Effects of Combined Alcohol and Cannabis on Young Drivers' Simulated Driving
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Psychomotor Impairment: Standard Deviation of Lateral Position
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Active alcohol/active cannabis
Participant will drink an alcoholic beverage to obtain a target blood alcohol content of 0.08mg% and will smoke a delta 9 tetrahydrocannabinol (potency 12.5%) cigarette.
干预措施: alcohol (Drug)
Active alcohol/placebo cannabis
Participant will drink an alcoholic beverage to obtain a target blood alcohol content of 0.08mg% and will smoke a placebo delta 9 tetrahydrocannabinol (< 0.03%) cigarette.
干预措施: placebo delta 9 tetrahydrocannabinol (Drug)
Placebo alcohol/placebo cannabis
Participant will drink tonic water (capped with a minimal amount of alcohol to enhance alcohol cues) and will smoke a placebo delta 9 tetrahydrocannabinol (< 0.03%) cigarette.
干预措施: placebo delta 9 tetrahydrocannabinol (Drug)
Placebo alcohol/active cannabis
Participant will drink tonic water (capped with a minimal amount of alcohol to enhance alcohol cues) and will smoke a delta 9 tetrahydrocannabinol (potency 12.5%) cigarette.
干预措施: delta 9 tetrahydrocannabinol (Drug)
Active alcohol/active cannabis
Participant will drink an alcoholic beverage to obtain a target blood alcohol content of 0.08mg% and will smoke a delta 9 tetrahydrocannabinol (potency 12.5%) cigarette.
干预措施: delta 9 tetrahydrocannabinol (Drug)
Placebo alcohol/active cannabis
Participant will drink tonic water (capped with a minimal amount of alcohol to enhance alcohol cues) and will smoke a delta 9 tetrahydrocannabinol (potency 12.5%) cigarette.
干预措施: placebo alcohol (Drug)
Active alcohol/placebo cannabis
Participant will drink an alcoholic beverage to obtain a target blood alcohol content of 0.08mg% and will smoke a placebo delta 9 tetrahydrocannabinol (< 0.03%) cigarette.
干预措施: alcohol (Drug)
Placebo alcohol/placebo cannabis
Participant will drink tonic water (capped with a minimal amount of alcohol to enhance alcohol cues) and will smoke a placebo delta 9 tetrahydrocannabinol (< 0.03%) cigarette.
干预措施: placebo alcohol (Drug)
结局指标
主要结局
Psychomotor Impairment: Standard Deviation of Lateral Position
时间窗: 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).
次要结局
- 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.)
- 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.)
- 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.])
- 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.)
研究者
Christine Wickens
Independent Scientist, Institute for Mental Health Policy Research
Centre for Addiction and Mental Health