酒精和大麻对年轻司机技能的综合影响
结合酒精和大麻对年轻驾驶员模拟驾驶的影响
研究概览
地位
条件
详细说明
拟议的研究将追求以下主要目标:
目标 1:检查中等剂量大麻 (12.5% THC) 与令人陶醉的酒精 (BAC=0.08) 结合使用的急性影响 关于年轻司机驾驶模拟器的表现。 在 19 至 29 岁的男性和女性司机急性药物暴露前后,将同时测量模拟驾驶性能、认知、语言记忆和情绪测试以及 BAC 和生物体液中的大麻素水平。 BAC 和生物体液将在药物暴露后长达 5 小时内进行测量。
目标 2:探索驾驶历史、驾驶态度和个体差异测量(例如,人口统计学、药物和酒精使用等)对酒精和大麻对年轻驾驶员驾驶模拟器性能的急性影响的影响。 将进行探索性分析以确定大麻加酒精对驾驶模拟器任务的急性影响是否受到这些措施的影响。
研究设计和持续时间
这项研究将是一项受试者内、双盲、双模拟、安慰剂对照、平衡、随机的临床试验,评估酒精和大麻结合对驾驶员行为的影响。 虽然安慰剂条件是研究的一部分,但这不是治疗研究。
与潜在参与者的初步联系将通过电话进行,研究人员将通过电话筛选资格。 通过电话确认资格后,参与者将被要求参加 CAMH 进行资格评估。 参与者将参加 CAMH 总共 6 个学习课程(资格评估、练习日和 4 个测试课程)。
在四个测试环节中的每一个环节中,参与者都将经历以下酒精和大麻暴露条件之一:1) 安慰剂酒精和安慰剂大麻; 2) 醉人剂量的酒精和安慰剂大麻; 3) 安慰剂酒精和活性大麻,以及; 4) 中毒剂量的酒精和活性大麻。 这些条件的顺序将随机分配。 参与者将完成酒精操纵,然后是大麻操纵。 接触酒精和大麻的时间至少要间隔 72 小时。
参与者将被要求在参加 CAMH 之前 72 小时内不得使用大麻,48 小时内不得饮酒。
在某些情况下,合格研究者可能会要求参与者返回进行重新筛选,例如 重复进行尿检或其他评估以进行资格评估。 此外,如果计划参与研究出现意外延误,合格研究人员将确定是否需要要求参与者重复某些评估,例如体检。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
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Ontario
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Toronto、Ontario、加拿大、M5S 2S1
- Centre for Addiction and Mental Health
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 每周至少使用一次大麻,通过尿液即时检测确认;
- 报告在过去 6 个月内大约 2 小时内至少喝了 5 杯酒的男性和报告在过去 6 个月内至少喝过 4 杯酒的男性,以及在过去 6 个月中至少有一次快速饮酒的事件(在一个跨度内喝了 3 杯或更多酒)小时)
- 19-29岁;
- 持有 G 类或 G2 安大略省驾照(或其他司法管辖区的同等驾照)至少 12 个月;
- 愿意在练习和考试之前 48 小时戒酒,72 小时戒大麻。
- 愿意在研究期间放弃所有非医疗用途的其他药物;
- 提供书面和知情同意。
排除标准:
- 根据资格评估,尿液毒理学筛查对大麻呈阴性;
- 严重的医疗或精神疾病的诊断;
- 女性:怀孕或哺乳;
- 符合酒精或物质依赖(当前或终生)标准 (DSM-IV);
- 经常服用影响大脑功能的药物(即抗抑郁药、苯二氮卓类药物、兴奋剂);
- 正在服用药物或有任何禁忌饮酒的身体状况;
- 一级亲属确诊为精神分裂症;
- 对柑橘(柠檬酸橙)严重过敏。
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器: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.
|
将给参与者一支大麻香烟(效力 12.5% delta 9 四氢大麻酚),让他们在 10 分钟内随意吸食。
如果大麻香烟没有吸完,剩余部分将被称重以估计剂量。
其他名称:
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%.
其他名称:
|
|
有源比较器: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.
|
将给参与者一支大麻香烟(效力 12.5% delta 9 四氢大麻酚),让他们在 10 分钟内随意吸食。
如果大麻香烟没有吸完,剩余部分将被称重以估计剂量。
其他名称:
A single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage.
其他名称:
|
|
有源比较器: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.
|
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%.
其他名称:
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.
|
|
安慰剂比较: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.
|
A single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage.
其他名称:
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.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Psychomotor Impairment: Standard Deviation of Lateral Position
大体时间: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.
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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).
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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.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Psychomotor Impairment: Mean Speed
大体时间: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.
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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.
|
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Psychomotor Impairment: Standard Deviation of Speed
大体时间: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.
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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.
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Psychomotor Impairment: Maximum Speed
大体时间: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.]
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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.
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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.]
|
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Psychomotor Impairment: Brake Latency
大体时间: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.
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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.
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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.
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合作者和调查者
调查人员
- 首席研究员:Christine M Wickens, PhD、Centre for Addiction and Mental Health
出版物和有用的链接
一般刊物
- Lenne 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.
- 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.
- Di Ciano P, Brands B, Fares A, Wright M, Stoduto G, Byrne P, McGrath M, Hasan OSM, Le Foll B, Wickens CM. The Utility of THC Cutoff Levels in Blood and Saliva for Detection of Impaired Driving. Cannabis Cannabinoid Res. 2023 Jun;8(3):408-413. doi: 10.1089/can.2022.0187. Epub 2023 Feb 2.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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