipulation followed by the cannabis manipulation. The alcohol and cannabis exposure sessions will be separated by at least 72 hours. Participants will be asked not to use cannabis for 72 hours and alcohol for 48 hours prior to attending CAMH. In certain instances, the Qualified Investigator may ask a participant to return for re-screening, e.g. repeat of urine test or other assessments performed for eligibility assessment. Also, in case of unforeseen delays in scheduling study participation, the Qualified Investigator will determine if there is a need to ask a participant to repeat some assessments, e.g., physical examination.
Interventions
DRUGalcohol
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%.
DRUGplacebo alcohol
A single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage.
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.
DRUGplacebo 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.
Sponsors
Centre for Addiction and Mental Health
Canadian Institutes of Health Research (CIHR)
Health Canada
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
This is a within-subjects, counterbalanced, placebo-controlled study. Four sessions are completed by participants: 1) alcohol and cannabis (placebo alcohol and placebo cannabis; 2) placebo alcohol and active cannabis; 3) alcohol and placebo cannabis; 4) alcohol and active cannabis). Session order is randomized. Participants and Investigator are blinded.
Eligibility
Sex/Gender
ALL
Age
19 Years to 29 Years
Healthy volunteers
Yes
Inclusion criteria
* Use of cannabis at least once a week confirmed by urine point-of-care testing; * Males who report consuming at least 5 drinks and females who report consuming at least 4 drinks in about 2 hours in the past 6 months and at least one episode of rapid alcohol consumption in the past 6 months (3 or more drinks over a span of one hour) * 19-29 years of age; * Holds a class G or G2 Ontario driver's licence (or equivalent from another jurisdiction) for at least 12 months; * Willing to abstain from using alcohol for 48 hours and cannabis for 72 hours prior to Practice and Test Sessions. * Willing to abstain from all other drugs not prescribed for medical purposes for the duration of the study; * Provides written and informed consent.
Exclusion criteria
* Urine toxicology screens negative for cannabis upon eligibility assessment; * Diagnosis of severe medical or psychiatric conditions; * Females: Pregnancy or breastfeeding; * Meets criteria for Alcohol or Substance Dependence (current or lifetime) (DSM-IV); * Is a regular user of medications that affect brain function (i.e., antidepressants, benzodiazepines, stimulants); * Taking medications or have any medical condition for which alcohol is contraindicated; * First-degree relative diagnosed with schizophrenia; * Severe allergy to citrus (lemon-lime).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychomotor Impairment: Standard Deviation of Lateral Position | 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. | The driving simulator objectively measures changes in driving behavior after alcohol and/or cannabis exposure. Standard deviation of lateral position (SDLP) is a measure of lane control (higher SDLP indicates worse lane control). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychomotor Impairment: Mean Speed | 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. | The driving simulator will objectively measure changes in driving behavior after alcohol and/or cannabis exposure. Mean speed during the driving scenarios is measured by the simulator. |
| Psychomotor Impairment: Standard Deviation of Speed | 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. | The driving simulator will objectively measure changes in driving behavior after alcohol and/or cannabis exposure. The simulator also (in addition to mean speed) measures standard deviation of speed. |
| Psychomotor Impairment: Maximum Speed | 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.] | The driving simulator will objectively measure changes in driving behavior after alcohol and/or cannabis exposure. The simulator measures maximum speed over the duration of the scenarios. |
| Psychomotor Impairment: Brake Latency | Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur at baseline and approximately 45 minutes after Time 0. | The driving simulator objectively measures changes in driving behavior after alcohol and/or cannabis exposure. During specific reaction time scenarios, participants must stop as quickly as possible after certain visual cues. The brake latency variable is measured as the mean stop/reaction time in seconds after the visual cue is presented. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORChristine M Wickens, PhD
Centre for Addiction and Mental Health
Participant flow
Pre-assignment details
Interim analyses allowed us to check if stopping the trial was warranted, because it is not justified to keep going if there is an effect with a smaller sample size. The analysis was conducted with n = 28 participants and SDLP was used as the primary measure. It was determined that stopping the study at a smaller sample size was warranted as we were powered to see an effect with 27 participants. The study continued until 30 participants had completed all study procedures.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 22.5 years STANDARD_DEVIATION 2.5 |
| Body Mass Index | 24.5 kg/m2 STANDARD_DEVIATION 3.4 |
| Race/Ethnicity, Customized Asian-South | 2 Participants |
| Race/Ethnicity, Customized Asian-South East | 1 Participants |
| Race/Ethnicity, Customized East Asian | 3 Participants |
| Race/Ethnicity, Customized Latin American | 2 Participants |
| Race/Ethnicity, Customized mixed heritage | 3 Participants |
| Race/Ethnicity, Customized White European | 10 Participants |
| Race/Ethnicity, Customized White North American | 7 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 41 | 0 / 40 | 0 / 38 |
| other Total, other adverse events | 13 / 40 | 6 / 41 | 7 / 40 | 4 / 38 |
| serious Total, serious adverse events | 0 / 40 | 0 / 41 | 0 / 40 | 0 / 38 |
Outcome results
None listed